This year, the federal government’s new health equity regulations began taking effect. The regulations represent the government’s increased commitment to health equity advancement as a major part of its regulatory enforcement. As these changes go into effect, states and businesses have begun to implement laws and policies in order to comply with the updated regulatory framework.
The regulation of drug prices has received significant recent bipartisan support in Congress. Democrats and Republicans in both houses have proposed approximately eighty bills relating to drug pricing over the past two years. The charts below summarize the key provisions of representative bills.[i]
Although the proposed price-regulating mechanisms differ from bill to bill, the bills do not indicate a clear difference in the parties’ goals when viewed at a high level. Many of the proposed bills focus on price transparency as well as reporting to the Department of Health and Human Services (HHS). Certain bills would require pharmaceutical manufacturers to provide data on, and justifications for, the pricing of certain drugs that would exceed specified price increase limits. These bills usually include penalties for reporting failures; however, they usually do not provide a procedure to lower a price that triggers the reporting provisions. Instead, they often establish or enhance public databases for the reported information, and some go as far as requiring pharmacists to communicate this information to the patient at the point of sale.
The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine.
This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, such as CTX001 (CRISPR-Cas9-modified autologous hematopoietic stem cells), currently under study for the treatment of b-thalassemia and severe sickle cell anemia. Another CRISPR-based product, AGN-151587, is injected into the eye with the goal of eliminating a genetic mutation in patients with Leber congenital amaurosis 10, a leading cause of childhood blindness. In parallel, others are working to harness the CRISPR/Cas system to develop drugs for rare diseases, including bespoke therapies tailored to an individual patient’s needs.
Among its various attempts to regulate drug prices, the Trump administration recently sought to force pharmaceutical advertisements to disclose the wholesale acquisition cost (WAC) of certain drugs. This effort was dealt a setback in June, when the D.C. Circuit found that the Department of Health and Human Services (HHS) overstepped its regulatory authority by compelling disclosure of these costs. Merck & Co., Inc. v. U.S. Dep’t Health & Human Servs. (“Merck”). Although limited to a particular rule, the Merck decision foreshadows the likely future success of similar forced-disclosure rules.
President Obama’s Affordable Care Act has survived yet another challenge in the federal courts. In a resounding 8-1 decision this Monday, April 27, 2020, the U.S. Supreme Court ruled that health insurance companies who suffered losses entering the new marketplaces established by the Affordable Care Act (“ACA”) were entitled to compensation for those losses.
Chambers and Partners released its first ever Pharmaceutical Advertising 2018 guide, authored by Proskauer partners Lawrence Weinstein and Alexander Kaplan with assistance from several litigation associates. The guide provides a comprehensive look at the laws and regulations governing pharmaceutical advertising in various markets, and provides important developments in the most…
The D.C. Circuit recently blocked a proposed merger between two of the nation’s three largest health care insurers – Anthem and Cigna, raising doubts about the viability of the efficiencies defense in merger cases despite such a defense having been explicitly recognized in the 2010 FTC and DOJ Horizontal Merger…
West Virginia recently passed legislation aimed at shielding an in-state hospital merger from antitrust review by the Federal Trade Commission, and if the West Virginia Health Care Authority and West Virginia Attorney General approve the merger, other states could follow suit. Recent developments, including the FTC’s reaction to West Virginia’s proposed legislation, preview how future battles between the FTC and other states may unfold as the FTC continues to oppose state action grants of immunity from federal antitrust laws.