Drug Safety, Medical Device, And Laboratory Regulation
US Congress 113th Congress
Safe and Affordable Drugs from Canada Act of 2014 [S.2549]
Safe and Affordable Drugs from Canada Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services (HHS) to promulgate regulations permitting individuals to safely import into the United States, with exceptions, a prescription drug purchased from an approved Canadian pharmacy that: is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice
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Sponsored by: Sen. John McCain
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 06/26/2014
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 [S.242]
Pandemic and All-Hazards Preparedness Act Reauthorization of 2013 - Amends the Public Health Service Act (PHSA) to require the Secretary of Health and Human Services (HHS) to submit the National Health Security Strategy to Congress in 2014. Gives the Assistant Secretary for Preparedness lead responsibility within HHS for emergency preparedness and response policy and coordination. Requires the Secretary to establish the National Advisory Committee on Children and Disasters. Prescribes requirements for the voluntary emergency reassignment of state
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Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/07/2013
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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 [S.2389]
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 - Title I: Agricultural Programs - Appropriates FY2015 funds for the following Department of Agriculture (USDA) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of the Chief Economist; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Office of the Chief Information Officer; (6) Office of the Chief Financial Officer; (7) Office of the Assistant Secretary for Civil Rights;
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Sponsored by: Sen. Mark Pryor
Committee On Appropriations. Original Measure Reported To Senate By Senator Pryor. With Written Report No. 113-164. on 05/22/2014
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Sunscreen Innovation Act [S.2141]
Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective. Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed
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Sponsored by: Sen. Jack Reed
Signed By President. on 11/26/2014
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Act to Ban Zohydro [S.2134]
Act to Ban Zohydro - Ends the sale and distribution of pure hydrocodone bitartrate extended-release capsules (marketed as Zohydro ER) within 45 days by withdrawing approval for its new drug application. Prohibits the Commissioner of Food and Drugs (FDA) from approving any new drug application for the capsules unless they are formulated to prevent abuse.
Sponsored by: Sen. Joe Manchin
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/13/2014
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Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 [S.2007]
Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 or the PROTECT Act of 2014 - Expresses the sense of Congress concerning: interagency coordination to foster health information technology and mobile health innovation, development of legislation to establish a risk-based regulatory framework for clinical software and health software, oversight by the National Institute of Standards and Technology (NIST) of technical standards used by clinical software, and work by NIST on next steps regarding health information technology, such
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Sponsored by: Sen. Angus King
Sponsor Introductory Remarks On Measure. (cr S853-854) on 02/10/2014
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STAR Act of 2013 [S.1860]
Steps Toward Access and Reform Act of 2013 or STAR Act of 2013 - Limits the commencement of a health care lawsuit, except in certain cases including fraud or intentional concealment, to three years after the date of manifestation of injury or one year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. Limits to $250,000 the amount of noneconomic damages in such a lawsuit, but allows a claim for the full amount of any economic damages. Requires the court, in any health
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Sponsored by: Sen. Dean Heller
Read Twice And Referred To The Committee On Finance. on 12/19/2013
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Increasing the Safety of Prescription Drug Use Act of 2013 [S.1657]
Increasing the Safety of Prescription Drug Use Act of 2013 - Amends the Public Health Service Act, with respect to state databases for controlled substance monitoring programs, to require the state to: (1) ensure that its database is interoperable with other such programs and electronic health records and provides updated patient information available to a practitioner; (2) require practitioners to use database information to help determine whether to prescribe or renew a prescription for a controlled substance; and (3) require dispensers, where
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Sponsored by: Sen. Robert Casey
Committee On United States Senate Caucus On International Narcotics Control. Hearings Held. on 05/14/2014
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Preventing Antibiotic Resistance Act of 2013 [S.1256]
Preventing Antibiotic Resistance Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration. Defines “medically important antimicrobial”
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Sponsored by: Sen. Jack Reed
Sponsor Introductory Remarks On Measure. (cr S5503-5504) on 06/27/2013
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Expressing support for designation of the month of September as "Clinical Research Innovation Month". [HR-733]
Expresses support for the designation of September 2014 as Clinical Research Innovation Month. Honors and recognizes the contributions of Clinical Research Organizations.
Sponsored by: Rep. Jackie Speier
Referred To The Subcommittee On Health. on 09/19/2014
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Recognizing the importance of transformative breakthroughs in biomedicine, biotechnology, and life sciences in the diagnosis, management, curing, and treatment of illness and the existence of a ''Valley of Death'' in biotechnology and life sciences funding that stifles innovation and impedes translational medical research. [HR-709]
Recognizes the value of biomedicine, biotechnology, and life sciences; the challenges those industries face; and ways those challenges can be addressed.
Sponsored by: Rep. Bobby Rush
Referred To The Subcommittee On Health. on 08/01/2014
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Expressing the sense of the House of Representatives that the Food and Drug Administration should encourage the use of abuse-deterrent formulations of drugs. [HR-161]
Expresses the sense of the House of Representatives that the Food and Drug Administration (FDA) should exercise its acknowledged authority to: (1) refuse to approve generic versions of non-abuse-deterrent opioid products that have been replaced in the market with abuse-deterrent formulations, and (2) require generic versions of abuse-deterrent opioid products to be formulated with comparable abuse-deterrent features.
Sponsored by: Rep. William Keating
Referred To The Subcommittee On Health. on 04/19/2013
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Food and Drug Administration Continuing Appropriations Resolution, 2014 [HJR-77]
Food and Drug Administration Continuing Appropriations Resolution, 2014 - Makes appropriations, out of any money in the Treasury not otherwise appropriated, and out of applicable corporate or other revenues, receipts, and funds, for the Food and Drug Administration (FDA) for FY2014, and for other purposes, such amounts as may be necessary, at a rate for operations as provided in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 (division A of P.L. 113-6), for continuing projects or activities
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Sponsored by: Rep. Robert Aderholt
Read The Second Time. Placed On Senate Legislative Calendar Under General Orders. Calendar No. 212. on 10/09/2013
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 [HB-942]
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology items designed and configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, and functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) and instrumental ADLs. Directs the Secretary of Health and Human Services (HHS) to: (1) designate
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 03/08/2013
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Consolidated and Further Continuing Appropriations Act, 2015 [HB-83]
Requires the Secretary of the Interior to establish within the Empowering Insular Communities activity a team of technical, policy, and financial experts to: (1) develop an energy action plan addressing the energy needs of each of the insular areas (American Samoa, the Northern Mariana Islands, Puerto Rico, Guam, and the Virgin Islands) and Freely Associated States (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and (2) assist each of the insular areas and Freely Associated States in implementing
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Sponsored by: Rep. Gregorio Sablan
Became Public Law No: 113-235. on 12/16/2014
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Delivering Antimicrobial Transparency in Animals Act of 2013 [HB-820]
Delivering Antimicrobial Transparency in Animals Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to revise reporting requirements for the sponsor of a new animal drug containing an antimicrobial active ingredient. Requires a sponsor's annual report to the Secretary of Health and Human Services (HHS) to specify for each dosage form the known or estimated amounts of the antimicrobial active ingredient sold or distributed for use in each food-producing animal for which the new animal drug is approved. Repeals the requirement that such
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Sponsored by: Rep. Mike Quigley
Referred To The Subcommittee On Health. on 03/01/2013
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Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of 2014 [HB-594]
Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of 2014 - (Sec. 2) Amends the Public Health Service Act to revise the muscular dystrophy research program of the National Institutes of Health (NIH). Expands the range of forms of muscular dystrophy included within the program. Requires the research conducted through Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers to include cardiac and pulmonary function research. Requires the Director of NIH to ensure the sharing of data between such
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Sponsored by: Rep. Ted Poe
Became Public Law No: 113-166. on 09/26/2014
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Counterfeit Drug Enforcement Act of 2014 [HB-5874]
Counterfeit Drug Enforcement Act of 2014
Sponsored by: Rep. Steve Israel
Referred To The House Committee On Energy And Commerce. on 12/11/2014
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To allow the importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients who execute an informed consent document. [HB-5854]
Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the importation, distribution, or sale of investigational drugs or devices for terminally ill patients.
Sponsored by: Rep. Alan Grayson
Referred To The House Committee On Energy And Commerce. on 12/11/2014
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Andrea Sloan Compassionate Use Reform and Enhancement Act [HB-5805]
Andrea Sloan Compassionate Use Reform and Enhancement Act
Sponsored by: Rep. Michael McCaul
Referred To The Subcommittee On Health. on 12/12/2014