2022 NCBIO Year in Review

whether they came from clinical laboratories or from commercial companies, was not successful nor was the PASTEUR Act included, which would have helped bolster the antibiotic market to combat an increasingly serious threat of antimicrobial resistance.

NCBIO and its allies continued to push back against the drug-price “negotiations” authorized by the Inflation Reduction Act for Medicare as a number of advocacy organizations and drug companies went to court to block the policy. A new study estimated that there would be 237 fewer FDA approvals of new medicines over the next decade and 1.1 million lost jobs if proposals to expand government-mandated drug pricing policies are fully implemented.

• In March, the NIH rejected a petition to use so-called march-in rights to take ownership of patents tied to the prostate cancer drug Xtandi. HHS and the Department of Commerce launched an interagency review of the government’s authorities under the Bayh-Dole Act, which grants the march-in rights.
• ARPA-H was established in March 2022 and became fully operational with the hiring of program managers and mission office directors. The agency will establish three hubs in different locations, one of them being in the Washington, D.C. area. In June, North Carolina learned that it would not be the site of an ARPA-H hub despite an intense lobbying effort led by the NC Biotechnology Center, RTI International and a consortium of other stakeholders, including NCBIO.
• The Tax Cuts & Jobs Act of 2017 changed the longstanding deduction for R&D expenditures to a mandatory five-year amortization for domestic R&D and a 15-year amortization for foreign R&D. NCBIO is supporting legislation in both chambers cosponsored by several members of North Carolina’s delegation to restore the deduction.
• The TRIPS waiver gained more attention from lawmakers, especially those on the Democratic side (which included Rep. Deborah Ross), who increasingly voiced their discontent with this flawed policy. The TRIPS waiver allowed the World Trade Organization to waive certain intellectual property rights for COVID-19 vaccines, and the WTO is still considering doing the same for COVID-related diagnostics and therapeutics.
• The Centers for Medicare & Medicaid Services is working with industry stakeholders, including medical device companies, as well as physician societies and patient groups to develop an alternative, expedited pathway to coverage and payment for emerging devices and diagnostics called Transitional Coverage for Emerging Technologies.
• Congress is looking for more visibility into the practices of pharmacy benefit managers and into the 340B program. In the 340B program, hospitals are exploiting lax eligibility criteria and program guardrails to profit from the substantial 340B discounts that were intended to ensure low-income access to discounted prescription drugs and services. Congress was also concerned that PBMs are no longer serving the interests of patients by negotiating better prices for prescription drugs, especially as more drug stores and PBMs are being bought up by insurance companies.

Attorneys from global law firm Akin Gump were on hand for the Feb. 23 NCBIO CEO Roundtable discussion, “Preparing for Price Setting under the Inflation Reduction Act,” held at the NC Biotechnology Center.