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BIO Submits Comments Re: 340 B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation Interim Final Rule

BIO submitted comments in response to the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Interim Final Rule (the "Interim Final Rule") published in the Federeal Register on March 20, 2017.

In the balance of this letter, we discuss each of our concerns in detail, focusing on the need to delay the effective date of the Final Rule until HRSA can complete revisions to the Final Rule through notice-and-comment rulemaking that address:

  • The significant burden of the “penny pricing” policy finalized in the Final Rule;
  • The need to revise the regulatory definition of the “knowing and intentional” standard to comply with its statutory intent; and
  • The need to revise the treatment of ceiling price calculations for newlylaunched drugs and the definition of “instances of overcharging” to mitigate the significant and undue burden these Final Rule provisions place on manufacturers.

 

Dear Secretary Price and Acting Administrator Macrae:

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide feedback in response to the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Interim Final Rule (the “Interim Final Rule”) published in the Federal Register on March 20, 2017.1 BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treatpatients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. BIO agrees with and appreciates the Health Resources and Services Administration’s (HRSA’s) decision to delay the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Final Rule, published on January 5, 2017, and seek stakeholder feedback on a further delay. As a threshold matter, a delay will allow the Agency the necessary time to consider the Final Rule in the context of current Trump Administration priorities, including the so-called “Priebus Memorandum”2—which delayed the original effective date until such a time as questions of fact, law, and policy raised by the Final Rule could be reviewed by the new Administration—and the Administration’s broader goal of removing or minimizing unwarranted economic and regulatory burdens related to the Affordable Care Act (ACA), the law that added provisions to the 340B statute that are the subject of the Final Rule.3