The new law that defines and broadens the FDA's oversight over drug compounders, some of which have become small manufacturers, relies on the so-called outsourcers putting their hands in the air and volunteering for oversight. So the big question was how many of the 3,000 or so firms would sign up. The answer as of Friday was 11.
"We're hopeful that market forces will drive more firms to register with FDA as outsourcers, but only time will tell," agency spokesman Steven Immergut told Reuters.
In November, Congress passed the Drug Quality and Security Act in response to the 2012 fungal meningitis outbreak, tied to a compounder, that sickened more than 750 people, 64 fatally. The FDA was criticized for not having a better handle on compounders, some of which have grown significantly in recent years as hospitals and doctors sought new sources for drugs that were in short supply. Some of the companies have extensive sales forces and distribute drugs on a national basis.
The FDA pointed out that states have traditionally had oversight over the compounders and said court rulings had raised questions about its authority over them. It asked for a new law that would require the largest companies to register and submit to regular review. Instead, Congress crafted a law creating a voluntary program with the idea that hospitals would want to buy from regulated companies with an FDA seal of approval.
FDA Commissioner Margaret Hamburg is pushing them to do just that, Reuters reported. In a letter sent to hundreds of hospitals last week, she said, "As a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities."
To be part of the program, the so-called outsourcing facilities must register with the FDA, agree to routine inspections and report adverse events associated with their products. And they must pay a fee for the opportunity. The FDA is listing on its website those companies that have registered. Of the 14 facilities that are listed, four are owned by PharMedium Services, a large compounding company that has supported the new regulations. It also shows that two of the 14, Allergy Laboratories of Oklahoma City and Medi-Fare Drug & Home Health Center of Blacksburg, SC, received warning letters from the FDA after the agency started a crash inspection program in response to the meningitis outbreak. Those companies that do not sign up will be regulated by their states, but the law also makes clear that in case of questionable practices, the FDA can step in.
Allan Coukell of the The Pew Charitable Trusts told Reuters he considered 11 companies a good start for the new program. "Very few have gotten off to as fast a start as this one," Coukell said. Pew was a supporter of the new legislation.