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Is the FDA Trying to Cover Up Criticism of a Dangerous Proposal by Hiding Comments?

Oct. 22, 2014

Is the FDA Trying to Cover Up Criticism of a Dangerous Proposal by Hiding Comments?

Proposed Guidance Would Let Pharmaceutical Industry Tell Doctors Medications Are Safer Than They Really Are

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should release all comments to the public that were submitted about a recent proposal to allow the pharmaceutical industry to circumvent labeling rules and tell doctors that its products have fewer risks than those described in FDA-approved labeling, Public Citizen said in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell today.

Public Citizen calls on the Secretary to order the FDA to withdraw the dangerous proposal.

Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency’s website in the 58 days since the comment period closed. Public Citizen, on Oct. 15, requested the FDA, under the Freedom of Information Act, to release the full text of all the comments.

The FDA says that it may redact or withhold comments if they contain proprietary information, inappropriate language or duplicate language (indicating they were generated by a mass email campaign). But this couldn’t account for all the missing submissions, Public Citizen maintains.

“The draft guidance ultimately lets the pharmaceutical industry tell doctors that medications are safer than they really are. If finalized as written, it will be very dangerous to public health and safety,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “It is likely that a large proportion of the 1,780 undisclosed comments are in objection to this reckless proposed FDA guidance. By not making these comments public, it looks as if the FDA is trying to cover up opposition to the inherent dangers of the proposal.”

In June, the FDA issued draft guidance that would allow pharmaceutical companies that believe that the FDA-approved labeling information overstates a medication’s risks to tell doctors that the risks are lower. Company salespeople could inform physicians of the purportedly lower risks by distributing peer-reviewed articles – without the agency seeing the articles, reviewing the data or approving them – and discuss with doctors the information about the “lower” risks.

In an August article published in the Journal of the American Medical Association’s JAMA Internal Medicine, Wolfe wrote that to protect patients and the public health, when new information supports a reduction in risk, the company should inform the FDA and provide the evidence, as is required under current regulations. If the agency is convinced, the label can be changed.

Read Public Citizen’s letter to Burwell.