Analysis: Compounding groups fought FDA oversight before NECC disaster

As regulators grapple with a meningitis outbreak linked to a compounding pharmacy's products, new insights on the issue highlight a history of failed attempts to give the FDA greater oversight of compounding operations. And Reuters has spotlighted some of the aggressive lobbying and politics that have allowed compounding pharmacies to escape the kind of regulation that governs pharmaceutical manufacturers.

The news wire's analysis of compounding regulation comes after the death toll from fungal meningitis cases connected to tainted steroids reached 15 yesterday, as the Los Angeles Times reported, with many more patients suffering from infections from the injectable meds that regulators have traced back to New England Compounding Center (NECC) in Framingham, MA.

Reuters has traced some of the defeated policies over the past decade or so that would have increased federal regulation of compounding outfits. Congress thwarted efforts to create an FDA oversight committee on pharmacy compounding in 2003. Then lobbying efforts stymied a bipartisan effort led by the late Sen. Edward Kennedy in 2007 to give the FDA the power to regulate how compounders' drugs are prescribed, distributed across state lines and manufactured sterilely, Reuters reported.

The International Academy of Compounding Pharmacists, a trade group out of Texas, has had a hand in lobbying against new legislation over compounding pharmacies and has a membership that has included NECC and more than 2,700 others involved in compounding, according to Reuters' article.

Compounding pharmacies have had a place in preparing and providing treatments since the dawn of the drug industry, evolving from major sources of prescriptions to niche players today. As cited by Reuters, Kaiser Permanente found in 2006 that 5%, or 30 million, of annual prescriptions came from compounding pharmacies, which are allowed to prepare meds with non-FDA approved ingredients under certain rules from state authorities. And compounding pharmacists have provided hard-to-find meds and treatments in short supply that might not be available from pharmaceutical manufacturers.

Yet for more than a decade the FDA and others have made a case for ratcheting up regulation of compounding pharmacists. In a limited survey in 2001, according to Reuters' article, U.S. regulators found that 10 of 29 meds from compounding shops had quality problems, compared with four of more than 3,000 drugs analyzed from FDA-regulated manufacturers. Sarah Sellers, a quality consultant and former FDA employee, left the agency after multiple attempts to increase regulation of compounding pharmacies failed, Reuters reported.

"They had ample warning of problems in this industry," Sellers said, as quoted by the news service.

- check out Reuters' article
- and the Los Angeles Times report