Insights on Pharmaceuticals & Medical Devices

As the most recent state to address the issue of what to do with unused medications, on July 10, 2018, New York Governor Andrew Cuomo signed the Drug Take Back Act (the Act).

On June 28, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) dropped their lawsuit challenging the constitutionality of Nevada’s recent drug price transparency law.

In-house counsel for health industry organizations face unique challenges – but those challenges can be met.

On June 20, 2018, the Centers for Medicare & Medicaid Services issued a Request for Information seeking input from the public on how to address the undue regulatory impact and burden imposed on health care providers under the Stark Law.

The California Office of Statewide Health Planning and Development (OSHPD) has posted a preliminary working draft of the regulations implementing California’s prescription drug price transparency law.

Connecticut and Maine recently joined the increasing number of states to enact drug price transparency laws. Maine’s drug price transparency law (the Maine Law) became effective on May 1, 2018.

On May 17, 2018, CMS issued a strongly-worded letter to Part D plan sponsors stating that pharmacy “gag clauses” are unacceptable.

Following delays and much build up, the White House and the Department of Health and Human Services (HHS) have released their plan to address rising pharmaceutical prices and out-of-pocket costs directly impacting patients.

HRSA published a notice in the Federal Register on May 7, 2018 proposing its intention to delay – for the fifth time – the implementation of a January 5, 2017 Final Rule regarding calculation of 340B ceiling prices and the imposition of civil monetary penalties.

Pharmaceutical manufacturers whose drugs are reimbursed under Medicare Part B must now report certain product and financial data (including Average Sales Price, or ASP) to the Centers for Medicare & Medicaid Services through the Fee-for-Service Data Collection System.

On April 13, 2018, the US Court of Appeals for the Fourth Circuit found Maryland’s new drug price-gouging prohibition law unconstitutional under the dormant Commerce Clause of the United States Constitution.

Arent Fox Health Care Partner Linda Baumann discussed the potential compliance risks facing hospitals in connection with recalled medical devices  for Bloomberg Law in an article titled, “Gaps in Hospital Recalled Device Reporting a ‘Wake-Up Call.’”

This Special Report is written by Helen Ji, Schiff Hardin LLP associate, Rekha Hanu, executive director and chief IP counsel at Akorn Pharmaceuticals, and Christine Simmon, SVP for policy and strategic alliances at the Association for Accessible Medicines.

The Centers for Medicare & Medicaid Services (CMS) published a final notice in the Federal Register on March 23, 2018, to amend and update for the first time since its original release in 1991 the Medicaid National Drug Rebate Agreement (NDRA).

The Centers for Medicare & Medicaid Services published a final notice in the Federal Register on March 23, 2018, to amend and update for the first time since its original release in 1991 the Medicaid National Drug Rebate Agreement.

Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California, Nevada, and Maryland, which have all adopted pricing and/or transparency laws of some variety over the past year.

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.

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.