99 Percent of Commenters Agree: FDA Proposed Guidance Is a Bad Idea, Undermines Purpose of FDA and Puts Patients at Risk

Draft Guidance Would Let Pharmaceutical Industry Tell Doctors Its Products Are Safer Than FDA Has Deemed Them

WASHINGTON, D.C. – Ninety-nine percent of people or organizations that commented on a government proposal to allow the drug industry to misinform doctors about potential risks of medications oppose the plan, a Public Citizen analysis shows.

The 1,771 commenters urging the U.S. Food and Drug Administration (FDA) to reject its idea include consumers, doctors and other health professionals, academics, individuals in the pharmaceutical industry and various organizations. The FDA's proposed guidance would undermine the purpose of the agency and put patients at risk, Public Citizen said today in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell.

The draft guidance, issued in June 2014, would give companies that believe that the FDA-approved labeling information overstates risks free rein to tell doctors that the risks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.

"As most of the comments stated, this proposed guidance is reckless and seriously undermines FDA authority," said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. "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."

After the agency closed the comment period in August, only one of the 1,782 comments submitted on the proposal was posted on the FDA's website. On Oct. 15, Public Citizen requested under the Freedom of Information Act the full text of all the comments. After obtaining the comments, Public Citizen read each response, finding only 11 commenters – less than one percent – in support of the proposed FDA guidance. The 11 comments came from pharmaceutical companies and their trade associations, along with a single academic.

"As predicted, the proposal's few supporters primarily are industry companies and their associations, all of which would benefit from being allowed and encouraged to sell more of their products by making them seem safer than the FDA has judged them to be," said Wolfe.

After analyzing the comments opposing the guidance, two themes emerged. First, responders viewed it as giving Big Pharma the green light to push information on to patients' own doctors that contradicts government-approved warning labels. A second related theme was a widespread and increasing distrust of the FDA for proposing such guidance.

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.

In its letter today, Public Citizen urges Burwell to immediately withdraw the proposed guidance.

Read the letter, which includes 42 of the comments that were submitted.

Suggested Articles

BMS’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease.

The Japanese approval, under the brand name Jyseleca, came a month after an FDA complete response letter that asked Gilead for more data.

The Trump Administration has opened the doors for Florida and other states to import prescription drugs from Canada—despite industry objections.