On Friday, The Wall Street Journal editorialized on free speech in the context of sharing scientific and medical information, something critical for the U.S. Food and Drug Administration (FDA).
FDA’s critical work depends on the free flow of information. But as the Journal notes, the FDA’s current interpretation of laws and regulations governing medical communications puts that free flow in jeopardy, prohibiting biopharmaceutical companies from sharing with health care professionals certain accurate, data-driven information about FDA-approved uses and medically accepted alternative uses of FDA-approved drugs.
Why does this matter? Because, as the Journal notes, “[a]bout one of five U.S. prescriptions are for non-FDA-sanctioned uses” and “off-label use is vital for complex conditions like cancer and psychiatric disorders that require trial and error for individual patients, who can’t wait for the FDA’s blessing.” And in situations where off-label prescribing is commonplace, it is important to patients that their physicians have the best and most complete information available when making prescribing decisions.
The Journal adds that the courts aren’t waiting to act. In 2012, the U.S. Second Circuit of Appeals ruled that the provision of truthful and non-misleading information by pharmaceutical companies to physicians is constitutionally protected, even if the information provided is not contained on the label. More recently, a federal court in New York ruled that the FDA cannot prohibit a biopharmaceutical from providing information about a non-FDA approved use as long as the information is truthful and non-misleading.
These judicial rulings should compel the FDA to update its regulatory framework for biopharmaceutical company communications with healthcare professionals. In Food and Drug Law Journal earlier this year, my colleagues here at PhRMA proposed a modified regulatory paradigm to do so.
Until then, “[t]he Second Circuit—and likely the Supreme Court—could protect both medical progress and the Constitution by rebuking the FDA’s power grab,” the Journal concludes.
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Read additional posts by PhRMA General Counsel Mit Spears.