- In response to an FDA proposal, Public Citizen has sent a letter to HHS Secretary Sylvia Burwell requesting that pharma sales reps not be allowed to circulate risk data from peer-reviewed articles showing that a drug has less risk than labeling suggests.
- The new proposal is rooted in the FDA's contention "that the safety profile of a drug evolves throughout its lifecycle as the extent of exposure to the product increases."
- Under this proposal, companies would not be allowed to distribute literature about newly identified risks, or risks that are worse than labeling conveys.
This proposal has really evoked the ire of Public Citizen, which contends that reps "already stretch the truth more than enough." The watchdog group obtained 1,771 public comments under an open records request from the FDA. All but 1% of the comments were against reps being able to distribute new risk data that puts the drug in question in a more favorable light. Clearly, there are valid concerns about how this type of data—no matter how well grounded in a well-designed clinical trial---might be used to downplay actual risks.
On the other side, pharma advocates from the Medical Information Working Group have said that they should be allowed to distribute this type of medical literature based on First Amendment rights. As of now, neither the FDA nor HHS have commented on this situation.