Staking Out Ground
FDA sought to stake out ground for regulating compounding about a decade ago. In his Oct. 23, 2003, testimony before Senate HELP, the then-head of FDA’s Center for Drug Evaluation and Research, Steven K. Galston, M.D., outlined four areas where tighter federal regulation was appropriate:
- Removing from the market compounded drugs made from ingredients FDA deemed to be unsafe.
- Addressing the quality of bulk drug substances used in compounding.
- Investigating allegations of poor-quality compounded drugs, in conjunction with the states whenever possible.
- Determining when a pharmacy crosses the line from “appropriate” pharmacy compounding and larger-scale manufacturing warranting more regulation.
Those are good areas to start increasing FDA’s scrutiny, though the agency shouldn’t necessarily always act along with states given the patchwork of rules each state maintains. FDA should hold clear authority over the states in enforcement of compounding standards, though it could deputize states to act on its behalf in overseeing of smaller pharmacies based on volume or other measures.
“There should be some very clear national quality criteria that pharmacies have to meet. They should be standardized and national,” Cabaleiro said.
Sounds good, though PCAB envisions every state board of pharmacy switching to a singular set of rules based on the nonprofit U.S. Pharmacopeial Convention, whose standards for identity, strength, quality, and purity of medicines FDA already has power to enforce. Yet state boards have not always articulated uniform standards on other issues, and it remains to be seen whether they would respond with urgency to a single national standard envisioned by Cabaleiro, or whether the boards will go their own ways once the meningitis outbreak fades from the headlines.
“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” declares Kevin Outterson, an associate professor who teaches corporate law and health law at Boston University’s School of Law and School of Public Health, on his blog The Incidental Economist. The rising toll in meningitis deaths and sick cases should finally change that, and soon.