OTC Drugs and Cosmetics

That did not take long.  As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees.  Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened?  Well, …

As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law.  This law amended the FDC Act to include, among other things, an OTC monograph drug user fee program, under which FDA is authorized to assess and …

Under the Sunscreen Innovation Act (SIA), GAO was to review and report on FDA’s regulation of sunscreens and other over-the-counter (OTC) drugs.  In late July, 2020, GAO issued its report on its performance audit conducted from July 2019 through July 2020.  The report focuses on …

Amidst the onslaught of regulatory and legislative announcements and changes occurring daily during this unprecedented time, a long-awaited (in some quarters) legislative change quietly and finally became law.   On March 27, 2020, President Trump signed into law the CARES Act which includes an array of …

We knew it would be back. It was never dead, though perhaps forgotten by some (never us), but OTC Monograph Reform is back in the public eye again.  Lawmakers appear to be taking to heart CDER Director Janet Woodcock’s remarks last week in which she urged …

Last week FDA issued a final regulation regarding consumer antiseptic rubs.  In 2016, FDA had proposed that 28 active ingredients, including triclosan, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs.   FDA requested but did not receive …

Back in 2014, The Sunscreen Innovation Act (“SIA”) amended the Federal Food, Drug, and Cosmetic Act with the goal of accelerating the review of sunscreen ingredients that had been proposed for addition to the sunscreen monograph.  Although the original focus of the SIA was on …

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

On Dec. 6, FDA announced that it is formally seeking data, comments and information related to the assessment of safety and effectiveness of food handler antiseptic drug products (rubs and washes) for over-the-counter (OTC) use. Although this is a positive development, judging from the questions …

Only ten years after initiating the withdrawal process, FDA approval for prescription PEG-3350 is officially withdrawn. The D.C. Circuit issued an unpublished opinion this week affirming FDA’s April 2018 Order withdrawing approval for several PEG-3350 ANDAs and denying requests for a hearing by the affected …

On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit. The Petition seeks review of a final FDA order published in the Federal Register on …

On January 17, 2018, in an effort to overhaul the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey introduced bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315. As readers of this blog know, the current monograph system, which …

As previously discussed, pursuant to a consent decree, FDA was to finalize the over-the-counter (OTC) topical health care antiseptic drug products monograph with respect to triclosan by January 15, 2018. Rather than limiting the rulemaking to the single active ingredient, triclosan, FDA took it upon …

As readers of this blog may recall (see here), the purpose of the Sunscreen Innovation Act (SIA) was to speed up FDA’s review of time and extent applications (TEAs). TEA process provides a pathway for adding an active ingredient to an existing over-the-counter (OTC) drug …

Public Citizen sued FDA last week, in an effort to force Agency action on the tentative final monograph (“TFM”) for OTC oral health care drug products. That TFM currently permits the marketing of OTC benzocaine oral health care drug products labeled for use to relieve …