Kohl, Leahy Introduce Bill
To Stop Frivolous Citizen Petitions,
Speed Generic Drug Approval

WASHINGTON (Thursday, Sept. 28) – In an effort to increase generic drug availability, U.S. Senators Herb Kohl (D-WI) and Patrick Leahy (D-VT) have introduced legislation to prohibit brand name drug companies from abusing the Food and Drug Administration’s (FDA) “citizen petition” review process.  Citizen petitions can delay the approval of a generic drug by months or years.  

“Generics are a big part of the solution to health care costs that are spiraling out of control,” Kohl said. “While this citizen petition process was put in place for good reason, in recent years it has been abused by big drug companies looking to extend their product’s monopoly. We can’t sit back and do nothing while these companies game the system and profit off of consumers and the federal government.”

Leahy said, “The major drug companies have found yet another way to game the system to keep lower-cost generics off the shelves.  They are misusing a law that was intended to protect ordinary Americans, not corporate drug giants, and they are using it to pick the public’s pockets.  We are blowing the whistle on this practice, and we are out to close this loophole to keep drug giants from using it against consumers.” 

One example of this practice can be seen with the drug, Oxybutynin, a generic equivalent of Ditropan XL. Ditropan’s patent owner, the Alza Corporation, submitted a citizen petition to the FDA one month before its generic competitor, Ozybutynin was expected to be released for sale. The FDA is now in month 13 of its review of this petition.  Mylan laboratories, the maker of Ozybutynin, estimates that Ditropan XL generates more than $1.8 million in sales, daily.

Of the 21 citizen petitions reviewed and ruled upon by the FDA since 2003, 20 have been found to be without merit.  Of these, ten were identified as “eleventh hour petitions” -- those filed less than 6 months prior to the estimated entry date of the generic drug – and none were found to have merit.

The Citizen Petition Fairness and Accuracy Act of 2006 gives the Department of Health and Human Services (HHS) – the FDA’s parent agency – the power to sanction those who abuse the citizen petition process, or who file citizen petitions simply to keep competition off the market. Possible sanctions include a fine up to one million dollars, a suspension or permanent revocation of the right of the violator to file future citizens’ petition, and a dismissal of the petition. The bill also instructs HHS that all citizen petitions be reviewed within six months of filing – putting an end to excessive delays in bringing needed generic drugs to market.

Prescription drugs make up 11 percent of national health care spending but are one of the largest and fastest growing health care expenditures. The U.S. spent over $250 billion on prescription drugs in 2005, with generics accounting for 56 percent of the prescriptions but less than 13 percent of the costs.  One study estimates that every 1 percent increase in generic use could save $4 billion dollars. 

Last June, Kohl and Leahy introduced legislation, the Preserve Access to Affordable Generics Act (S. 3582), to prohibit anti-competitive “payoff settlements” that keep generics off pharmacy shelves. Payoff settlements occur when a brand name drug company pays a generic drug maker to delay the sale of their competing generic drug. 

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