Citizen Petitions Blamed for Delaying Generic Drug Approvals

A tactic by branded pharmaceutical manufacturers to delay the introduction of generic competition has come under scrutiny at the FDA. Officials are investigating the practice of filing citizen petitions with the agency challenging the right of a potential competitor to secure approval for a lower-cost generic version. Even if the patent has expired on the branded drug, the citizen petition freezes the FDA's ability to act.

Once a petition is filed, it can take months or even years to resolve the issues blocking FDA action on a generic approval. But, according to Sen Debbie Stabenow (D, Mich), the overwhelming majority of such petitions filed with the FDA by branded drug manufacturers are ultimately rejected as groundless.

Stabenow cites the example of Wellbutrin XL, a top-selling antidepressant that was facing the prospect of competition from cheaper generics late last year. When the drug's manufacturer, Biovail Corp, filed a citizen petition raising concerns about the safety of its potential rivals, it put a freeze on efforts by generic drug manufacturers to secure approval to market lower-cost versions of the drug.

The situation has prompted bipartisan concerns in Congress. Stabenow and Sen Trent Lott (R, Miss) fired off letters to FDA Acting Commissioner Andrew von Eschenbach, MD, charging that the delays caused by this citizen petition are costing consumers $37 million a month. "Biovail's petition is a sham, designed solely to delay the onset of generic competition for its Wellbutrin XL product."