Withdraw FDA scientific pubs distribution guide: Public Citizen

Public Citizen tells FDA it should withdraw draft guidance that it believes will allow drugmakers to tell physicians marketed drugs are less risky than their labels indicate.

Sidney Wolfe

Public Citizen has told HHS secretary Sylvia Burwell that FDA should withdraw its recent draft guidance on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products — Recommended Practices because it would allow pharmaceutical companies to tell physicians that marketed drugs could be less risky than FDA-approved labels say they are.

In an October 22 letter to Burwell, the group’s founder and senior advisor, Sidney M. Wolfe wrote that the guidance would allow pharmaceutical salespeople to “inform physicians of the purportedly lower risks by distributing peer-reviewed articles assessing a drug’s risks and discussing with doctors the information about the ‘lower’ risks, without the FDA reviewing the articles, analyzing the data, or approving distribution of that information.”

Wolfe said FDA had acknowledged its awareness of this danger in response to two petitions from the drug and medical device industry that sought, in Wolfe’s words, “authority to engage in the distribution and communication” of off-label use information.

FDA’s response, Wolfe wrote Burwell, stated that “Information that emphasizes the drugs’ claimed benefits, while minimizing the drugs’ limitations and adverse effects, may inappropriately influence a physician’s prescribing decisions in a manner that is not in the patient’s best interest.”

His letter also complained about FDA’s decision to withhold over 1,700 public comments on the draft guidance, suggesting that it is trying to cover-up criticism of the proposal.

“Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency’s Web site in the 58 days since the comment period closed,” Wolfe wrote, adding that on 10/15 it requested under the Freedom of Information Act the release of the comments.

In a recent JAMA article, Wolfe wrote that the draft guidance “strikes the balance more toward the industry’s view of its First Amendment right to commercial speech than toward the agency’s mandate for patient protection.”

He said that when evidence supports a reduction in the risk associated with use of a prescription drug or biological product, the manufacturer should send the evidence to FDA, state the basis for the reduction in risk, and request a labeling change. If the agency is convinced, he says, the label can be changed. But, “off-label risk reduction is a misguided approach.”