Pharmacy benefit managers estimate when a generic medicine will enter the market long in advance of a brand medicine?s patent expiration. They make careful budget projections, only to learn that the FDA has delayed the generic?s approval. Why?
Often, it is because the brand company - or its lawyers - has filed a citizen petition questioning the generic application. Although US citizens have a constitutionally protected right to petition the federal government, some brand pharmaceutical companies, their lawyers, or others routinely abuse this practice by filing citizen petitions on pending abbreviated new drug applications (ANDA) with the FDA on the eve of a generic product?s approval. This tactic typically results in the FDA delaying ANDA approval until the issue underlying the citizen petition is thoroughly resolved, resulting in generic market entry delays of months, if not years. These needless delays also cost patients and the health care system millions of dollars.
The FDA has expressed its concern about the filing of frivolous citizen petitions. As the FDA?s chief counsel said in 2005, ?The citizen petition process is in some cases being abused. Sometimes, stakeholders try to use this mechanism to unnecessarily delay approval of a competitor?s products....[We?ve] already seen several examples of citizen petitions that appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application, but rather to delay approval by compelling the agency to take the time to consider arguments raised in the petition, whatever their merits, and regardless of whether the petitioner could have made those very arguments months and months before.?
Furthermore, in testimony before Congress last year, the FDA acknowledged that ?a high percentage of the petitions? reviewed by its Office of Generic Drugs are denied. The FDA explained that ?very few of these petitions on generic drug matters have presented data or analysis that significantly altered the FDA?s policies.? The FDA?s review of petitions answered between calendar years 2001 and 2005 showed that, ?of the 42 citizen-petition responses examined, only 3 petitions led to a change in agency policy on the basis of data or information submitted in the petition.?
It is clear that, because many of these petitions are filed immediately prior to a generic medicine?s approval, they are blatantly being used as a way to extend the patent on a brand product and maintain monopolies. The statistics bear this out: according to one analysis, 76% of petitions were rejected as having no merit, and a Federal Trade Commission study showed that most citizen petitions filed between 1992 and 2000 were rejected.
Fortunately, there is bipartisan action in Congress to close the citizen-petition loophole and enable patients to have more timely access to affordable generic medicines. Thanks to the leadership of Sens Debbie Stabenow (D, Mich), Trent Lott (R, Miss), John Thune (R, SD), Sherrod Brown (D, Ohio), Herb Kohl (D, Wis), Orrin Hatch (R, Utah), and Tom Coburn (R, Okla) and Rep Henry Waxman (D, Calif), legislation is moving forward that would curb brand pharmaceutical companies? practice of filing frivolous citizen petitions to delay patient access. The legislation would require that the generic approval process continue while a petition is considered. It also would require that final action on a petition be taken within 6 months of the petition being received.
Reform of the citizen-petition process is long overdue. Congress now has a real opportunity to close a loophole that has delayed access to safe, effective, and affordable generics, and in doing so it will save patients and our health care system millions of dollars.