More Drug Shortages in Fungal Meningitis Aftermath
Are New Laws Needed? continued...
With this kind of head start, the FDA can help relieve shortages by looking for other manufacturers who can make the drug. Or it can speed pending approvals for companies that already have asked to make the drug. In a news release, FDA Commissioner Margaret Hamburg, MD, says the FDA already has prevented 145 drug shortages this year.
Moreover, the July 2012 Food and Drug Administration Safety and Innovation Act established user fees for generic drugmakers that will allow the FDA to speed the approval process. It also expands the FDA's authority to inspect drug-making facilities.
But new legislation proposed by Rep. Edward Markey (D-Mass.) would vastly restrict what compounding pharmacies can manufacture and greatly increase FDA oversight.
Vaida says he's not sure additional legislation is needed.
"We haven't followed through or monitored compounding pharmacies as well as we could," he says. "Something has to come out of this [fungal meningitis outbreak]. Compounding pharmacies are going to have to be inspected, either by state boards -- given better resources and insisting on stricter requirements they have to follow -- or by the FDA if they are into drug manufacturing."
David Ball, a spokesman for the IACP trade group, agrees that changes are on the way.
"What the compounding profession hopes for is that whatever changes occur don't disrupt the legitimate care provided to patients," he says. "The hope is that compounders continue to be available to provide these services. ... What we want to see is that organizations operating outside their license, that are manufacturing drugs without a permit to do so, are dealt with. We want to make sure people in the profession are in compliance with the law."
Meanwhile, the toll from the fungal meningitis outbreak continues to mount. As of Nov. 2, the tainted drugs have caused 395 cases of fungal meningitis and nine cases of fungal joint infections. The injections have killed 29 of these people.