Life Science Compliance Update

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September 25, 2017

FDA Guidances Being Issued Slower than Expected

Fda

We found an interesting Regulatory Focus story on the lack of FDA guidance documents since the start of President Trump’s tenure in office. FDA announced it intended to release more than 100 draft guidances in 2017 but has not been close to that amount. Recent guidances, to illustrate, can be found at the following link.

Unclear reason

Regulatory Focus speculates it could possibly be related to President Trump’s Executive Order aiming to reduce regulatory activity. Or, before Commissioner Gottlieb was confirmed, it may have been the lack of a top official at the agency. The answer from the administration is particularly interesting. Regulatory Focus wrote:

“The answers remain unclear. FDA referred Focus questions on the matter to the White House, which referred Focus to the Department of Health and Human Services and the Office of Management and Budget, which did not respond to questions.”

Some industries are patiently waiting for more FDA guidances, for example, on the Food Safety Modernization Act. However, we have seen guidances issued in several areas released in the month of August:

Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry - Draft Guidance - 08/18/17

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products - Final Guidance - 08/08/17

CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports - Draft Guidance -08/08/17

Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry - Draft Guidance - 08/02/17

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases - Final Guidance -08/01/17

We will continue to monitor the trends of FDA guidance documents in the coming months as Commissioner Gottlieb continues to build his staff and direct the future of the agency.

As Regulatory Focus reported, Rachel Sachs, an associate professor of law at Washington University in St. Louis, is quoted as saying: “I think they're waiting for Gottlieb to set his priorities, and they'll move forward then. The other thing I'll say is that they've been busy behind the scenes on things like the -UFAs [user fee agreements], so I wouldn't be surprised if a lot of time has gone into that.”

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