Glucophage Won’t Get Exemption in Pediatric Drug Bill
Bristol-Myers Squibb's diabetes drug Glucophage will not receive an exemption in legislation to renew the 1997 FDA Modernization Act that could have allowed it three extra years of patent protection, bill sponsor Rep. Jim Greenwood (R-Pa.) said yesterday, CongressDaily/AM reports. The legislation would grant six months of market exclusivity for drugs whose effectiveness in children is tested in clinical research. Bristol-Myers has argued that in addition to receiving a six-month patent extension for Glucophage for pediatric tests conducted under the 1997 law, the company should also receive three years of exclusive marketing rights under the 1984 Hatch-Waxman law. That law awards drug companies three years of exclusive marketing rights "if they discover a new use for a drug," and pediatric tests of Glucophage have found that the drug can help teenagers. However, supporters of the Best Pharmaceuticals for Children Act said "they never intended to provide more than six months" of market exclusivity for any drug. Both the House and Senate bills include a provision that would allow generic versions of drugs to be sold regardless of whether brand-name companies hold extended marketing rights, provided that the generic labels exclude the pediatric information. Bristol-Myers had launched a "furious lobbying campaign" to persuade House and Senate negotiators working on a compromise bill to drop the provision or award the company a "special exemption" for Glucophage.
The Senate has "remained adamant about not giving the firm special treatment," according to CongressDaily. In a letter earlier this week to Senate leaders, an "ideologically diverse" group of nine senators -- Sens. Richard Durbin (D-Ill.), Larry Craig (R-Idaho), Charles Schumer (D-N.Y.), Mike Crapo (R-Idaho), Jay Rockefeller (D-W.Va.), John McCain (R-Ariz.), Hillary Clinton (D-N.Y.), Paul Wellstone (D-Minn.) and Patrick Leahy (D-Vt.) -- "threatened to block the bill" unless the contested provisions remained intact. They wrote that moving to drop the provision "would lead to the possibility of indefinite delay of the final passage of this bill." They added that "consumers, federal and state programs and private insurers will be adversely affected. The overall cost impact will be in the multibillion dollar range." Greenwood said that House and Senate negotiators would likely conclude debate next week (CongressDaily/AM, 12/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.