Perspectives on Pharmaceuticals & Medical Devices

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

Recently, the Health Resources and Services Administration released a new addendum to amend the existing Pharmaceutical Pricing Agreements that drug manufacturers participating in the 340B Drug Pricing Program must have in place with the Secretary of Health and Human Services.

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

Rising prescription drug costs have been big news this year, and states are beginning to respond.

Texas Health and Human Services Commission (HHSC) has finally issued final regulations transitioning to the use of the National Average Drug Acquisition Cost (NADAC) to establish Medicaid ingredient cost reimbursement instead of utilizing manufacturer-reported prices.

VA recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract.

Today, the Department of Health and Human Services announced that it is re-opening the comment period on its June 17, 2015 proposed rule (the Proposed Rule).

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.