Watchdog Blasts FDA’s Lax Drug Safety Oversight
The Government Accountability Office highlights the lack of post-market monitoring of drugs that were cleared in expedited approval programs. In other pharmaceutical news, Anthem is turning the tables on Express Scripts over drug pricing, and the FDA rejects a drug application for a muscular dystrophy treatment.
STAT:
FDA Faulted For Failure To Track Safety Issues With Drugs Already On Market
Most Americans assume that drugs approved by the Food and Drug Administration are safe to take as directed. But safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications. On Thursday, however, a federal watchdog agency said the FDA is failing to sufficiently track and publicly disclose instances in such cases. (Kaplan, 1/14)
CQ Healthbeat:
FDA Struggles To Track Safety Of Approved Fast-Track Drugs, GAO Finds
Despite an increase in the number of drugs approved through expedited pathways, the Food and Drug Administration struggles to track the safety of those drugs once they are on the market, a report made public Thursday by the Government Accountability Office found. Expedited FDA pathways can allow for the approval of drugs based on clinical trials that are shorter or smaller than typically required. When any new drug goes on sale, the FDA monitors its safety and legally must report on some of its postmarket surveillance efforts. (Siddons, 1/14)
Bloomberg:
Champion Of Lower Drug Prices Fights Own Overcharging Allegation
Express Scripts Holding Co. has led the charge in complaining about costly drugs it believes are overpriced. The biggest U.S. pharmacy-benefit manager has pitted drugmaker against drugmaker in an effort to negotiate lower prices on behalf of insurers and employers -- sometimes triggering price wars with its aggressive actions. Now its biggest customer, Anthem Inc., is using that playbook on Express Scripts. The giant insurer’s Chief Executive Officer Joseph Swedish said Tuesday that Express Scripts is overcharging Anthem to the tune of $3 billion a year. (Langreth, 1/14)
The Wall Street Journal:
FDA Rejects New Drug Application For BioMarin’s Duchenne Treatment
BioMarin Pharmaceutical Inc. on Thursday said the U.S. Food and Drug Administration had rejected its new drug application for a treatment of a fatal form of muscular dystrophy because of questions about the drug’s effectiveness. The biopharmaceutical company said it would work with the FDA to determine next steps for the treatment, called drisapersen, and that studies will continue. (Steele, 1/14)
The Seattle Times:
FDA Denies Duchenne Drug, Disappointing Local Family
Federal regulators Thursday declined to approve an experimental drug to treat patients with a deadly muscle-wasting disease, including a Maple Valley boy whose family was counting on it. The Food and Drug Administration (FDA) turned down the application for Kyndrisa, generically known as drisapersen, to treat Duchenne muscular dystrophy, a genetic disorder that primarily affects boys. (Aleccia, 1/14)
