By Julie Rovner
WASHINGTON (Reuters Health) – Nine US senators have written to leaders in that chamber vowing to block the final version of the pediatric exclusivity renewal bill if a key provision is changed to benefit a particular drugmaker.
The Best Pharmaceuticals for Children Act would renew a law set to expire at the end of the year that gives brandname pharmaceutical manufacturers an additional 6 months of market exclusivity if they agree to test their products on children at the request of the US Food and Drug Administration.
But lawyers for Bristol-Myers Squibb, whose patent for the blockbuster diabetes drug Glucophage is expiring, discovered that if they combined the six months from the pediatric law with a provision of the 1984 Hatch-Waxman act, they could win an additional 3-1/2 years without generic competition.
Lawmakers in both the House and Senate agreed that they never intended to provide that much additional market exclusivity, and both versions of the bill currently in a House-Senate conference committee would close the loophole.
But lobbyists for the drug company have been urging Congress not to cut off what they say the firm has gained legally. House Energy and Commerce Chairman Billy Tauzin, R-La., told reporters last week that House Republican leaders had asked him to try to find a compromise "acceptable to both sides [that would also] make sure that no one could do this in the future."
But Democratic and Republican senators say any change that would allow Bristol-Myers Squibb more than the 6 months it should have earned as a result of doing its pediatric research is unacceptable.
Changing the measure "would lead to the possibility of indefinite delay of the final passage of this bill," said the letter, which was signed by Sens. Richard Durbin, D-Ill., Larry Craig, R-Idaho, Charles Schumer, D-N.Y., Michael Crapo, R-Idaho, John D. Rockefeller IV, D-W. Va., John McCain, R-Ariz., Patrick Leahy, D-Vt., Hillary Rodham Clinton, D-N.Y., and Paul Wellstone, D-Minn.
The senators said that unless the bill closes the loophole, "consumers, federal and state programs, and private insurers will all be adversely affected. The overall cost impact will be in the multi-billion dollar range…At a time when many consumers are desperately in need of relief from the high cost of prescription drugs, Congress should…not increase that burden."
Aides to the members of the conference say that discussions on the final version of the measure are nearly complete and they expect to bring it to the House and Senate floor for final votes next week.
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