FDA Hiding Comments Critical Of Rule Relaxing Drug Side Effect Warnings, Public Citizen Claims

A prominent consumer watchdog group is calling on federal drug regulators to release public comments submitted about a controversial proposed regulation, which critics suggest will allow pharmaceutical companies to lie to doctors about potential drug side effects. 

Public Citizen sent a letter (PDF) to Department of Health and Human Services Secretary Sylvia Matthews Burwell on October 22, calling for the FDA to withdraw a proposed pharmaceutical industry guidance that they suggest will allow drug companies to tell doctors that their drugs are not as risky as the label warnings indicate.

The group accuses the agency of withholding a trove of public comments submitted on the issue, which it suspects the FDA has kept secret due to the mounting backlash against the proposed regulation.

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The FDA’s proposed draft “Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products — Recommended Practices” (PDF) was released on June 11. Since then, the agency has received more than 1,750 comments on the proposed guidance. However, the agency has only published one comment.

While the agency can withhold or redact comments that contain proprietary information, duplicate language due to mass email campaigns, or bad language, Public Citizen says that cannot possibly account for the comments the agency has not released. The group filed a Freedom of Information Act request on October 15, seeking access to the comments.

“The draft guidance ultimately lets the pharmaceutical industry tell doctors that medications are safer than they really are.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,” Dr. Sidney Wolfe, founder of Public Citizen’s Health Research Group, said in a press release. “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.”

Allowing pharmaceutical companies to undermine or deny label warnings in official interactions with doctors, Public Citizen argues that the proposal would essentially allow off-label marketing of their drugs, which is illegal.

Although doctors are free to prescribe any FDA approved medications for whatever purpose they see fit, pharmaceutical companies are prohibited from marketing such “off-label” use until the FDA determines they are safe and effective.

The proposed guidance would give the industry a run-around of that long-standing rule, Public Citizen warns.

The FDA guidance refers to new risk information, which the agency defines as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate greater seriousness or risk.”

As an example, the FDA says it could include data suggesting that rate or level of risk of a known side effect is lower than what was mentioned on the label when the drug was released.

“FDA recognizes that the safety profile of a drug evolves throughout its lifecycle as the extent of exposure to the product increases and that it can be helpful for health care practitioners to receive significant new risk information about an approved product in a timely manner,” the guidance states. “Firms may distribute to healthcare entities and healthcare professionals newrisk information under appropriate circumstances, even if such data are not consistent with the risk information currently in approved labeling.”


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