A Message from Kathleen Jaeger: Citizen Petition Reform Is Long Overdue

Pharmacy Times, Volume 0, 0

Pharmacy benefit managers estimatewhen a generic medicine willenter the market long in advance of abrand medicine?s patent expiration.They make careful budget projections,only to learn that the FDA has delayedthe generic?s approval. Why?

Often, it is because the brand company -or its lawyers - has filed a citizenpetition questioning the genericapplication. Although US citizens havea constitutionally protected right topetition the federal government, somebrand pharmaceutical companies, theirlawyers, or others routinely abuse thispractice by filing citizen petitions onpending abbreviated new drug applications(ANDA) with the FDA on the eveof a generic product?s approval. Thistactic typically results in the FDA delayingANDA approval until the issueunderlying the citizen petition is thoroughlyresolved, resulting in genericmarket entry delays of months, if notyears. These needless delays also costpatients and the health care systemmillions of dollars.

The FDA has expressed its concernabout the filing of frivolous citizen petitions.As the FDA?s chief counsel said in2005, ?The citizen petition process is insome cases being abused. Sometimes,stakeholders try to use this mechanismto unnecessarily delay approval of acompetitor?s products....[We?ve] alreadyseen several examples of citizenpetitions that appear designed not toraise timely concerns with respect tothe legality or scientific soundness ofapproving a drug application, butrather to delay approval by compellingthe agency to take the time to considerarguments raised in the petition,whatever their merits, and regardlessof whether the petitioner could havemade those very arguments monthsand months before.?

Furthermore, in testimony beforeCongress last year, the FDA acknowledgedthat ?a high percentage of thepetitions? reviewed by its Office ofGeneric Drugs are denied. The FDAexplained that ?very few of these petitionson generic drug matters havepresented data or analysis that significantlyaltered the FDA?s policies.? TheFDA?s review of petitions answeredbetween calendar years 2001 and 2005showed that, ?of the 42 citizen-petitionresponses examined, only 3 petitionsled to a change in agency policy on thebasis of data or information submittedin the petition.?

It is clear that, because many ofthese petitions are filed immediatelyprior to a generic medicine?s approval,they are blatantly being used as a wayto extend the patent on a brand productand maintain monopolies. The statisticsbear this out: according to oneanalysis, 76% of petitions were rejectedas having no merit, and a FederalTrade Commission study showed thatmost citizen petitions filed between1992 and 2000 were rejected.

Fortunately, there is bipartisan actionin Congress to close the citizen-petitionloophole and enable patients tohave more timely access to affordablegeneric medicines. Thanks to the leadershipof Sens Debbie Stabenow (D,Mich), Trent Lott (R, Miss), John Thune(R, SD), Sherrod Brown (D, Ohio), HerbKohl (D, Wis), Orrin Hatch (R, Utah), andTom Coburn (R, Okla) and Rep HenryWaxman (D, Calif), legislation is movingforward that would curb brand pharmaceuticalcompanies? practice of filingfrivolous citizen petitions to delaypatient access. The legislation wouldrequire that the generic approvalprocess continue while a petition isconsidered. It also would require thatfinal action on a petition be taken within6 months of the petition beingreceived.

Reform of the citizen-petition processis long overdue. Congress now has areal opportunity to close a loopholethat has delayed access to safe, effective,and affordable generics, and indoing so it will save patients and ourhealth care system millions of dollars.