FDA renews OTC committee for two more years
FDA head Stephen Ostroff said it is in the public interest to renew the discretionary committee, which advises the commissioner on the safety and effectiveness of over-the-counter drugs.
Committee members have a say on switching drugs between prescription and non-prescription status, and on monographs for approving new drug applications and recognising safe, effective, and not misbranded drugs. The group can also conduct peer review of FDA-sponsored scientific biomedical programmes related to regulation.
The committee is made up of ten voting members, including a chair, who serve for up to four years. Ostroff selects experts in internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and other specialties. The committee members may include one representative of consumer interests and one non-voting member who represents the pharma industry.
The group’s original remit was until August 27th, 2015.
In 2014 the committee met to discuss, among other topics, standards for demonstrating safety and effectiveness in OTC topical antiseptics; data submitted by Merck & Co. in a new drug application for OTC allergy tablets; the possibility of removing certain nebulisers from the monograph on over-the-counter bronchodilators; and labelling of active ingredients in sunscreen.
Current voting members are:
- Michael Cohen, President, Institute for Safe Medication Practices (Pharmacist);
- Ralph D’Agostino, Director, Statistics and Consulting Unit, Boston University (Statistician);
- Janet Eagle, Head, Department of Pharmacy Practice, University of Illinois (Clinical Pharmacy);
- Lorraine Gudas, Chair, Department of Pharmacology, Weill Cornell Medical College (Pharmacology);
- Michael Paasche-Orlow, Associate Prof of Medicine, Boston University School of Medicine (Internal Medicine);
- Paul Pisarik, doctor, St John Health System Urgent Care (Family Medicine);
- Maria Pruchnicki, Associate Professor, Clinical Pharmacy, Ohio State University (Pharmacist);
- Christianne Roumie, Associate Prof, Internal Medicine and Paediatrics, Vanderbilt University (Internal Medicine/Paediatrics);
- Lee Sanders, Associate Prof, Paediatrics, Stanford University (Paediatrics, Health Literacy, Chronic Illness Care); and
- Estela Pledge, a health education specialist at Western Illinoi University (Consumer Interests).
Lorna Totman, a drug safety consultant, is representing the pharmaceutical industry as a non-voting member. The committee has four vacancies, including chair.
