WEBINAR: The 340B Program for Drug Manufacturers

HRSA's Implementation of the Program

Foley Hoag hosted a webinar on the 340B Drug Pricing Program on March 5. This webinar lays out the current status of HRSA’s orphan drug rule and the “Mega-Rule.” The webinar also discusses HRSA’s authority in continuing the implementation of the program’s expansion following the orphan drug rule litigation in the D.C. District Court.

Foley Hoag attorneys Tom Barker and Igor Gorlach:

  1. Provide an overview of the Affordable Care Act’s expansion of the 340B program and HRSA’s progress in implementing the expansion;
  2. Discuss the status of HRSA’s orphan drug rule;
  3. Discuss the impact of the litigation between HRSA and PhRMA on HRSA’s future policies implementing the 340B program;
  4. Discuss the future of the “Mega-Rule;” and
  5. Outline the interaction between 340B and the CMS AMP Proposed Rule.

Click here to download the slides.