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Wednesday, June 21, 2017


Report Examines the Challenges Confronting the FDA Under the Trump Administration

Yale’s Collaboration for Research Integrity and Transparency (CRIT) released a new white paper on June 20, 2017, entitled "What’s in Your Medicine Cabinet? Ensuring the Safety and Efficacy of Prescription Drugs, Biologics and Medical Devices in the United States." The document is focused on federal regulation of medical products by the U.S. Food and Drug Administration (FDA), but also takes aim at 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.

The report warns of 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. It also confronts claims that the FDA’s speed of approval and other policies are hindering access to new medications for patients and unnecessarily delaying marketing of new products. In a forward-looking analysis, the faculty and staff of CRIT—Yale’s new partnership between its law, medical and public health schools—articulate an agenda for reform.  The agenda seeks to balance the competing demands on the FDA to protect the public health and ensure patient safety, but to also conduct expeditious evaluation of new medical products so that patients can receive safe and effective new treatments in a timely manner.

In particular, the white paper offers an analysis of the challenges currently facing the FDA and the regulation of medical products in general 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.

CRIT is an inter-disciplinary initiative launched in 2016 to enhance the quality and transparency of the research base for medical products.  Through research, advocacy, and litigation, CRIT is focused on ensuring that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products is accurate, comprehensive, accessible, and reliable. Read a blog post about this white paper.