Orange Book Blog

Continuing their collaboration on new laws relating to pharmaceuticals, Senators Herbert Kohl (D-WI) and Patrick Leahy (D-VT) recently introduced legislation to stop perceived abuses of the FDA’s citizen petition procedure that result in delaying approval of generic drugs.  The bill is entitled the Citizen Petition Fairness & Accuracy Act of 2006.

According to Sen. Leahy’s press release announcing the new bill:

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.

If enacted, the new law would allow the Dept. of Health and Human Services (HHS) to sanction companies "who file citizen petitions simply to keep competition off the market."  Possible sanctions include a fine, a suspension or revocation of the right to file future citizen petitions, and a dismissal of the petition.  The bill also requires HHS to review citizen petitions within six months of filing.

Click here to read the complete text of the proposed bill.

NOTE:  thanks to Kurt Karst for alerting me to this proposal.