MASSACHUSETTS: PUBLIC HEALTH OFFICIALS OPPOSE BILL
Officials for the Massachusetts Department of Public HealthThis is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
testified yesterday against a proposed bill that would create a
list of special drugs that require "approval of a doctor and
pharmacist" before a generic version of a drug "could be
dispensed," BOSTON GLOBE reports. DuPont Merck Pharmaceuticals
Inc., the sole manufacturer of Coumadin, filed the legislation
after the FDA approved in March a generic version of the drug by
Barr Laboratories Inc. Coumadin is classified as a "narrow
therapeutic index" drug, meaning that it requires close
monitoring. Barr officials contend that their drug "meets all
the FDA requirements -- same active ingredient, identical in
strength, dosage form and labeling as Coumadin -- and provides
the same therapeutic benefit."
ARGUMENTS: According to Nancy Ridley, assistant
commissioner for the bureau of health quality management at the
Department of Public Health, the state "already has the authority
to review all drugs for public safety." The state's 20-year-old
Drug Formulary Commission reviews drugs, and can pull a drug off
the market in Massachusetts if the drug does not meet "state
safety and health requirements." Ridley said, "I just don't see
the need for this legislation. We already have regulations
requiring close communication between physician, patient and
pharmacy." However, GLOBE reports that supporters of the bill
maintain that the substitution of narrow therapeutic index drugs
should be given special attention because they "require such
careful patient monitoring." Although DuPont Merck has filed
similar legislation in "nearly a dozen other states," only North
Carolina has passed a bill requiring a narrow therapeutic index
drug list; and California legislators rejected the proposal last
week (see AHL 5/16) (Rosenberg, 5/21).