Drugs

Sweeping Changes Coming to OTC Monographs: Attorneys

Three Mintz Levin attorneys say the next phase of the over-the-counter (OTC) reform process coming from provisions in the CARES Act “will entail sweeping changes to the process for bringing OTC drugs to market and will impose some significant burdens on FDA and manufacturers alike.” Writing in a National Law Review online article, the attorneys say that although the reforms streamline the agency’s process for making GRASE (generally recognized as safe and effective) determinations and other monograph decisions in some respects, they also add flexibility for industry to request and for the agency to implement changes, which will require additional resources.

“The OTC drug industry will likely take full advantage of the ability to request meetings with FDA, putting time and resource strains on the agency,” the attorneys write. “Even with user fees helping to defray the fiscal burdens, the need for additional personnel to handle these administrative processes will likely be significant. In addition, the program reforms require OTC manufacturers to draft formal applications to request new or updated administrative orders for OTC monographs and pay user fees, which will put new resource burdens on the industry.”

The article presents an overview of OTC monograph reform covering the administrative order process, minor changes in dosage form, marketing exclusivity, OTC monograph user fees, formal meetings with FDA, and OTC monograph reform-related guidances.

Key takeaways from a 5/29 FDA Webinar cover products that remain on the market and monograph reform submissions and FDA meetings.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome