Insights on Pharmaceuticals & Medical Devices

As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).

Federal regulations require institutions and institutional review boards (IRB) that are responsible for review and oversight of human subject research to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings.

The Center for Medicaid and CHIP Services, a division of the Centers for Medicare & Medicaid Services, issued a Medicaid Drug Rebate Program notice to state Medicaid contacts emphasizing appropriate access to, and coverage of, direct-acting antiviral drugs used to treat hepatitis C virus.

On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 into law. The two year budget deal increases overall spending limits and prevents the United States from defaulting on its debts by suspending the debt limit through March 2017.

The United States District Court for the District of Columbia issued a ruling which could have significant positive implications for those drug manufacturers unhappy with a particular Department of Health and Human Services Health Resources and Services Administration’s interpretive rule.

The Health Resources and Services Administration, as administrator of the 340B Drug Pricing Program on behalf of the Department of Health and Human Services (HHS), published its proposed 340B Drug Pricing Program Omnibus Guidance on August 28, 2015.

On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 15-11.

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs.

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a long-awaited proposed rule setting forth revisions to the current regulations governing the 340B Drug Discount Program (340B Program) as set forth in 42 C.F.R. part 10 (Proposed Rule).

Pharmaceutical manufacturers could face a new line of attack related to Hatch-Waxman reverse payment settlement agreements (so-called, “pay-for-delay” settlements).

Health Care Co-Leader Stephanie Trunk will present at Informa’s Medicaid Drug Rebate Program Summit.

Health Care Co-Leader Stephanie Trunk and Health Care Partner Rachel Hold-Weiss will present at AHLA’s 2019 Annual Meeting.

Health Care Co-Leader Stephanie Trunk will present at CBI’s 21st Annual Medicaid and Government Pricing Congress.

Health Care Co-Leader Stephanie Trunk will present at the Healthcare Distribution Alliance’s 2019 Distribution Management Conference and Expo.

Health Care Co-Leader Stephanie Trunk will present at CBI’s 4th Drug Pricing Transparency Congress.

Health Care Partner Stephanie Trunk will present at the Medicaid Drug Rebate Program.

Health Care Partner Stephanie Trunk will present at the GRx+Biosims Conference on the “Drug Pricing and Update on State Legal Issues” panel.

Health Care Partner Douglas Grimm will speak at The Rossdale Group’s CLE webinar entitled “Mastering Opioid Law & Regulation.”

Health care Partner Stephanie Trunk will speak at CBI’s 4th Annual GPO Membership Eligibility and Class of Trade Maintenance Forum.