Regulatory Update: February 28, 2022

We are pleased to provide our most recent installment of the bi-weekly regulatory reports intended to keep PHA members informed on regulatory changes of interest to our industry. McGuireWoods, PHA’s legal counsel, produced the report.

1.         Delaware District Court Rules Against HHS in 340B Lawsuit. On February 16, the U.S. District Court of Delaware ruled in favor of pharmaceutical company AstraZeneca in a lawsuit regarding 340B drug discounts. The Department of Health and Human Services (HHS) has been attempting to require pharmaceutical companies to offer 340B drug discounts to hospitals, regardless of the number of contract pharmacies employed to dispense the drugs. Pharmaceutical companies have taken issue with this effort, and several different lawsuits were filed on the matter.

With the February 16 decision, the district court vacated a May 2021 letter from the Health Resources and Services Administration (HRSA) in which the agency threatened to fine AstraZeneca and five other pharmaceutical companies if they continued to restrict 340B drug discounts.

2.         Bills Introduced in Senate to Ease Provider Relief Fund Requirements and Update Health Privacy Laws. On February 9, Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced the Provider Relief Fund (PRF) Improvement Actwhich aims to delay PRF reporting requirements until the end of the public health emergency. In addition, the bill would extend the use of PRF funding to improve workplace safety. The bill text can be found here.

Also on February 9, Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduced the Health Data Use and Privacy Commission Act, which aims to modernize health privacy laws and regulations by creating a health and privacy commission to research and make recommendations to Congress. In their press release, the Senators state that healthcare technology companies have demonstrated the limits of the Health Insurance Portability and Accountability Act (HIPAA). The bill text can be found here.

3.         FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives. On February 9, the Food and Drug Administration (FDA) published a draft guidance titled “Development of Non-Opioid Analgesics for Acute Pain.” The guidance provides recommendations to companies for developing non-opioid analgesics for acute pain lasting up to 30 days. The guidance includes information about what type of data would be necessary to demonstrate acute pain management. The guidance stresses the FDA’s commitment to providing non-addictive alternatives to opioids and decreasing exposure to opioids. The FDA will accept public comments on the draft guidance until April 11, 2022. The draft guidance can be found here.

4.         COVID-19 Vaccine and Testing Updates. On February 16, the FDA announced that it had awarded priority review vouchers under the agency’s medical countermeasure priority review voucher program to Moderna and BioNTech for their COVID-19 vaccines. Both vaccines have received FDA approval. The vouchers can be used to receive priority review for future product applications.

On February 17, Senator Tim Kaine (D-VA) led a group of six senators in a letter to the HHS Assistant Secretary for Preparedness and Response Dawn O’Connell. In the letter, the senators encourage Assistant Secretary O’Connell to outline the department’s plan to develop next-generation COVID-19 vaccines. The letter was also signed by Senators Roger Marshall (R-KS), Bob Casey (D-PA), Mitt Romney (R-UT), Chris Murphy (D-CT), Tammy Baldwin (D-WI) and Tina Smith (D-MN). The full letter can be found here.

5.         Members of Congress Write to Congressional Leadership Expressing Concern with the Physician Fee Schedule. On February 8, Representatives Bobby Rush (D-IL) and Gus Bilirakis (R-FL) led 61 members of Congress in a letter to House and Senate leadership expressing their concerns regarding recent changes to the Physician Fee Schedule. In the letter, the members state that the 2022 Physician Fee Schedule cuts for office-based specialists will threaten the viability of these specialists, and request that relief be provided in upcoming omnibus appropriations legislation. The letter can be found here.