The FDA has allowed Emergent BioSolutions to resume production of the drug substance used in Johnson & Johnson's COVID-19 vaccine at its previously troubled plant, although the facility has yet to be fully authorized by the FDA and individual lots of vaccines still need to be inspected by the agency prior to shipment and administration, according to an unnamed administration official.
The FDA's Center for Drug Evaluation and Research sent an untitled letter to online retailer Amazon for misbranding drugs and marketing unapproved drugs in violation of certain sections of the Federal Food, Drug and Cosmetic Act. In a letter sent to Amazon CEO Andy Jassy, the FDA said it identified 26 weight loss and sexual enhancement products being sold on Amazon that contained one or more of the active pharmaceutical drug ingredients tadalafil, sildenafil or vardenafil, that were not declared on the labeling of the products.
Confirmatory evidence of clinical efficacy is lacking on 112 of 253 drugs the FDA has approved through an accelerated pathway, and some of them have been on the market for more than 20 years, according to an article in The BMJ. "Despite the pathway's good intentions to accelerate 'the availability of drugs that treat serious diseases,' experts are concerned that it is now being exploited, to the detriment of patients -- who may be given a drug that offers little benefit and possible harm -- and of taxpayers," author Elisabeth Mahase wrote.
PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for 266 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.
Contact PCMA Charles Cote
Vice President, Strategic Communications