Bill Aims to Enhance Public Health by Improving Off-Label Use of Prescription Drugs and Devices

Strategic Insights -

Sens. Connie Mack and Bill Frist have introduced a bill that would allow drug companies to disseminate information about the off-label uses of their medications to physicians. The information would have to come from a source that was not sponsored by the pharmaceutical company and would disclose that the FDA has not approved the medication for the off-label use. This bill aims to improve public health by increasing the flow of information to medical and scientific communities about the off-label uses of prescription drugs and devices. However, critics argue that the bill could harm the public's health by encouraging physicians and patients to make treatment decisions based on inadequately supported claims.

Key Takeaways:

  • The bill, introduced by Sens. Connie Mack and Bill Frist, would allow drug companies to distribute information about off-label uses of medications to physicians from peer-reviewed medical and scientific journals or textbooks, accredited continuing medical education programs, and information about uses reimbursed by the federal government.
  • The information would have to disclose that the FDA has not approved the medication for the off-label use and that the manufacturer is paying for the dissemination.
  • The bill would require that the information be distributed only to providers, managed care organizations, insurers, and government agencies, and not to the general public.
  • According to the Office of Technology Assessment, the drug industry spends $11 billion a year on promotion, compared with $10 billion on research and development of new drugs.
  • The Pharmaceutical Research and Manufacturers of America supports the bill, while the People's Medical Society, a consumer watchdog group, opposes it.
  • Critics argue that the bill contains inadequate safeguards and that peer review or inclusion in a CME course is no guarantee that a study is unbiased.
  • A study in the New England Journal of Medicine found that as much as 41% of the proceedings of educational symposia published in medical literature and sponsored by pharmaceutical companies included misleading claims.

Statistics:

  • 40-60% of prescriptions written each year are for the off-label use of a drug.
  • 1.5 billion drug prescriptions are written each year, worth more than $50 billion.
  • 11 billion dollars are spent each year on drug industry promotion, compared with $10 billion on research and development of new drugs.
  • 2.9% of emergency department visits are attributable to adverse drug reactions.
  • 23% of hospitalized patients experience adverse reactions to commonly prescribed drugs.

Sources:

  • Article from the Washington Post
  • The Mack/Frist bill
  • The Pharmaceutical Research and Manufacturers of America
  • The People's Medical Society
  • The New England Journal of Medicine
  • The Office of Technology Assessment
  • The FDA's proposed regulations on CME
  • Washington Legal Foundation v. Kessler