FDA Legislation Tracker

Posted 03 June 2015 By Alexander Gaffney, RAC

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Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists? Please email us at news@raps.org so we can add it to the tracker.

Last updated: 3 June 2015

Legislation Passed Into Law

Legislation and SummaryLink to TextExecutive SummarySigned Into Law
Designer Anabolic Steroid Control Act of 2014Link to legislationWould ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products.18 December 2014
Adding Ebola to the FDA Priority Review Voucher Program ActLink to legislationWould add the Ebola virus to a list of diseases eligible for a special priority review voucher. Also reforms the voucher to be easier to use and more valuable.16 December 2014
Sunscreen Innovation ActLink to legislationReforms FDA's regulation of pending and new sunscreen ingredients. Also makes reforms to FDA's Time-and-Extent (TEA) process.Became law on 26 November 2014.
Drug Quality and Security ActLink to legislationExpands FDA's regulation of compounding pharmacies, and establishes new controls on the pharmaceutical supply chain.Became law on 27 November 2013.
To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines.Link to legislationAdded a recently-approved influenza vaccine to a list of those eligible for legal liability protections under the law.Became law on 25 June 2013.
Animal Drug and Animal Generic Drug User Fee Reauthorization ActLink to legislationEstablishes user fees for veterinary pharmaceutical products.Became law on 13 June 2013
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)Link to legislationAuthorizes FDA to grant emergency use authorization to products in advance of a pandemicBecame law on 13 March 2013
FDA User Fee Corrections Act of 2012Link to legislationAllowed FDA to collect generic drug user fees subject to a temporary ban.Became law on 5 October 2012.
Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES ) Act of 2010Link to legislationEnhanced penalties for anyone found guilty of stealing or counterfeiting medical products.Became law on 5 October 2012.
Food and Drug Administration Safety and Innovation Act (FDASIA)Link to legislationMassive reform legislation reauthorized numerous user fee programs, created new user fee programs for biosimilars and generic drugs, and created several new regulatory pathways and programs.Became law on 9 July 2012.

 

Proposed Legislation

Legislation and SummaryLink to TextExecutive SummaryDate Introduced
2015
Accelerating Innovation in Medicine ActLink to LegislationWould create a new reimbursement process for some medical devices by establishing an "Accelerating Innovation in Medicine" (AIM) list. Patients could pay for an otherwise ineligible device directly.1 June 2015
Surrogate Endpoint Improvement and Utilization Act of 2015Link to LegislationComponent part of the 21st Century Cures Act21 May 2015
A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes.Link to LegislationSimilar to the already-introduced OPEN Act. Would grant additional periods of marketing exclusivity to old drugs approved for new (and rare) conditions.21 May 2015
21st Century Cures ActLink to LegislationWould create a dramatic overhaul of the way FDA regulates many healthcare products, including drugs, medical devices and clinical trials.19 May 2015
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compoundingLink to LegislationWould permit office use compounding by 503A compounding pharmacies.20 May 2015
To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products.Link to LegislationComponent part of the 21st Century Cures Act20 May 2015
To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To facilitate the responsible communication of scientific and medical developments.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic informationLink to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicineLink to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to use of antimicrobial drugs in food animalsLink to LegislationWould require FDA to collect and release additional information regarding the use of antimicrobial drugs in food animals.19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with regard to the Reagan-Udall Foundation.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.Link to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnosticsLink to LegislationComponent part of the 21st Century Cures Act19 May 2015
To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of health software, and for other purposes.Link to LegislationWould more narrowly structure the way in which FDA is able to regulate healthcare software.18 May 2015
To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes.Link to LegislationWould require FDA to systematically take into account the experiences and viewpoints of patients in the regulatory process.14 May 2015
To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devicesLink to LegislationWould create a pathway through which medical devices intended for high-need populations could be reviewed more quickly for approval.14 May 2015
Stop Tampering of Prescription Pills Act of 2015Link to LegislationWould require generic opioid painkillers to have the same abuse-deterrent proprties as the drugs they reference.14 May 2015
Safe and Affordable Drugs from Canada ActLink to legislationWould allow consumers to import drugs from Canadian pharmacies for personal use. Companion legislation to bill introduced in the Senate.1 May 2015
Research for All ActLink to LegislationRequires FDA to ensure greater gender equity in clinical trials for drugs granted expedited approval. Also establishes an expedited pathway for drugs intended to treat one sex differently than the other in life-threatening diseases.29 April 2015
Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) ActLink to LegislationWould exempt low-risk medical software and mobile apps from FDA regulation and provide greater certainty regarding what software will be regulated by the agency27 April 2015
Advancing Breakthrough Devices for Patients ActLink to LegislationWould create a new pathway to expedite the regulatory review of "breakthrough" medical devices23 April 2015
FDA Accountability for Public Safety ActLink to LegislationWould require the FDA commissioner personally approve an opioid drug if an advisory committee has recommended against its approval.15 April 2015
Charlotte's Web Medical Access Act of 2015Link to LegislationWould exclude cannabidiol from falling under the definition of marijuana in the Controlled Substances Act25 March 2015
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015Link to LegislationWould direct the GAO to investigate FDA's regulation of nonbiologic complex drugs, and whether the agency needs new regulatory authority.24 March 2015
Compassionate Access, Research Expansion and Respect States (CARERS) Act of 2015Link to LegislationWould make it easier to conduct research on marijuana's medicinal purposes.23 March 2015
Advancing Hope Act of 2015Link to LegislationBill would make permanent FDA's rare pediatric disease priority review voucher program, and make several other changes to FDA's voucher programs.23 March 2015
Preservation of Antibiotics for Medical Treatment Act of 2015Link to LegislationBill reserves eight classes of antibiotics from being routinely fed to animals23 March 2015
Infection Reduction Labeling ActLink to LegislationWould allow solid antimicrobial copper products to be labeled with statements regarding infection reduction properties, and exempt those products from drug and device regulations.18 March 2015
Speeding Access to Already Approved Pharmaceutical Act of 2015Link to LegislationWould allow companies whose products are approved in the EU to request an expedited review process. FDA would review products in 90 days.18 March 2015
Patient Choice Act of 2015Link to LegislationAllows terminally ill patients to access 'adequately safe' drugs through a provisional approval pathway. Bill introduced in 2013 under same title.16 March 2015
PATIENT Act of 2015Link to LegislationWould give some drugs an additional 24 months of marketing exclusivity if they are reformulated to be safer, more effective or more abuse-resistant.13 March 2015
Saving Kids from Candy-Flavored Drugs ActLink to LegislationWould increase penalties for marketing scheduled drugs contained within candy or fruit-flavored substances.12 March 2015
Compassionate Access, Research Expansion and Respect States Act of 2015Link to LegislationWould make it easier to research the medicinal properties of marijuana, and reschedule marijuana as a Class II substance under the Controlled Substances Act.10 March 2015
Increasing the Safety of Prescription Drug Use Act of 2015Link to LegislationWould require FDA to consider whether Naloxone should be available over-the-counter to consumers.3 March 2015
Preventing Antibiotic Resistance ActLink to LegislationWould seek to restrict the use of "medically important" antibiotics.2 March 2015
Synthetic Abuse and Labeling of Toxic Substances Act of 2015 (SALTS Act)Link to LegislationWould make it easier to controll substances if they are found to be intended for human consumption.27 February 2015
Clinical Trials Modernization Act of 2015Link to LegislationWould promote the use of adaptive clinical trial designs.25 February 2015
FDA Safety Over Sequestration (FDA SOS) ActLink to LegislationWould exempt FDA's user fee funding from the effects of any future budget sequestration.25 February 2015
Orphan Product Extensions Now Accelerating Cures & Treatments Act (OPEN ACT)Link to LegislationWould provide added marketing exclusivity for companies that work to get their drug products approved in new, rare conditions.13 February 2015
Andrea Sloan Compassionate Use Reform and Enhancement (CURE) ActLink to legislationWould require some pharmaceutical companies to make more information about their compassionate use programs available to the public.12 February 2015
Compassionate Freedom of Choice Act of 2015Link to LegislationWould provide a liability shield to doctors and companies providing expanded access treatments to terminally ill patients.5 February 2015
Vaccine Access, Certainty, and Innovation Act of 2015Link to LegislationIntended to make it easier to develop, market and export vaccine products.5 February 2015
Medical Innovation Act of 2015Link to LegislationWould require large drug companies settling with the US government to help fund NIH.4 February 2015
Improving Regulatory Transparency for New Medical Therapies ActLink to LegislationWould require the DEA to schedule FDA-approved drug products more quickly, and would extend marketing exclusivity to take into account the DEA review process.2 February 2015
Clinical Trial Cancer Mission 2020 ActLink to legislationRequires clinical trials results to be posted to ClinicalTrials.gov regardless of trial outcome.28 January 2015
Food Safety ActLink to legislationWould remove FDA's ability to regulate food products, potentially including dietary supplements.28 January 2015
DISARM Act of 2015Link to legislationWould create a new regulatory designation status--DISARM status--which would increase federal reimbursement for certain antibiotics.22 January 2015
Combination Drug Development Incentive Act of 2015Link to legislationWould explicitly make eligible combination drug products for five-year "new drug" exclusivity.20 January 2015
Promise for Antibiotics and Therapeutics for Health (PATH) ActLink to legislationWould create a new pathway for antibiotic approvals in "limited populations."16 January 2015

Medical Testing Availability Act of 2015

Link to legislationWould make it easier for sponsors of "Research Use Only" (RUO) products to sell their products without violating federal law.13 January 2015
FAIR Generics ActLink to legislationWould establish limits on the ability of companies to enter into pay-for-delay agreements.12 January 2015
Safe and Affordable Drugs from Canada ActLink to legislationWould allow consumers to import drugs from Canadian pharmacies for personal use.8 January 2015
Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015Link to legislationTargets chemical analogues of banned or scheduled substances by making them illegal to import.6 January 2015
Transnational Drug Trafficking Act of 2015Link to legislationTargets manufacturers or chemicals used to manufacture scheduled substances under the Controlled Substances Act.6 January 2015
2014
Counterfeit Drug Enforcement Act of 2014Link to legislationWould increase penalties for counterfeiting pharmaceuticals. Gives FDA new recall authority.11 December 2014
Dormant Therapies ActLink to legislationWould give drugs approved for unmet needs 15 years of marketing exclusivity.11 December 2014
Promise for Antibiotics and Therapeutics for Health (PATH) ActLink to legislationWould create a new pathway for antibiotic approvals in "limited populations."10 December 2014
Andrea Sloan Compassionate Use Reform and Enhancement (CURE) ActLink to legislationWould require some pharmaceutical companies to make more information about their compassionate use programs available to the public.8 December 2014
MEDTECH ActLink to legislationBill would exempt many types of software from regulation as a medical device.4 December 2014
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014Link to legislationWould provide added marketing exclusivity for companies that work to get their drug products approved in new, rare conditions.20 November 2014
Adding Ebola to the FDA Priority Review Voucher Program ActLink to legislationWould add the Ebola virus to a list of diseases eligible for a special priority review voucher. Also reforms the voucher to be easier to use and more valuable.12 November 2014. (Became law on 16 December 2014)
Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014Link to legislationWould require the DEA to schedule FDA-approved drug products more quickly.18 September 2014
Fair Access for Safe and Timely (FAST) Generics ActLink to legislationWould make it easier for generic drug companies to access copies of drugs subject to distribution restrictions by FDA.18 September 2014
Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act of 2013Link to legislationCreates new marketing exclusivity for drugs created for unmet needs.17 September 2014
Safe and Affordable Drugs from Canada Act of 2014Link to legislationAllows the personal import of drugs obtained from Canadian pharmacies26 June 2014
Speeding Access to Already Approved Pharmaceuticals ActLink to legislationWould require FDA to significantly expedite the review and approval of drugs and medical devices already approved in the EU.19 June 2014
Designer Anabolic Steroid Control Act of 2014Link to legislationWould ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products.29 May 2014. (Became law on 18 December 2014.)
Compassionate Freedom of Choice ActLink to legislationWould allow terminally ill patients to import unapproved drugs.10 April 2014
Strategies to Address Antimicrobial Resistance ActLink to legislationFDA asked to consult with Antimicrobial Resistance Office on any new antibiotics.10 April 2014
Improving Regulatory Transparency for New Medical Therapies ActLink to legislationWould require the DEA to schedule FDA-approved drug products more quickly.26 March 2014
Independent Innovator and Repurposing ActLink to legislationBill would extent marketing exclusivity for some biological products.24 March 2014
Sunscreen Innovation ActLink to legislationReforms FDA's regulation of pending and new sunscreen ingredients. Also makes reforms to FDA's Time-and-Extent (TEA) process.13 March 2014 (Became law on 26 November 2014.)
Regenerative Medicine Promotion Act of 2014Link to legislationWould task FDA with establishing a council to recommend regulatory improvements for regenerative medicine.13 March 2014
Act to Ban ZohydroLink to legislationWould require FDA to revoke the approval of Zohydro, a hydrocodone-based painkiller.13 March 2014
Preventing Regulatory Overreach To Enhance Care Technology Act of 2014Link to legislationBill would exempt many types of software from regulation as a medical device.10 February 2014
2013
Antibiotic Development to Advance Patient Treatment Act of 2013Link to legislationBill would permit FDA to approve antibiotics for limited populations.12 December 2013
Protecting Consumer Access to Generic Drugs Act of 2013Link to legislationWould prohibit pay-for-delay agreements by allowing FDA to cancel remaining marketing exclusivity.11 December 2013
Healthcare Innovation and Marketplace Technologies ActLink to legislationWould require FDA to establish an Office of Wireless Health Technology to better regulate mobile health apps3 December 2013.
SOFTWARE Act of 2013Link to legislationBill would exempt many types of software from regulation as a medical device.22 October 2013
Drug Quality and Security ActLink to legislationExpands FDA's regulation of compounding pharmacies, and establishes new controls on the pharmaceutical supply chain.27 September 2013. (Became law on 25 June 2013.)
Compounding Clarity Act of 2013Link to legislationWould enhance the regulation of compounding pharmacies and impose new registration requirements.12 September 2013
Medical Testing Availability Act of 2013Link to legislation&Would make it easier for sponsors of "Research Use Only" (RUO) products to sell their products without violating federal law.2 August 2013
Combination Drug Development Incentive Act of 2013Link to legislationWould explicitly allow fixed-dose combination drugs to be eligible for five-year "new drug" exclusivity.2 August 2013
S.A.F.E. Compounded Drugs Act of 2013Link to legislationWould enhance the regulation of compounding pharmacies and impose new restrictions on their manufacture.2 August 2013
Dietary Supplement Labeling Act of 2013Link to legislationWould require supplement manufacturers to provide more information about their products to FDA, and tighten labeling regulations.1 August 2013
FDA User Fee Protection ActLink to legislationWould exempt FDA from the federal budget sequester of 2013.31 July 2013
Food and Drug Administration Safety Over Sequestration Act of 2013Link to legislationWould exempt FDA from the federal budget sequester of 2013.18 July 2013
Combating Prescription Drug Abuse ActLink to legislationWould establish a commission, including FDA, to combat the abuse of prescription drugs.10 July 2013
Preventing Antibiotic Resistance Act of 2013Link to legislationWould restrict the use of antibiotics in agricultural settings.27 June 2013
Preserving Access to Orphan Drugs Act of 2013Link to legislationWould exempt orphan drug products approved by FDA from fees under Obamacare.11 June 2013
VALID Compounding ActLink to legislationWould establish a list of drugs not allowed to be compounded.23 May 2013
Patient Choice Act of 2013Link to legislationAllows terminally ill patients to access 'adequately safe' drugs through a provisional approval pathway22 May 2013
Trial and Experimental Studies Transparency (TEST) ActLink to legislationWould require companies to submit the results of all registered trials to ClinicalTrials.gov16 May 2013
Drug Supply Chain Security ActLink to legislationCompanion legislation to the Drug Quality and Security Act (DQSA), which became law in November 2013.15 May 2013
Pharmaceutical Quality, Security, and Accountability ActLink to legislationPrecursor legislation to the Drug Quality and Security Act of 2013. Called for the establishment of a national track and trace system for pharmaceuticals.15 May 2013
Gray Market Drug Reform and Transparency Act of 2013Link to legislationWould more stringently regulate pharmaceutical wholesalers14 May 2013
Safeguarding America's Pharmaceuticals Act of 2013Link to legislationPrecursor legislation to the Drug Quality and Security Act of 2013. Called for the establishment of a national track and trace system for pharmaceuticals.9 May 2013
Antimicrobial Data Collection ActLink to legislationRequires further FDA study of the relationship between antibiotics prescribing and antimicrobial resistance trends.8 May 2013
Cody Miller Initiative for Safer Prescriptions ActLink to legislationWould require consumer-friendly language on all drug labeling information, including package inserts.17 April 2013
Animal Drug and Animal Generic Drug User Fee Reauthorization ActLink to legislationEstablishes user fees for veterinary pharmaceutical products.20 March 2013. (Became law on 13 June 2013.)
Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES ) Act of 2010Link to legislationEnhanced penalties for anyone found guilty of stealing or counterfeiting medical products.20 March 2013. (Became law on 5 October 2012.)
Asthma Inhalers Relief Act of 2013Link to legislationWould prohibit FDA from banning remaining CFC-based inhalers.15 March 2013
Preservation of Antibiotics for Medical Treatment Act of 2013Link to legislationFDA can reject an application for an animal antibiotic if they believe its approval would put human health at risk.14 March 2013
Delivering Antimicrobial Transparency in Animals Act of 2013Link to legislationWould enhance data reporting requirements for marketers of antibiotics.26 February 2013
Preserve Access to Affordable Generics ActLink to legislationWould, in general, prohibit pay-for-delay agreements4 February 2013
To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines.Link to legislationAdded a recently approved influenza vaccine to a list of those eligible for legal liability protections under the law.4 February 2013. (Became law on 25 June 2013.)
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)Link to legislationAuthorizes FDA to grant emergency use authorization to products in advance of a pandemic18 January 2013. (Became law on 13 March 2013.)
2012
FDA User Fee Corrections Act of 2012Link to legislationAllowed FDA to collect generic drug user fees subject to a temporary ban.19 September 2012. (Became law on 5 October 2012.)
Food and Drug Administration Safety and Innovation Act (FDASIA)Link to legislationMassive reform legislation reauthorized numerous user fee programs, created new user fee programs for biosimilars and generic drugs, and created several new regulatory pathways and programs.15 May 2012. (Became law on 9 July 2012.)

 

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