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CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

 

Facing the Challenges Confronting the Food and Drug Administration (FDA) Under the Trump Administration

June 21, 2017

The federal Food and Drug Administration is at a crossroads. A new commissioner of the Food and Drug Administration (FDA), Dr. Scott Gottlieb, was sworn in on May 11, 2017. Dr. Gottlieb’s tenure began on the heels of the enactment of a major piece of legislation affecting the agency—the 21st Century Cures Act—and on the cusp of approval of another major bill, the Food and Drug Administration (FDA) Reauthorization Act of 2017.

The FDA must balance regulatory speed and access to new therapies with the need for a strong evidence base for the safety and efficacy of drugs, biologics and medical devices that Americans use on a daily basis. Despite claims that the FDA’s approval speed and pre-market requirements are hindering access to new medications for patients and unnecessarily delaying marketing of new products, the FDA is consistently the fastest regulator in the world, approving new medical products before they reach the market in Europe and Canada. We are concerned about a growing erosion in the evidence base supporting the use of new drugs, devices and biologics, in the context of political pressure to further relax evidentiary standards for these products’ approval.

Today, Yale’s Collaboration for Research Integrity and Transparency released a new white paper, entitled What’s in Your Medicine Cabinet? Ensuring the Safety and Efficacy of Prescription Drugs, Biologics and Medical Devices in the United States. We focus on federal regulation of medical products by the US Food and Drug Administration (FDA), but also address the courts’ and Congress’ influence on the safety and efficacy of drugs, devices and biologics, and the critical role of industry in the development both of new products and of the evidence base supporting their use.

In particular, the white paper offers an analysis of the challenges currently facing the FDA and proposes solutions in seven areas:

  1. The current expedited framework for pre-market regulation of new medical products and the potential for new products to be approved without adequate scrutiny to establish their safety and efficacy;
  2. The problems with post-market follow-up of medical products where required additional studies to confirm the safety and clinical efficacy of new products are not completed or completed in a timely manner;
  3. The difficulty in getting manufacturers to participate in expanded access programs for pre-approval access to experimental therapies;
  4. The problems with using less rigorous forms of real-world evidence to make key regulatory decisions;
  5. The use of the expansion of corporate speech rights by the courts to expand off-label marketing under a standard of “truthful and non-misleading” outside of any evaluation of the off-label indication being safe and effective by the FDA;
  6. The substantially weaker pre-market and post-market evaluation and surveillance for medical devices, and;
  7. The need for the FDA and other federal agencies to take further proactive measures to enhance access to clinical trial data, including patient level data, summary level data and meta-data.

The faculty and staff of CRIT articulate an agenda for reform that balances the competing demands on the FDA—protecting the public health and ensure patient safety, while also conducting expeditious evaluation of new medical products so that patients can receive safe and effective new treatments in a timely manner.