BIO Submits Comments Re: CMP & Ceiling Price Proposed Rule

Dear Secretary Burwell and Commander Pedley:

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit the following comments to the Department of Health and Human Services (HHS) in response to the proposed rule issued by the Health Resources and Services Administration (HRSA) on June 17, 2015, entitled 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation [RIN-0906-AA89] (the “Proposed Rule”).

BIO represents an industry devoted to discovering new treatments and ensuring patient access to them. Accordingly, we support the 340B program as a way to improve access to therapies for needy patients. We believe that compliance with 340B program requirements by all parties—including manufacturers—is an important part of ensuring the sustainability of the 340B program.

We appreciate HRSA’s efforts to implement the manufacturer civil monetary penalty (CMP) provision added to the 340B statute by the Affordable Care Act (ACA), as well as to provide further clarity regarding the calculation of 340B ceiling prices, via the Proposed Rule.  We note that BIO submitted comments in response to HRSA’s Advance Notice of Proposed Rulemaking (ANPRM) on the topic of CMPs in November 2010, as well as the Agency’s proposed Information Collection Requests (ICRs) related to the collection of manufacturer data to verify 340B ceiling price calculations in both November 2014 and May 2015, and we have attached each of these comment letters for your reference.