Katie Lapins, Principal, Government Pricing Specialists, LLC and Joy Sturm, Partner, Hogan Lovells US LLP will discuss the new compliance requirements for pharmaceutical and biologics contractors.
Regulations recently issued in the Federal Acquisition Regulation (FAR) require pharmaceuticals and biologics manufacturers that contract with the government to meet a host of new compliance requirements. These rules require contractors, among other things, to:
- Establish a Code of Business Ethics and Conduct;
- Disclose instances where there is credible evidence of significant overpayments or where certain criminal laws may have been violated in connection with a Federal contract;
- Participate in a new reporting system "FAPIIS" which requires certification of detailed data as to a company's responsibility and performance under prior contracts; and
- Report on the contractor's executive compensation, first-tier subcontractor executive compensation, and subcontract awards.
Even pharmaceuticals and biologics companies that have established considerable expertise in Federal contracting – and with the Federal Supply Schedule requirements, in particular – are taking time to study these new regulations and implement additional controls.
In this session, the speakers will provide a legal and operational overview aimed at answering the following questions:
- What are the various requirements of these regulations?
- How can manufacturers achieve compliance with these new requirements in a way that is cost-effective and meaningful to the organization?