Perspectives on Pharmaceuticals & Medical Devices

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Nevada is the latest state in the Union to adopt some form of a drug pricing transparency law, after Nevada Governor Brian Sandoval signed Senate Bill No. 539 into law on June 15, 2017.

Alleged price gouging by drug manufacturers and distributors has been in the news the past several years, causing many lawmakers to threaten to take action. 

Pursuant to the Bipartisan Budget Act of 2015, manufacturers participating in the Medicaid Drug Rebate Program must pay an Additional Discount on Non-Innovator products to the extent the Average Manufacturer Prices of their products are rising faster than inflation.

In a notice published in the Federal Register on Friday, May 19, 2017, the Health Resources and Services Administration announced that it would further delay the effective date of a final rule applicable to all drug manufacturers participating in the 340B Drug Pricing Program.

Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program.

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.