On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would
Yesterday, on August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that contain product claims. These types of ads must include, among other things, what is often called a “major statement,” i.e., information relating to the advertised drug’s “major side effects and contraindications” in either the audio or the audio and visual parts of the ad. 21 CFR 202.1(e)(1).
In the FR notice, the agency explained that it is considering a new approach to satisfy this requirement called a “limited risks plus disclosure strategy.” Under this approach, the major statement would be limited to 1) “severe (life-threatening), serious, or actionable” risks and 2) a disclosure to alert consumers that there are other risks not included in the ad. The Federal Register notice elaborated on the definitions of “serious” and “actionable” risks.
On February 19, 2015, the U.S. Food and Drug Administration (FDA or the Agency) authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. The test is intended only for postnatal