zli12321/Bills huggingface dataset:
Swift Approval, Full Evaluation Drug Act or the SAFE Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to: (1) order postmarket studies of approved drugs upon receiving evidence of a significant issue regarding the safety or lack of effectiveness of such a drug; and (2) establish restrictions on the distribution or use of the drug during the period in which the study is conducted.Directs the Secretary to amend regulations to require postmarket studies of drugs approved under an accelerated approval process for new drugs for serious or life-threatening illnesses. Deems a drug or device to be misbranded if there is a failure to comply with requirements under this Act.Prohibits discrimination against individuals who provide information in an investigation or proceeding regarding a violation of any law, rule, or regulation, censorship, distortion, or suppression of scientific information, research, or analysis, or the willful disclosure of false, misleading, or incomplete scientific information.Authorizes Food and Drug Administration (FDA) officers, employees, and sponsored individuals to publish in peer-reviewed journals and other scientific publications and make oral presentations at professional society meetings and other meetings of their peers, with certain exceptions.Prohibits an FDA officer or employee from directing any other FDA officer or employee to: (1) censor, distort, or suppress any scientific research, analysis, opinion, or recommendation; or (2) willfully disclose scientific information that is false, misleading, or incomplete.Requires the Secretary to publish a summary statement of the scientific basis for approval of any new drug and how the final decision balanced the risk and benefits within 48 hours after approval of an application.

Date: 2007-02-16
Topic: Health (Drug Industry)
Subject: Health
Preserve Access to Affordable Generics Act - Amends the Clayton Act to make it unlawful for a person, in connection with the sale of a drug product, to be a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market, or sell the generic product for any period. Excludes a resolution or settlement that includes no more than the right to market the generic product prior to the expiration of the patent. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreements are complete, final, and exclusive. Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the Federal Trade Commission (FTC) or the court that an agreement has violated this Act.

Date: 2007-03-09
Topic: Health (Drug Industry)
Subject: Commerce
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.

Date: 2007-03-13
Topic: Health (Drug Industry)
Subject: Health
Beating Infections through Research and Development Act of 2007 - Sets forth circumstances under which the term of a patent may be extended for qualified infectious disease products.Requires the Secretary of Health and Human Services to designate qualified infectious disease products as fast-track products for approval.Amends the Public Health Service Act to require the Director of the National Institute of Allergy and Infectious Diseases to expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products.Amends the Internal Revenue Code to establish an infectious disease research credit and a qualified infectious disease products manufacturing facilities investment credit.Establishes the Commission on Infectious Diseases Product Development to identify drug-resistant infectious pathogens that are a significant threat to public health and make recommendations to the Secretary on how best to address such pathogens.Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary, acting through the Commissioner of Food and Drugs, to issue guidelines for the conduct of clinical trials with respect to antibiotic drugs.

Date: 2007-03-13
Topic: Health (Drug Industry)
Subject: Health
Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to repeal the Medicare prescription drug benefit late enrollment penalty.

Date: 2007-03-14
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-03-19
Topic: Health (Drug Industry)
Subject: Health
Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

Date: 2007-04-17
Topic: Health (Drug Industry)
Subject: Health
Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved or licensed.Prohibits the Secretary from designating a similar biological product as therapeutically equivalent to the reference product.Prohibits the Secretary from approving a product that is claimed to be similar to or the same as a reference product under any other provision of law.Authorizes any person to request issuance of product-class specific guidance applicable to a qualified biological product and its class.Requires the Secretary to establish a Similar Biological Products Advisory Committee.Sets forth provisions governing the naming of biotechnology-derived therapeutic protein and other biological products. Amends the Federal Food, Drug, and Cosmetic Act to deem a biotechnology-derived therapeutic protein to be misbranded if its labeling fails to meet the requirements of this Act.

Date: 2007-04-19
Topic: Health (Drug Industry)
Subject: Health
Vaccine Safety and Public Confidence Assurance Act of 2007 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services. Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships for research on vaccine safety. Requires the Commissioner of Food and Drugs to provide the Director, upon request, with complete access to all vaccine-related information submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. Requires the Director to require vaccine manufacturers to: (1) provide for postmarketing surveillance and clinical testing for any acute or chronic adverse reactions associated with the vaccine; and (2) register in a qualified public registry each clinical trial conducted or supported by the manufacturer with respect to the vaccine. Transfers to the Agency Centers for Disease Control and Prevention (CDC) responsibilities for the Vaccine Safety Datalink Project, the Clinical Immunization Safety Assessment Centers, or any other post-licensure vaccine safety monitoring activities. Requires the Secretary to establish an advisory council in the Agency.

Date: 2007-04-19
Topic: Health (Drug Industry)
Subject: Health
Mercury in Dental Fillings Disclosure and Prohibition Act - Amends the Federal Food, Drug, and Cosmetic Act to deem any drug or device to be adulterated if it contains mercury intended for use in a dental filling, effective January 1, 2009.Deems a device that contains mercury intended for use in a dental filling to be misbranded, effective December 31, 2007, unless it bears a specified warning label that it: (1) contains mercury, a highly toxic element; (2) should not be administered to children under age 18 or to pregnant or lactating women; and (3) poses health risks.

Date: 2007-05-01
Topic: Health (Drug Industry)
Subject: Health
Amputee Veteran Assistance Act - Directs the Secretary of Veterans Affairs to ensure that all Department of Veterans Affairs (VA) orthotic-prosthetic laboratories and clinics are certified by either the American Board for Certification in Orthotics and Prosthetics or the Board of Orthotics and Prosthetic Certification. Requires the Secretary to contract with a non-VA entity for the service and repair of prosthetic devices for a veteran if: (1) the Secretary determines that VA facilities are unable to perform such service or repair due to a lack of technology or any other reason; or (2) the veteran needing such service or repair resides more than 55 miles from the nearest VA facility capable of furnishing such service or repair. Directs the Secretary to: (1) develop and carry out a plan to inform disabled veterans at least twice a year of technological advances in the field of prosthetics; (2) review all VA orthotic-prosthetic laboratories and clinics to ensure that the VA is capable of servicing and repairing the most technologically advanced prosthetic devices; and (3) review VA prosthetists and orthotists to determine the level and kinds of education required to ensure their qualification to provide the most technologically advanced prosthetic devices.

Date: 2007-05-03
Topic: Health (Drug Industry)
Subject: Armed forces and national security
Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation. Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.

Date: 2007-05-10
Topic: Health (Drug Industry)
Subject: Health
TRICARE Mail-Order Pharmacy Pilot Program Act - Directs the Secretary of Defense to conduct a two-year pilot program to educate and motivate beneficiaries to voluntarily increase their use of the TRICARE (a Department of Defense [DOD] managed care program) mail-order pharmacy. Requires the program to include at least 2,000 eligible beneficiaries in each TRICARE region, of whom at least 1,000 in each region shall be enrolled in Medicare Part B.

Date: 2007-05-15
Topic: Health (Drug Industry)
Subject: Armed forces and national security
FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA). Deems a breast implant to be a class III medical device. Requires premarket approval of breast implants irrespective of whether the implant has been cleared for commercial distribution in interstate commerce before the date of enactment of this Act.Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a a breast implant unless the applicant involved has demonstrated its safety for the life of the implant. Deems an already approved breast implant to be unsafe under the conditions of use prescribed, recommended, or suggested in the labeling. Requires the Secretary to: (1) issue appropriate, voluntary guidance for clinical care, removal, and replacement for breast implants; (2) require such guidance to be clearly expressed in the labeling and all marketing materials; and (3) require dissemination of such guidance to patients who have already received the implant. Requires the Breast Implant Advisory Panel of the General and Plastic Surgery Advisory Committee to review the results and quality of the research on saline breast implants and silicone gel implants.Requires the Secretary to study the ionization and levels of platinum in silicone breast implants.Requires the Secretary, acting through the Commissioner of Food and Drugs, to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by females of childbearing potential under the age of 18.

Date: 2007-05-24
Topic: Health (Drug Industry)
Subject: Health
Human Cloning Prohibition Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make it unlawful for any person, including a governmental entity, to: (1) perform or attempt to perform human cloning; or (2) ship, mail, transport, or receive the product of human somatic cell nuclear transfer technology knowing that such product is for the purpose of human cloning. Sets forth criminal and civil penalties for violations of this Act.

Date: 2007-06-05
Topic: Health (Drug Industry)
Subject: Health
Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any FDA-regulated product. Establishes an exception for accepting funds from a consortium of companies whose products are FDA-regulated if the Secretary determines that such acceptance would not result in any conflict of interest and issues a waiver.

Date: 2007-06-06
Topic: Health (Drug Industry)
Subject: Health
Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription.Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment.Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers.Sets forth civil penalties and establishes a a private cause of action for violations of this Act.

Date: 2007-06-06
Topic: Health (Drug Industry)
Subject: Health
340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such requirements, including for drugs unavailable through the program and to facilitate generic substitution when a generic covered drug is available at a lower price. Expands the program to include a drug used in connection with an inpatient or outpatient service by enrolled hospitals. (Currently, only outpatient drugs are covered under the program.)Requires hospitals enrolled in the 340B drug discount program to provide to each state a credit on the estimated annual costs to such hospital of single source and innovator multiple source drugs and noninnovator multiple source drugs provided to Medicaid recipients for inpatient use. Sets forth a formula for calculating the credit. Allows a hospital to avoid paying such credits under certain circumstances. Requires the Secretary to: (1) carry out activities to improve compliance by manufacturers and covered entities with the requirements of the drug discount program; and (2) establish an administrative process for resolving claims by covered entities and manufacturers of violations of such requirements.Requires manufacturers to offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such a drug is made available to any other purchaser at any price.

Date: 2007-06-07
Topic: Health (Drug Industry)
Subject: Health
Reducing Fraudulent and Imitation Drugs Act of 2007 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible. Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses. Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: (1) overt optically variable counterfeit-resistant technologies into packaging; and (2) required prescription drug packaging technologies into multiple elements of the physical packaging of the drugs. Requires prescription drug shipments to include a label on the shipping container that incorporates packaging technologies. Deems a prescription drug to be misbranded if the packaging or labeling of the drug is in violation of a requirement or prohibition of this Act. Requires the Secretary to publish the National Specified List of Susceptible Prescription Drugs, consisting of not less than 30 of the most frequently counterfeited prescription drugs in the United States.

Date: 2007-06-14
Topic: Health (Drug Industry)
Subject: Health
DSHEA Full Implementation and Enforcement Act of 2007 - Authorizes and makes appropriations to: (1) carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and all applicable regulatory requirements for dietary supplements under the Federal Food, Drug, and Cosmetic Act; and (2) expand research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Food and Drug Administration (FDA) to fully and appropriately use such funds to regulate dietary supplements. Directs the Secretary of Health and Human Services to report to Congress on the implementation and enforcement of DSHEA.

Date: 2007-06-14
Topic: Health (Drug Industry)
Subject: Agriculture and food
Safe Tissue Act - Requires the Food and Drug Administration (FDA) to inspect, at least once every two years, each establishment that engages in the manufacture of human cells, tissues, and cellular and tissue-based products. Allows the Secretary of Health and Human Services to establish a user fee to fund such inspections. Requires the FDA to conduct periodic audits of all documentation submitted by each such establishment to determine compliance with all applicable requirements, including requirements related to ensuring: (1) that human cells, tissues, or cellular or tissue-based products are obtained legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice. Requires the Secretary to publish a model form containing minimum requirements for establishments to use in obtaining consent from a potential donor of human cells, tissues, or cellular or tissue-based products. Sets forth penalties for failing to comply with model form requirements or for knowingly using fraudulent information. Directs the Secretary to: (1) accredit establishments and the personnel of such establishments who participate in the recovery, processing, storage, labeling, packaging, or distribution of human cells, tissues, or cellular or tissue-based products; and (2) define "reasonable payments" that are associated with donation of human tissue and tissue-based products for purposes of the National Organ Transplant Act.

Date: 2007-06-14
Topic: Health (Drug Industry)
Subject: Health
Unique Device Identification System for Medical Devices Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations requiring the labeling of medical devices to bear a unique identifier.

Date: 2007-06-20
Topic: Health (Drug Industry)
Subject: Health
Fair Balance Prescription Drug Advertisement Act of 2007 - Amends the Internal Revenue Code to disallow a tax deduction for: (1) expenses for direct-to-consumer prescription drug advertising that fails to provide adequate information on drug side effects, contraindications, or lack of effectiveness; and (2) expenses for direct-to-consumer prescription drug advertising of a new drug, a new combination of active substances, or a new delivery system for an existing drug for a two-year period after the introduction of such drug into interstate commerce.Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to report to the Secretary of the Treasury on misbranding and other violations relating to direct-to-consumer prescription drug advertising.

Date: 2007-06-21
Topic: Health (Drug Industry)
Subject: Health
Drug and Medical Device Company Gift Disclosure Act - Amends the Federal Food, Drug, and Cosmetic Act to require prescription drug or medical device manufacturers, packers, and distributors to annually disclose to the Commissioner of Food and Drugs the value, nature, and purpose of any : (1) gift made in connection with detailing, promotion, or other marketing activity to any physician, nurse, therapist, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to prescribe or dispense prescription drugs; and (2) cash rebate, discount, or other financial consideration given to any pharmaceutical benefit manager in connection with such marketing activities. Defines "gift" to include any fee, payment, subsidy, amenity, object, service, or other economic benefit, except: (1) free samples of prescription drugs; (2) reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial; and (3) certain scholarships or other support for medical students, residents, or fellows to attend conferences. Applies such provisions only if the total value of the gift or gifts is $50 or more during the calendar year. Requires the Commissioner to: (1) make such information available to the public; and (2) keep confidential any information related to a trade secret. Establishes civil penalties for violations.Gives the Commissioner authority to investigate compliance with this Act. Authorizes the Commissioner to file a petition in the United States District Court for an order requiring submission of a report or other appropriate relief.

Date: 2007-07-12
Topic: Health (Drug Industry)
Subject: Health
Skin Cancer Prevention, Education, and Consumer Right-To-Know Act - Amends the Federal Food, Drug, and Cosmetic Act to deem a drug that is a sunscreen product whose labeling violates this Act to be adulterated.Prohibits the labeling of a drug that is a sunscreen product that fails to meet the standards adopted under this Act from: (1) describing the product using the term "broad-spectrum"; or (2) including a specified symbol adopted to indicate broad-spectrum.Requires the Secretary of Health and Human Services to adopt: (1) a standard for broad-spectrum protection in sunscreen products; and (2) an easily recognized symbol for inclusion in the labeling of sunscreen products meeting such standards.Sets forth minimum standards that the Secretary shall adopt for such broad-spectrum protection, including a minimum ratio of UVA protection factor to sun protection factor, a minimum level of UVB radiation protection, and specified truth in labeling requirements. Requires sun protection factors to be measured using standardized, reproducible testing methods that take photo-degradation into account.Requires the Secretary to implement an education campaign identifying the risks posed by sun exposure without the use of a sunscreen providing broad-spectrum protection.

Date: 2007-07-18
Topic: Health (Drug Industry)
Subject: Health
Voluntary State Discount Prescription Drug Plan Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to require drug manufacturers to pay rebates to state prescription drug discount programs as a condition of participating in a Medicaid rebate agreement for outpatient prescription drugs, but only if the state has elected to establish an optional state prescription drug discount program.

Date: 2007-08-01
Topic: Health (Drug Industry)
Subject: Health
Community Clinical Laboratory Fairness in Competition Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to repeal the mandate for a Medicare Competitive Bidding Demonstration Project for Clinical Laboratory Services. Amends federal civil service to subject the Centers for Medicare & Medicaid Services of the Department of Health and Human Services (solely with respect to its capacity to issue rules governing the Medicare part B fee schedule for clinical laboratory services) to the requirement to submit to a small business advocacy review panel for comment any proposed rule which will have a significant economic impact on a substantial number of small entities.

Date: 2007-08-04
Topic: Health (Drug Industry)
Subject: Health
Everson Walls and Ron Springs Gift for Life Act of 2007 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to establish a National Organ Tissue Donor Registry Resource Center, which shall: (1) advance the development, expansion, and evaluation of state organ and tissue donor registries; (2) facilitate timely access to, and the exchange of accurate donor information between, such registries 24 hours a day; (3) ensure that funded registries comply with requirements; (4) provide technical assistance to states for such registries; and (5) maintain a registry information clearinghouse.Requires the Secretary to award grants or cooperative agreements to eligible entities for such registries. Requires recipients to agree to establish benchmarks for improvement in organ and tissue donation and to maintain registries that: (1) allow a donor to include a statement or symbol that the donor has made, amended, or revoked an anatomical gift; (2) allow organ procurement organizations to access that information, at or near the donor's death, 24 hours a day; and (3) bar the use or disclosure of personally identifiable information for any other purpose without the donor's consent.Directs the Comptroller General to study and report to Congress on the feasibility of establishing a living donor database to track short- and long-term health effects for donors associated with living organ donation.

Date: 2007-09-24
Topic: Health (Drug Industry)
Subject: Health
Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and (2) amend the order to include a recall if necessary.

Date: 2007-11-05
Topic: Health (Drug Industry)
Subject: Health
Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements.Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress.

Date: 2007-11-06
Topic: Health (Drug Industry)
Subject: Health
Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product.Prohibits licensure under this Act of a biological product containing specified agents or toxins.Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.Provides for confidentiality of information received pursuant to this Act.Sets forth provisions governing patent infringement actions related to this Act.Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.

Date: 2008-03-13
Topic: Health (Drug Industry)
Subject: Health
Safeguarding America's Pharmaceuticals Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and certain adulterated or misbranded imported drugs.Requires the manufacturer of a prescription drug to provide to each wholesale distributor or dispenser a packing list or comparable document that includes information identifying the drug's proprietary and established names and National Drug Code number.Requires each person engaged in wholesale distribution of a prescription drug to provide information on each prior transaction involving the drug.Requires the Secretary of Health and Human Services (the Secretary) to report to Congress on the feasibility and operational efficiencies of adopting security technologies, including track and trace technology throughout the prescription drug supply chain. Phases in requirements for standardized numerical identifiers that are unique to each unit of a prescription drug.Requires the Secretary to issue regulations to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for such an identifier.Requires the Comptroller General to study the availability and cost of technologies to dispensers to comply with this Act.Requires the Secretary to: (1) award matching grants for drug identification and tracking systems to ensure the security and integrity of the drug supply chain; and (2) issue guidelines for wholesale distributors that prescribe requirements that include mandatory background checks and physical inspection of facilities.Sets forth civil penalties for violations of this Act.Requires the Secretary to study threats to the domestic prescription drug supply chain and make recommendations for improvements.

Date: 2008-04-17
Topic: Health (Drug Industry)
Subject: Health
Early Access to Treatment Act - Amends the Federal Food, Drug, and Cosmetic Act to require a drug that is not approved for marketing, but that is under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available, to be made available for treatment use by an individual patient if: (1) the drug is intended to treat such condition; (2) there is no comparable or satisfactory alternative available to treat that stage of the disease; (3) the drug is under investigation in a controlled clinical trial as an investigational new drug or all clinical trials have been completed; and (4) an application for treatment use has been filed with the Food and Drug Administration (FDA) by a licensed practitioner which sets forth the intended use of the drug, an explanation of the rationale for its use, the treatment protocol, statements of the practitioner's qualifications to use the drug and familiarity with its safety and effectiveness, and a notarized statement of the patient's informed consent. Requires the Secretary of Health and Human Services, within 30 days after an application is filed, to grant permission to the sponsor to furnish such drug to the practitioner under such terms as the sponsor, practitioner, and patient determine to be appropriate, including any agreement to waive liability. Provides for application transmission by telephone or other means of rapid communication and for rapid action on it in an emergency situation.Requires (current law authorizes) the Secretary to approve an application under the Public Health Service Act for a fast track product determined to have an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit.

Date: 2008-05-14
Topic: Health (Drug Industry)
Subject: Health
Responsibility in Drug and Device Advertising Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising in the first three years after approval of a new drug or device. Authorizes the Secretary of Health and Human Services to: (1) waive such prohibition if such advertising would have an affirmative value to public health; and (2) continue such prohibition in subsequent years if the drug or device has significant adverse health effects.Requires any direct-to-consumer advertisement to include a fair balance of the benefits and risks associated with the drug or device.Deems a drug to be misbranded if a direct-to-consumer television advertisement for such drug does not prominently display a statement encouraging individuals to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Requires the Secretary to discontinue the study designed to determine if such a statement is appropriate for television advertisements.Deems a device to be misbranded if a direct-to-consumer television advertisement for such device does not include a statement encouraging individuals to report negative side effects of medical devices to the FDA.Sets forth civil monetary penalties for violations relating to the advertising and promotion of a drug or device. Allows the Secretary to order the distribution of materials to notify the public and the medical community of such a violation and to provide corrective information.Requires the Secretary to conduct an education campaign to increase public awareness of risks that, for some patients, may outweigh the benefits of using a particular drug or device.Authorizes additional appropriations to regulate direct-to-consumer drug and device advertisements.

Date: 2008-05-22
Topic: Health (Drug Industry)
Subject: Health
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.

Date: 2008-06-12
Topic: Health (Drug Industry)
Subject: Health