Executive Briefing Series (formerly The Food & Drug Letter)

Due to summer holidays, The Food & Drug Letter will not be published July 13. The next issue will be published July 27.

The FDA user fee bill that lawmakers sent to President Barack Obama this week requires drugmakers to notify the agency six months before implementing any production changes that could trigger a drug shortage. But already, in the six months since Obama ordered the agency to step up efforts to address the problem, some positive signs are emerging. According to FDA Commissioner Margaret Hamburg, the number of drug shortages has dropped by more than 50 percent and early shortage notifications from drugmakers are on the rise. Still, questions remain about which drugs fall under the notification provision and whether the FDA is prepared to handle the deluge of reports that could ensue. This issue of The Food & Drug Letter offers a roundup of the latest FDA, Hill and industry efforts to deal with drug shortages.

Drug shortages, poor product quality, poor corrective actions and other “manufacturing breakdowns” have conspired to create a crisis state that demands not only strong regulatory enforcement, but also active collaboration among drugmakers, FDA officials say.

Congress is pointing a finger at the FDA for spurring the increase in drug shortages through stepped up enforcement actions, despite agency efforts to mitigate the trend.

While drug shortages remain a problem, the FDA has seen a dramatic uptick in early shortage notifications from drugmakers and the number of drug shortages halved in the six months since President Barack Obama ordered the agency to request more action from industry.

The finalized FDA user fee bill requires early notification on manufacturing changes that could create drug shortages, but the language is so vague that drugmakers will flood the agency with reports, causing more harm than good, a former FDA associate commissioner says.

Pharma stakeholders are calling on the FDA to publish a list of critical drugs to help clarify what products fall under current requirements and possible future laws for drug shortage notification.

The Federal Trade Commission (FTC) may not issue the advisory opinion the generic drug industry is waiting for before launching its third-party drug shortage program, possibly derailing the initiative.

Rogue online pharmacies looking to cash in on drugs in short supply are peddling counterfeit versions of Teva’s attention-deficit/hyperactivity disorder drug Adderall, the FDA warns.