Collins Ensures 21st Cures Legislation will Improve FDA Hiring & Clinical Trials

U.S. Representative Chris Collins (NY-27) today released the following statement after the House Energy and Commerce Committee approved H.R. 6, the 21st Century Cures Act.

“This bipartisan legislation is the culmination of years of work and will help revolutionize how the health care industry fights rare diseases,” said Congressman Chris Collins.  “I was glad to introduce provisions that will enhance and accelerate clinical trials, and measures to expedite and improve the FDA hiring process, so the world’s best minds are working towards finding cures.”

Congressman Collins’ provisions include:

Section 2061

• Encourages the broader application of Bayesian statistics and adaptive trial designs.
• Requires the FDA to establish guidelines for adaptive trials, which allows the clinical trials used for the development of drugs to have a framework on how to tailor their studies to meet the individual DNA of their participants.
• The clinical trial framework can then be combined with what we know about the human genome to cater new drugs to specific patient populations.

Section 2281

• Removes the cap on the number of FDA biomedical researchers that can be hired.
• Enables the FDA to hire biomedical researchers more efficiently by allowing the FDA to directly hire senior researchers, without having to go through the almost year-long bureaucratic government hiring process currently in place.
• Establishes pay rates for senior biomedical researchers that are competitive with industry standards.
• These incentives will recruit greater talent to the FDA and ensure timely, safe and accurate approval of new drugs and therapies for patients.

Details of the full committee markup can be read here.