Top Legislation - View All

Latest Action: 01/04/2007 - Sponsor introductory remarks on measure. (CR S64-65)

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. 1/4/2007--Introduced. 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 [...]

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Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.

Bill Text
To provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU-486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for other purposes. 1/4/2007--Introduced. RU-486 Suspension and Review Act of 2007 - Deems the approved application for the drug mifepristone (marketed as Mifeprex, commonly known as RU-486, and used for the chemically induced termination of intrauterine pregnancy) to have been withdrawn. Deems the drug misoprostol to be misbranded under the Federal Food, Drug, and Cosmetic Act (FFDCA) if it bears labeling providing that the drug may be used for the medical termination of intrauterine pregnancy. Directs the Comptroller General to review and report on the process by which the Food and Drug Administration (FDA) approved mifepristone. Provides for the [...]

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Latest Action: 05/17/2007 - Conference papers: Senate report and manager's statement and message on House action held at the desk in Senate.

Bill Text
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2008 and including the appropriate budgetary levels for fiscal years 2007 and 2009 through 2012. 5/16/2007--Conference report filed in House.    (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2008, including the appropriate budgetary levels for FY2007 and FY2009-FY2012. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2007-FY2012, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits; (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security and specified major functional categories for FY2007-FY2012. Title II: Budget Process [...]

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Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. 1/10/2007--Introduced. Pharmaceutical Market Access and Drug Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.[...]

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Latest Action: 01/31/2007 - Sponsor introductory remarks on measure. (CR S1454-1455)

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients [...]

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Latest Action: 03/14/2007 - Committee on Health, Education, Labor, and Pensions. Hearings held.

Bill Text
A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. 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 [...]

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Latest Action: 02/08/2007 - Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (text of measure as introduced: CR S1786)

Bill Text
A bill to prohibit products that contain dry ultra-filtered milk products, milk protein concentrate, or casein from being labeled as domestic natural cheese, and for other purposes.

2/8/2007--Introduced.

Quality Cheese Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the Commissioner of the Food and Drug Administration from using federal funds to amend specified regulations to include dry ultra-filtered milk, milk protein concentrate, or casein in the definition of "milk" or "nonfat milk" as specified in the domestic natural standards for cheese and cheese products.

Latest Action: 02/08/2007 - Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.

Bill Text
A bill to require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella. 2/8/2007--Introduced. Domestic Pet Turtle Market Access Act of 2007 - Prohibits the Food and Drug Administration (FDA) from restricting the sale by a turtle farmer or other commercial retail seller of a turtle that is less than 10.2 centimeters in diameter as a pet if: (1) the turtle is raised, shipped, and sold using methods proven to keep the turtle free of salmonella, using salmonella safety standards comparable to standards for other animals allowed for sale as pets or animal products allowed for sale as food products; (2) the FDA has approved a plan submitted by the turtle farmer or seller relating to compliance with this Act; and (3) the farmer or seller makes certain disclosures to the buyer. Sets forth required disclosures, which include: (1) information regarding the dangers that could result if the [...]

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Latest Action: 02/12/2007 - Sponsor introductory remarks on measure. (CR S1855-1857)

Bill Text
A bill to reduce the Federal budget deficit, and for other purposes. 2/12/2007--Introduced. Act for Our Kids - Repeals the Television Broadcasting to Cuba Act. Amends the Cuban Liberty and Democratic Solidarity (LIBERTAD) Act of 1996 to prohibit federal funding of television broadcasting to Cuba. Terminates the U.S. Court of Federal Claims. Requires federal agencies to reduce administrative expenses. Eliminates the Medicare Advantage Regional Plan Stabilization (SLUSH) Fund. Amends the federal criminal code to prohibit profiteering and fraud involving a contract or the provision of goods or services in connection with a war or military action. Requires: (1) suspension and debarment of unethical contractors; (2) disclosure by federal agencies, upon request, to the appropriate committee chairman or ranking member of audit reports regarding federal contractors; and (3) public access to information on federal contractor penalties and [...]

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Latest Action: 02/13/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 2/13/2007--Introduced. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.Requires the Comptroller [...]

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Latest Legislation - View All

Latest Action: 07/30/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. 7/30/2008--Reported to House amended.    (There is 1 other summary) Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.Authorizes appropriations for FY2009-FY2013.Requires the Secretary to report to Congress and make publicly available information [...]

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Latest Action: 04/14/2008 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.

Bill Text
To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 3/13/2008--Introduced. 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 [...]

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Latest Action: 06/05/2008 - Mr. Spratt brought up conference report H. Rept. 110-659 for consideration under the provisions of H. Res. 1214.

Bill Text
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2009 and including the appropriate budgetary levels for fiscal years 2008 and 2010 through 2013. 5/20/2008--Conference report filed in House.    (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2009, including the appropriate budgetary levels for FY2008 and FY2010-FY2013. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2008-FY2013, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits (on-budget); (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security, U.S. Postal Service discretionary administrative expenses, and specified major functional [...]

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Latest Action: 04/25/2008 - Referred to the Subcommittee on Livestock, Dairy, and Poultry.

Bill Text
To authorize appropriations for the seafood inspection regime of the Food and Drug Administration.

1/29/2008--Introduced.

Authorizes appropriations to implement the seafood inspection regime of the Food and Drug Administration (FDA).

Latest Action: 11/06/2007 - Referred to the House Committee on Energy and Commerce.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes.

11/6/2007--Introduced.

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.

Latest Action: 11/06/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes.

11/6/2007--Introduced.

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.

Latest Action: 11/05/2007 - Referred to the House Committee on Energy and Commerce.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. 11/5/2007--Introduced. 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 [...]

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Latest Action: 10/09/2007 - Referred to the Subcommittee on Health.

Bill Text
To direct the Commissioner of Food and Drugs to revise the Federal regulations applicable to the declaration of the trans fat content of a food on the label and in the labeling of the food when such content is less than 0.5 gram.

10/9/2007--Introduced.

Trans Fat Truth in Labeling Act of 2007 - Directs the Commissioner of Food and Drugs to promulgate a final regulation revising federal regulations applicable to the declaration of the trans fat content on a food label to require that if the trans fat content of a serving of a food is less than .5 grams and is declared in the nutrition information on the label or in the labeling of the food, such content shall be expressed through the use of an asterisk or other notation stating that such content is less than .5 grams (instead of zero).