(Reuters) - Consumer watchdog Public Citizen has called on U.S. health regulators to withdraw a proposal that would allow pharmaceutical companies to distribute medical literature suggesting a drug’s risk is less than stated on the label.
In a letter released on Wednesday, the organization urged Health and Human Services Secretary Sylvia Burwell to withdraw the proposal, saying pharmaceutical companies could “sell more drugs by making them seem safer than FDA has judged them to be.”
Last June the Food and Drug Administration proposed allowing the distribution of new risk information about approved drugs, saying that a drug’s safety profile “evolves” as exposure to the product increases.
The FDA said it would allow distribution of new information in medical journals showing that the severity or frequency of a side effect is lower than described on the product label. The new data could even “call into question a causal relationship between a drug and an event in the approved labeling.”
Companies would not be allowed to distribute literature about newly identified risks or information that shows an already identified risk is more serious than stated on the label. Such information would need to be reviewed by the FDA and potentially included in the label.
The proposal, critics say, would strip all meaning from current laws requiring FDA approval of a drug’s label, which includes its risks, benefits and other prescribing information.
HHS said it would respond to Public Citizen’s letter.
“Secretary Burwell appreciates hearing from stakeholders,” a spokesperson said. “The FDA is currently reviewing and considering all comments received from the dockets on the draft guidance.”
An FDA spokeswoman said the agency “does not have any specific timeline to share” on when its review might be complete.
The FDA requested public comment on the proposal and has not yet issued final guidance. Public Citizen obtained copies of 1,771 public comments under an open records request and made them available publicly. Of those comments, roughly 99 percent oppose the proposal.
“This is a misguided FDA proposal that could result in physicians relying not on approved warning labels but on information provided by drug companies that may be more concerned with profits than patients,” wrote one commentator.
Another said “drug reps stretch the truth more than enough.” Yet another asked: “How can this be considered in any way? Where I come from you do not let the fox in the hen house.”
Among supportive comments, Public Citizen drew attention to one from the Medical Information Working Group, representing big drug companies including Allergan Inc, Amgen Inc, Pfizer Inc and GlaxoSmithKline Inc, who argue they should be allowed to distribute the literature under the First Amendment.