Insights on Pharmaceuticals & Medical Devices

This past November, the US Supreme Court heard oral arguments in a case that may dramatically affect how patents covering biologic drugs are litigated: Oil States Energy Services, LLC v Greene’s Energy Group, LLC.

A new administrative rule promulgated and adopted by the Attorney General for the state of New Jersey (the AG) will “regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers.”

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report titled “Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates.”

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

On August 21, 2017, the Health Resources and Services Administration published a proposed rule that would entertain even further delays of the implementation of a January 5, 2017 Final Rule regarding calculation of 340B ceiling prices.

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3,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