FDA to ease pharma-payer communications

FDA will release a final guidance "shortly" on communication of pharmacoeconomic information between manufacturers and “sophisticated intermediaries” such as PBMs and hospital-based pharmacy and therapeutics committees, FDA Commissioner Scott Gottlieb said Thursday. He did not specify when the guidance will be released. It is likely to be part of the Trump administration’s package of drug pricing reforms that is slated for release next week.

While Gottlieb did not describe the guidance's contents, he noted in prepared remarks to the Pharmaceutical Care Management Association (PCMA) that “reliable scientific and economic information, including information that may not be in the FDA approved label, can support more flexible drug pricing and coverage agreements, including indication-based payments.”...