FDA Faces Heavy Criticism Over Avastin Decision

Contributing Author: Meghan A. McCaffrey

An FDA panel voted unanimously to withdraw approval of Roche’s breast cancer drug, Avastin, for use in the treatment of metastatic breast cancer.  The panel concluded that studies on the drug did not show enough of a benefit to breast cancer patients to outweigh the risks.  The final decision on Avastin, manufactured by Roche subsidiary Genentech, is expected in a few months, after the period of public comment closes at the end of the month.  Although the final decision will be made by FDA Commissioner Margaret Hamburg, the FDA generally tends to follow panel recommendations. 

The FDA’s withdrawal of approval for metastatic breast cancer patients will not, however, remove the drug from the market.  Avastin has been approved for treatment of other types of cancers.  This could present a difficult situation for the drug’s manufacturer, as it presents a possibility for off-label promotion and prescription by doctors.  As AbnormalUseposits, does this increase the potential liability for the manufacturer, especially given the high profile nature of the FDA’s decision (with coverage in the Wall Street Journal, the New York Times, and even NBC Nightly News)?  And while preemption arguments are always possible in any drug-related cases, given the recent trend in Supreme Court decisions on preemption, the outcome of any such cases — for either plaintiffs or manufacturers — is far from certain. 

In another interesting twist, it looks like politics will be weighing in on the Avastin issue as well.  The House Energy and Commerce Committee is set to hold a hearing today on the re-authorization of the 2007 prescription drug user fee act.  A decision by the Committee against re-authorization could impact the agency’s authority, and perhaps more importantly, its budget.  Aides to Chair Fred Upton have already communicated the representatives “grave” concerns over the decision and warned that FDA drug division director Janet Woodcock should be prepared to “answer tough questions about the FDA and Avastin,” according to the Wall Street Journal.  The timing of such questions is not ideal for the agency.  Last month the House voted to reduce the FDA’s food-safety budget by 10%, even as the agency is seeking approval for $1.4 billion to enact new food safety laws.