A major Federal Court ruling today could significantly impact FDA regulation of commercial speech (and of drugs). The agency may no longer be able to exert its regulatory authority over drugs by simply restricting the flow of certain “unapproved” scientific information that is otherwise truthful, non-misleading, and serves public health interests.
There are public health costs to FDA’s existing regime. It can leave patients and doctors less informed about new science. Now the courts have clearly indicated that such “off label” speech is also commercial speech and protected by the First Amendment.
While today’s ruling applied to “oral statements” made about drugs, this case and others should extend similar principles to written material that sponsors share with doctors. This should oblige FDA to re-think how it regulates drug labeling, and how the agency creates incentives for sponsors to go through the new drug approval process and seek new indications on their products. It should prompt FDA to come up with a more balanced approach that allows findings from scientific studies to be disseminated even if these results aren’t in the FDA-approved label and haven’t met the agency’s high bar. This should be especially true in the case of unmet medical needs like cancer, where the science is fast moving and FDA labels often woefully out of date.
Critics of this court ruling will argue that the decision guts FDA’s authority. It does not. The FDA regime had become over-reaching, with the agency attempting to restrict the ability of sponsors to even share the results of major government-funded studies with physicians. FDA feared that doctors would be “misled” by this information. But it was never in FDA’s legal purview to regulate medical practice decisions by restricting doctors’ access to truthful information. It was inevitable that the courts would strike down the FDA’s expansive actions. By over-interpreting its authority, the agency invited challenge.