FDA Drug Warning Guidance Receives Strong Opposition From Public

A flood of comments have been submitted in opposition to proposed guidance issued by federal drug regulators last year, suggesting that the rules change may allow drug sales representatives to downplay side effects associated with the medications they are promoting. 

In a letter (PDF) sent this week to Sylvia Burwell, secretary of the Department of Health and Human Services, the prominent consumer watchdog Public Citizen indicates that it has conducted an analysis of nearly 1,800 comments submitted in response to the FDA guidance on distributing scientific and medical information on prescription drugs proposed last year.

The group found that 99% of those who commented on the proposed guidance are opposed to the FDA plans, with most suggesting that it will undermine the FDA’s authority and put patients at risk.

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Data on the comments were released by Public Citizen because the FDA has not provided the information. To date, the agency has only published about 80 of the comments received following release of the proposed guidance.

Public Citizen obtained them through a Freedom of Information Act Request filed in October 2014. At that time, the FDA hd only published one comment.

At issue are FDA draft guidance published in June 2014, which proposes that drug companies should be allowed to provide information to healthcare professionals that rebuts or even contradicts new risk information on drug labels.

Opponents say that the guidance essentially gives drug sales representatives carte blanche to lie to doctors and tell them that serious health risks can be ignored or do not actually exist.

Public Citizen accuses the FDA of hiding the massive response because, out of 1,782 individuals, organizations or companies that submitted comments on the guidance, only 11 were in favor of it. Comments in support of the proposed guidance included 10 from the pharmaceutical industry and one academic.

“As most of the comments stated, this proposed guidance is reckless and seriously undermines FDA authority,” Dr. Sidney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, and the letter’s author, said in a press release. “The FDA is supposed to be the government shield that protects patients when the industry pushes products that might not have a favorable benefit-to-risk ratio in order to line their own pockets. This guidance completely undermines that safety shield.”

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.


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