Restoring Free Speech in Medicine: How State Lawmakers Can Overcome FDA Regulations That Keep Doctors and Payers in the Dark
Goldwater Institute policy paper
25 Pages Posted: 7 Jun 2017 Last revised: 18 Aug 2017
Date Written: June 6, 2017
Better-informed physicians and payers, such as health insurance carriers, other third-party payers, and plan sponsors, can help patients gain access to a wider array of potentially effective treatment options. But federal regulations restrict physician and payer access to the most current medical information.
These regulations are related to the way the U.S. Food and Drug Administration, or FDA, restricts the labeling and marketing of prescription drugs, biologics, and medical devices. These rules prohibit the sharing of knowledge that could help doctors discover optimal medical treatments, and patients obtain them.
Commonly known as “off-label use,” about one- fifth of prescriptions written annually are legally prescribed for purposes, patient populations, or dosages different from what the FDA originally approved. For example, aspirin is FDA approved for a variety of ailments, including pain, fever, and cardiovascular disease, but is also a commonly used prophylaxis for coronary disease in diabetic and other high-risk patients, a use for which it is not FDA-approved, making it “off-label.” The FDA limits how and what information drug, biologic, and medical device companies can share with healthcare providers and payers about the already-legal use of their products.
These speech restrictions have serious implications for patients. According to a recent survey of specialists and primary care physicians, roughly one-quarter indicated that FDA approvals for narrow indications had a high impact on treatment decisions.
Companies are at constant risk of prosecution and criminal penalties for “misbranding,” or communicating off-label uses for a product outside of a narrow and often murky set of federal requirements. But the sharing of truthful, scientific information about off-label uses need not conflict with patients’ interests and well-being.
The benefits of off-label prescribing include expanding physicians’ and other providers’ arsenals of treatments and bringing potential treatments to patients sooner. Restrictions barring the truthful, scientific sharing of information about an FDA-approved device or treatment are not only increasingly inconsistent with the rapid availability of healthcare information in the 21st century, but they are also at odds with constitutionally protected speech. Indeed, the U.S. Constitution provides a floor of protection for individual rights, not a ceiling, leaving states free to enact laws that protect those rights more broadly than the federal Constitution does.
Just as informed patients are empowered to engage in a more productive conversation with their physicians, physicians who are up to speed on the latest medical and pharmaceutical advances are best equipped to provide optimal treatment for their patients. That is why state lawmakers can and should take steps to pursue reforms to ensure access to information for physicians and payers.
These reforms should: • Allow for truthful and nonmisleading information to be shared between manufacturers and healthcare providers, whether solicited or not, • Provide that shared information be truthful and nonmisleading, and • Allow for manufacturers to communicate with payers.
Keywords: free speech, FDA, off-label, first amendment, federalism, free speech in medicine
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