
- ONCOLOGY Vol 13 No 12
- Volume 13
- Issue 12
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
The Senates 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.
Articles in this issue
almost 26 years ago
Clinton Medical Records Privacy Proposalalmost 26 years ago
Call for Stronger Recommendations About Supplement Use During Chemotherapyalmost 26 years ago
Book Review:Pediatric Hematology, Second Editionalmost 26 years ago
Women Are Replacing Old Breast Implants With Newalmost 26 years ago
FTC Warns Against Home-Use Tests for HIValmost 26 years ago
Book Review:Wintrobe’s Clinical Hematology, 10th EditionNewsletter
Stay up to date on recent advances in the multidisciplinary approach to cancer.