wo high-ranking House Republicans have accused the US Department of Health and Human Services of delaying eagerly awaited guidelines for off-label marketing of drugs and devices. And the charge comes amid growing frustration among companies that the US Food and Drug Administration is squelching their free speech-rights.
In a letter sent Thursday to HHS Secretary Sylvia Burwell, the lawmakers wrote they are “perplexed” the FDA has not yet issued new guidelines covering off-label marketing or held a promised meeting. And they worry that court rulings will, instead, become the basis for determining policy. Then they claimed the delay is the result of disagreement between HHS and FDA leadership.
“It is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange,’” of useful information about drugs and devices, wrote Fred Upton, a Republican from Michigan and Joe Pitts, a Republican from Pennsylvania. They also attached a draft bill that would allow companies to market products for unapproved uses.
Drug and device makers have increasingly argued that current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their products. Doctors can prescribe medicines for any purpose, which is called off-label use, but companies can only promote medicines for uses approved by the FDA.
For its part, the FDA maintains public health can be compromised if marketing claims are not backed up by solid evidence. The agency, however, promised to issue new guidelines after a federal appeals court overturned a criminal conviction of a sales rep for off-label promotion. The court ruled his speech was protected, since the information was truthful and not misleading. The FDA also agreed to holding a meeting on the topic, but that has also been delayed.
The issue accelerated last year when Amarin filed a lawsuit to argue its right to distribute information about unapproved uses of a drug is protected by the First Amendment. Amarin sought to give doctors clinical trial data not directly pertaining to approved uses of a pill. In March, the FDA settled the case by allowing Amarin to proceed if information given doctors is truthful and not misleading.
Only a month before that, a federal court jury in Texas decided that the medical device maker Vascular Solutions and its president were not guilty of off-label promotion since the information the company gave to doctors about a laser therapy device was deemed truthful and not misleading. These developments underscored industry anxiety over the delay in issuing a guidance.
We asked the HHS for comment and will update you accordingly. In a speech earlier this month, FDA Commissioner Dr. Robert Califf said the agency is “reviewing our policies,” but did not provide a timeline for releasing the guidance. An FDA spokeswoman said the agency will review the letter, but did not have any further information on the release of the guidance.
One source, who speaks regularly with both agencies, told us this: “HHS leadership doesn’t trust industry to do the right thing … HHS leadership believes off-label speech will lead to more aggressive marketing of new products that will raise costs to [Medicare and Medicaid]. They are allowing both their prejudices [industry as the bad guy] and priorities [keeping spending down] to get in the way … The White House shares these fears, and as a result the FDA’s desire to issue guidance is stymied.”
One Washington insider cautioned that the may lose the initiative if the agency does not release a guidance.
“After the recent court decisions, the FDA realizes that it must either lead the effort to disseminate off-label information that is truthful, accurate, and non-misleading, or lose its ability to direct the speed, direction, and quality of these communications,” said Peter Pitts, a former FDA associate commissioner, who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by industry. “Things are moving fast and unless the FDA acts, we’ll have federal judges making these decisions for us. That’s not good for the FDA or the public health.”
As for the draft legislation, a spokeswoman for the House Committee on Energy and Commerce wrote us that the bill may not be introduced. She noted that the language was discussed with the FDA during conversations related to the 21st Century Cures Act, but was ultimately not included in the bill.
One consumer advocate, meanwhile, criticized the draft.
“The threat to patient health posed by the draft bill attached to their letter is tremendous,” said Michael Carome, who heads Public Citizen Health Research Group. “FDA approval of a drug for one use tells us nothing about whether the drug is safe and effective for another use. Yet this bill would allow drug manufacturers to advertise and promote drugs and devices, both to doctors and directly to consumers, for uses never approved by the FDA.”