This resource library features Legal Analysis written by NASHP experts that address issues raised by the pharmaceutical industry. Also included are State Legal Filings that provide summaries and links to state documents that defend their drug cost containment actions in federal court.
NASHP Legal Analysis
These legal analyses, written by NASHP experts, address key issues that the pharmaceutical industry raises in its legal challenges of state actions to contain drug costs.
States have passed an unprecedented number of laws addressing drug prices over the past few years and some have faced legal challenges. This NASHP legal brief,Navigating Legal Challenges to State Efforts to Control Drug Prices: PBM Regulation, Price Gouging, and Price Transparency, by Katherine L. Gudiksen, PhD, Samuel M. Chang, JD, and Jaime S. King, JD, PhD, explores those challenges. The brief analyzes the arguments industry groups have made against pharmacy benefit manager regulations, anti-price-gouging laws, and drug price transparency requirements using the Dormant Commerce Clause and federal patent and trade secret laws.
Dormant Commerce Clause
When states pass laws designed to control prescription drug costs, the pharmaceutical industry often responds with lawsuits claiming states are hindering interstate commerce and violating the federal Dormant Commerce Clause (DCC). NASHP’s legal experts believe states can craft drug cost policies that can withstand industry challenges.
This briefby Anna Zaret, JD, and Darien Shankse, PhD, JD, MA, provides insight and analysis about DCC case law and highlights what state policymakers need to consider when drafting drug cost polices.
NASHP’s blog about the Dormant Commerce Clause and drug cost regulation.
NASHP’s easy-to-understand table featuring Dormant Commerce Clause’s “Dos and Don’ts.”
Patent Law Analysis
This brief by Robin Feldman, Betty Chang Rowe, Rabiah Oral, Amy Y. Gu, and Katherine Gudiksen provides a Patent Law Analysis of NASHP Rate-Setting Model Act.
NASHP’s blog to learn more about Patent Law Analysis and drug cost regulation.
A Glossary of Pharmaceutical Terms
The terms used to describe different classes of drugs, the various players in the pharmaceutical industry, and drug approval and marketing can be complicated. NASHP’s easy-to-use glossary explains these complex references.
State Legal Filings
Below are links to pertinent state legal documents filed in response to industry challenges of drug cost containment legislation. This is not a comprehensive list, however it provides information about what arguments states are making to defend their legislation.
The Pharmaceutical Care Management Association (PCMA) filed suit against the Arkansas 2015 law regulating reimbursement rates paid to pharmacies by pharmacy benefit managers. The US Court of Appeals for the Eighth Circuit ruled that the law was pre-empted by the Employee Retirement Income Security Act (ERISA) of 1974. The US Supreme Court took up Arkansas’ appeal of the Eighth Circuit ruling and is expected to issue a decision in 2020.
The Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association, filed a lawsuit challenging Maryland’s anti-price-gouging law in US District Court for the District of Maryland. Below are the case filings:
Maryland Attorney General’s request that the US Supreme Court review the Fourth Circuit decision that overturned Maryland’s anti-price-gouging law and answer the question: “Does the Commerce Clause prohibit a state from protecting consumer access to essential off-patent and generic prescription drugs by requiring manufacturers to refrain from unconscionably raising the price of those drugs sold in the state?” 10/2018
The US Supreme Court denied Maryland’s request to review the Fourth Circuit’s ruling, which struck down the law. 2/19/19
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovations Organization (BIO) challenged Nevada’s drug cost transparency law in US District Court for the District of Nevada. PhRMA and BIO dropped the lawsuit in June 2018 after Nevada’s Department of Health and Human Services adopted regulations that allow manufacturers and pharmacy benefit managers to request that specific price report information be kept confidential. Below are the case filings and new regulations: