Off-Label Drug Promotion

The Senate’s only physician, Sen. Bill Frist (R-TN), told FDA Commissioner Jane Henney, MD, that when Congress rewrites the “off-label” drug marketing law, the new version should give physicians more credit for being sophisticated consumers of pharmaceutical information. The original law, passed as part of the 1997 FDA Modernization Act (FDAMA), was invalidated last summer by Washington, DC, federal court judge Royce Lamberth. He argued that the conditions drug companies had to meet in order to send physicians information on off-label use represented unconstitutional barriers to free speech. At the October hearings before the Senate Public Health Subcommittee that he chairs, Frist said he agreed with Lamberth and asked Henney, who was appearing before the subcommittee, whether Congress should rewrite the off-label provision. Since the FDA is appealing the ruling, Henney advised Congress to wait and see what happens in court. Oral arguments are scheduled for January 10. But Henney said that she believes “very strongly that Congress got it right” in FDAMA.