Virginia Regulatory Town Hall
Virginia Department of Health
State Board of Health
Prescription Drug Price Transparency Regulation [12 VAC 5 ‑ 219]
Action Promulgation of New Regulation to Implement Chapter 304 of the 2021 Acts of Assembly, Special Session I
Stage Emergency/NOIRA
Comment Period Ended on 2/16/2022
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2/15/22  5:04 pm
Commenter: Gil Roth, Pharma & Biophama Outsourcing Association (PBOA)

Suggestion to exempt Contract Manufacturing Organizations from requirement

Pharma & Biopharma Outsourcing Association (PBOA) is the non-profit trade association representing the legislative, regulatory and general business interests of Contract Manufacturing Organizations (CMOs) in the bio/pharma industry. Our members provide manufacturing, packaging, labeling, and testing services for clients who hold the licenses and applications for drugs, vaccines and other medical products (NDAs, ANDAs, BLAs, sBLAs). In some cases, a Co-Licensed Partner may pay the license holder and employ a CMO for manufacture of a drug product.

Several of our members have received requests from Virginia’s Department of Health (VDH) requiring them to comply with VA Emergency Regulation 12VAC5-219 et seq., the Prescription Drug Price Transparency Regulation, which requires pharmaceutical manufacturers to register and provide information that only an approved Application Holder or their Co-Licensed Partners would be able to provide.

In their role as CMOs, my members & the rest of their sector are not involved in the setting of prices of drug products that they manufacture on behalf of their license-holding clients, nor are they involved in the distribution and marketing of these drug products. Similarly, they are not made aware of their clients’ changes to product prices or Wholesale Acquisition Cost (WAC), nor are they involved in negotiations with wholesalers, insurers, PBMs or other payors.

Requiring such facilities to register and report with the Nonprofit Data Services Organization (NDSO) under 12VAC5-219 would only result in undue compliance burden on their part and more work for the DoH board, while generating no WAC or other pricing data that VDH intends to collect with this regulation.

We suggest that the regulation explicitly exclude CMOs, which provide manufacturing services but are not involved in pricing or marketing/distribution, from registering and reporting requirements under VA Emergency Regulation 12VAC5-219.

This could be achieved by including language specifying that only manufacturers who set or change WAC should register and report, or preferably, we recommend the regulation explicitly adopt the definition for Manufacturer used in Drug Supply Chain Security Act (DSCSA, Public Law 113-54, Nov. 27, 2013) which provides clarity for an approved Application Holder and a Co-Licensed Partner. As per the DSCSA’s definitions, the Application Holder or Co-Licensed Partner — the party that markets a prescription drug product and/or who sets pricing for that drug — would be more appropriate entities than CMOs to register and report under 12VAC5-219 and VA Code at § 32.1-23.4 and § 54.1-3442.02. License holders and their partners are already familiar with such definitions as part of their DSCSA requirements.

We thank you for the opportunity to comment and hope you will consider these suggestions to improve the effectiveness of your initiative for drug pricing transparency.

—Gil Roth, President, PBOA

CommentID: 119249