CURE ID Undermines FDA Off-Label Speech Censorship: Column

Former Washington Legal Foundation (WLF) chief counsel Richard Samp asks how FDA justifies its continuing efforts to bar drug manufacturers from disseminating information on off-label uses of their products when the agency itself is facilitating “crowdsourcing” of off-label information through its CURE ID program launched 12/2019. “FDA deserves praise for its decision to launch CURE ID,” Samp writes online in an On the WLF Legal Pulse column. “As FDA acknowledges, many patients would receive sub-optimal care if their doctors were limited to prescribing drugs only for FDA-approved uses.”

Samp says that doctors’ ability to effectively employ off-label uses of FDA-approved products is predicated on their access to reliable information about the effectiveness of new off-label treatments. He says the launch of CURE ID advances that educational process by giving doctors invaluable information in deciding how to treat patients who have not responded to FDA-approved treatments.

The post reviews the arguments FDA has advanced to defend its ban against manufacturer dissemination of off-label information and says courts have not accepted some of the agency’s views.

Samp notes that “conspicuously absent from those invited to contribute clinical data to CURE ID are drug manufacturers. Only ‘healthcare providers’ are invited to supply off-label information to the Internet-based repository. In other words, in launching CURE ID, FDA is not signaling an intent to loosen its ban on manufacturer off-label speech.”

As a scientific policy, he writes, that decision makes little sense since manufacturers of FDA-approved products are very likely to be familiar with all available data regarding off-label uses of their products and are the entities best positioned to distinguish scientifically validated off-label information from off-label information that lacks solid scientific support. “By preventing manufacturers from being part of the conversation,” Samp cautions, “FDA likely is causing medical professionals to make worse decisions on whether to make off-label use of FDA-approved products when treating their patients.”

Samp concludes by saying that the agency’s launch of CURE ID undermines its remaining First Amendment defense since manufacturers will now have a reduced incentive to invest in the well-controlled studies needed to obtain approval for new indications. “In the absence of evidence that commercial speech suppression directly and substantially advances an important government interest, the First Amendment prohibits speech suppression,” he writes.