FDA Draft Guidance on the Distribution of Risk Information by Pharmaceutical Companies Falls Short of Ensuring Patient Safety

Written by Jennifer Y. Seo, MD, JD

The FDA has proposed a guidance directed at pharmaceutical companies regarding their distribution of published studies that include new information about the already-identified risks of approved prescription drugs. That is, the guidance addresses the distribution of studies that may contradict or mitigate the known risks of a drug. While the FDA’s intentions may be to provide best-practice recommendations, the draft guidance does not adequately protect patients from harm. Rather, it leaves the door open for potentially misleading information to be distributed to healthcare providers.

The problem is that the guidance is too broad and at times too vague. It states that the distributed studies must be “well-designed,” “at least as persuasive” as the original risk data, and “published in an independent, peer-reviewed journal.” Many flawed studies could be deemed by pharmaceutical companies to meet these broad requirements, and asking the companies themselves to disclose any limitations of the studies does not decrease the potential for providers to be misled. While this concern could be mitigated by FDA review of such articles, the guidance does not require this.

The burden is thus shifted to prescribing providers to critically evaluate the distributed studies. However, busy providers may make misguided shifts of their risk-benefit calculations based on quick glances at these pharmaceutical company-provided studies. And the ultimate bearer of harm would be the patient.

To address these concerns, the NPA FDA Task Force recently submitted comments to the FDA on the draft guidance. The comments can be found here. To learn more about the work of NPA’s FDA Taskforce, click here.