Next victim, off-label prescriptions? That appears to be the intention of Henry Waxman and his man at the FDA.
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It’s no wonder industry observers and the medical community suspect that Waxman’s acolyte Joshua Sharfstein will soon turn his sights toward restricting this important and beneficial mechanism that inexpensively facilitates the dissemination of valuable information to physicians and their patients.
Opponents of off-label prescribing seem unable to balance the regulatory objective of protecting patients from unsafe drugs against the prerogative of physicians to use their best professional judgment to treat individual patients. They downplay the costs of FDA approval, exaggerate the credulity of physicians and their willingness to unquestioningly trust information distributed by drug manufacturers, and ignore the significant benefits off-label prescribing offers for patient care.
Physicians are reluctant to see FDA further restrict information about off-label uses. They know that the practice has large benefits and few costs. Its use should be extended, not curtailed by stricter regulation. Unfortunately, the FDA has a long, troubling history of succumbing to political pressure even when it harms the interests of doctors and their patients.