December 14, 2018

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight Healthcare Blog
Sara M. Klock | Michael J. Werner

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and others. He made these remarks at the Food and Drug Law Institute's Enforcement, Litigation and Compliance Conference.

Improving the FDA's Ability to Keep Dangerous and Illegal Products Off of the Market

The FDA was recently granted new authority through the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act signed into law in October 2018, which allows the agency to "efficiently detain, refuse and destroy unlabeled imports that are found to contain active ingredients or analogs of active ingredients that are in FDA-approved drugs." The FDA no longer has to make a determination that the incoming unlabeled article may be a drug before taking action against it. As a result, the FDA has allocated resources, and plans to increase the number of incoming packages it opens and reviews.

According to Mr. Gottlieb, the agency is "taking robust action" to curb the sale and distribution of opioids online. The FDA has had discussions with internet providers and stakeholders, who have subsequently taken concrete steps to combat the illegal sale of opioids through their platforms and services. Furthermore, the FDA has and is continuing to issue warning letters to online networks and providers who sell opioids online illegally. The agency will be keeping up this enforcement.

Increased Regulatory Oversight and Enforcement on Compounding, Stem Cells and Dietary Supplements

After the 2012 New England Compounding Center outbreak, the FDA and Congress established a new framework focused on patient protection to regulate compounding practices. The FDA has recommitted to put additional resources behind compounding regulatory compliance and enforcement, including "piloting new processes to more quickly send [enforcement] referrals" to the Department of Justice.

The FDA will also be "stepping up action" in the stem cell space, and those operating "rogue stem cell outfits that are putting patients at risk" should "expect to see brisk activity from the FDA." In addition to the rogue clinics, the FDA plans on putting firms on notice that the agency is "aware that they're manufacturing cell and tissue products that are subject to [the FDA's] oversight."

The dietary supplement space has grown "bigger and riskier faster than [the FDA's] policies and [] capacity to manage," as a result, the agency is planning on implementing new policies to improve regulatory oversight very soon. This includes a recently formed Dietary Supplement Working Group to "take a hard look at what more the FDA can be doing within [its] existing authorities" and perusing new policy measures to modernize the agency's overall approach to dietary supplements. 

Protecting Data Integrity

Finally, according to Mr. Gottlieb, the FDA is concerned about data integrity and the lack of accurate drug quality data and information. The agency is allocating resources towards uncovering and ultimately preventing product quality and safety lapses. Shortly after the Commissioner's remarks, the FDA published a new guidance on Data Integrity and Compliance With Drug CGMP, to help manufacturers address and correct data integrity lapses, "implement best practices" and "ensure consistent awareness and commitment to ensuring data integrity." This is likely the first of more steps to come.

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