BIO Submits Comments Re: 340B "Mega" Guidance
The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to submit the following comments in response to the proposed Notice, issues by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on August 28, 2015, entitled 340B Drug Pricing Program Omnibus Guidance [RIN-9096-AB08] (“Proposed Notice”).
Re: 340B Drug Pricing Program Omnibus Guidance [RIN-0906-AB08]
Dear Secretary Burwell, Acting Administrator Macrae, and Director Captain Pedley:
The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to
submit the following comments in response to the proposed Notice, issued by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on August 28, 2015, entitled 340B Drug Pricing Program Omnibus Guidance [RIN-9096-AB08] (“Proposed Notice”).
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 indigent 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. Accordingly, we applaud HRSA’s recent commitment and activities to enforce program oversight and compliance, as well as HRSA’s effort to provide further program guidance by means of the Proposed Notice. Given the widely recognized need for greater programmatic guidance and oversight, we strongly urge HRSA
to finalize the guidance proposed in the Proposed Notice in a timely fashion, after careful consideration of the recommendations articulated in this letter.
