In re: FDA Payor Communications Guidance
- Case Date: 4/20/2017
- Project Name: Health Care Project
On April 20, 2017, WLF filed formal comments with the Food and Drug Administration (FDA), encouraging FDA to revise its January 2017 draft Payor Communications Guidance. That document purports to govern the sorts of health care economic information (HCEI) that drug and device manufacturers may share with payors, formulary committees, and similar entities. WLF argued in its comments that permitting manufacturers to disseminate truthful HCEI is critical to delivery of health care in this country. Without this information, healthcare providers and payors cannot make economically rational decisions regarding which medical products to include in their formularies. WLF applauded FDA for providing long-overdue guidance to manufacturers—it was 20 years ago that Congress adopted legislation encouraging manufacturers to share HCEI with payors. But WLF also argued that the draft guidance restricts speech more severely than is permitted under either the First Amendment or the 1997 statute.
|Awaiting FDA response.|
More Information and Downloads:
|4/20/2017: Download the Comments|
|Press Release: WLF Encourages New FDA “Payor Communications” Guidance to Come into Compliance with Federal Law|