Summary: Food and Drug Administration Safety and Innovation Act - 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 revise and impose new requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. 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 for FY2014 and subsequent fiscal years for the required level of user fee revenue amounts. Requires the Secretary, not later than 60 days before the start of each fiscal year, to establish, for the next fiscal year, application, product, and establishment fees based on revenue amounts established by this title. (Sec. 104) Requires the Secretary to prepare and submit to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions (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. Requires such report to include, for each review division, per fiscal year, the number of: (1) original standard new drug applications and biologics license applications filed, (2) priority new drug applications and biologics license applications filed, (3) standard efficacy supplements, (4) priority efficacy supplements, (5) applications filed for review under accelerated approval, (6) applications filed for review as fast track products, (7) applications filed for orphan-designated products, and (8) breakthrough designations. (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: Fees Relating to Devices - 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 if the Secretary finds that such waiver or reduction is in the interest of public health. (Sec. 204) Requires the Secretary to prepare and 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 User 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 prepare and 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. Sec. 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. Terminates this authority three years after enactment of this Act. Sec. 308) Requires the Secretary, beginning in FY2013 and ending after FY2017, to report to specified congressional committees on all applications for approval of a generic drug, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year. 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 prepare and 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. Sec. 408) Requires the Secretary to report to specified congressional committees within 120 days after the end of each fiscal year for which biosimilar biological product fees are collected (beginning in FY2014) on: (1) the number of applications for approval of a biological license, and (2) the percentage of applications approved by the Secretary. Title V: Pediatric Drugs and Devices - (Sec. 501) Makes permanent the: (1) the Best Pharmaceuticals for Children Act granting extended market exclusivity for new and already-marketed drugs for the pediatric population, and (2) the Pediatric Research Equity Act of 2003 relating to research into pediatric uses for drugs and biological products. (Sec. 502) 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. (Sec. 503) Requires the Secretary, not later than one year after enactment of this Act, to issue internal standard operating procedures for the review of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests for studies under the FFDCA. Requires such procedures to be made publicly available on the FDA website. (Sec. 504) Requires the Secretary, not later than three years after enactment of this Act, to make publicly available the medical, statistical, and clinical pharmacology reviews of, and corresponding written requests issued to an applicant, sponsor, or holder for, pediatric studies submitted between January 4, 2002, and September 27, 2007, under the FFDCA for which six months of market exclusivity was granted and that resulted in a labeling change. (Sec. 505) Grants the Secretary authority to extend a deadline for a pediatric drug study under specified circumstances. (Sec. 506) 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. (Sec. 507) Amends the Best Pharmaceuticals for Children Act to reauthorize: (1) the Pediatric Advisory Committee, and (2) the Pediatric Subcommittee of the Oncologic Drug Advisory Committee. Amends the FFDCA to extend through FY2017 the authorization of appropriations for the humanitarian device exemption. Amends the Public Health Service Act to extend through FY2017 the authorization of appropriations for the pediatric study of drugs program. (Sec. 508) Requires the Secretary to report to specified congressional committees within four years after enactment of this Act and every five years thereafter on the effectiveness of the pediatric study of drugs and research into pediatric uses for drugs and biological products under the FFDCA, and make such report publicly available on the FDA website. Sets forth the required content of such report. (Sec. 510) Requires the Secretary to: (1) hold at least one public meeting within 18 months after enactment of this Act to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases; and (2) issue a report that includes a strategic plan for developing treatments for such diseases. (Sec. 511) Amends the Best Pharmaceuticals for Children Act to require the staff of the Office of Pediatric Therapeutics in the FDA to include individuals with expertise in pediatric epidemiology and neonatology. Title VI: Medical Device Regulatory Improvements - (Sec. 601) 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. 602) Defines "necessary" for purposes of information required for the premarket approval regulatory process to mean 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. 603) 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. 604) 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. (Sec. 605) Requires the Secretary to: (1) establish a program to assess information relating to recalls of medical devices, and (2) document the basis for termination by the FDA of a device recall. (Sec. 606) Authorizes the Secretary to prohibit the sponsor of an investigation of the effectiveness of a medical device from conducting such investigation (clinical hold) if the Secretary makes a determination that the device represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation. (Sec. 607) 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. (Sec. 609) 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. 611) Extends until October 1, 2017, authority for programs for third-party review and inspection of medical devices. (Sec. 613) Expands the exemption from the prohibition on profit for medical devices that have been granted humanitarian device exemptions to include devices intended for use in adults if such a device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients, or that occurs in such numbers that the device's development is impossible, highly impracticable, or unsafe. (Sec. 614) 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. 615) 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. (Sec. 616) Authorizes the Secretary to order postmarket surveillance for specified medical devices either at the time of their approval or clearance or at any time thereafter. Requires device manufacturers to start surveillance not later than 15 months after the date the Secretary issues an order. (Sec. 617) Exempts from premarket approval requirements medical devices for small or unique populations that are created or modified to comply with the order of an individual physician or dentist and that are designed to treat a unique pathology or physiological condition that no other device is domestically available to treat. (Sec. 618) Requires the Secretary to post on the websites of the FDA, the Federal Communications Commission (FCC), and the Office of the National Coordinator for Health Information Technology within 18 months after enactment of this Act a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. (Sec. 619) Classifies notices that set forth changes in interpretations of a regulation or FDA policy, including a notice to industry advisory letter, as a guidance document subject to FDA's good guidance practice rules. (Sec. 620) Reauthorizes through FY2017 the grant program for promoting pediatric medical device development by non-profit consortia. Requires the Secretary to issue a proposed rule to implement the requirement for including information on pediatric uses of medical devices in applications and to issue a final rule implementing such requirement by December 31, 2013. Title VII: Drug Supply Chain - (Sec. 701) Imposes new or expanded FDA registration requirements for domestic and foreign drug establishments. (Sec. 703) Expands drug product listing information to include information on drug excipient establishments, including all establishments used in the production of such excipient, a unique facility identifier of such establishment, and a point-of-contact e-mail address for each excipient manufacturer. (Sec. 704) Requires the Secretary, after specifying a unique facility identifier system, to maintain an electronic database to enable FDA personnel to identify and inform risk-based inspections. (Sec. 705) Requires the Secretary to: (1) conduct risk-based inspections of registered drug establishments, including biennial inspections for medical devices; and (2) post on the FDA website, beginning in 2014, a report on the number of domestic and foreign establishments registered in the previous fiscal year, the number of inspections of such establishments, and the percentage of the FDA budget used to fund such inspections. (Sec. 706) 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. (Sec. 707) 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 would constitute delaying, denying, or limiting inspection. (Sec. 708) 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 and produce testimony prior to the destruction of a drug. (Sec. 709) 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. 710) Exempts the FDA from freedom of information disclosure requirements with respect to information about drugs obtained from a foreign government if: (1) the information alerts the FDA to a potential need for a safety investigation; (2) the information is provided to the FDA voluntarily on the condition that it is not be released to the public; and (3) the information is covered by, and subject to, a written agreement between the FDA and the foreign government. (Sec. 711) 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. 712) Authorizes the Secretary to enter into arrangements and agreements with a foreign government to recognize the inspection of importers in order to facilitate risk-based inspections. (Sec. 713) Authorizes the FDA to require importers of drugs to provide certain information to allow the FDA to assess the risk of importing such drugs. (Sec. 714) 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. 715) Requires a manufacturer, commercial importer, wholesale distributor, or other non-retail distributor (regulated person) to notify the FDA if such regulated person knows: (1) that the use of any drug in the United States may result in serious injury or death; (2) of a significant loss or known theft of such drug intended for use in the United States; or (3) that such drug has been or is being counterfeited and the counterfeit product is in commerce in the the United States, or such drug has been or is being imported into the United States or may reasonably be expected to be offered for import into the United States. (Sec. 716) 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 to humans or animals. (Sec. 717) Amends the federal criminal code to extend the penalties for trafficking in counterfeit goods and services to trafficking in counterfeit drugs (drugs that use a counterfeit mark on or in connection with a drug). Directs the U.S. Sentencing Commission to review, and if appropriate, amend its guidelines and policy statements to include persons convicted of trafficking in counterfeit drugs. (Sec. 718) Grants extraterritorial jurisdiction over any violation of the 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. Title VIII: Generating Antibiotic Incentives Now - (Sec. 801) 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 intended to treat serious or life-threatening infections, including those caused by: (1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or (2) qualifying pathogens designated by the Secretary. Requires the Secretary to establish and maintain a list of qualifying pathogens and make public the methodology for developing such list. (Sec. 802) Makes qualified infectious disease products eligible for priority and fast track review. (Sec. 804) 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. 805) 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. 806) 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. Title IX: Drug Approval and Patient Access - (Sec. 901) 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. (Sec. 902) Requires the Secretary, at the request of a sponsor of a drug, to expedite the development and review of such drug if the drug treats a serious or life-threatening disease or condition and the drug demonstrates substantial improvement over existing therapies (breakthrough therapy). (Sec. 903) Provides for consultation with stakeholders and external experts on rare diseases, targeted therapies, and genetic targeting of treatments. (Sec. 904) Requires the Architectural and Transportation Barriers Compliance Board to convene a stakeholder working group to develop best practices on access to information on prescription drug container labels for blind or visually-impaired individuals. (Sec. 905) Requires the Secretary to implement a structured risk-benefit assessment framework in the revised drug approval process of this Act. (Sec. 906) Extends through FY2017 the authorization of appropriations for grants and contracts for the development of drugs for rare diseases and conditions (orphan drugs). (Sec. 907) Requires publication on the FDA website and transmittal to Congress of a report examining the extent to which current requirements for clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups, including sex, age, race, and ethnicity, are included in applications submitted to the FDA. (Sec. 908) Directs the Secretary to: (1) award a priority review voucher (providing for FDA review within six months) to a sponsor of a rare pediatric disease product application, and (2) establish a user fee program for such sponsors. Requires the Comptroller General to study and report on the effectiveness of awarding rare pediatric disease priority vouchers. Title X: Drug Shortages - (Sec. 1001) Revises requirements for notifying the Secretary of drug shortages. (Sec. 1002) Requires the Secretary to submit an annual report to specified congressional committees on drug shortages that includes: (1) a specification of the number of manufacturers that submitted a drug shortage notification and the number of drug shortages occurring during the calendar year, (2) a list of major actions taken by the Secretary to prevent or mitigate drug shortages, and (3) a description of the coordination between the FDA and the Drug Enforcement Administration (DEA) to prevent or alleviate drug shortages. (Sec. 1003) Requires the Secretary to establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages. (Sec. 1004) Requires the Secretary to 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. (Sec. 1005) 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 if a request pertains to a drug in shortage. (Sec. 1006) 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 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. 1007) 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. (Sec. 1008) Requires the Comptroller General to study and report on the cause of drug shortages and formulate recommendations to prevent or alleviate such shortages. Title XI: Other Provisions - Subtitle A: Reauthorizations - (Sec. 1101) Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers. (Sec. 1102) Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative. Subtitle B: Medical Gas Product Regulation - (Sec. 1111) 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. (Sec. 1112) 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: Miscellaneous Provisions - (Sec. 1121) Requires the Secretary, within two years after enactment of this Act, to issue guidance regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA. (Sec. 1122) 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 and the treatment of prescription drug dependence, (2) post a report on the HHS website of the findings of such review, and (3) promulgate guidance on the development of abuse-deterrent drug products. (Sec. 1123) Requires the Secretary to: (1) work with other regulatory authorities and international organizations to foster and encourage uniform, scientifically driven clinical trial standards for medical products around the world; and (2) accept data from clinical investigations conducted outside of the United States, including in the European Union, in determining whether to approve, license, or clear a drug or device for which an application has been submitted. (Sec. 1124) Requires the Secretary to develop a strategy and implementation plan for advancing regulatory science for medical products to promote public health and advance innovation in regulatory decisionmaking. (Sec. 1125) Requires the Secretary to report to Congress on: (1) the development and implementation of a comprehensive information technology strategic plan to align the information technology systems modernization projects with FDA strategic goals, (2) efforts to finalize and approve a comprehensive inventory of FDA information technology systems, (3) the ways in which the FDA uses the strategic plan to guide and coordinate its modernization projects and activities, and (4) the extent to which the FDA has fulfilled or is implementing recommendations of the Government Accountability Office (GAO) with respect to the FDA and information technology. Requires GAO to report on the strategic plan by January 1, 2016. (Sec. 1126) Requires the Secretary to expand activities related to nanomaterials included in FDA-regulated products and to address the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems. (Sec. 1127) Requires the Comptroller General to report on problems posed by pharmacy Internet websites that violate federal or state law. (Sec. 1128) Requires the FDA to report to Congress within one year after enactment of this Act on its small business initiatives and programs. (Sec. 1129) Extends whistleblower protections to officers of the Commissioned Corps of the Public Health Service. (Sec. 1130) Requires sunscreen drug products subject to a specified FDA final rule to comply with such rule by December 17, 2012 (by December 17, 2013, for products with annual sales of less than $25,000). (Sec. 1131) Requires the Secretary to submit to Congress within one year after enactment of this Act a strategic integrated management plan for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. (Sec. 1132) Revises the risk evaluation and mitigation strategy system. (Sec. 1133) Extends from 30 to 40 months, effective between the enactment date of this Act and September 30, 2015, the period during which a generic drug applicant may obtain tentative FDA approval without forfeiting its 180-day exclusivity period. Reduces such period to 36 months beginning on October 1, 2015, and ending on September 30, 2016. (Sec. 1134) 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. 1135) 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. 1136) 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. 1137) Requires the Secretary to develop and implement strategies to solicit the views of patients during the medical product development process. (Sec. 1138) Requires the Commissioner of Food and Drugs to: (1) review and modify, as necessary, the FDA's communication plan to inform and educate health care providers and patients on the benefits and risk of medical products, with particular focus on underrepresented subpopulations, including racial subgroups; (2) issue such communication plan within one year after enactment of this Act; and (3) post such plan on the website of the FDA's Office of Minority Health. (Sec. 1139) Requires the Secretary to hold a public meeting within 60 days after enactment of this Act to solicit advice and recommendations from a variety of stakeholders with respect to the scheduling of drug products containing hydrocodone, combined with other analgesics or as an antitussive. (Sec. 1140) Directs the Comptroller General to conduct a study and report on the benefits and efficiencies of electronic patient labeling of prescription drugs. (Sec. 1141) Authorizes the Secretary to facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription drug information across state lines by states receiving grant funds under the Harold Rogers Prescription Drug Monitoring Programs and the Controlled Substance Monitoring Program. Requires the Secretary to report to Congress on enhancing the interoperability of state prescription drug monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and drug abuse. (Sec. 1142) Revises requirements relating to the disclosure of conflicts of interest by individuals recruited to serve on FDA advisory committees. (Sec. 1143) Prohibits the FDA from issuing any draft or final guidance on the regulation of laboratory-developed tests under the 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. Terminates such prohibition five years after enactment of this Act. Subtitle D: Synthetic Drugs - Synthetic Drug Abuse Prevention Act of 2012 - (Sec. 1152) - Amends the Controlled Substances Act to add as a Schedule I controlled substance: (1) any material, compound, mixture, or preparation which contains specified cannabimimetic agents (or the salts, isomers, or salts of isomers thereof); and (2) specified additional hallucinogenic substances. (Sec. 1153) Extends the period for which the Attorney General may temporarily include a substance in Schedule I to avoid an imminent hazard to public safety to two years with a one-year extension (currently, one year with a six-month extension).

innovation 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 new infectious disease drugs drug manufacturer reporting 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 fy2014 subsequent fiscal years required level user fee revenue amounts requires secretary later days start fiscal year establish fiscal year application product establishment fees based revenue amounts established title sec requires secretary prepare 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 requires report include review division fiscal year number original standard new drug applications biologics license applications filed priority new drug applications biologics license applications filed standard efficacy supplements priority efficacy supplements applications filed review accelerated approval applications filed review fast track products applications filed orphan designated products breakthrough designations 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 fees relating devices 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 secretary finds waiver reduction interest public health sec requires secretary prepare 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 user 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 prepare 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 sec 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 terminates authority years enactment act sec requires secretary beginning fy2013 ending fy2017 report specified congressional committees applications approval generic drug amendments applications prior approval supplements respect applications filed previous fiscal year 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 prepare 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 sec requires secretary report specified congressional committees days end fiscal year biosimilar biological product fees collected beginning fy2014 number applications approval biological license percentage applications approved secretary title pediatric drugs devices sec makes permanent best pharmaceuticals children act granting extended market exclusivity new marketed drugs pediatric population relating research pediatric uses drugs biological products sec provides exclusivity completion pediatric study studies shall granted subject written request sec requires secretary later year enactment act issue internal standard operating procedures review significant modifications initial pediatric study plans agreed initial pediatric study plans written requests studies ffdca requires procedures publicly available fda website sec requires secretary later years enactment act publicly available medical statistical clinical pharmacology reviews corresponding written requests issued applicant sponsor holder pediatric studies submitted january september ffdca months market exclusivity granted resulted labeling change sec grants secretary authority extend deadline pediatric drug study specified circumstances sec requires applicant approval pediatric drug submit secretary initial pediatric study plan prior submission drug safety assessments sec amends best pharmaceuticals children act reauthorize pediatric_advisory_committee amends ffdca extend fy2017 authorization appropriations humanitarian device exemption amends public_health_service_act extend fy2017 authorization appropriations pediatric study drugs program sec requires secretary report specified congressional committees years enactment act years effectiveness pediatric study drugs research pediatric uses drugs biological products ffdca report publicly available fda website sets forth required content report sec requires secretary hold public meeting months enactment act discuss ways encourage accelerate development new therapies pediatric rare diseases issue report includes strategic plan developing treatments diseases sec amends best pharmaceuticals children act require staff office_of_pediatric_therapeutics fda include individuals expertise pediatric epidemiology title medical device regulatory improvements 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 mean 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 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 sec requires secretary establish program assess information relating recalls medical devices document basis termination fda device recall sec authorizes secretary prohibit sponsor investigation effectiveness medical device conducting investigation clinical hold secretary makes determination device represents unreasonable risk safety persons subjects clinical investigation 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 sec authorizes secretary respect medical devices enter arrangements nations methods approaches regulatory requirements activities including inspections common international labeling symbols sec extends october authority programs party review inspection medical devices sec expands exemption prohibition profit medical devices granted humanitarian device exemptions include devices intended use adults device intended treatment diagnosis disease condition occur pediatric patients occurs numbers device development impossible highly impracticable unsafe 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 sec authorizes secretary order postmarket surveillance specified medical devices time approval clearance time requires device manufacturers start surveillance later months date secretary issues order sec exempts premarket approval requirements medical devices small unique populations created modified comply order individual physician dentist designed treat unique pathology physiological condition device domestically available treat sec requires secretary post websites fda federal_communications_commission fcc months enactment act report contains proposed strategy recommendations appropriate risk based regulatory framework pertaining health information technology including mobile medical applications promotes innovation protects patient safety avoids regulatory duplication sec classifies notices set forth changes interpretations regulation fda policy including notice industry advisory letter guidance document subject fda good guidance practice rules 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 issue final rule implementing requirement december title vii drug supply chain sec imposes new expanded fda registration requirements domestic foreign drug establishments sec expands drug product listing information include information drug establishments including establishments production unique facility identifier establishment point contact mail address manufacturer sec requires secretary specifying unique facility identifier system maintain electronic database enable fda personnel identify inform risk based inspections sec requires secretary conduct risk based inspections registered drug establishments including biennial inspections medical devices post fda website beginning report number domestic foreign establishments registered previous fiscal year number inspections establishments percentage fda budget fund inspections sec requires owner operator establishment engaged manufacture preparation propagation compounding processing drug provide fda records information advance inspection 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 constitute 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 exempts fda freedom information disclosure requirements respect information drugs obtained foreign government information alerts fda potential need safety investigation information provided fda voluntarily condition released public information covered subject written agreement fda foreign government 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 authorizes secretary enter arrangements agreements foreign government recognize inspection importers order facilitate risk based inspections sec authorizes fda require importers drugs provide certain information allow fda assess risk importing drugs 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 requires manufacturer commercial importer wholesale distributor non retail distributor regulated person notify fda regulated person knows use drug united_states result injury death significant loss known theft drug intended use united_states drug counterfeit product commerce united_states drug imported united_states reasonably expected offered import united_states sec increases criminal penalties knowingly intentionally drug adulteration creates reasonable probability causing adverse health consequences death humans animals sec amends federal criminal code extend penalties trafficking counterfeit goods services trafficking counterfeit drugs drugs use counterfeit mark connection drug directs review appropriate amend guidelines policy statements include persons convicted trafficking counterfeit drugs sec grants extraterritorial jurisdiction violation ffdca article regulated act article intended import united_states act furtherance violation committed united_states title viii extends years exclusivity period qualified infectious disease products defines qualified infectious disease product antibacterial antifungal drug human use intended treat life threatening infections including caused antibacterial antifungal resistant pathogen including novel emerging infectious pathogens qualifying pathogens designated secretary requires secretary establish maintain list qualifying pathogens public methodology developing list sec makes qualified infectious disease products eligible priority fast track review 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 title drug approval patient access sec expresses sense congress fda apply accelerated approval fast track provisions expedite development availability treatments life threatening diseases conditions maintaining safety effectiveness standards treatments sec requires secretary request sponsor drug expedite development review drug drug treats life threatening disease condition drug demonstrates substantial improvement existing therapies breakthrough therapy sec provides consultation stakeholders external experts rare diseases targeted therapies genetic targeting treatments sec requires architectural_and_transportation_barriers_compliance_board convene stakeholder working group develop best practices access information prescription drug container labels blind visually impaired individuals sec requires secretary implement structured risk benefit assessment framework revised drug approval process act sec extends fy2017 authorization appropriations grants contracts development drugs rare diseases conditions orphan drugs sec requires publication fda website transmittal congress report examining extent current requirements clinical trial participation inclusion safety effectiveness data demographic subgroups including sex age race ethnicity included applications submitted fda sec directs secretary award priority review voucher providing fda review months sponsor rare pediatric disease product application establish user fee program sponsors requires comptroller general study report effectiveness awarding rare pediatric disease priority vouchers title drug shortages sec revises requirements notifying secretary drug shortages sec requires secretary submit annual report specified congressional committees drug shortages includes specification number manufacturers submitted drug shortage notification number drug shortages occurring calendar year list major actions taken secretary prevent mitigate drug shortages description coordination fda drug_enforcement_administration dea prevent alleviate drug shortages sec requires secretary establish task force develop implement strategic plan enhancing secretary response preventing mitigating drug shortages sec requires secretary maintain date list drugs determined shortage including drug shortage manufacturer drug shortage reason shortage estimated duration shortage sec amends controlled substances act require attorney general review requests increase quotas controlled substances determination days request pertains drug shortage 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 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 sec requires comptroller general study report cause drug shortages formulate recommendations prevent alleviate shortages title provisions subtitle sec extends october deadline applications elections relating marketing exclusivity certain drugs containing single sec extends fy2017 authorization appropriations implement fda critical path initiative subtitle medical gas product regulation 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 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 miscellaneous provisions sec requires secretary years enactment act issue guidance promotion internet including social media medical products regulated fda sec requires secretary review current federal initiatives identify gaps opportunities respect ensuring safe use prescription drugs potential abuse treatment prescription drug dependence post report hhs website findings review promulgate guidance development abuse deterrent drug products sec requires secretary work regulatory authorities international organizations foster encourage uniform scientifically driven clinical trial standards medical products world accept data clinical investigations conducted outside united_states including european_union determining approve license clear drug device application submitted sec requires secretary develop strategy implementation plan advancing regulatory science medical products promote public health advance innovation regulatory decisionmaking sec requires secretary report congress development implementation comprehensive information technology strategic plan align information technology systems modernization projects fda strategic goals efforts finalize approve comprehensive inventory fda information technology systems ways fda uses strategic plan guide coordinate modernization projects activities extent fda fulfilled implementing recommendations government_accountability_office gao respect fda information technology requires gao report strategic plan january sec requires secretary expand activities related included fda regulated products address potential toxicology potential benefit new therapies derived nanotechnology effects biological systems interaction biological systems sec requires comptroller general report problems posed pharmacy internet websites violate federal state law sec requires fda report congress year enactment act small business initiatives programs sec extends whistleblower protections officers sec requires sunscreen drug products subject specified fda final rule comply rule december december products annual sales sec requires secretary submit congress year enactment act strategic integrated management plan center_for_drug_evaluation_and_research center_for_biologics_evaluation_and_research center_for_devices_and_radiological_health sec revises risk evaluation mitigation strategy system sec extends months effective enactment date act september period generic drug applicant obtain tentative fda approval day exclusivity period reduces period months beginning october ending september sec requires secretary issue final substantive determination petition filed generic drug applicant determining drug withdrawn safety effectiveness reason later days filing petition sec revises rules relating review citizen petitions generic biosimilar applications reduces period fda required act petitions days submission sec requires electronic submission drug generic drug biologic biosimilar applications beginning earlier months issuance final fda guidance developed public notice comment period sec requires secretary develop implement strategies solicit views patients medical product development process sec requires commissioner food drugs review modify necessary fda communication plan inform educate health care providers patients benefits risk medical products particular focus underrepresented subpopulations including racial subgroups issue communication plan year enactment act post plan website fda office_of_minority_health sec requires secretary hold public meeting days enactment act solicit advice recommendations variety stakeholders respect scheduling drug products containing hydrocodone combined sec directs comptroller general conduct study report benefits efficiencies electronic patient labeling prescription drugs sec authorizes secretary facilitate development recommendations interoperability standards inform facilitate exchange prescription drug information state lines states receiving grant funds harold rogers prescription drug monitoring programs requires secretary report congress enhancing interoperability state prescription drug monitoring programs technologies databases detecting reducing fraud diversion drug abuse sec revises requirements relating disclosure conflicts interest individuals recruited serve fda advisory committees 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 terminates prohibition years enactment act subtitle synthetic drugs synthetic drug abuse prevention act sec amends controlled substances act add schedule controlled substance material compound mixture preparation contains specified cannabimimetic agents salts isomers salts isomers thereof specified additional substances sec extends period attorney general temporarily include substance schedule avoid imminent hazard public safety years year extension currently year month extension


Summary: Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act 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; and (2) 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 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 provide development publicly accessible electronic repository requires secretary publish food_and_drug_administration fda website link website


Summary: Preventing Abuse of Cough Treatments Act of 2012 or the PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is: (1) made pursuant to a validly issued prescription; or (2) to an individual who provides proof of being married, the parent of a child, or actively enrolled in the military. Imposes civil monetary penalties that escalate upon repeated violation. Deems to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act. Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services (HHS) as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between registered, licensed, or approved persons. Imposes additional civil monetary penalties for such possession and distribution violations.

preventing abuse treatments act pact act amends federal food drug cosmetic act prohibit sale offering sale drug containing dextromethorphan subject practitioner supervision requirements individual age sale pursuant validly issued prescription individual provides proof married parent child actively enrolled military imposes civil monetary penalties repeated violation deems adulterated unfinished dextromethorphan possessed received distributed violation act prohibits person possessing receiving unfinished dextromethorphan person registered secretary health_and_human_services hhs producer drug device registered licensed approved pursuant federal state law engage practice pharmacy pharmaceutical production manufacture distribution drug ingredients distributing unfinished dextromethorphan person registered authorized person excludes prohibitions common carriers possess receive distribute unfinished dextromethorphan purposes distributing registered licensed approved persons imposes additional civil monetary penalties possession distribution violations


Summary: Taking Essential Steps for Testing Act or the TEST Act - 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 test 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: 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: Ethical Pathway Act of 2012 - Directs the Commissioner of Food and Drugs (FDA) to establish a mechanism by which an applicant to sell any new pharmaceutical drug, vaccine, biologic product, or medical device that requires regulatory approval by the Secretary of Health and Human Services (HHS) (regulated product) may request a cost-sharing arrangement under which the applicant shall: (1) verify that intended clinical investigations involving humans or vertebrate animals have not been performed or initiated by another person; (2) make reasonable efforts to obtain voluntary agreements to use existing evidence regarding the safety and efficacy of new pharmaceutical drugs or biological products used to obtain marketing approval for use in humans or vertebrate animals (regulatory test data); and (3) notify the Commissioner if there is a failure to reach a voluntary agreement, at which point the Commissioner shall ask the parties to agree to binding arbitration to determine the reasonable and fair fee for relying upon relevant regulatory test data. Permits such applicant to request such arrangement if, but for the arrangement: (1) the applicant would be required to conduct clinical investigations involving human subjects that violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects in order to obtain regulatory approval of the regulated product, or (2) the duplication of the clinical investigations required for such application would violate other applicable ethical standards concerning the testing of products on humans or other vertebrate animals. Requires the fee for reliance by the applicant on such regulatory test data to be determined after considering: (1) the actual out-of-pocket costs of the applicable clinical investigations; (2) the risks of the investigations; (3) any federal grants, tax credits, or other subsidies; (4) the expected share of the global market for the product involved; and (5) the amount of time the holders of the relevant applications or licenses have benefited from exclusive rights and the cumulative revenue earned on the products that relied upon the data at issue. Directs the Secretary to adopt procedures and rules under which sufficient information about costs and fees will be made public.

ethical pathway act directs commissioner food drugs fda establish mechanism applicant sell new pharmaceutical drug vaccine biologic product medical device requires regulatory approval secretary health_and_human_services hhs regulated product request cost sharing arrangement applicant shall verify intended clinical investigations involving humans animals performed initiated person reasonable efforts obtain voluntary agreements use existing evidence safety efficacy new pharmaceutical drugs biological products obtain marketing approval use humans animals regulatory test data notify commissioner failure reach voluntary agreement point commissioner shall ask parties agree binding arbitration determine reasonable fair fee relying relevant regulatory test data permits applicant request arrangement arrangement applicant required conduct clinical investigations involving human subjects violate article declaration ethical principles medical research involving human subjects order obtain regulatory approval regulated product duplication clinical investigations required application violate applicable ethical standards concerning testing products humans animals requires fee reliance applicant regulatory test data determined considering actual pocket costs applicable clinical investigations risks investigations federal grants tax credits subsidies expected share global market product involved time holders relevant applications licenses benefited exclusive rights cumulative revenue earned products relied data issue directs secretary adopt procedures rules sufficient information costs fees public


Summary: Medicaid Information Technology to Enhance Community Health Act of 2012 or MITECH Act - Amends title XIX (Medicaid) of the Social Security Act to extend payments to encourage the adoption and use of certified electronic health record (EHR) technology to qualified safety net clinics (QSNCs). Defines a QSNC as a clinic or network of clinics operated by a private non-profit or public entity at least 30% percent of whose patient volume is attributable to needy individuals. Defines a "QSNC-based" individual as one who furnishes substantially all of his or her professional services in a QSNC and through use of the clinic's facilities and equipment, including qualified EHRs. Directs the Secretary of Health and Human Services (HHS) to establish a procedure through which a QSNC may demonstrate meaningful use of certified EHR technology in order to receive incentive payments.

enhance community health act act amends title xix medicaid social security act extend payments encourage adoption use certified electronic health record ehr technology qualified safety net clinics defines clinic network clinics operated private non profit public entity percent patient volume attributable needy individuals defines based individual furnishes substantially professional services use clinic facilities equipment including qualified directs secretary health_and_human_services hhs establish procedure demonstrate meaningful use certified ehr technology order receive incentive payments


Summary:
Small Supplier Fairness in Bidding Competition Act of 2013 - Amends part B (Supplementary Medical Insurance Benefits for Aged and Disabled) of title XVIII (Medicare) of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS).

Requires the Administrator of the Centers for Medicare & Medicaid Services (CMS) to report to Congress on the impact of competitive bidding on small clinical laboratories.

Includes CMS (solely with respect to its capacity to issue rules governing the Medicare part B fee schedule for clinical laboratory services) as an agency for purposes of the requirement to assure the opportunity for participation of small entities in the making of rules that will have a significant economic impact on them.

small supplier fairness bidding competition act amends supplementary medical insurance benefits aged disabled title xviii medicare social security act repeal medicare competitive acquisition program durable medical equipment prosthetics orthotics supplies dmepos requires administrator centers cms report congress impact competitive bidding small clinical laboratories includes cms solely respect capacity issue rules governing medicare fee schedule clinical laboratory services agency purposes requirement assure opportunity participation small entities making rules significant economic impact


Summary:
Stop Tampering of Prescription Pills Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for abuse-deterrent 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 abuse-deterrent if an abuse-deterrent 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 an abuse-deterrent 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 abuse-deterrent 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 abuse-deterrent 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 abuse-deterrent may have its approval withdrawn or suspended.

stop tampering prescription act amends cosmetic act prescribe new drug application requirements abuse deterrent 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 abuse deterrent abuse deterrent 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 abuse deterrent drug include testing information demonstrating generic drug manipulation effect manipulation degree comparable listed drug authorizes secretary deny approval generic application listed drug abuse deterrent generic drug active differ material respect listed drug declares approved generic drug shall considered having therapeutic effect listed drug listed drug abuse deterrent generic drug demonstrates manipulation effect manipulation degree comparable listed drug prescribes requirements governing drug abuse deterrent approval withdrawn suspended


Summary: Protect Medical Innovation Act of 2013 - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

protect medical innovation act amends internal revenue code repeal excise tax medical device manufacturers importers


Summary: First Responder Medical Device Tax Relief Act - Amends the Internal Revenue Code to exempt a qualified emergency medical device from the excise tax on medical devices. Defines "qualified emergency medical device" as a medical device furnished by first responders or ambulance services in providing out-of-hospital or pre-hospital care, or transport to a medical care facility, for individuals with illnesses, injuries, or other medical emergencies or in need of medical transport, extrication, or evacuation.

responder medical device tax relief act amends internal revenue code exempt qualified emergency medical device excise tax medical devices defines qualified emergency medical device medical device furnished responders ambulance services providing hospital pre hospital care transport medical care facility individuals illnesses injuries medical emergencies need medical transport evacuation


Summary: Amends the National Organ Transplant Act to prohibit acquiring, receiving, or otherwise transferring a cord blood unit (the neonatal blood collected from the placenta and umbilical cord of a single newborn baby) for valuable consideration for use in human transplantation if the transfer affects interstate commerce.

amends national_organ_transplant_act prohibit acquiring receiving transferring cord blood unit neonatal blood collected umbilical cord single newborn baby valuable consideration use human transplantation transfer affects interstate commerce


Summary: Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers.

amends supplementary_medical_insurance title xviii medicare social security act exclude average sales price calculating medicare payments drugs biologicals customary prompt pay discounts manufacturers wholesalers


Summary: Say No to Drug Ads Act - Amends the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertisement of a prescription drug.

drug ads act amends internal revenue code deny tax deduction cost direct consumer advertisement prescription drug


Summary:
Preservation of Antibiotics for Medical Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration.

Defines “medically important antimicrobial” as a drug intended for use in food-producing animals and composed wholly or partly of: (1) any kind of specified antibiotics, including penicillin and tetracycline; or (2) a drug from an antimicrobial class that is listed on the World Health Organization’s list of critically important antimicrobials.

Requires the Secretary to withdraw approval for the nontherapeutic use in food-producing animals of a medically important antimicrobial marketed for human use unless the Secretary makes a final written determination that, based on either the application holder's demonstration or an HHS risk analysis, there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the drug's nontherapeutic use.

Requires the Secretary to rescind approval of an exemption for investigational use of, or of approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in a food-producing animal two years after the exemption is granted or the application for approval is submitted. Exempts from this requirement any drugs for which there has been found a reasonable certainty of no harm to human health.

Prohibits the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. Requires the administration of the antimicrobial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.

preservation_of_antibiotics_for_medical_treatment_act amends cosmetic act require applicant approval new animal drug medically important antimicrobial demonstrate reasonable certainty harm human health development antimicrobial resistance attributable nontherapeutic use drug requires secretary health_and_human_services hhs refuse approval applicant fails demonstration defines medically important antimicrobial drug intended use food producing animals composed wholly partly kind specified antibiotics including drug antimicrobial class listed world_health_organization list critically important antimicrobials requires secretary withdraw approval nontherapeutic use food producing animals medically important antimicrobial marketed human use secretary makes final written determination based application holder demonstration hhs risk analysis reasonable certainty harm human health development antimicrobial resistance attributable drug nontherapeutic use requires secretary rescind approval exemption investigational use approval new drug application medically important antimicrobial nontherapeutic use food producing animal years exemption granted application approval submitted exempts requirement drugs found reasonable certainty harm human health prohibits administration medically important antimicrobial including means animal feed food producing animal disease control significant risk disease infection present premises transmitted food producing animal requires administration antimicrobial necessary prevent reduce risk transmission shortest duration possible prevent reduce risk transmission scale greater barn house pen level fewest animals possible prevent reduce risk transmission


Summary:
Asthma Inhalers Relief Act of 2013 - Directs the Administrator of the Environmental Protection Agency (EPA) to: (1) permit the distribution, sale, and consumption in the United States of remaining inventories of CFC epinephrine inhalers manufactured pursuant to the exception for medical devices under the Clean Air Act; (2) not take any enforcement action or otherwise seek to restrict the distribution, sale, or consumption of such inhalers on the basis of any federal law implementing the Montreal Protocol on Substances that Deplete the Ozone Layer; and (3) issue, in response to a request of any distributor or seller of such inhalers, a No Action Assurance Letter stating that the EPA will not initiate an enforcement action relating to the distribution or sale of any such inhaler occurring prior to August 1, 2013.

Defines "CFC epinephrine inhaler" to mean any epinephrine inhaler containing chlorofluorocarbons that was manufactured and classified as over-the-counter before January 1, 2012.

Terminates this Act on August 1, 2013.

asthma inhalers relief act directs administrator environmental_protection_agency epa permit distribution sale consumption united_states remaining inventories cfc epinephrine inhalers manufactured pursuant exception medical devices clean air act enforcement action seek restrict distribution sale consumption inhalers basis federal law implementing montreal protocol substances ozone layer issue response request distributor seller inhalers action assurance letter stating epa initiate enforcement action relating distribution sale occurring prior august defines cfc epinephrine mean epinephrine containing chlorofluorocarbons manufactured classified counter january terminates act august


Summary: Hearing Aid Assistance Tax Credit Act 2013 - Amends the Internal Revenue Code to allow a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for the taxpayer, the taxpayer's spouse, or a dependent of the taxpayer. Denies such tax credit to any taxpayer whose modified adjusted gross income exceeds $200,000.

hearing aid assistance tax credit act amends internal revenue code allow nonrefundable income tax credit purchase qualified hearing aid taxpayer taxpayer spouse dependent taxpayer denies tax credit taxpayer modified adjusted gross income exceeds


Summary: Stop Oxy Abuse Act of 2013 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain.

stop abuse act directs commissioner food drugs fda days actions necessary modify approval limit subsequent approval drug containing controlled release use relief severe pain instead moderate severe pain


Summary:
Safe Cosmetics and Personal Care Products Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of cosmetics by the Secretary of Health and Human Services (HHS).

Requires any brand owner engaged in bringing a cosmetic to market for use in the United States to register annually and pay a fee for oversight and enforcement of this Act.

Requires the Secretary to: (1) establish labeling requirements, (2) establish a safety standard that provides a reasonable certainty of no harm from exposure to a cosmetic or an ingredient in a cosmetic and that protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient, and (3) issue guidance prescribing good manufacturing practices for cosmetics and ingredients.

Requires brand owners to submit to the Secretary safety data for the ingredients listed on the cosmetic label and the cosmetic itself, which shall be published in a database.

Requires the Secretary to review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce, including nanotechnology and contaminants of concern linked to severe acute reactions or long-term adverse health effects.

Requires the Secretary, based on an initial review and evaluation, to establish three lists for ingredients: (1) a prohibited and restricted list, (2) a safe without limits list, and (3) a priority assessment list.

Authorizes the Secretary to order a recall or cease of distribution for a cosmetic that is adulterated, misbranded, or otherwise in violation of the FFDCA.

 Requires reporting of any serious adverse event associated with cosmetics.

Requires the Secretary to take action to minimize the use of animal testing of ingredients and cosmetics.

Establishes an Interagency Council on Cosmetic Safety.

Requires the Secretary of Labor to promulgate an occupational safety and health standard relating to cosmetics for professional use.

safe cosmetics personal care products act amends cosmetic act provide regulation cosmetics secretary health_and_human_services hhs requires brand owner engaged bringing cosmetic market use united_states register annually pay fee oversight enforcement act requires secretary establish labeling requirements establish safety standard provides reasonable certainty harm exposure cosmetic ingredient cosmetic protects public known anticipated adverse health effects associated cosmetic ingredient issue guidance prescribing good manufacturing practices cosmetics ingredients requires brand owners submit secretary safety data ingredients listed cosmetic label cosmetic shall published database requires secretary review evaluate safety cosmetics ingredients cosmetics marketed interstate commerce including nanotechnology contaminants concern linked severe acute reactions long term adverse health effects requires secretary based initial review evaluation establish lists ingredients prohibited restricted list safe limits list priority assessment list authorizes secretary order recall cease distribution cosmetic adulterated misbranded violation ffdca requires reporting adverse event associated cosmetics requires secretary action minimize use animal testing ingredients cosmetics requires secretary labor promulgate occupational safety health standard relating cosmetics professional use