FDA Policy/General

Bill with FDA Responsibilities Moves to Senate Floor

David McFarland

— 3 min read
Share

A Senate pandemic-related bill that outlines many new FDA responsibilities is headed to the Senate floor for a vote after being marked-up 3/15 by Health, Education, Labor and Pensions (HELP) Committee members. The Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) was introduced 1/25 by Sens. Patty Murray (D-WA) and Richard Burr (R-NC), the chair and ranking member of the Senate HELP Committee. A discussion draft of the legislation said it is “focused on strengthening the nation’s public health and medical preparedness and response systems in the wake of the Covid-19 pandemic.”

 

A HELP Committee overview says the legislation would, among other provisions: 

  • require FDA to issue three guidances to modernize and improve clinical trials;
  • codify FDA’s successful Coronavirus Treatment Acceleration Program;
  • clarify FDA authority to consult with third parties to evaluate and make recommendations on the validity, accuracy, and reliability of in vitro diagnostic tests for use during a public health emergency;
  • require FDA to issue or revise guidance on using real-world data and real-world evidence to support regulatory decision-making;
  • require FDA to issue guidance on the implementation of a new advanced platform technology designation;
  • give FDA authority to share more safety and effectiveness information with the public about products authorized for emergency use;
  • require FDA to publish a report on the agency’s best practices for communicating with medical product sponsors and other stakeholders and a plan for implementing the best practices;
  • direct the Government Accountability Office to issue a report assessing FDA’s hiring, recruiting, and retention practices, policies, and processes and their impact on its ability to carry out its public health mission;
  • require FDA to conduct a pilot program to increase the conduct of unannounced inspections of foreign drug facilities;
  • strengthen FDA enforcement authority against and increase the penalties for selling counterfeit medical devices, including personal protective equipment; and
  • authorize FDA to request from medical device manufacturers, in addition to drug manufacturers, certain records in advance of or in place of an inspection and require the agency to provide drug and device manufacturers with a rationale for its request for such records.

An amendment offered by Senator Rand Paul (R-KY) on allowing laboratories more regulatory freedom for lab-developed tests was tabled for further discussion. HELP committee chair Murray said she and ranking member Burr are working on a bipartisan policy to try and improve the regulation of laboratory developed tests that will be part of the user fee reauthorization bill later this year. Burr told the committee members that more clarity on the regulatory architecture of diagnostic tests is needed. He noted that he introduced a bill last year to create a diagnostic test regulation framework at FDA that would bring certainty to the regulatory process and keep FDA from over-regulating laboratories and create a predictable risk-based pathway for such tests.

 

Another amendment, introduced by Senator Mike Braun (R-IN) would have allowed FDA to, at its discretion, expedite the approval of drugs that have been approved and used in other countries. Senator Murray and Burr both objected to the amendment because it would lower FDA’s review gold standard. “I served in Congress when we tried to harmonize FDA standards with the EU,” Burr said, “and it sounded good on the surface. But when you began to look at all the members of the EU, and the different approval standards that some of their country members had, you realize that that wasn’t going to work with the gold standard that was set by the FDA… I am critical of how long the FDA takes and I'm critical a lot of things that the FDA does, but I'm not critical of the outcome that they reach. And I think it would be a huge mistake for us to say: ‘if you haven't done something in 90 days, then it's automatically approved.’ I'm not sure that that's anywhere near the gold standard that we accept.”

Read more