Congressman Chris Collins released the following statement after passage of H.R. 6, the 21st Century Cures Act:
"The 21st Century Cures Act will help millions of Americans battling rare diseases. It is the culmination of years of work and will help revolutionize how the health care industry develops cures to deadly diseases. This legislation provides America's medical innovators the guidance they need to lead a new age of medical innovations, and I am confident its positive effects will be felt by hundreds of thousands of Western New Yorkers."
Collins played a pivotal role in the legislation authoring several key provisions:
•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.
•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.