What We’re Reading: Abortion Pill Access Arguments; Clinical Research Site Inspections; AstraZeneca 340B Lawsuit

US Supreme Court Seems Likely to Reject Challenge to Abortion Pill Access

The Supreme Court on Tuesday seemed likely to reject a challenge to the abortion pill mifepristone, according to NBC News. The court heard oral arguments on the Biden administration’s appeal of lower court rulings that restricted access to the pill, including by mail. During the arguments, there was little discussion of whether the FDA’s decisions to lift restrictions on the drug were unlawful. Instead, the justices focused on whether the anti-abortion doctors who brought the lawsuit had legal standing to do so; the plaintiffs argued that the FDA failed to adequately evaluate mifepristone’s safety risks. Both conservative and liberal justices probed whether the doctors could show that they were directly injured merely because they object to abortion and could be required to give emergency treatment to a woman suffering from serious adverse events. Conversely, only 2 justices appeared eager to discuss whether the FDA acted unlawfully.

FDA Still Struggling to Inspect Clinical Research Sites, Watchdog Finds

Inspectors told the Government Accountability Office (GAO) that the FDA’s Bioresearch Monitoring program is inspecting far fewer pharmaceutical companies conducting clinical research, according to Government Executive. The GAO reported that the FDA conducted 537 inspections in 2022, a 45% decline from its peak in 2017 despite the number of applications before the agency remaining consistent. Also, the FDA is increasingly not conducting random inspections or launching investigations when issues are flagged. Instead, it is prioritizing pharmaceutical companies’ pending applications. An auditor warned that this is leading to less informed drug approvals. Additionally, when FDA employees do conduct inspections, their recommendations for findings of “serious deficiencies” in the research process are typically being downgraded, leading to frustrations within the workforce and drug companies not being held accountable. Some of the slowdown was due to the COVID-19 pandemic, while others were due to its staffing issues; FDA officials said the agency needs to double its workforce to meet inspection demands.

AstraZeneca Sues Arkansas to Block 340B Program Law

AstraZeneca has sued to block an Arkansas law that it said would unlawfully expand the federal 340B Drug Discount program to include for-profit pharmacy chains, according to Reuters. The lawsuit was filed in Little Rock federal court on Monday against the Arkansas insurance department, saying the state measure violates provisions of the US Constitution and federal patient law. Under federal law, drugmakers provide discounts to a specific list of “covered” health care providers that serve low-income populations under the federal 340B drug program; program participation is required for pharmaceutical companies to receive funds from programs like Medicare and Medicaid. AstraZeneca argues that for-profit chains, like CVS and Walgreens, are not covered entities and that the Arkansas law expands the discounted drug requirement to these pharmacies purposefully not included in the federal program. In response, Arkansas said it will challenge the lawsuit.