FDA Communication Guidances Draw Comments

AbbVie says FDA’s issuance of a payor guidance and medical products communications guidance are “an important step forward in improving the communication of information that is related to approved uses and consistent with a drug’s PI but that does not appear in that PI or meet FDA’s traditional substantial evidence standard.” Its comment letter says the draft guidances can be improved in a number of ways.

“The scope of information covered by each draft guidance should be made uniform,” the company says. “Similarly, the evidence necessary to support communications under each draft is sufficiently similar that one standard should apply across both documents. Harmonizing the standards between the two guidances would provide clarity, reduce confusion, and lower the administrative burden of determining the appropriateness of product communications for both the agency and firms.”

In its letter, Genentech says the guidance recommendations are an important step forward to ensure that complete, accurate information about medical products is available to individuals who need it. It suggests that the draft guidance on medical product communications consistent with FDA labeling is unclear about communications on use of approved products in conjunction with other products or therapeutic modalities. It also says that the guidance suggests that the agency may cite lawful communication of information that is consistent with the label as evidence of a new intended use, which, according to the company, contradicts case law and other FDA guidance.

Genentech calls on FDA to expand its advisory comment process as firms seek to apply the draft.

Pharmaceutical Research and Manufacturers of America says that FDA regulation of manufacturer communication should adhere to principles that ensure sophisticated audiences will benefit from accurate, data-driven information from all sources, including the companies that research and develop new medicines. It notes that it and the Biotechnology Innovation Organization (BIO) released 7/2016 principles stating that communications should be based on analyses using scientifically- and statistically-sound methodologies, should clearly disclose appropriate contextual information, and should be tailored to the sophistication level of the intended audience.

BIO’s comment letter says that FDA policies on companies’ communication about their products to healthcare providers and payors have remained virtually unchanged over the past several decades, and updates “are critically necessary to align guidance with the Constitution, sound public policy, and to inform the increasing complexity of healthcare models and population health management.”

Finally, AdvaMed says it applauds the agency for providing helpful clarification, including examples and multi-pronged factors, to help industry assess when communications that present information not contained in the labeling may be ‘consistent’ with the FDA-required labeling.” It then offers specific comments and requests for changes.