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# McDermott Will & Emery FDA 2019 Review
- URL: https://www.fdaweb.com/mcdermott-will-emery-fda-2019-review/
- Published: 2020-01-15T12:00:00.000Z
- Updated: 2026-09-14T15:58:45.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, Devices, #legacy-id-D5145854

Attorneys from McDermitt Will & Emery say that in 2019 the CDER Office of Prescription Drug Promotion (OPDP) issued a total of six untitled letters and three Warning Letters, a slight increase over the 2018 total. Writing in their firm’s [review](https://www.jdsupra.com/post/fileServer.aspx?fName=eab9911a-4d9a-4d00-b3e4-b9347e21b271.pdf&ref=fdaweb.com) of the year 2019 for FDA, they say that two of the untitled letters focused on the pre-approval promotion of investigational products as safe and effective, two untitled letters and one Warning Letter included allegations for false or misleading claims about the efficacy of the products named, and four of the untitled letters and two of the Warning Letters included allegations about failing to provide adequate risk information or false or misleading risk presentations.

The attorneys suggest that OPDP may continue a more targeted approach to advertising and promotion in light of ongoing First Amendment concerns.

The report points out that three of the untitled letters cited claims on the drug makers’ Web sites and three cited claims in direct-to-consumer videos or broadcast ads reflecting, the authors say, the agency’s continued focus on digital marketing.

The report also says the agency’s overall enforcement actions decreased slightly from 2018, a continued indication of FDA’s current focus on more targeted risk-based enforcement in the wake of high profile court cases.

Looking ahead, the attorneys say it remains to be seen whether new FDA commissioner **Stephen Hahn** will advance a number of the initiatives that former commissioner **Scott Gottlieb** began, including those focused on youth vaping, stem cell therapies, and tighter regulations on dietary supplement manufacturers and drug compounders. “Many industry stakeholders have embraced and applauded FDA’s pragmatic approaches for creating new and expedited market pathways for digital health and innovative technologies,” they write. “Others, however, have signaled the need for new legislation or additional medical device authorities to justify certain aspects of the agency’s digital health framework. FDA’s role in regulating products containing cannabis and cannabis-derived compounds, including CBD, will continue to evolve as FDA actively works to learn more about the safety of these products and publishes additional guidance on their use in drugs, dietary supplement, foods, or cosmetics.”

The report also looks at 2019 in terms of drugs and biologics, combination products, Drug Quality Security Act implementation, digital health, medical devices, laboratory-developed tests and precision medicine, food and dietary supplements, tobacco, cannabis, and clinical investigations.