340B: BIO’s Comments to HRSA Regarding the Burden to Conduct 340B Audits

The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments in response to “Proposed Collection:  Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)—Extension” (the “Notice”) published in the Federal Register by the Office of Pharmacy Affairs (“OPA”) within the Health Resources and Services Administration (“HRSA”) on October 26, 2012.[1]

BIO is the largest trade organization to serve and represent the biotechnology industry in the United States and around the globe. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in the United States. BIO members are involved in the research and development of health care, agricultural, industrial, and environmental biotechnology products.

As the representative of an industry that is devoted to improving health care through the discovery of new therapies, BIO understands the significance of the 340B drug pricing program in increasing prescription drug access for the low-income uninsured.  BIO members include manufacturers that participate in the 340B program, enabling BIO to provide views with respect to HRSA’s burden estimates that are based on actual operational experience.  BIO believes that information will be useful to OPA in its efforts to ensure the integrity of the 340B program.

As you know, the 340B statutory scheme gives participating manufacturers certain audit rights.  BIO and its members place great importance on these oversight rights, but believe such rights only are meaningful if they can be operationalized and actually result in remedial action.  With that as context, BIO includes in this letter comments not only on HRSA’s burden estimates but also on the audit process more generally and related opportunities for HRSA to make manufacturer audit rights more accessible and effective.  We recognize that HRSA may require new or expanded authorities to implement these recommendations and urge you to undertake formal processes (e.g., notice and comment rule-making, a request for congressional action) that meaningfully engage stakeholders to assist you in putting into place a viable audit program. BIO strongly believes that its recommendations set forth below will increase the integrity of the 340B program, thereby ensuring that the 340B program can continue to effectively improve access to vital medications for those patients which the program was originally intended to benefit: the low-income uninsured.



[1]77 Fed. Reg. 65392 (Oct. 26, 2012).