Summary: Prescription Drug Labeling Promotion Act of 2012 - Directs the Secretary of Health and Human Services (HHS) to establish a working group to develop best practices on access to prescription drug labeling for the visually impaired. Requires the working group to: (1) include equal representation of consumer and industry advocates; (2) promulgate guidance on best practices for pharmacies to ensure that blind and visually impaired individuals have safe, consistent, reliable, and independent access to the information in the labeling of prescription drugs; (3) consider the use of Braille, specified auditory means, and enhanced visual means to provide such access; and (4) consider whether there are technical, financial, manpower, or other factors that may fundamentally impact the ability of pharmacies with 20 or fewer retail locations to implement the best practices. Directs the Commissioner of Food and Drugs (FDA) to conduct an informational and educational program to inform the public and pharmacists about such guidance and practices. Directs the Comptroller General: (1) 18 months after such guidance and practices are published, to review pharmacy compliance and the extent to which access barriers continue; and (2) by September 30, 2016, to report on such review, including recommendations for reducing such barriers.

prescription drug labeling promotion act directs secretary health_and_human_services hhs establish working group develop best practices access prescription drug labeling visually impaired requires working group include equal representation consumer industry advocates promulgate guidance best practices pharmacies ensure blind visually impaired individuals safe consistent reliable independent access information labeling prescription drugs consider use specified auditory means enhanced visual means provide access consider technical financial manpower factors fundamentally impact ability pharmacies fewer retail locations implement best practices directs commissioner food drugs fda conduct informational educational program inform public pharmacists guidance practices directs comptroller general months guidance practices published review pharmacy compliance extent access barriers continue september report review including recommendations reducing barriers


Summary: Online Pharmacy Safety Act - Amends the the Federal Food, Drug, and Cosmetic Act to permit the dispensing of drugs only pursuant to a "valid prescription" and requires such a prescription to include at least one in-person medical evaluation of the patient by a licensed health care practitioner. Requires the the Secretary of Health and Human Services (HHS) to establish a Registry of Legitimate Online Pharmacy Websites for the purpose of educating consumers and promoting public health and safety. Allows only those pharmacies designated as legitimate by the Secretary on the site. Sets forth criteria for determining the legitimacy of a pharmacy. Requires the Secretary to: (1) engage in a campaign to educate consumers on the availability and use of the Registry to promote public health and safety; and (2) make consumer education materials available, on the Food and Drug Administration's (FDA) website, regarding how to safely purchase drugs over the Internet.

online pharmacy safety act amends cosmetic act permit dispensing drugs pursuant valid prescription requires prescription include person medical evaluation patient licensed health care practitioner requires secretary health_and_human_services hhs establish registry legitimate online pharmacy websites purpose educating consumers promoting public health safety allows pharmacies designated legitimate secretary site sets forth criteria determining pharmacy requires secretary engage campaign educate consumers availability use registry promote public health safety consumer education materials available food_and_drug_administration fda website safely purchase drugs internet


Summary: Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards. Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition. Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.

fast act expresses sense congress food_and_drug_administration fda apply specified accelerated approval fast track provisions expedite development availability treatments life threatening diseases conditions maintaining appropriate safety effectiveness standards amends cosmetic act direct secretary health_and_human_services hhs request sponsor new drug include fast track product new drug combination drugs intended treatment life threatening disease condition permits secretary approve application approval product life threatening disease condition including fast track product determination product effect surrogate endpoint reasonably likely predict clinical benefit clinical endpoint including endpoint measured earlier irreversible morbidity mortality reasonably likely predict effect irreversible morbidity mortality clinical benefit directs secretary conjunction planned reviews new drug review process contract independent entity expertise assessing development regulatory review programs evaluate fda application fast track processes development availability innovative treatments patients suffering life threatening conditions


Summary: Cosmetics Safety Enhancement Act of 2012 - Amends the the Federal Food, Drug, and Cosmetic Act to require the registration of cosmetic products and cosmetic manufacturing facilities, including, for each product: (1) a unique facility identifier, (2) every product's brand name, and (3) product ingredients. Sets registration fees. Requires a cosmetic manufacturer: (1) before the introduction into interstate commerce of a cosmetic product, to establish a file containing scientific evidence substantiating the product's safety; (2) to report any serious adverse event information received that is associated with the use of a cosmetic product; and (3) maintain records concerning any cosmetic product that may be adulterated, misbranded, or otherwise in violation of the Act, including all records relating to cosmetic product safety substantiation or relating to serious adverse event reports. Deems a cosmetic product adulterated if its manufacture, packing, or holding do not conform to current good manufacturing practice regulations. Provides each manufacturer with an opportunity to cease distribution and recall of a cosmetic product if it is determined that there is a reasonable probability that the product is adulterated and the use of, or exposure to, such product will cause serious adverse health consequences or death to humans. Permits the issuance of an order requiring a recall if there is not a voluntary recall of an adulterated product.

cosmetics safety enhancement act amends cosmetic act require registration cosmetic products cosmetic manufacturing facilities including product unique facility identifier product brand product ingredients sets registration fees requires cosmetic manufacturer introduction interstate commerce cosmetic product establish file containing scientific evidence product safety report adverse event information received associated use cosmetic product maintain records concerning cosmetic product adulterated misbranded violation act including records relating cosmetic product safety substantiation relating adverse event reports deems cosmetic product adulterated manufacture packing holding conform current good manufacturing practice regulations provides manufacturer opportunity cease distribution recall cosmetic product determined reasonable probability product adulterated use exposure product cause adverse health consequences death humans permits issuance order requiring recall voluntary recall adulterated product


Summary: Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with respect to such drug, unless the failure in meeting the extended period is caused by a change in or review of approval requirements. Limits extension coverage to applications filed within 30 months preceding the enactment of this Act. Reduces such extended period by six months per year over a five-year period, beginning on October 1, 2013. Directs the Secretary of Health and Human Services (HHS) to maintain the Office of Generic Drugs as a separate office within the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA).

amends cosmetic act extend months application period applicant generic drug obtain tentative approval day exclusivity period respect drug failure meeting extended period caused change review approval requirements limits extension coverage applications filed months preceding enactment act reduces extended period months year year period beginning october directs secretary health_and_human_services hhs maintain separate office fda


Summary: Patient Safety and Drug Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application. Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.

patient improvement act amends cosmetic act allow holder approved abbreviated new drug application generic drug approval change labeling drug approved manner authorized regulation holder approved new drug application allows conforming changes ordered labeling equivalent listed drug drug approved abbreviated new drug application process corresponds listed drug


Summary: Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Services (HHS). Requires such manufacturers to submit to the Secretary: (1) a cosmetic and ingredient statement for each manufactured cosmetic containing a unique registration number for the manufacturing establishment where the cosmetic is manufactured, the brand name for the cosmetic, the ingredients in the cosmetic, and contact information for individuals responsible for filing and maintaining the cosmetic and ingredient statement; and (2) a report on any serious and unexpected adverse event allegedly associated with the use of a cosmetic product. Requires the Secretary to: (1) establish good manufacturing practices for the manufacture, processing, filling, or packaging of cosmetics; and (2) establish and maintain in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) an electronic National Cosmetic Regulatory Databank to hold information pertaining to the regulation of cosmetics. Grants the Secretary authority to review the findings of the Cosmetic Ingredient Review Expert Panel with respect to any cosmetic products. Authorizes the Secretary to: (1) establish a tolerance level for a nonfunctional constituent in a cosmetic product, (2) evaluate the safety of any ingredient in a cosmetic product, and (3) obtain access to and copy records for determining whether a cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. Denies entry into the United States of a cosmetic product if: (1) the importer does not present the unique cosmetic establishment registration number and the unique cosmetic and ingredient statement number, or (2) either of such numbers is not correct.

cosmetic safety amendments act amends cosmetic act require registration domestic foreign establishment engaged manufacture cosmetic intended marketed united_states secretary health_and_human_services hhs requires manufacturers submit secretary cosmetic ingredient statement manufactured cosmetic containing unique registration number manufacturing establishment cosmetic manufactured brand cosmetic ingredients cosmetic contact information individuals responsible filing maintaining cosmetic ingredient statement report unexpected adverse event allegedly associated use cosmetic product requires secretary establish good manufacturing practices manufacture processing filling packaging cosmetics establish maintain fda electronic hold information pertaining regulation cosmetics grants secretary authority review findings cosmetic ingredient review expert panel respect cosmetic products authorizes secretary establish tolerance level constituent cosmetic product evaluate safety ingredient cosmetic product obtain access copy records determining cosmetic product adulterated presents threat adverse health consequences death humans denies entry united_states cosmetic product importer present unique cosmetic establishment registration number unique cosmetic ingredient statement number numbers correct


Summary: Gluten in Medicine Identification Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.

medicine identification act amends cosmetic act deem misbranded drug intended human use contains ingredient constitutes derived grain starch containing ingredient label fails include statement identifying source ingredient constituted derived


Summary: Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH). Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the grantee has not submitted clinical trial information within the 30-day correction period for noncompliance.

revises clinical trial registry data bank provisions public_health_service_act include device drug clinical trial results positive negative outcome subject clinical trials funded department_of_defense dod requirements certify information submissions director national_institutes_of_health nih restricts funding grantee makes grantee liable united_states repayment grant provided grantee submitted clinical trial information day correction period noncompliance


Summary: Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

amends cosmetic act direct secretary health_and_human_services hhs request sponsor drug expedite drug development review intended combination treat life threatening disease condition preliminary clinical evidence indicates drug demonstrate substantial improvement existing therapies clinically significant endpoints authorizes drug sponsor request secretary designate drug breakthrough therapy requires secretary days request determine drug meets criteria designation followed appropriate actions expedite development review approval requires annual report secretary congress drugs breakthrough designations requested approved directs secretary issue guidance implementing requirements respect breakthrough therapies amend promulgated regulations requires comptroller general assess manner food_and_drug_administration fda applied processes established act impact development timely availability innovative treatments patients affected life threatening conditions


Summary: Food and Drug Administration Reform Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and to revise and impose new requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; and (4) registration of drug manufacturers and reporting of drug shortages. Title I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA drug development process and the process for the review of human drug applications. Increases for FY2013-FY2017 the level of required prescription drug user fee revenues. Provides for an inflation adjustment and a workload adjustment for FY2013 and subsequent fiscal years for the required level of user fee revenue amounts. (Sec. 104) Requires the Secretary to submit to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions (the specified congressional committees) after the end of each fiscal year for which user fees are collected under this title (beginning with FY2013) a report on the progress of the FDA in achieving the goals identified in the letters sent by the Secretary to the Committees, the future plans of the FDA, and the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving such goals. (Sec. 105) Terminates: (1) the authority of the Secretary to assess and collect prescription drug user fees on October 1, 2017, and (2) reporting requirements on January 31, 2018. (Sec. 106) Provides that the amendments made by this title shall take effect on the later of October 1, 2012, or the enactment date of this Act, except that user fees shall be assessed for all human drug applications received on or after October 1, 2012, regardless of the enactment date of this Act. (Sec. 107) Limits the applicability of this title to human drug applications and supplements filed before the enactment of this title. Title II: Medical Device User Fee Amendments of 2012 - Medical Device User Fee Amendments of 2012 - (Sec. 203) Extends through FY2017 the authority of the Secretary to assess and collect fees for medical device applications and submissions. Increases for FY2013-FY2017 the level of required medical device user fee revenues. Provides for an inflation adjustment to such revenues in FY2014 and each subsequent fiscal year. Authorizes the Secretary to grant a waiver or reduction of medical device user fees in the interest of public health. (Sec. 204) Requires the Secretary to submit to specified congressional committees annual reports for each fiscal year for which medical device user fees are collected on the progress of the FDA in achieving goals identified in letters from the Secretary to such committees. Requires publication of such reports on the FDA website. (Sec. 205) Limits the effect of this title on medical device applications and supplements filed before the enactment of this title. (Sec. 206) Makes the amendments made by this title effective on the later of October 1, 2012, or the enactment date of this Act. (Sec. 207) Terminates the medical device user fee program on October 1, 2017, and the reporting requirements on January 31, 2018. (Sec. 208) Authorizes the Secretary to appoint employees to positions in the FDA to perform, administer, or support activities related to the review of medical device applications and to meet performance objectives, without regard to requirements governing appointments in the competitive service. Terminates this authority three years after enactment of this Act. Title III: Fees Relating to Generic Drugs - Generic Drug Use Fee Amendments of 2012 - (Sec. 302) Directs the Secretary, beginning in FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for certain active pharmaceutical ingredient information; and (4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for such a drug shall not require the payment of any fee. Terminates such authority on October 1, 2017. (Sec. 303) Requires the Secretary to submit to specified congressional committees annual reports for each fiscal year for which generic drug fees are collected on the progress of the FDA in achieving goals identified in letters from the Secretary to such committees and on the implementation of the authority for such fees and the use of such fees by the FDA in each fiscal year. Requires publication of such reports on the FDA website. (304) Terminates: (1) the authority to assess and collect generic drug user fees on October 1, 2012, and (2) the reporting requirements with respect to the generic drug user fee program on January 31, 2018. (Sec. 305) Makes the amendments made by this title effective on the later of October 1, 2012, or the enactment date of this title. (Sec. 306) Deems as misbranded a drug or active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid or for which identifying information has not been provided. (Sec. 307) Authorizes the Secretary to appoint employees to positions in the FDA to perform, administer, or support activities related to human generic drug activities, without regard to requirements governing appointments in the competitive service. Title IV: Fees Relating to Biosimilar Biological Products - Biosimilar User Fee Act of 2012 - (Sec. 402) Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee; (2) a biosimilar biological product application and supplement fee; (3) a biosimilar biological product establishment fee; and (4) a biosimilar biological product fee. Waives such fees for the first biosimilar biological product application of a small business. Terminates such authority on October 1, 2017. (Sec. 403) Requires the Secretary to submit to specified congressional committees annual reports for each fiscal year for which biosimilar user fees are collected on the progress of the FDA in achieving goals identified in letters from the Secretary to such committees, the implementation of the authority for such fees, and the use of such fees by the FDA in each fiscal year. Requires publication of such reports on the FDA website. (Sec. 404) Terminates: (1) the authority to assess and collect biosimilar drug user fees on October 1, 2012, and (2) the reporting requirements with respect to the biosimilar drug user fee program on January 31, 2018. (Sec. 405) Makes the amendments made by this title effective on the later of October 1, 2012, or the enactment date of this title. Title V: Reauthorization of Best Pharmaceuticals for Children Act and Pediatric Research Equity Act - (Sec. 501) Makes permanent the: (1) the Best Pharmaceuticals for Children Act (BPCA) granting extended market exclusivity for new and already-marketed drugs for the pediatric population, and (2) the Pediatric Research Equity Act of 2003 (PREA) relating to research into pediatric uses for drugs and biological products. Provides that exclusivity for the completion of a pediatric study or studies shall be granted only for those that are the subject of a written request. Requires an applicant for approval of a pediatric drug to submit to the Secretary an initial pediatric study plan prior to the submission of drug safety assessments. Extends through FY2017 the authorization of appropriations for pediatric studies of drugs. Requires the Secretary to hold a public meeting not later than December 31, 2013, on the impact of pediatric research activities under BPCA and PREA on the development of new therapies for children with cancer. (Sec. 502) Requires the Secretary submit to specified congressional committees (and make publicly available on the FDA website) periodic reports on the implementation of pediatric studies of drugs and research into pediatric uses for drugs and biological products. (Sec. 503) Authorizes the FDA Internal Committee for the review of pediatric plans, assessments, deferrals, and waivers to review deferral extensions under PREA. Requires such Committee to include FDA employees with expertise in neonatology. (Sec. 504) Amends BPCA to require the staff of the FDA Office of Pediatric Therapeutics to include one or more additional individuals with expertise in pediatric epidemiology and neonatology. (Sec. 505) Amends BPCA to make permanent: (1) the Pediatric Advisory Committee, and (2) the Pediatric Subcommittee of the Oncologic Drug Advisory Committee. Title VI: Food and Drug Administration Administrative Reforms - (Sec. 601) Requires the Secretary to publish in the Federal Register at least 30 days' advance notice of the Secretary's intent to issue a draft guidance document that: (1) sets forth initial interpretations of a statute or regulation, (2) sets forth changes in interpretation or policy that are of more than a minor nature, (3) includes complex scientific issues, or (4) covers highly controversial issues. (Sec. 602) Revises requirements relating to the disclosure of conflicts of interest by individuals recruited to serve on FDA advisory committees. (Sec. 603) Requires electronic submission of drug, generic drug, biologic, and biosimilar applications beginning not earlier than 24 months after issuance of a final FDA guidance developed after a public notice and comment period. (Sec. 604) Prohibits the FDA from issuing any draft or final guidance on the regulation of laboratory-developed tests under FFDCA without, at least 60 days prior to such issuance: (1) notifying specified congressional committees of its intent to issue guidance, and (2) including in such notification the anticipated details of such action. Title VII: Medical Device Regulatory Improvements - Subtitle A: Premarket Predictability - (Sec. 701) Prohibits the Secretary from disapproving an application for approval of a medical device for investigational use on the basis that: (1) the investigation may not support a substantial equivalence or de novo classification determination or approval of the device; (2) the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or (3) an additional or different investigation may be necessary to support clearance or approval of the device. (Sec. 702) Defines "necessary," for purposes of information required for the premarket approval regulatory process, as the minimum required information that would support a determination by the Secretary that a medical device application provides reasonable assurance of the effectiveness of the device (least burdensome standard). (Sec. 703) Requires the Secretary to provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding medical devices. Authorizes supervisory review of a significant decision. (Sec. 704) Requires the Secretary to regularly publish detailed decision summaries for each clearance of a premarket submission of a medical device intended for human use. (Sec. 705) Requires the Secretary to: (1) submit to specified congressional committees a report on when a premarket notification should be submitted for a modification or change to a legally marketed medical device, (2) withdraw certain draft guidance relating to changes to an existing device, (3) suspend issuance of any draft guidance or proposed regulation that addresses when to submit a premarket notification for changes and modifications made to a manufacturer's previously cleared device until receipt of the Secretary's report by the appropriate congressional committees, and (4) suspend any final guidance or regulation for one year after the receipt of such report. Subtitle B: Patients Come First -(Sec. 711) Requires the Secretary, not later than 90 days after the enactment of this Act, to establish a schedule for promulgation of regulations to require premarket approval of certain medical devices for which no final regulation has been promulgated requiring premarket approval. (Sec. 712) Requires the Secretary to: (1) establish a program to assess information relating to recalls of medical devices and to identify strategies for mitigating health risks presented by defective or unsafe devices, and (2) document the basis for termination by the FDA of a device recall. Subtitle C: Novel Device Regulatory Relief - (Sec. 721) Authorizes the Secretary to: (1) classify certain new medical devices without first issuing a determination that such devices are not substantially equivalent to existing devices; and (2) change the classification of a medical device, based upon new information about such device, by administrative order instead of by regulation Subtitle D: Keeping America Competitive Through Harmonization - (Sec. 731) Authorizes the Secretary, with respect to medical devices, to enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activities, including inspections and common international labeling symbols. (Sec. 732) Authorizes the Secretary to participate in appropriate fora, including the International Medical Device Regulators Forum, and to provide guidance to such fora on strategies and other activities. Subtitle E: FDA Renewing Efficiency From Outside Reviewer Management - (Sec. 741) Extends until October 1, 2017, authority for programs for third-party review and inspection of medical devices Subtitle F: Humanitarian Device Reform - (Sec. 751) Extends the humanitarian device exemption until October 1, 2017. Subtitle G: Records and Reports on Devices - (Sec. 761) Requires the Secretary to: (1) issue proposed regulations establishing a unique medical identification system by December 31, 2012, and to finalize such proposed regulations within six months after the close of the comment period; and (2) implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than two years after the regulations are finalized, taking into account patient access to medical devices and therapies. (Sec. 762) Requires the Secretary to include medical devices in the postmarket risk identification and evaluation system (Sentinel) and to engage outside stakeholders in the development of the system. Subtitle H: Miscellaneous - (Sec. 771) Modifies the exemption from FFDCA performance standards and premarket approval requirements for custom devices created or modified to comply with the order of an individual physician or dentist for the treatment of a unique pathology or physiological condition. (Sec. 772) Reauthorizes through FY2017 the grant program for promoting pediatric medical device development by non-profit consortia. Requires the Secretary to issue: (1) a proposed rule to implement the requirement for including information on pediatric uses of medical devices in applications by December 31, 2012, and (2) a final rule implementing such requirement by December 31, 2013. (Sec. 773) Directs the Secretary, not later than 18 months after the enactment of this Act, to report to specified congressional committees on: (1) a strategy for coordinating the regulation of health information technology to avoid regulatory duplication; and (2) recommendations on an appropriate regulatory framework for health information technology, including a risk-based framework. Title VIII: Drug Regulatory Improvements - Subtitle A: Drug Supply Chain - Imposes new or expanded FDA registration and inspection requirements for domestic and foreign drug establishments. (Sec. 802) Authorizes the Secretary to inspect domestic and foreign drug establishments on a risk-based schedule based on multiple risk factors, including: (1) the compliance history of the establishment; (2) the inspection frequency and history of the establishment; (3) the record, history, and nature of recalls linked to the establishment; and (4) the inherent risk of the drug manufactured. Requires the Secretary to report to Congress not later than February 1 of each year on inspections of drug establishments. Requires such report to be made publicly available on the FDA website. (Sec. 803) Defines "current good manufacturing practice" to include the implementation of oversight and control over the manufacture of drugs to ensure quality, including managing the risk of, and establishing the safety of, raw materials, materials used in the manufacturing of drugs, and finished drug products. (Sec. 804) Deems a drug adulterated if the owner or operator of a factory, warehouse, or establishment in which such drug was manufactured, processed, packed, or held delays, denies, or limits inspection or refuses to permit entry or inspection. Requires the Secretary to issue guidance within one year after enactment of this Act on what constitutes delaying, denying, or limiting inspection. (Sec. 805) Authorizes the FDA to destroy counterfeit or adulterated imported drug products that have minor monetary value or that have a reasonable probability of causing serious adverse health consequences or death. Requires the FDA to issue regulations providing for notice and an opportunity to appear before the FDA to produce testimony prior to the destruction of a drug. (Sec. 806) Authorizes the FDA to detain, for a reasonable period, drugs found during inspection to be adulterated or misbranded. Requires the FDA to issue implementing regulations for such detention authority. (Sec. 807) Increases criminal penalties for trafficking in counterfeit drugs. (Sec. 808) Requires domestic and foreign drug establishments to have a unique facility identification number. (Sec. 809) Authorizes the Secretary to require the submission of documentation or other information for a drug that is imported or offered for import into the United States and to refuse admission of such of such drug unless all required information is submitted. (Sec. 810) Requires the registration of commercial drug importers with the FDA. Requires the Secretary to promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure that imported drugs are in compliance with this Act and the Public Health Service Act. (Sec. 811) Makes it a prohibited act under FFDCA to fail to notify the Secretary: (1) that the use of a drug may result in serious injury or death, (2) of a significant loss or known theft of such drug, or (3) that such drug has been or is being counterfeited. (Sec. 812) Exempts drug-related information obtained by the Secretary from disclosure under the Freedom of Information Act (FOIA) and other laws when such information has been provided by a federal, state, local, or foreign government agency that has requested that the information be kept confidential. (Sec. 813) Grants extraterritorial jurisdiction over any violation of FFDCA for any article regulated by such Act if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States. (Sec. 814) Increases criminal penalties for knowingly and intentionally adulterating a drug if such adulteration creates a reasonable probability of causing serious adverse health consequences or death. (Sec. 815) Requires the owner or operator of an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug to provide the FDA with records or other information in advance of an inspection. Subtitle B: Medical Gas Safety - (Sec. 821) Provides for expanded FDA regulation of medical gases. Defines: (1) "medical gas" as a drug that is manufactured or stored in a liquefied, non liquefied, or cryogenic state and administered as a gas; and (2) "designated medical gas" as oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, medical air, and other medical gas designated by the Secretary that meets specified standards. Allows any person to file with the Secretary a request for certification of a medical gas as a designated medical gas. (Sec. 822) Requires the Secretary, after obtaining input from medical gas manufacturers and the public, to: (1) determine whether any changes to federal drug regulations are necessary for medical gases; and (2) issue final regulations on medical gases, within 48 months after enactment of this Act, if changes are deemed necessary. Subtitle C: Generating Antibiotic Incentives Now - (Sec. 831) Extends by five years the exclusivity period for qualified infectious disease products. Defines "qualified infectious disease product" as an antibacterial or antifungal drug for human use that treats or prevents an infection caused by pathogens specified by this Act. (Sec. 832) Requires the Comptroller General (GAO) to study and report on the need for incentives to encourage research on and development and marketing of qualified infectious disease biological products. (Sec. 833) Requires the Secretary to review and, as appropriate, revise guidance documents for the conduct of clinical trials for antibacterial and antifungal drugs. Allows the sponsor of a qualified infectious disease product to request the Secretary to provide written recommendations for nonclinical and clinical investigations the Secretary deems necessary for obtaining approval of such products. (Sec. 834) Requires the Secretary to report to specified congressional committees within five years after enactment of this Act on qualified infectious disease products, including the number of initial designations of drugs as qualified infectious disease products, the number of approvals of such products, and whether such products address the need for antibacterial and antifungal drugs to treat serious and life-threatening infections. (Sec. 835) Requires the Secretary to publish draft guidance by June 30, 2013, and final guidance by December 31, 2014, that: (1) specifies how preclinical and clinical data can be utilized to inform an efficient and streamlined pathogen-focused antibacterial drug development program that meets FDA approval standards, and (2) provides advice on approaches for the development of antibacterial drugs that target a more limited spectrum of pathogens. Subtitle D: Accelerated Approval - (Sec. 841) Expresses the sense of Congress that the FDA should apply accelerated approval and fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining safety and effectiveness standards for such treatments. Requires the Secretary, at the request of a sponsor of a drug, to: (1) expedite the development and review of a drug if the drug treats a serious or life-threatening disease or condition and the drug demonstrates substantial improvement over existing therapies (breakthrough therapies), and (2) issue draft guidance to implement such expedited review. (Sec. 843) Authorizes the Secretary to contract with an independent entity to evaluate the FDA's implementation of the expedited review of drugs that treat a serious or life-threatening disease or condition. Subtitle E: Critical Path Reauthorization - (Sec. 851) Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative. Subtitle F: Miscellaneous - (Sec. 861) Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers. (Sec. 862) Extends from 30 to 45 months, effective between the enactment date of this Act and September 30, 2013, the period during which a generic drug applicant may obtain tentative FDA approval without forfeiting its 180-day exclusivity period. Reduces such period each year until it is 36 months beginning on October 1, 2015, and ending on September 30, 2016. (Sec. 863) Revises rules relating to review of citizen petitions regarding generic and biosimilar applications. Reduces the period in which the FDA is required to act on such petitions from 180 to 150 days after submission. (Sec. 864) Requires the Secretary to issue a final, substantive determination on any petition filed by a generic drug applicant for determining whether a drug was withdrawn for a safety or effectiveness reason no later than 270 days after the filing of any such petition. (Sec. 865) Requires the Secretary to: (1) award priority review vouchers to sponsors of a rare pediatric disease product application, (2) establish a user fee program for financing priority review activities, (3) require rare pediatric disease product applications to include a plan for marketing such product in the United States, and (4) publish a notice in the Federal Register and on the FDA website after issuance of a priority review voucher or approval of a rare pediatric disease drug. Requires the Government Accountability Office to study and report on the effectiveness of awarding rare pediatric disease priority vouchers. (Sec. 866) Requires the Secretary to: (1) review current federal initiatives and identify gaps and opportunities with respect to ensuring the safe use of prescription drugs with the potential for abuse, (2) report to Congress on such review, and (3) promulgate guidance on the development of tamper-deterrent drug products. (Sec. 867) Revises the risk evaluation and mitigation strategy system. (Sec. 868) Requires the Secretary to develop and maintain a list of external experts for consultation with the FDA on rare disease issues. (Sec. 869) Requires the Secretary to expedite the development and review of a drug for the treatment of a serious or life-threatening disease or condition that demonstrates substantial improvement over existing therapies (breakthrough therapies). (Sec. 870) Extends through FY2017 the authorization of appropriations for grants and contracts for the development of drugs for rare diseases and conditions (orphan drugs). Title IX: Drug Shortages - (Sec. 901) Revises provisions requiring notification to the Secretary of a discontinuance of the manufacture of a drug or an interruption of the manufacture of a drug that is life-supporting, life-sustaining, and intended for use in the prevention or treatment of a debilitating disease. Requires notification to the Secretary of a discontinuance or interruption at least six months prior to the date of the discontinuance or interruption. (Sec. 902) Requires the Secretary to: (1) maintain an up-to-date list of drugs determined to be in shortage, including the name of each drug in shortage, the name of each manufacturer of a drug in shortage, the reason for the shortage, and the estimated duration of the shortage; and (2) make such list available to the public. (Sec. 903) Amends the Controlled Substances Act to require the Attorney General to review requests to increase quotas of controlled substances and make a determination within 30 days after receipt of a request if such request pertains to a drug in shortage. (Sec. 904) Requires the Secretary to expedite review of a supplemental application for a major manufacturing change if the manufacturer notifies the FDA that a drug product is subject to a discontinuance or interruption in manufacturing and the manufacturer certifies that the major manufacturing change may prevent or alleviate the discontinuance or interruption in the manufacturing of the drug. Requires the Secretary to complete review of the supplemental application within 60 days after receiving the manufacturer's certification. Denies expedited review to any manufacturer who makes a certification in bad faith. (Sec. 905) Requires the Comptroller General to study and report on the cause of drug shortages and formulate recommendations to prevent or alleviate such shortages. (Sec. 906) Requires the Secretary to report annually to specified congressional committees on drug shortages. (Sec. 907) Requires the Attorney General to submit an annual report to the House Committee on Energy and Commerce and the Senate Committee on the Judiciary on drug shortages that identifies requests by manufacturers pertaining to controlled substances in shortage, describes the coordination between the Drug Enforcement Administration (DEA) and the FDA on efforts to prevent or alleviate drug shortages, and identifies drugs containing a controlled substance determined by the Secretary to be in shortage. (Sec. 908) Allows a hospital that is owned and operated by the same entity and that shares access to databases with drug order information for its patients to repackage a drug in shortage (i.e., divide its volume into smaller amounts) and transfer it to another hospital within the same health system without incurring otherwise applicable FDA registration requirements.

food_and_drug_administration reform act amends cosmetic act ffdca reauthorize establish new food_and_drug_administration fda prescription drug user fee programs revise impose new requirements relating prescription pediatric generic drugs medical devices biosimilar biological products registration drug manufacturers reporting drug shortages title fees relating drugs prescription drug user fee amendments sec extends fy2017 authority secretary health_and_human_services hhs assess collect human drug application supplement fees prescription drug establishment fees prescription drug product fees support fda drug development process process review human drug applications increases fy2013 fy2017 level required prescription drug user fee revenues provides inflation adjustment workload adjustment fy2013 subsequent fiscal years required level user fee revenue amounts sec requires secretary submit house_committee_on_energy_and_commerce labor pensions specified congressional committees end fiscal year user fees collected title beginning fy2013 report progress fda achieving goals identified letters sent secretary committees future plans fda progress center_for_drug_evaluation_and_research center_for_biologics_evaluation_and_research achieving goals sec terminates authority secretary assess collect prescription drug user fees october reporting requirements january sec provides amendments title shall effect later october enactment date act user fees shall assessed human drug applications received october regardless enactment date act sec limits applicability title human drug applications supplements filed enactment title title medical device user fee amendments medical device user fee amendments sec extends fy2017 authority secretary assess collect fees medical device applications submissions increases fy2013 fy2017 level required medical device user fee revenues provides inflation adjustment revenues fy2014 subsequent fiscal year authorizes secretary grant waiver reduction medical device user fees interest public health sec requires secretary submit specified congressional committees annual reports fiscal year medical device user fees collected progress fda achieving goals identified letters secretary committees requires publication reports fda website sec limits effect title medical device applications supplements filed enactment title sec makes amendments title effective later october enactment date act sec terminates medical device user fee program october reporting requirements january sec authorizes secretary appoint employees positions fda perform administer support activities related review medical device applications meet performance objectives regard requirements governing appointments competitive service terminates authority years enactment act title iii fees relating generic drugs generic drug use fee amendments sec directs secretary beginning fy2013 assess collect following fees related generic drugs time backlog fee abbreviated new drug applications pending october drug master file fee abbreviated new drug application prior approval supplement filing fee additional fee certain active pharmaceutical ingredient information generic drug facility fee active pharmaceutical ingredient facility fee provides submission application positron emission tomography drug active pharmaceutical ingredient drug shall require payment fee terminates authority october sec requires secretary submit specified congressional committees annual reports fiscal year generic drug fees collected progress fda achieving goals identified letters secretary committees implementation authority fees use fees fda fiscal year requires publication reports fda website terminates authority assess collect generic drug user fees october reporting requirements respect generic drug user fee program january sec makes amendments title effective later october enactment date title sec deems misbranded drug active pharmaceutical ingredient manufactured prepared propagated compounded processed facility fees paid identifying information provided sec authorizes secretary appoint employees positions fda perform administer support activities related human generic drug activities regard requirements governing appointments competitive service title fees relating fee act sec directs secretary beginning fy2013 assess collect following fees related biosimilar biological products biosimilar program development fees encompassing initial biosimilar biological development fee annual biosimilar biological product development fee reactivation fee biosimilar biological product application supplement fee biosimilar biological product establishment fee biosimilar biological product fee waives fees biosimilar biological product application small business terminates authority october sec requires secretary submit specified congressional committees annual reports fiscal year biosimilar user fees collected progress fda achieving goals identified letters secretary committees implementation authority fees use fees fda fiscal year requires publication reports fda website sec terminates authority assess collect biosimilar drug user fees october reporting requirements respect biosimilar drug user fee program january sec makes amendments title effective later october enactment date title title reauthorization best pharmaceuticals children act pediatric research equity act sec makes permanent best pharmaceuticals children act granting extended market exclusivity new marketed drugs pediatric population relating research pediatric uses drugs biological products provides exclusivity completion pediatric study studies shall granted subject written request requires applicant approval pediatric drug submit secretary initial pediatric study plan prior submission drug safety assessments extends fy2017 authorization appropriations pediatric studies drugs requires secretary hold public meeting later december impact pediatric research activities development new therapies children cancer sec requires secretary submit specified congressional committees publicly available fda website periodic reports implementation pediatric studies drugs research pediatric uses drugs biological products sec authorizes review pediatric plans assessments deferrals waivers review deferral extensions requires committee include fda employees expertise sec amends require staff include additional individuals expertise pediatric epidemiology sec amends permanent pediatric_advisory_committee title sec requires secretary publish federal_register days advance notice secretary intent issue draft guidance document sets forth initial interpretations statute regulation sets forth changes interpretation policy minor nature includes complex scientific issues covers highly controversial issues sec revises requirements relating disclosure conflicts interest individuals recruited serve fda advisory committees sec requires electronic submission drug generic drug biologic biosimilar applications beginning earlier months issuance final fda guidance developed public notice comment period sec prohibits fda issuing draft final guidance regulation laboratory developed tests ffdca days prior issuance notifying specified congressional committees intent issue guidance including notification anticipated details action title vii medical device regulatory improvements subtitle premarket predictability sec prohibits secretary disapproving application approval medical device investigational use basis investigation support substantial equivalence novo classification determination approval device investigation meet requirement including data requirement relating approval clearance device additional different investigation necessary support clearance approval device sec defines necessary purposes information required premarket approval regulatory process minimum required information support determination secretary medical device application provides reasonable assurance effectiveness device burdensome standard sec requires secretary provide substantive summary scientific regulatory rationale significant decision center_for_devices_and_radiological_health medical devices authorizes supervisory review significant decision sec requires secretary regularly publish detailed decision summaries clearance premarket submission medical device intended human use sec requires secretary submit specified congressional committees report premarket notification submitted modification change legally marketed medical device withdraw certain draft guidance relating changes existing device suspend issuance draft guidance proposed regulation addresses submit premarket notification changes modifications manufacturer previously cleared device receipt secretary report appropriate congressional committees suspend final guidance regulation year receipt report subtitle patients come requires secretary later days enactment act establish schedule promulgation regulations require premarket approval certain medical devices final regulation promulgated requiring premarket approval sec requires secretary establish program assess information relating recalls medical devices identify strategies mitigating health risks presented defective unsafe devices document basis termination fda device recall subtitle novel device regulatory relief sec authorizes secretary classify certain new medical devices issuing determination devices substantially equivalent existing devices change classification medical device based new information device administrative order instead regulation subtitle keeping america competitive harmonization sec authorizes secretary respect medical devices enter arrangements nations methods approaches regulatory requirements activities including inspections common international labeling symbols sec authorizes secretary participate appropriate fora including provide guidance fora strategies activities subtitle sec extends october authority programs party review inspection medical devices humanitarian device reform sec extends humanitarian device exemption october subtitle records reports devices sec requires secretary issue proposed regulations establishing unique medical identification system december finalize proposed regulations months close comment period implement final regulations respect devices implantable life saving life sustaining later years regulations finalized taking account patient access medical devices therapies sec requires secretary include medical devices postmarket risk identification evaluation system engage outside stakeholders development system subtitle miscellaneous sec modifies exemption ffdca performance standards premarket approval requirements custom devices created modified comply order individual physician dentist treatment unique pathology physiological condition sec reauthorizes fy2017 grant program promoting pediatric medical device development non profit consortia requires secretary issue proposed rule implement requirement including information pediatric uses medical devices applications december final rule implementing requirement december sec directs secretary later months enactment act report specified congressional committees strategy coordinating regulation health information technology avoid regulatory duplication recommendations appropriate regulatory framework health information technology including risk based framework title viii drug regulatory improvements subtitle drug supply chain imposes new expanded fda registration inspection requirements domestic foreign drug establishments sec authorizes secretary inspect domestic foreign drug establishments risk based schedule based multiple risk factors including compliance history establishment inspection frequency history establishment record history nature recalls linked establishment inherent risk drug manufactured requires secretary report congress later february year inspections drug establishments requires report publicly available fda website sec defines current good manufacturing practice include implementation oversight control manufacture drugs ensure quality including managing risk establishing safety raw materials materials manufacturing drugs finished drug products sec deems drug adulterated owner operator factory warehouse establishment drug manufactured processed packed held delays denies limits inspection refuses permit entry inspection requires secretary issue guidance year enactment act constitutes delaying denying limiting inspection sec authorizes fda destroy counterfeit adulterated imported drug products minor monetary value reasonable probability causing adverse health consequences death requires fda issue regulations providing notice opportunity appear fda produce testimony prior destruction drug sec authorizes fda detain reasonable period drugs found inspection adulterated misbranded requires fda issue implementing regulations detention authority sec increases criminal penalties trafficking counterfeit drugs sec requires domestic foreign drug establishments unique facility identification number sec authorizes secretary require submission documentation information drug imported offered import united_states refuse admission drug required information submitted sec requires registration commercial drug importers fda requires secretary promulgate regulations establish good importer practices specify measures importer shall ensure imported drugs compliance act public_health_service_act sec makes prohibited act ffdca fail notify secretary use drug result injury death significant loss known theft drug drug sec exempts drug related information obtained secretary disclosure freedom information act foia laws information provided federal state local foreign government agency requested information kept confidential sec grants extraterritorial jurisdiction violation ffdca article regulated act article intended import united_states act furtherance violation committed united_states sec increases criminal penalties knowingly intentionally drug adulteration creates reasonable probability causing adverse health consequences death sec requires owner operator establishment engaged manufacture preparation propagation compounding processing drug provide fda records information advance inspection subtitle sec provides expanded fda regulation medical gases defines medical gas drug manufactured stored liquefied non liquefied state administered gas designated medical gas oxygen nitrogen nitrous oxide carbon dioxide helium carbon monoxide medical air medical gas designated secretary meets specified standards allows person file secretary request certification medical gas designated medical gas sec requires secretary obtaining input medical gas manufacturers public determine changes federal drug regulations necessary medical gases issue final regulations medical gases months enactment act changes deemed necessary subtitle generating antibiotic incentives sec extends years exclusivity period qualified infectious disease products defines qualified infectious disease product antibacterial antifungal drug human use treats prevents infection caused pathogens specified act sec requires comptroller general gao study report need incentives encourage research development marketing qualified infectious disease biological products sec requires secretary review appropriate revise guidance documents conduct clinical trials antibacterial antifungal drugs allows sponsor qualified infectious disease product request secretary provide written recommendations clinical investigations secretary deems necessary obtaining approval products sec requires secretary report specified congressional committees years enactment act qualified infectious disease products including number initial designations drugs qualified infectious disease products number approvals products products address need antibacterial antifungal drugs treat life threatening infections sec requires secretary publish draft guidance june final guidance december specifies preclinical clinical data utilized inform efficient streamlined pathogen focused antibacterial drug development program meets fda approval standards provides advice approaches development antibacterial drugs target limited spectrum pathogens subtitle accelerated approval sec expresses sense congress fda apply accelerated approval fast track provisions expedite development availability treatments life threatening diseases conditions maintaining safety effectiveness standards treatments requires secretary request sponsor drug expedite development review drug drug treats life threatening disease condition drug demonstrates substantial improvement existing therapies breakthrough therapies issue draft guidance implement expedited review sec authorizes secretary contract independent entity evaluate fda implementation expedited review drugs treat life threatening disease condition subtitle critical path reauthorization sec extends fy2017 authorization appropriations implement fda critical path initiative subtitle miscellaneous sec extends october deadline applications elections relating marketing exclusivity certain drugs containing single sec extends months effective enactment date act september period generic drug applicant obtain tentative fda approval day exclusivity period reduces period year months beginning october ending september sec revises rules relating review citizen petitions generic biosimilar applications reduces period fda required act petitions days submission sec requires secretary issue final substantive determination petition filed generic drug applicant determining drug withdrawn safety effectiveness reason later days filing petition sec requires secretary award priority review vouchers sponsors rare pediatric disease product application establish user fee program financing priority review activities require rare pediatric disease product applications include plan marketing product united_states publish notice federal_register fda website issuance priority review voucher approval rare pediatric disease drug requires government_accountability_office study report effectiveness awarding rare pediatric disease priority vouchers sec requires secretary review current federal initiatives identify gaps opportunities respect ensuring safe use prescription drugs potential abuse report congress review promulgate guidance development tamper deterrent drug products sec revises risk evaluation mitigation strategy system sec requires secretary develop maintain list external experts consultation fda rare disease issues sec requires secretary expedite development review drug treatment life threatening disease condition demonstrates substantial improvement existing therapies breakthrough therapies sec extends fy2017 authorization appropriations grants contracts development drugs rare diseases conditions orphan drugs title drug shortages sec revises provisions requiring notification secretary discontinuance manufacture drug interruption manufacture drug life supporting life sustaining intended use prevention treatment debilitating disease requires notification secretary discontinuance interruption months prior date discontinuance interruption sec requires secretary maintain date list drugs determined shortage including drug shortage manufacturer drug shortage reason shortage estimated duration shortage list available public sec amends controlled substances act require attorney general review requests increase quotas controlled substances determination days receipt request request pertains drug shortage sec requires secretary expedite review supplemental application major manufacturing change manufacturer notifies fda drug product subject discontinuance interruption manufacturing manufacturer certifies major manufacturing change prevent alleviate discontinuance interruption manufacturing drug requires secretary complete review supplemental application days receiving manufacturer certification denies expedited review manufacturer makes certification bad faith sec requires comptroller general study report cause drug shortages formulate recommendations prevent alleviate shortages sec requires secretary report annually specified congressional committees drug shortages sec requires attorney general submit annual report house_committee_on_energy_and_commerce senate_committee judiciary drug shortages identifies requests manufacturers pertaining controlled substances shortage describes coordination drug_enforcement_administration dea fda efforts prevent alleviate drug shortages identifies drugs containing controlled substance determined secretary shortage sec allows hospital owned operated entity shares access databases drug order information patients drug shortage divide volume smaller amounts transfer hospital health system incurring applicable fda registration requirements


Summary: Gray Market Drug Reform and Transparency Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.

transparency_act amends cosmetic act prohibited act misbranding wholesale distributor prescription drugs purchase receive prescription drug pharmacy pharmacist require annual reporting wholesale distributors prescription drugs require secretary health_and_human_services hhs establish maintain national database information reported wholesale distributors prescription drugs require database include information actions taken states wholesale distributors disciplinary actions license revocations require secretary assess collect fees wholesale distributors prescription drugs require wholesale distributors prescription drugs provide recipients prescription drug shortage sales price drug time sale time prior sale drug shortage


Summary: Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.

medical device patient safety act directs secretary health_and_human_services hhs acting commissioner food_and_drugs establish program enhance oversight food_and_drug_administration fda medical device recalls requires program routinely systematically assess information submitted secretary pursuant device recall order issued cosmetic act fdca information required reported device manufacturer secretary manufacturer correction removal device requires secretary use information proactively identify strategies mitigating health risks presented defective unsafe devices requires program designed identify things recall trends causes recalls time complete recall requires secretary develop explicit criteria assessing person subject recall order manufacturer reporting requirement performed effective correction removal action requires secretary document publish specified information concerning termination recall permits secretary conditionally clear introduction interstate commerce commercial distribution medical device intended human use medical device cleared pursuant specified fdca reporting requirements concerning introduction devices interstate commerce permits secretary conditional clearance impose specified restrictions sale distribution use device require specified labeling device require maintenance specified records enable fda track device determine safety effectiveness device


Summary: Taking Essential Steps for Testing Act of 2012 - Amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.

taking essential steps testing act amends public_health_service_act revise sanctions laboratories intentionally refer proficiency testing samples required certification laboratory analysis giving secretary health_and_human_services hhs discretion substitute intermediate sanctions violations instead year prohibition ownership operation apply making year certificate revocation laboratory optional mandatory


Summary: Truth in Trials Act - Amends the federal criminal code to: (1) allow any person on trial for a federal marijuana-related offense to introduce evidence that the alleged marijuana-related activities were performed in compliance with state law regarding the medical use of marijuana, (2) allow an affirmative defense to a marijuana prosecution that the alleged marijuana-related activities complied with state law regarding the medical use of marijuana, (3) limit the criminal liability of persons convicted of federal marijuana-related offenses, (4) require the preservation and return (if a defendant is acquitted) of property seized in connection with a marijuana prosecution, and (5) prohibit the seizure of plants grown or stored under a physician's recommendation or by order of a state or municipal agency in accordance with state law regarding the medical use of marijuana.

truth trials act amends federal criminal code allow person trial federal marijuana related offense introduce evidence alleged marijuana related activities performed compliance state law medical use marijuana allow affirmative defense marijuana prosecution alleged marijuana related activities complied state law medical use marijuana limit criminal liability persons convicted federal marijuana related offenses require preservation return defendant property seized connection marijuana prosecution prohibit seizure plants grown stored physician recommendation order state municipal agency accordance state law medical use marijuana


Summary: Stop Tampering of Prescription Pills Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for tamper-resistant drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects. Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not tamper-resistant if a tamper-resistant drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need. Requires an abbreviated new (generic) drug application for a tamper-resistant drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is tamper-resistant and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug. Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes tamper-resistant unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.

stop tampering prescription act amends cosmetic act prescribe new drug application requirements tamper resistant drugs containing active drug makes work way controlled substance classified opium opiate derivative formulated oral administration exhibiting properties making significantly difficult ineffective altering drug characteristics purposes misuse abuse containing additional ingredients intended deter abuse potential pharmacological effects requires secretary refuse new drug application new brand drug containing opium opiate derivative active tamper resistant tamper resistant drug containing active approved discontinued marketing authorizes secretary approve application failing meet requirements approval necessary prevent alleviate drug shortage address significant unmet public health need requires abbreviated new generic drug application tamper resistant drug include testing information demonstrating generic drug manipulation effect manipulation degree comparable listed drug authorizes secretary deny approval generic application listed drug tamper resistant generic drug active differ material respect listed drug declares approved generic drug shall considered having therapeutic effect listed drug listed drug tamper resistant generic drug demonstrates manipulation effect manipulation degree comparable listed drug prescribes requirements governing drug tamper resistant approval withdrawn suspended


Summary: Patient Choice Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary. Prohibits the Secretary from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug). Applies the provisional approval only to the indication for the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety. Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.

patient choice act amends cosmetic act authorize provisional approval fast track products determined secretary health_and_human_services hhs adequately safe treats provisional approval manner approval drug provisional approval subject requirements related informed consent continued pursuit safety efficacy data purposes gaining approval drug defines term adequately safe mean population risk death morbidity caused directly adverse effect drug unlikely greater combined direct secondary risks death morbidity disease existing therapies drug valid marketing authorization years specified countries data adequate approval marketing authorization submitted secretary prohibits secretary imposing requirements safety studies data addition different requirements studies establish safety purposes phase initial introduction investigational new drug humans phase controlled clinical studies evaluate effectiveness drug particular indication patients disease condition study determine common short term effects risks associated drug applies provisional approval indication drug related treatment condition respect drug designated fast track product drug demonstrated adequately safety prescribes requirements termination provisional approval withdrawal approval application market exclusivity fast track approval products


Summary: Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.

amends title xviii medicare social security act authorize direct payment supplementary medical insurance benefits aged disabled pharmacy certain covered compound drugs prepared pharmacy specific beneficiary effective use implanted infusion pump


Summary: Medicare DMEPOS Market Pricing Program Act of 2012 - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to establish a market pricing program for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) as a replacement for the competitive acquisition program for DMEPOS, which is hereby terminated. Directs the Secretary to: (1) conduct annual market-priced auctions from among entities supplying market priced items and services in an eligible market area selected in the auction design, (2) establish a lead product for each of specified product categories, and (3) award a contract to any entity in an eligible market area in which an auction is conducted whose bid is below a clearing price equal to the highest cost bid that will meet capacity targets in the market area. Requires the Secretary to contract with an auction expert to assist in, and a market monitor to monitor, the design, development, and functioning of the auction. Adjusts the covered DME item update for 2012 through 2014 and each subsequent year.

amends supplementary_medical_insurance title xviii medicare social security act direct secretary health_and_human_services hhs establish market pricing program durable medical equipment dme prosthetics orthotics supplies dmepos replacement competitive acquisition program dmepos terminated directs secretary conduct annual market priced auctions entities supplying market priced items services eligible market area selected auction design establish lead product specified product categories award contract entity eligible market area auction conducted bid clearing price equal highest cost bid meet capacity targets market area requires secretary contract auction expert assist market monitor monitor design development functioning auction adjusts covered dme item update subsequent year


Summary: Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination: (1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and Drug Administration (FDA) guidance; and (2) includes at least two drugs that are not approved. Requires the Secretary to develop, publish, and revise annually a list of combinations of two or more drugs designated as significant drug combinations. Extends the market exclusivity for a drug by six months if it is designated as a significant drug combination before it is approved as a new drug. Requires the Secretary to review and take action on a drug in a significant drug combination designated under this Act within six months after receiving an application for approval of a new drug application or licensure of a biosimilar biological product. Requires the Secretary, at the request of the sponsor of a drug, to expedite development and review for designated drug combinations. Requires the Secretary to establish an interagency task force to encourage the co-development of drugs in significant drug combinations. Requires the task force to develop, revise in response to public comments, and update annually a list of types of drug combinations it recommends that the Secretary designate as significant drug combinations. Directs the Secretary to study the impact of the extension of market exclusivity under this Act.

combination therapy act amends cosmetic act authorize secretary health_and_human_services hhs designate combination drugs significant drug combination combination includes drugs biological products combination offer potential significantly advance treatment life threatening disease combination meet criteria development drug combinations food_and_drug_administration fda guidance includes drugs approved requires secretary develop publish revise annually list combinations drugs designated significant drug combinations extends market exclusivity drug months designated significant drug combination approved new drug requires secretary review action drug significant drug combination designated act months receiving application approval new drug application licensure biosimilar biological product requires secretary request sponsor drug expedite development review designated drug combinations requires secretary establish interagency task force encourage development drugs significant drug combinations requires task force develop revise response public comments update annually list types drug combinations recommends secretary designate significant drug combinations directs secretary study impact extension market exclusivity act


Summary: Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs. Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances. Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; (2) require the sponsor of a new drug or biological product to submit PMI as part of the new drug or abbreviated (generic) new drug application and provide for approval or disapproval of the PMI as part of the application process; (3) require the sponsor of any drug lawfully marketed in the United States to submit PMI for the drug to the Secretary for approval or disapproval of the PMI; (4) require the PMI for a generic drug to be identical to the PMI for the listed drug, except for excluding any portion of such PMI that is protected by patent or an exclusivity period under FFDCA; and (5) provide for the development of a publicly accessible electronic repository for all PMI. Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.

safer prescriptions act amends cosmetic act ffdca direct secretary health_and_human_services hhs promulgate regulations authorship content format dissemination requirements patient medication information prescription drugs requires regulations require drug scientifically accurate based approved professional labeling authoritative peer reviewed literature include plain language promotional tone content requires language include established drug drug uses clinical benefits general directions proper use contraindications common effects risks drug measures patients reduce effects risks patient contact health care professional instructions share medications key storage requirements recommendations relating proper disposal unused portion drug known clinically important interactions drugs substances requires regulations include standards related performing timely updates drug information ensuring common information applied consistently simultaneously similar drug products drugs classes medications developing process assess quality effectiveness promoting patient understanding safe effective use require sponsor new drug biological product submit new drug abbreviated generic new drug application provide approval disapproval application process require sponsor drug lawfully marketed united_states submit drug secretary approval disapproval require generic drug identical listed drug excluding portion protected patent exclusivity period ffdca provide development publicly accessible electronic repository requires secretary publish food_and_drug_administration fda website link website


Summary: Trafficking in Organs Victims Protection Act - States that it shall be U.S. policy to: (1) end the offensive practice of exploiting the poor and vulnerable for the purpose of harvesting and trafficking their organs, and (2) combat criminal trade in human organs. Amends the Foreign Assistance Act of 1961 to include in the annual country reports on human rights practices information on post-operative and rehabilitation care for victims of trafficking in human organs and the extent to which violations of a country's laws against trafficking in human organs have occurred. Amends the Trafficking Victims Protection Act of 2000 to include in the definition of "coercion" exploitation of a person through the promise of payments or benefits in order to compel or entice the person to consent to the removal of one or more of the person's organs for a transplant operation in a manner contrary to certain World Health Organization (WHO) standards. Defines: (1) "trafficking in human organs" as the recruitment, transportation, transfer, harboring, or receipt of a person, either living or dead, for the purpose of removing one or more of the person's organs by coercion, abduction, deception, abuse of power, or transfer of payments or benefits, and the illicit transportation and transplantation of those organs in one or more other persons for profit or any other purpose; and (2) "organ" as the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof, and any other human organ or subpart (including that derived from a fetus) specified by the President. Includes in the definition of "severe forms of trafficking in persons" trafficking in human organs. Amends the State Department Basic Authorities Act of 1956 to prohibit the issuance of a passport to, and revoke a previously issued passport from, a person convicted of trafficking in human organs who used a passport or otherwise crossed an international border in committing such offense. Authorizes the President to exercise specified authorities under the International Emergency Economic Powers Act in connection with: (1) the export of anti-rejection human organ transplant drugs to countries identified as the largest source of illegally trafficked human organs or the largest recipients of illegally trafficked human organs, or (2) the travel abroad by U.S. citizens to participate in any activity relating to human organ trafficking.

trafficking organs victims protection shall policy end offensive practice poor vulnerable purpose harvesting trafficking organs combat criminal trade human organs amends foreign assistance act include annual country reports human rights practices information post operative rehabilitation care victims trafficking human organs extent violations country laws trafficking human organs occurred amends trafficking_victims_protection_act include definition coercion exploitation person promise payments benefits order compel person consent removal person organs transplant operation manner contrary certain standards defines trafficking human organs recruitment transportation transfer harboring receipt person living dead purpose removing person organs coercion abduction deception abuse power transfer payments benefits illicit transportation transplantation organs persons profit purpose organ human including fetal kidney liver heart lung bone marrow eye bone skin subpart thereof human organ subpart including derived fetus specified president includes definition severe forms trafficking persons trafficking human organs amends state_department basic authorities act prohibit issuance passport revoke previously issued passport person convicted trafficking human organs passport international border committing offense authorizes president exercise specified authorities international_emergency_economic_powers_act connection export anti rejection human organ transplant drugs countries identified largest source illegally trafficked human organs largest recipients illegally trafficked human organs travel abroad citizens participate activity relating human organ trafficking