Public Citizen slams FDA over lax oversight of 'compounding pharmacies'

Strengthened enforcement over compounding pharmacies that act as drug manufacturers would help alleviate drug shortages by creating incentives for mainstream drug manufacturers to produce high-quality, Food and Drug Administration (FDA)-approved medication, US consumer advocacy group Public Citizen said in comments submitted to the FDA’s Drug Shortages Task Force.

The FDA has been lax in enforcing existing laws against companies calling themselves compounding pharmacies, allowing them to mass produce standardized drugs without seeking approval from the FDA. These “pharmacies,” which are really drug manufacturers in disguise, are permitted to flood the market with cheaply produced, substandard drugs, Public Citizen said. This practice discourages mainstream manufacturers from investing in the more expensive practice of producing safe, regulated and FDA-approved medications to meet consumer needs and prevent drug shortages.

“When the FDA allows companies calling themselves compounding pharmacies to manufacture drugs without meeting approval and quality control requirements, of course they will be able to undersell the FDA-approved product,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, noting that “this means the availability of high-quality, safe treatment options dwindles, leaving patients at the mercy of a poorly regulated industry.”