Summary: Medicare Orthotics and Prosthetics Improvement Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act with respect to recognized independent accreditation organizations which apply quality standards to which suppliers of items and services relating to prosthetic devices and orthotics and prosthetics. Directs the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization for such purposes only if it is the American Board for Certification in Orthotics and Prosthetics, Inc., the Board for Orthotist/Prosthetist Certification, or a program that the Secretary determines has accreditation and approval standards essentially equivalent to those of such a Board. Requires application to prosthetic devices and orthotics and prosthetics generally of existing accreditation and licensure requirements for certain prosthetics and custom-fabricated orthotics. Directs the Secretary to report to Congress on: (1) the steps taken by the Department of HHS to ensure that such licensure and accreditation requirements are enforced; and (2) the effect of the requirements of this Act on the occurrence of fraud and abuse under the Medicare program with respect to prosthetic devices and orthotics and prosthetics. Modifies the Medicare payment methodology for prosthetic devices and orthotics and prosthetics to account for practitioner qualifications and complexity of care.

medicare_orthotics prosthetics improvement act amends title xviii medicare social security act respect recognized independent accreditation organizations apply quality standards suppliers items services relating prosthetic devices orthotics prosthetics directs secretary health_and_human_services hhs designate approve independent accreditation organization purposes program secretary determines accreditation approval standards essentially equivalent board requires application prosthetic devices orthotics prosthetics generally existing accreditation licensure requirements certain prosthetics custom fabricated orthotics directs secretary report congress steps taken ensure licensure accreditation requirements enforced effect requirements act occurrence fraud abuse medicare program respect prosthetic devices orthotics prosthetics modifies medicare payment methodology prosthetic devices orthotics prosthetics account practitioner qualifications complexity care


Summary: Science Free Speech Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide that a food or dietary supplement is not a drug solely because a claim is made regarding legitimate scientific research in accordance with this Act.States that a food is not misbranded if its label makes a claim regarding legitimate scientific research in accordance with this Act.Declares that the use of truthful and not misleading information on legitimate scientific research in connection with the sale or distribution of a food or dietary supplement to consumers shall not be treated as a violation under the FFDCA and shall not be deemed evidence of an intent to sell a drug.Prohibits the Secretary of Health and Human Services from: (1) restricting in any way the distribution of truthful and not misleading information on legitimate scientific research; or (2) prohibiting manufacturers or distributors of foods or dietary supplements from including citations to legitimate scientific research in the labeling of a food or dietary supplement, even if the citation expressly or implicitly references a disease or a disease condition.Places the burden of proof on the Secretary in any administrative or judicial proceeding in which the Secretary contests the use of material being disseminated or cited as legitimate scientific research.Prohibits the Secretary from prohibiting or restricting a retailer or wholesaler of any agricultural product, including fresh produce, in any way from: (1) testing any of its agricultural products for any pathogens that may potentially be transmitted to humans or potentially cause illness or disease in humans; or (2) communicating the results of such tests to the public.

science free speech act amends cosmetic act ffdca provide food dietary supplement drug solely claim legitimate scientific research accordance act states food misbranded label makes claim legitimate scientific research accordance act declares use truthful misleading information legitimate scientific research connection sale distribution food dietary supplement consumers shall treated violation ffdca shall deemed evidence intent sell drug prohibits secretary health_and_human_services restricting way distribution truthful misleading information legitimate scientific research prohibiting manufacturers distributors foods dietary supplements including citations legitimate scientific research labeling food dietary supplement citation expressly references disease disease condition places burden proof secretary administrative judicial proceeding secretary contests use material disseminated cited legitimate scientific research prohibits secretary prohibiting restricting retailer wholesaler agricultural product including fresh produce way testing agricultural products pathogens potentially transmitted humans potentially cause illness disease humans communicating results tests public


Summary: Citizen Petition Fairness and Accuracy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require that any citizen petition or request for stay of action related to an abbreviated new drug application include a statement that to the petitioner's best knowledge and belief, the petition: (1) includes all information and views on which the petitioner relies; (2) is well grounded in fact and is warranted by law; (3) is not submitted for an improper purpose; and (4) does not contain a materially false, misleading, or fraudulent statement. Requires the Secretary of Health and Human Services to investigate any petition that does not comply with such requirements. Allows the Secretary to impose penalties for knowingly and willfully submitting a petition for an improper purpose or that contains a materially false, misleading or fraudulent statement. Provides that such penalties may include: (1) imposition of a civil penalty; (2) suspension or revocation of the petitioner's authority to submit such a petition; and (3) dismissal of the petition. Requires the Secretary to refer such a violative petition to the Federal Trade Commission (FTC) for further action. Sets forth the factors that the Secretary shall consider in taking an enforcement action or determining the penalty. Permits any person aggrieved by a petition that may contain violations to submit a request, with a certification of good faith, for the Secretary to initiate an investigation. Subjects such person to civil penalties for knowing and intentional submission of a violative request. Requires the Secretary to take final agency action on such a petition within six months. Prohibits the Secretary from extending the review period for any reason.

amends cosmetic act require citizen petition request stay action related abbreviated new drug application include statement petitioner best knowledge belief petition includes information views petitioner relies grounded fact warranted law submitted improper purpose contain materially false misleading fraudulent statement requires secretary health_and_human_services investigate petition comply requirements allows secretary impose penalties knowingly willfully submitting petition improper purpose contains materially false misleading fraudulent statement provides penalties include imposition civil penalty suspension revocation petitioner authority submit petition dismissal petition requires secretary refer petition federal_trade_commission ftc action sets forth factors secretary shall consider taking enforcement action determining penalty permits person aggrieved petition contain violations submit request certification good faith secretary initiate investigation subjects person civil penalties knowing intentional submission request requires secretary final agency action petition months prohibits secretary extending review period reason


Summary: Private Property Rights Protection Act - Makes ineligible for federal funds any condemning authority or acquiring party that engages or participates in a taking or condemnation of any real property interest not for a public use or public purpose using the power of eminent domain, without the owner's consent. Requires any entity applying for federal funds to certify eligibility. Allows the Commissioner of the Internal Revenue Service (IRS) to audit any condemning authority or acquiring party that has made such a certification. Allows a property owner who is notified that his or her property will be taken to file for and attach a Fifth Amendment property protection statement (PPS) indicating that the condemning entity is exceeding its authority, which shall prohibit any acquiring party from claiming any benefit, deduction, or tax credit related to any activities conducted within the geographical boundaries comprising the jurisdiction of the condemning authority. Allows the condemning entity to seek a judicial determination of the statement's validity and an order releasing the PPS if not valid. Prohibits any government from engaging or participating in a taking or condemnation of any private real property interest under the power of eminent domain for any purpose that is not for a public purpose or a public use. Applies such prohibition to an exercise of eminent domain: (1) by the federal government; (2) related to a program or activity receiving federal financial assistance; or (3) that would affect commerce with foreign nations, among the states, or with Indian tribes. Allows a person to assert a violation of this act as a claim or defense in a judicial proceeding. Allows the United States to bring an action for injunctive or declaratory relief to enforce compliance with this Act.

act makes ineligible federal funds condemning authority acquiring party engages participates taking condemnation real property interest public use public purpose power eminent domain owner consent requires entity applying federal funds certify eligibility allows commissioner internal_revenue_service irs audit condemning authority acquiring party certification allows property owner notified property taken file attach fifth amendment property protection statement pps indicating condemning entity exceeding authority shall prohibit acquiring party claiming benefit deduction tax credit related activities conducted geographical boundaries comprising jurisdiction condemning authority allows condemning entity seek judicial determination statement validity order releasing pps valid prohibits government engaging participating taking condemnation private real property interest power eminent domain purpose public purpose public use applies prohibition exercise eminent domain federal government related program activity receiving federal financial assistance affect commerce foreign nations states indian tribes allows person assert violation act claim defense judicial proceeding allows united_states bring action injunctive declaratory relief enforce compliance act


Summary: Pharmaceutical Market Access Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, and wholesalers to import qualifying drugs from certain countries into the United States. Sets forth registration requirements for exporters. Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters. Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies. Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order. Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement. Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug. Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.

pharmaceutical market access act amends cosmetic act require secretary health_and_human_services promulgate regulations permitting pharmacists pharmacies wholesalers import qualifying drugs certain countries united_states sets forth registration requirements exporters requires secretary educate consumers regard availability qualifying drugs import personal use inspect facilities records importers registered exporters ensure compliance act establish registration fee program collect annual fee registered exporters deems prescription drug misbranded packaging drug complies requirements counterfeit resistant technologies prohibits failing register accordance act importing offering import prescription drug violation suspension order declares selling importing patented drug united_states sold abroad authority owner licensee patent patent infringement prohibits drug manufacturers discriminating person engages importation prescription drug including charging higher prices denying supplies drug allows secretary suspend terminate registration exporter failing maintain substantial compliance registration conditions


Summary: Fair Prescription Drug Competition Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the exclusivity period granted to the generic manufacturer.

fair prescription drug competition act amends cosmetic act prohibit holder new approved drug application commencing manufacture market sell distribute generic version drug time receipt notice generic manufacturer abbreviated new drug application submitted approval expiration forfeiture exclusivity period granted generic manufacturer


Summary: John R. Justice Prosecutors and Defenders Incentive Act of 2007 - Amends the Omnibus Crime Control and Safe Streets Act of 1968 to add a program for student loan repayment for prosecutors and public defenders. Defines "prosecutor" and "public defenders" to include individuals engaged in the supervision, education, or training of other prosecutors and public defenders. Includes within the definition of "public defender" full-time employees of nonprofit organizations who devote substantially all their time providing indigent criminal defense services and federal public defenders. Requires prosecutors and public defenders to prosecute or provide representation for juvenile delinquency cases.Directs the Attorney General to establish a program to assume the obligation to repay the student loans of any borrowers who are employed as prosecutors or public defenders and are not in default on their loans. Sets forth requirements for such program, including that: (1) the borrower will remain employed as a prosecutor or public defender for not less than three years; and (2) the borrower will repay to the Attorney General any repayment benefits received if the borrower is fired from employment for misconduct or voluntarily separates from employment.Limits the amount payable under such program to $10,000 per year for any borrower and to an aggregate total of $60,000 for any borrower.Authorizes the Attorney General to enter into subsequent agreements with a borrower for another three-year period or a lesser period.Requires the Attorney General to give priority in granting repayment benefits to borrowers who have the least ability to repay their loans.Authorizes the Attorney General to issue regulations to carry out this Act.Directs the Government Accountability Office to study and report to Congress on the impact of law school accreditation requirements and other factors on law school costs and access, including the impact of such requirements on racial and ethnic minorities.Authorizes appropriations.

defenders incentive act amends omnibus_crime_control_and_safe_streets_act add program student loan repayment prosecutors public defenders defines prosecutor public defenders include individuals engaged supervision education training prosecutors public defenders includes definition public defender time employees nonprofit organizations substantially time providing indigent criminal defense services federal public defenders requires prosecutors public defenders prosecute provide representation juvenile delinquency cases directs attorney general establish program assume obligation repay student loans borrowers employed prosecutors public defenders default loans sets forth requirements program including borrower remain employed prosecutor public defender years borrower repay attorney general repayment benefits received borrower fired employment misconduct voluntarily separates employment limits payable program year borrower aggregate total borrower authorizes attorney general enter subsequent agreements borrower year period lesser period requires attorney general priority granting repayment benefits borrowers ability repay loans authorizes attorney general issue regulations carry act directs government_accountability_office study report congress impact law school accreditation requirements factors law school costs access including impact requirements racial ethnic minorities authorizes appropriations


Summary: Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the general public; (5) taking corrective action if such an unreasonable risk may exist; and (6) making information about the safety and effectiveness of such drugs and biological products available to the public and health care providers in a timely manner. Requires the Drug Safety and Risk Management Advisory Committee to make recommendations to the Director on postmarket studies, drugs and biological products that may present an unreasonable risk, and appropriate corrective actions. Allows the Secretary of Health and Human Services to assess civil penalties for violations of this Act. Allows the Director to withdraw or suspend approval of a drug or license for a biological product using expedited procedures under certain circumstances. Transfers to the Center the functions and duties of the Office of Surveillance and Epidemiology.

amends cosmetic act establish biologics food_and_drug_administration fda requires director center conduct activities ensure safety effectiveness fda approved drugs licensed biological products including conducting postmarket risk assessment surveillance drugs products determining postmarket study required contracting requiring sponsor drug product contract holders domestic international patient databases conduct observational studies determining drug product present unreasonable risk health patients general public taking corrective action unreasonable risk exist making information safety effectiveness drugs biological products available public health care providers timely manner requires recommendations director postmarket studies drugs biological products present unreasonable risk appropriate corrective actions allows secretary health_and_human_services assess civil penalties violations act allows director withdraw suspend approval drug license biological product expedited procedures certain circumstances transfers center functions duties


Summary: Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs. Amends the Public Health Service Act to require the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases. Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.

innovation act amends cosmetic act require application approval new drug biological product include proposed risk evaluation mitigation strategy include labeling drug use health care providers submission reports drug statement analysis surveillance sufficient assess risks drug establishes drug safety oversight board requires secretary health_and_human_services establish reagan udall institute applied biomedical research nonprofit corporation advance critical path initiative modernize medical product development accelerate innovation enhance product safety requires institute board_of_directors allows board coordinate collaborate entities conduct research education outreach modernize sciences developing manufacturing evaluating safety effectiveness diagnostics devices biologics drugs amends public_health_service_act require secretary acting director national_institutes_of_health nih establish administer clinical trial registry database clinical trial results database requires responsible clinical trial submit clinical trial information director inclusion databases requires individual consideration term advisory committee providing advice recommendations secretary fda activities disclose industry financial interests


Summary: Living Kidney Organ Donation Clarification Act of 2007 - Provides that for purposes of provisions of the National Organ Transplant Act that prohibit the transfer of any human organ for use in human transplantation for valuable consideration, kidney paired donation does not involve such a transfer. Requires the Secretary of Health and Human Services to report to the appropriate congressional committees annually on progress toward understanding the long-term health effects of living organ donation.

living kidney organ donation clarification act provides purposes provisions national_organ_transplant_act prohibit transfer human organ use human transplantation valuable consideration kidney paired donation involve transfer requires secretary health_and_human_services report appropriate congressional committees annually progress understanding long term health effects living organ donation


Summary: Rural Opportunities Act of 2007 - Amends the Security and Rural Investment Act of 2002 to direct the Secretary of Agriculture to: (1) make state grants for extension, education, applied research, and development activities at institutions of higher education, state agencies, or partnerships for local and regional bioenergy and biobased product use and production; and (2) provide funds for basic research on next generation technology. Authorizes the Secretary to make supplemental rural cooperative development grants. Amends the Agricultural Research, Extension, and Education Reform Act of 1998 to direct the Secretary to: (1) establish regional bonus grant funds for bioenergy and biobased products competitive research, education, and extension programs; and (2) carry out agroforestry conversion and cellulosic production pilot programs. Extends: (1) the renewable energy systems and energy improvements program; and (2) the value-added agricultural grant program. Amends the Consolidated Farm and Rural Development Act to direct the Secretary to make state grants for development of the next generation of farmers, ranchers, and other land managers. Directs the Secretary to carry out specified pilot programs. Amends the Farm Security and Rural Investment Act of 2002 to extend: (1) the beginning farmer and rancher development program; and (2) the organic certification cost-share program. Directs the Secretary to identify barriers to small, beginning, limited resource, and socially disadvantaged producers in conservation and farm support programs. Authorizes funds for rural technology transfers. Amends the Food, Agriculture, Conservation, and Trade Act of 1990 to extend the best utilization of biological applications program. Establishes a federal-state matching grant program. Extends: (1) the national training program; (2) the organic agriculture research and extension program; and (3) the socially disadvantaged farmers and ranchers outreach and technical assistance program. Amends the Organic Foods Production Act of 1990 to direct the Secretary to establish a national organic agriculture conversion and stewardship incentives program. Authorizes geographic produce and food procurement preferences for certain Department of Defense and Department of Agriculture programs. Amends the Child Nutrition Act of 1966 to extend the women, infants, and children (WIC) farmers' market nutrition program. Amends the Farmer-to-Consumer Direct Marketing Act of 1976 to extend the farmers market promotion program. Amends the Food Stamp Act of 1977 to extend, and revise funding provisions for, assistance for community food projects. Requires: (1) broadband service providers to provide the Federal Communications Commission (FCC) with specified information; and (2) the FCC to provide Congress with demographic information for underserved areas. Sets forth specified offset provisions.

rural opportunities act amends security rural investment act direct secretary agriculture state grants extension education applied research development activities institutions higher education state agencies partnerships local regional bioenergy biobased product use production provide funds basic research generation technology authorizes secretary supplemental rural cooperative development grants amends education reform act direct secretary establish regional bonus grant funds bioenergy biobased products competitive research education extension programs carry conversion cellulosic production pilot programs extends renewable energy systems energy improvements program value added agricultural grant program amends consolidated_farm rural development act direct secretary state grants development generation farmers ranchers land managers directs secretary carry specified pilot programs amends farm_security rural investment act extend beginning farmer rancher development program organic certification cost share program directs secretary identify barriers small beginning limited resource socially disadvantaged producers conservation farm support programs authorizes funds rural technology transfers amends trade act extend best utilization biological applications program establishes federal state matching grant program extends national training program organic agriculture research extension program socially disadvantaged farmers ranchers outreach technical assistance program amends direct secretary establish national organic agriculture conversion stewardship incentives program authorizes geographic produce food procurement preferences certain programs amends child nutrition act extend women infants children wic farmers market nutrition program amends farmer consumer direct marketing act extend farmers market promotion program amends food stamp act extend revise funding provisions assistance community food projects requires broadband service providers provide federal_communications_commission fcc specified information fcc provide congress demographic information underserved areas sets forth specified offset provisions


Summary: Preservation of Antibiotics for Medical Treatment Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.Requires the Secretary of Health and Human Services to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met.Authorizes the Secretary of Agriculture to make payments to livestock or poultry producers to defray the costs of reducing the use of such drugs, with priority given to family-owned or small farms and ranches.Amends the Farm Security and Rural Investment Act of 2002 to direct the Secretary of Agriculture to award grants to colleges and universities to establish programs to phase out the nontherapeutic use of such drugs in livestock or poultry.Requires the manufacturer of such a drug or an animal feed for food-producing animals containing such a drug to report sales information to the Secretary of Health and Human Services.

preservation_of_antibiotics_for_medical_treatment_act amends cosmetic act require secretary health_and_human_services deny application new animal drug critical antimicrobial animal drug applicant demonstrates reasonably certainty harm human health development antimicrobial resistance attributable nontherapeutic use drug defines critical antimicrobial animal drug drug intended use food producing animals contains specified antibiotics drugs humans treat prevent disease infection caused microorganisms requires secretary health_and_human_services withdraw approval nontherapeutic use drugs food producing animals years date enactment act certain safety requirements met authorizes secretary agriculture payments livestock poultry producers defray costs reducing use drugs priority given family owned small farms amends farm_security rural investment act direct secretary agriculture award grants colleges universities establish programs phase nontherapeutic use drugs livestock poultry requires manufacturer drug animal feed food producing animals containing drug report sales information secretary health_and_human_services


Summary: Safe Internet Pharmacy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to set forth the conditions under which a licensed Internet pharmacy may dispense or offer to dispense a prescription drug to a person in the United States. Requires an Internet pharmacy to: (1) maintain patient medication profiles; (2) ensure patient confidentiality; (3) offer interactive and meaningful consultation by a licensed pharmacist to the caregiver or patient; (4) establish a mechanism for patients to report errors and suspected and adverse drug reactions and for the pharmacy to document its response and report such information to the Food and Drug Administration (FDA); and (5) verify the validity of prescriptions. Allows an Internet pharmacy to dispense a prescription for a controlled substance only if the treating provider confirms the accuracy of the prescription by direct communication.Allows the Secretary of Health and Human Services to suspend or terminate the license of an Internet pharmacy. Directs the Board of Governors of the Federal Reserve System to promulgate regulations to establish policies and procedures that are reasonably designed to prevent the introduction or completion of restricted transactions with unlicensed Internet pharmacies into a designated payment system.Requires the Secretary to provide for a system to identify and report Internet pharmacy websites in violation of federal or state law.Prohibits: (1) the ownership or operation of an Internet pharmacy in violation of this Act; and (2) the representation by an Internet pharmacy that a prescription drug may be obtained without a prescription. Sets forth penalties for violations of this Act.

safe internet pharmacy act amends cosmetic act set forth conditions licensed internet pharmacy dispense offer dispense prescription drug person united_states requires internet pharmacy maintain patient medication profiles ensure patient confidentiality offer interactive meaningful consultation licensed pharmacist caregiver patient establish mechanism patients report errors suspected adverse drug reactions pharmacy document response report information food_and_drug_administration fda verify validity prescriptions allows internet pharmacy dispense prescription controlled substance treating provider confirms accuracy prescription direct communication allows secretary health_and_human_services suspend terminate license internet pharmacy directs board_of_governors federal_reserve_system promulgate regulations establish policies procedures reasonably designed prevent introduction completion restricted transactions unlicensed internet pharmacies designated payment system requires secretary provide system identify report internet pharmacy websites violation federal state law prohibits ownership operation internet pharmacy violation act representation internet pharmacy prescription drug obtained prescription sets forth penalties violations act


Summary: Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product. Sets forth conditions for approval of such an application by the Secretary. Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Provides market exclusivity to such an interchangeable product. Requires the Secretary to defer issuing a determination of interchangeability for a subsequent comparable biological product during the period of market exclusivity for a prior interchangeable comparable biological product. Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications. Sets forth provisions governing patent infringement claims against an applicant or prospective applicant for a comparable biological product license.

access life saving medicine act amends public_health_service_act establish process approval abbreviated biological product application products contain similar active ingredients previously licensed biological product reference product allows person file abbreviated biological product application secretary health_and_human_services includes data demonstrating product comparable interchangeable reference product information conditions conditions use prescribed recommended suggested labeling proposed biological product previously approved reference product information route administration dosage form strength biological product reference product sets forth conditions approval application secretary allows applicant request secretary determination comparable product reference product based product expected produce clinical result reference product given patient provides market exclusivity interchangeable product requires secretary defer issuing determination subsequent comparable biological product period market exclusivity prior interchangeable comparable biological product requires secretary establish requirements efficient review approval suspension revocation comparable biological product applications sets forth provisions governing patent infringement claims applicant prospective applicant comparable biological product license


Summary: Tanning Accountability and Notification Act of 2007 - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to determine whether: (1) the labeling requirements for indoor tanning devices provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer; (2) adding the warning suggested by the American Academy of Dermatology or any other additional warning to the current warning label would communicate such risks more effectively; and (3) there is no warning that would be capable of adequately communicating such risks. Requires the Secretary, in making such determinations, to: (1) conduct appropriate consumer testing using the best available methods for determining consumer understanding of label warnings; and (2) hold public hearings and solicit comments from the public.

tanning accountability notification act requires secretary health_and_human_services acting commissioner food_and_drugs determine labeling requirements indoor tanning devices provide sufficient information consumers risks use devices pose development irreversible damage eyes skin including skin cancer adding warning suggested additional warning current warning label communicate risks effectively warning capable adequately communicating risks requires secretary making determinations conduct appropriate consumer testing best available methods determining consumer understanding label warnings hold public hearings solicit comments public


Summary: Laboratory Test Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a laboratory-developed test that is a direct-to-consumer test to be a prescription test if it satisfies the requirements of this Act. Deems any laboratory-developed test to be a medical device.Sets forth labeling and registration requirements for laboratory-developed tests.Requires the manufacturer of a laboratory-developed test that has not been cleared or approved for its intended use to submit the analytical and clinical validity of the test for its intended use to the Secretary of Health and Human Services. Requires the Secretary to include such information in a public database.Requires the Secretary to provide guidance to: (1) facilitate the use of reviews of the peer-reviewed biomedical literature and other information and data about the clinical validity of laboratory-developed tests and in vitro diagnostic products when clearing or approving such tests and products under the FFDCA; and (2) clarify when modifications to a laboratory-developed test require updating of the submitted information.Sets forth provisions regarding classification of laboratory-developed tests.Requires the Secretary to issue a proposed rule to establish a specialty area for the certification of laboratories for laboratory-developed tests to acquire genetic information, which shall include standards for proficiency testing of such tests.

laboratory test improvement act amends cosmetic act ffdca deem laboratory developed test direct consumer test prescription test satisfies requirements act deems laboratory developed test medical device sets forth labeling registration requirements laboratory developed tests requires manufacturer laboratory developed test cleared approved intended use submit analytical clinical validity test intended use secretary health_and_human_services requires secretary include information public database requires secretary provide guidance facilitate use reviews peer reviewed biomedical literature information data clinical validity laboratory developed tests vitro diagnostic products clearing approving tests products ffdca clarify modifications laboratory developed test require updating submitted information sets forth provisions classification laboratory developed tests requires secretary issue proposed rule establish specialty area certification laboratories laboratory developed tests acquire genetic information shall include standards proficiency testing tests


Summary: Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators and physicians access funding for pediatric medical device development. Requires the Secretary of Health and Human Services to award grants for demonstration projects to promote pediatric device development. Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Allows the Secretary to require: (1) postmarket surveillance on certain devices that are expected to have significant use in pediatric populations; and (2) a prospective surveillance period of more than 36 months for such devices, as necessary. Requires the Secretary, acting through the Commissioner of Food and Drugs, to establish a publicly accessible database of all studies and surveillance of medical devices.

pediatric medical device safety improvement act amends cosmetic act require application approval medical device product development protocol include description pediatric subpopulations suffer disease condition device intended treat diagnose cure number affected pediatric patients excludes medical device distributed pursuant humanitarian device exemption prohibition device sold exceeds cost device device intended treatment diagnosis disease condition occurs pediatric patients specified requirements met requires director national_institutes_of_health nih designate contact point help innovators physicians access funding pediatric medical device development requires secretary health_and_human_services award grants demonstration projects promote pediatric device development includes duty office_of_pediatric_therapeutics increasing pediatric access medical devices allows secretary require postmarket surveillance certain devices expected significant use pediatric populations prospective surveillance period months devices necessary requires secretary acting commissioner food_and_drugs establish publicly accessible database studies surveillance medical devices


Summary: Ryan Haight Online Pharmacy Consumer Protection Act of 2008 - Amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. Exempts telemedicine practitioners. Defines "valid prescription" as a prescription that is issued for a legitimate purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. Adds definitions to the Controlled Substances Act relating to online pharmacies and the issuance of prescriptions over the Internet.Imposes registration and reporting requirements on online pharmacies.Requires an online pharmacy to: (1) display on its Internet homepage a statement that it complies with the requirements of this Act; (2) comply with state laws for the licensure of pharmacies in each state in which it operates or sells controlled substances; (3) post on its Internet homepage specified information, including the name, address, and telephone number of the pharmacy, the qualifications of its pharmacist-in-charge, and a certification of its registration under this Act; and (4) notify the Attorney General and applicable state boards of pharmacy at least 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.Authorizes the Attorney General to issue a special registration under this Act for telemedicine practitioners.Increases criminal penalties involving controlled substances in Schedules III, IV, and V of the Controlled Substances Act. Authorizes states to apply for injunctions or obtain damages and other civil remedies against online pharmacies that are deemed a threat to state residents.Requires the U.S. Sentencing Commission, in determining whether to amend or establish new sentencing guidelines to conform the guidelines and policy statements to this Act, to consult with the Department of Justice (DOJ), experts, and other affected parties concerning which penalties for scheduled substances should be reflected.Requires the Drug Enforcement Administration (DEA) to report to Congress after the enactment of this Act and annually for two years after such initial report on: (1) the foreign supply chains and sources of controlled substances offered for sale without a valid prescription on the Internet; (2) DEA efforts and strategy to decrease such foreign supply chains; and (3) DEA efforts to work with domestic and multinational pharmaceutical companies and others in combating the sale of controlled substances over the Internet without a valid prescription.

pharmacy consumer protection act amends controlled substances act prohibit delivery distribution dispensing controlled substances internet valid prescription exempts telemedicine practitioners defines valid prescription prescription issued legitimate purpose practitioner conducted person medical evaluation patient adds definitions controlled substances act relating online pharmacies issuance prescriptions internet imposes registration reporting requirements online pharmacies requires online pharmacy display internet homepage statement complies requirements act comply state laws licensure pharmacies state operates sells controlled substances post internet homepage specified information including address telephone number pharmacy qualifications pharmacist charge certification registration act notify attorney general applicable state boards pharmacy days prior offering sell deliver distribute dispense controlled substances internet authorizes attorney general issue special registration act telemedicine practitioners increases criminal penalties involving controlled substances controlled substances act authorizes states apply injunctions obtain damages civil remedies online pharmacies deemed threat state residents requires determining amend establish new sentencing guidelines conform guidelines policy statements act consult department_of_justice doj experts affected parties concerning penalties scheduled substances reflected requires drug_enforcement_administration dea report congress enactment act annually years initial report foreign supply chains sources controlled substances offered sale valid prescription internet dea efforts strategy decrease foreign supply chains dea efforts work domestic multinational pharmaceutical companies combating sale controlled substances internet valid prescription


Summary: Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data collected and data that is publicly available or that is provided by the Secretary; (2) perform advanced research on identified drug safety risks; (3) identify safety questions that require further clinical study; and (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for, and communication of, postmarketing data collected.Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet site that: (1) provides comprehensive drug safety information for prescription drugs; and (2) improves communication of drug safety information to patients and providers.

safer data act amends cosmetic act require secretary health_and_human_services establish minimum standards collection transmission data elements electronic health data systems validated integrated postmarket risk identification analysis system integrate analyze safety data multiple sources directs secretary establish maintain active surveillance infrastructure collect report data pharmaceutical postmarket risk identification analysis requires secretary establish implement procedures secretary routinely collaborate qualified entity clean classify aggregate data collected data publicly available provided secretary perform advanced research identified drug safety risks identify safety questions require clinical study convene expert advisory committee oversee establishment standards ethical scientific uses communication data collected requires secretary improve transparency pharmaceutical data allow patients health care providers better access pharmaceutical data developing maintaining internet site provides comprehensive drug safety information prescription drugs improves communication drug safety information patients providers