You are currently viewing archive.bio.org. Head to our home page to check out our fresh new look!

BIO Submits Comments to HRSA Re: Enrollment and Re-certification of Entities in the 340B Program

<p>
CDR Krista M. Pedley, PharmD, MS, USPHS</p>
<p>
Director</p>
<p>
Office of Pharmacy Affairs</p>
<p>
Healthcare Systems Bureau</p>
<p>
Health Resources and Services Administration</p>
<p>
5600 Fishers Lane</p>
<p>
Parklawn Building, Room 10C-03</p>
<p>
Rockville, MD 20857</p>
<p>
<strong style="font-size: 1.2em; line-height: 1.7em;">Re: Agency Information Collection Activities: Proposed Collection: Comment Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations (OMB No. 0915-0327-[Revision])</strong></p>
<p>
<span style="font-size: 1.2em; line-height: 1.7em;">Dear Commander Pedley:</span></p>
<p>
<span style="font-size: 1.2em; line-height: 1.7em;">The Biotechnology Industry Organization (BIO) is pleased to submit the following comments in response to the Health Resources and Services Administration&rsquo;s (HRSA&rsquo;s) proposed Information Collection Notice entitled &ldquo;Proposed Collection: Comment Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations&rdquo;&nbsp;</span><span style="font-size: 1.2em; line-height: 1.7em;">(the &ldquo;Notice&rdquo;).&nbsp; BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in the United States and around the globe. BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products.</span></p>
<p>
&nbsp;</p>

Dear Commander Pedley:

The Biotechnology Industry Organization (BIO) is pleased to submit the following comments in response to the Health Resources and Services Administration’s (HRSA’s) proposed Information Collection Notice entitled “Proposed Collection: Comment Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations” (the “Notice”).  BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in the United States and around the globe. BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products.

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 also agree with HRSA that covered entities should have “confidence that the amounts being charged are in accordance with statutorily-defined ceiling prices.” We are concerned, however, that the proposed information collection request is both unnecessary and potentially unduly burdensome for manufacturers.

The following comments address three of the topics on which HRSA has solicited feedback, including: (1) the necessity and utility of the proposed information collection for the proper performance of HRSA’s functions; (2) the accuracy of the estimated burden; and (3) use of automated collection techniques or other forms of information technology to minimize the information collection burden.  We begin, however, with our concerns with HRSA’s apparent belief that amendments to the applicable statutes and regulations are incorporated into the Pharmaceutical Pricing Agreement (PPA) without need to amend that agreement, and conclude with a request that the agency provide appropriate context and security protections with respect to the proposed Internet platform for posting validated ceiling prices.

 

See the full comment letter here.