These issues made headlines as Congressional committees held hearings in September on the drug shortage crisis and broader supply chain problems. An FDA public workshop also provided a forum for health professionals, patient advocates, drug distributors, and manufacturers to air concerns and propose remedies. The resulting publicity has boosted support on Capitol Hill for legislation that addresses pharma supply chain issues in general, and the drug shortage situation in particular. FDA has prepared a report analyzing steps it can take to tackle shortages with its current limited authority, and the Government Accountability Office (GAO) is examining the causes of and responses to the drug shortage crisis.
One popular remedy is for manufacturers to inform FDA in advance of supply problems. The agency reports that early warnings helped it head off 38 potential shortages in 2010 and 99 so far this year. When FDA knows of a looming supply interruption, its staff can expedite the approval of new suppliers, alternative production sites, and changes in product specifications. Agency officials also can bend the rules to keep a violative product on the market, to encourage other firms to ramp up production, and to permit temporary importation of unapproved products to fill supply gaps.
FDA officials emphasize their regulatory flexibility to counter charges that overly aggressive enforcement of manufacturing rules aggravates supply problems. The agency doesn't halt production for minor violations, they insist, but only for significant problems with drug sterility and contamination. Before requesting a drug recall or seizure, they check to make sure such action won't precipitate a shortage. However, FDA enforcers will take action when they find glass and metal particles in vials and new impurities and degradants.
Under current law, FDA often lacks information on looming shortages because only sole-source manufacturers of critical medicines have to give notice of plans to discontinue production. Some companies voluntarily inform FDA of likely short supplies, but most do not, and often such information comes in too late for timely action.
To remedy this limitation, Congress is considering legislation requiring six-months advance notification of production changes for a broad range of prescription drugs. There would be penalties for noncompliance, along with leeway for companies able to demonstrate that a problem could not be anticipated.
While advance notification may help FDA head off some shortages, the danger is that early release of information on production problems could lead to hoarding and price gouging. Hospitals and doctors report that gray market profiteers are inundating them with faxes and phone calls offering scarce drugs at huge markups. In response, Rep. Elijah Cummings of Maryland, the top Democrat on the House Oversight and Government Reform Committee, launched an investigation last month of leading secondary distributors, seeking information on sources and profits on certain drugs.
And advance notification is not always possible. FDA officials concede that many manufacturing problems cannot be anticipated, such as equipment breakdowns, plant fires, and natural disasters such as earthquakes and volcanoes that can disrupt supplies without warning.