zli12321/Bills huggingface dataset:
Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product.Requires the Secretary of Health and Human Services, in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available.Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

Date: 2008-06-26
Topic: Health (Drug Industry)
Subject: Health
Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services to initiate debarment not later than one year after a person or individual is convicted of a felony. Requires the Secretary, in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

Date: 2008-06-26
Topic: Health (Drug Industry)
Subject: Health
Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act.

Date: 2008-06-26
Topic: Health (Drug Industry)
Subject: Health
Stephanie Tubbs Jones Organ Transplant Authorization Act of 2008 - Amends the Public Health Service Act to increase the maximum amount of funds provided for the establishment and operation of the Organ Procurement and Transplantation Network for any fiscal year. Directs the Secretary of Health and Human Services to request that the Executive Director of the Network report to Congress on the effects of the heart allocation policy change of 2006. Conditions increased funding on submission of such a report.

Date: 2008-07-10
Topic: Health (Drug Industry)
Subject: Health
Savings for the Uninsured on Rx Expenses (SURE) Act of 2008 - Requires the Secretary of Health and Human Services to establish a prescription drug discount card program modeled on the Medicare drug discount card program to provide access to prescription drug discounts for eligible individuals. Defines as "eligible" an individual who: (1) is a U.S. citizen, national, or alien lawfully admitted for permanent residence; (2) is not eligible for outpatient prescription drug coverage; and (3) is not eligible to enroll for prescription drug coverage under part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act. Applies the Medicare drug discount card program requirements related to enrollment and card features, with certain exceptions. Requires a prescription drug card sponsor to disseminate information concerning the use of health savings accounts to cover the costs of prescriptions drugs for which discounts are provided. Directs the Secretary to require that sponsors demonstrate that they have a marketing plan to effectively reach out to eligible individuals. Disallows judicial review of a determination not to endorse a prescription drug discount card program or not to enter into a contract with a sponsor.

Date: 2008-07-24
Topic: Health (Drug Industry)
Subject: Health
Independent Drug Education and Outreach Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug prescribers concerning such drugs and interventions. Requires that grantees receive no support from any entity that manufactures products used to treat the medical conditions discussed.

Date: 2008-07-31
Topic: Health (Drug Industry)
Subject: Health
Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 - Directs the Secretary of Health and Human Services to: (1) establish a negotiated rulemaking committee to negotiate and develop a proposed rule for a Medicare modernized clinical diagnostic laboratory fee schedule; (2) report to Congress on the fee schedule; and (3) promulgate final regulations to establish it.

Date: 2008-07-31
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2008-09-11
Topic: Health (Drug Industry)
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.

Date: 2008-09-26
Topic: Health (Drug Industry)
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.

Date: 2007-01-04
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-01-04
Topic: Health (Drug Industry)
Subject: Public lands and natural resources
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.

Date: 2007-01-10
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-01-30
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-01-31
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
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: 2007-02-01
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-02-01
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-02-08
Topic: Health (Drug Industry)
Subject: Agriculture and food
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.

Date: 2007-02-12
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-02-14
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-02-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-02-16
Topic: Health (Drug Industry)
Subject: Commerce
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.

Date: 2007-03-01
Topic: Health (Drug Industry)
Subject: Health
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: 2007-03-08
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-03-23
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
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.

Date: 2007-03-29
Topic: Health (Drug Industry)
Subject: Health
Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use. Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant. Limits market exclusivity provided for conducting pediatric studies of new or already approved drugs to only those drugs for which the Secretary of Health and Human Services approves labeling that provides specific, therapeutically meaningful information about the use of the drug in pediatric patients. Reduces market exclusivity for such studies for drugs with sales revenue that is $1 billion or more. Prohibits the Secretary from delaying approval of a new drug application while a petition seeking any action relating to such an application is being reviewed or considered. Requires the Secretary to take final agency action on a petition within 180 days of receipt, with no extensions allowed. Extends the 30-month period that the Secretary has to approve or disapprove an abbreviated application for a new drug by the amount of time that lapses from the date the Secretary receives a petition and the date of the final agency action on the petition, without regard to whether the Secretary grants or denies the petition.

Date: 2007-04-11
Topic: Health (Drug Industry)
Subject: Health
Best Pharmaceuticals for Children Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than nine months prior to the expiration of such period.Requires an applicant or holder who does not agree with a request to conduct pediatric studies to submit to the Secretary the reasons such pediatric formulation cannot be developed. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective that is not introduced onto the market within one year; and (2) create an internal review committee to review all written requests issued and all reports submitted. Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed $1 billion.Requires the Secretary to order the labeling of a drug to include information about the result of a pediatric study whether such study does or does not demonstrate that the drug is safe and effective.Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.Includes pediatric pharmacological research within the pediatric research loan repayment program.

Date: 2007-04-18
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 children's hospitals, critical access hospitals, and rural referral centers or sole community hospitals. 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 prohibition, 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: 2007-05-14
Topic: Health (Drug Industry)
Subject: Health
Dextromethorphan Distribution Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act.Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of pharmaceutical ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between authorized persons.

Date: 2007-05-14
Topic: Health (Drug Industry)
Subject: Health
Amends title XVIII (Medicare) of the Social Security Act to provide for Medicare coverage of certain medical mobility devices approved as a class III medical device pursuant to a premarket approval application under the Federal Food, Drug, and Cosmetic Act.

Date: 2007-05-23
Topic: Health (Drug Industry)
Subject: Health
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: 2007-05-24
Topic: Health (Drug Industry)
Subject: Health
Home Oxygen Patient Protection Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to restore Medicare treatment of ownership of oxygen equipment that existed prior to the enactment of the Deficit Reduction Act of 2005. Repeals the limitation of Medicare payment to the supplier for such equipment (including portable oxygen equipment) to 36 months of continuous use.

Date: 2007-05-24
Topic: Health (Drug Industry)
Subject: Health
Affordable Biologics for Consumers Act - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biosimilar, which is defined as a biological product that is claimed to be similar to a qualified biological product (the reference product). Defines a "qualified biological product" as a biotechnology-derived therapeutic biological or protein product licensed or approved under the Federal Food, Drug, and Cosmetic Act.Allows the Secretary of Health and Human Services to approve an application for a biosimilar only: (1) for indications for which the reference product is approved; and (2) if the application conforms to the applicable final product class-specific rule and the Secretary concludes that the product is safe, pure, and potent.Authorizes a person to request the issuance of a product class-specific rule applicable to a qualified biological product and its class. Requires the Secretary to establish a Biosimilars Advisory Committee.Prohibits the approval of a biosimilar until at least 14 years have elapsed from approval of the reference product.Prohibits the Secretary from: (1) approving a product that is claimed to be similar to or the same as a reference product under any other provision of law; (2) approving another biosimilar for one year after approving the first biosimilar that relies on the same reference product; and (3) designating a biosimilar as interchangeable with (or therapeutically equivalent to) the applicable reference product.Sets forth provisions related to patents for a reference product. Allows approval of an application for a biosimilar to be effective even if patent litigation has not concluded.Amends the Federal Food, Drug, and Cosmetic Act to deem as misbranded a biotechnology-derived therapeutic protein if its labeling fails to meet specified requirements.

Date: 2007-05-24
Topic: Health (Drug Industry)
Subject: Health
Preserving Access to Laboratory Services 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.

Date: 2007-09-26
Topic: Health (Drug Industry)
Subject: Health
Community Pharmacy Fairness Act of 2007 - Entitles independent pharmacies negotiating contract terms with a health plan for the provision of health care items or services to the same treatment under the antitrust laws as the treatment to which bargaining units recognized under the National Labor Relations Act are entitled. Treats such a pharmacy as an employee engaged in concerted activities in connection with such negotiations. Exempts actions taken in good faith reliance on this Act from being subject to criminal sanctions or civil penalties beyond actual damages incurred. Prohibits: (1) exempting from the antitrust laws any agreement or otherwise unlawful conspiracy that excludes, limits the participation or reimbursement of, or otherwise limits the scope of services to be provided by any independent pharmacy or group of independent pharmacies with respect to the performance of services that are within their scope of practice as defined or permitted by relevant law or regulation; and (2) applying this Act to negotiations between independent pharmacies and health plans pertaining to federal health benefits.

Date: 2007-10-15
Topic: Health (Drug Industry)
Subject: Commerce
Transparency in Medical Device Pricing Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to require manufacturers of implantable medical devices to report annually to the Secretary of Health and Human Services on sales prices and related data about such devices.

Date: 2007-10-23
Topic: Health (Drug Industry)
Subject: Health