Avalanche! Congress is Buried Under a Slew of FDA-Related Legislation as the 21st Century Cures Act Makes Its Official Debut

By Kurt R. Karst –      

On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act.  The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the bill (see our previous post here on the prior versions).  If enacted, the 21st Century Cures Act would dramatically change the the development and approval of medical products in the United States. 

Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) have spearheaded the Cures Act effort.  And the bill is being put on fast-track.  Representative Upton has indicated that “[h]is goal is to have the bill on the floor in June, go to conference with the Senate in the fall and then send it to the president before the end of the year.”  That’s a pretty aggressive schedule considering that the U.S. Senate – and in particular Senators Richard Burr (R-NC) and Lamar Alexander (R-TN), Chairman of the Senate Health, Education, Labor and Pensions Committee – have yet to weigh in on the Cures Act initiative and seem to have their own ideas for change, as outlined in a white paper released earlier this year.

Meanwhile, other members of the U.S. House of Representatives have decided to introduce stand-alone bills, either breaking out provisions from the 21st Century Cures Act, or seeking consideration of legislation addressing new FDA-related topics.  Indeed, May19th saw the introduction of at least 17 separate bills to amend the FDC Act.  (Other stand-alone bills, like H.R. 2456 and H.R. 2414, would amend related laws, such as the PHS Act, to ensure the sharing of data generated from research with the public, and to facilitate the responsible communication of scientific and medical developments.)  Here’s a list of the FDA bills introduced on May 19th (not including the 21st Century Cures Act): 

• H.R. 2459 – To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to use of antimicrobial drugs in food animals
• H.R. 2455 – To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine
• H.R. 2452 – To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information
• H.R. 2444 – To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing
• H.R. 2443 – To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics
• H.R. 2438 – To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs
• H.R. 2435 – To amend the Federal Food, Drug, and Cosmetic Act with regard to the Reagan-Udall Foundation
• H.R. 2433 – To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review
• H.R. 2428 – To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications
• H.R. 2427 – To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process
• H.R. 2426 – 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
• H.R. 2425 – To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards
• H.R. 2424 – To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept
• H.R. 2423 – To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence
• H.R. 2422 – To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment
• H.R. 2416 – 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
• H.R. 2415 – To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program

The introduction of these bills in the House on May 19th follows an already-busy May for new FDA-related legislation.  As noted on our popular FDA Legislation Tracker we also recently saw the introduction of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (H.R. 2396), the Stop Tampering of Prescription Pills Act of 2013 (H.R. 2335) (unchanged from previous versions – see our previous post here), legislation to to authorize priority review for breakthrough devices (H.R. 2337),  and legislation to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework  (H.R. 2338).