Stalling Cheap Generic Drugs With Citizen Petitions

A bipartisan Senate inquiry into Food and Drug Administration generic drug reviews suggests that Big Pharma's abuse of so-called "citizen petitions" is costing consumers tens of millions of dollars each month.

Not so, responds the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents brand-name drug makers. Their spin: citizen petitions "raise important regulatory, legal or scientific issues," according to PhRMA VP Carolyn Loew. So why do generic drug makers call the "citizen" actions "blocking petitions"? 

Exhibit 1: Biovail Corp., maker of the antidepressant Wellbutrin XL, filed a citizen petition to challenge rivals' formulations of the generic version. The FDA takes its time to examine the petitions (a process that the Clinton Administration began to streamline in 1999, but which the Bush Administration reversed after PhRMA's firm protest), so consumers may be paying $37 million per month more for the name brand drug while the FDA considers the "citizen" input, according to Sens. Debbie Stabenow (D. Mich.) and Trent Lott (R-Miss.) The senators have introduced a bill to implement more efficient review.

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