As I See It: Regulating compounders
James G. Dickinson
October's meningitis outbreak from the New England Compounding Center revealed an administrative weakness in FDA.
At an October 11 teleconference, the agency's global operations and policy chief, Deborah Autor, called on industry officials and lawmakers to adopt a new “regulatory scheme that appropriately controls the risk.” She seemed not to know that the agency has had the authorization for such a scheme since 1997. I refer to the FDA Modernization Act, which gave FDA the framework for implementing a regulatory scheme to police high-volume compounding facilities that are actually drug manufacturers whose owners registered as “pharmacies” rather than with FDA.
As they expanded, the volume compounders fought this, securing a 2002 Supreme Court decision that declared the act's ban on advertising and promotion by this new industry “unconstitutional.”
The Supremes left intact FDA's other new enforcement powers over compounders. But the agency caved to the industry's pressures there, too. Agency watchers have seen FDA's growing emasculation since the 1970s. Jimmy Carter's HHS secretary, Joe Califano, left FDA largely alone, but his successors couldn't resist the temptation to assert themselves in the safety agency's work.
Today's FDA can do nothing new without the assent of HHS. Until the meningitis outbreak, high-volume compounding didn't seem important enough.
Based on Autor's reported sentiments, neither today's FDA nor its HHS masters seem to know how to develop an effective regulatory scheme to appropriately control the risk they see—or even recognize the unused tools they already have.James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).