Pharmacy Policy Updates for September 2025

Federal Judge Blocks Arkansas Law Targeting PBM-Owned Pharmacies

A federal judge has struck down a new Arkansas law that would have prohibited pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state, dealing a setback to efforts aimed at curbing the influence of major PBMs.¹

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The law, signed earlier this year, was set to take effect August 5. It barred companies that own PBMs from also holding pharmacy licenses, a measure designed to protect independent pharmacies that have long accused PBM-owned chains of using their market power to drive out local competition.¹

US District Judge Brian S. Miller issued a preliminary injunction, finding the law likely unconstitutional under the Commerce Clause, which restricts states from interfering with interstate commerce. He also noted that the law may be preempted by federal TRICARE contracts, which cover military families nationwide. Miller wrote that the statute appeared to prioritize locally owned pharmacies at the expense of national PBM-affiliated ones, creating conflicts with federal law and interstate business practices.¹

The decision came after CVS and Express Scripts—2 of the nation’s largest PBMs, both of which operate their own pharmacy chains—sued to block the law. Arkansas Attorney General Tim Griffin has vowed to appeal.¹

The ruling reflects broader tensions surrounding PBMs. Federal Trade Commission reports have highlighted concerns that PBMs’ vertically integrated business models allow them to mark up specialty drugs and consolidate revenue within their affiliated pharmacies, raising costs for patients and employers.²

REFERENCES

1. Lagasse J. Judge blocks Arkansas law barring PBMs from owning pharmacies. Healthcare Finance. July 30, 2025. Accessed August 1, 2025. https://www.healthcarefinancenews.com/news/judge-blocks-arkansas-law-barring-pbms-owning-pharmacies

2. FTC releases second interim staff report on prescription drug middlemen. News release. Federal Trade Commission. January 14, 2025. Accessed August 1, 2025. https://www.ftc.gov/news-events/news/press-releases/2025/01/ftc-releases-second-interim-staff-report-prescription-drug-middlemen

FDA Orders Major Safety Label Changes for All Opioids

The FDA is requiring sweeping safety labeling changes for all opioid pain medications, marking the most significant federal update in years regarding how the drugs are described and prescribed. The new labels will more clearly outline the risks of long-term opioid use, including addiction, misuse, and both fatal and nonfatal overdoses. They will also remove language that could be interpreted as supporting indefinite opioid treatment.

The updates follow 2 large postmarketing studies mandated by the agency that found long-term use often leads to serious health risks without adequate evidence of lasting effectiveness.

“The death of almost 1 million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment, said FDA Commissioner Marty Makary, MD, MPH, in a news release. “This long-overdue labeling change is only part of what needs to be done—we also need to modernize our approval processes and postmarket monitoring so that nothing like this ever happens again.”

Among the required updates are clearer risk summaries, stronger dosing warnings, guidance limiting extended-release opioids to cases in which other treatments fail, information on safe discontinuation, and warnings about combining opioids with central nervous system depressants such as gabapentinoids. Labels will also include new risks, such as toxic leukoencephalopathy after overdose and opioid-related esophageal problems. Drugmakers have 30 days to submit revised labeling for FDA review. The agency also mandated a randomized clinical trial to further evaluate the long-term risks and benefits of opioid therapy.

REFERENCE

FDA requires major changes to opioid pain medication labeling to emphasize risks. News release. FDA. July 31, 2025. Accessed August 1, 2025. https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks

New Federal Health Data–Sharing Program Could Reshape Pharmacy Practice

The Trump administration has announced a nationwide program that will allow Americans to share personal health data and medical records across health systems and apps managed by private technology and health care companies. More than 60 organizations—including technology leaders such as Apple, Google, and Amazon, alongside health care giants such as CVS Health and UnitedHealth Group—have signed on to participate.

The initiative, which will initially focus on diabetes, weight management, and medication tracking, has direct implications for pharmacies. By enabling digital tools such as QR codes and conversational artificial intelligence (AI), the system is expected to streamline tasks such as registering patients for medication check-ins, tracking adherence, and coordinating chronic disease management. Pharmacies, particularly those integrated with pharmacy benefit managers and large health systems, could leverage this real-time access to improve medication synchronization, automate refill reminders, and enhance counseling with richer patient data.

The program could help eliminate long-standing barriers to data access for patients, such as reliance on fax machines or fragmented medical records. At the same time, however, the program raises questions about data privacy and security.

REFERENCE

Seitz A. Trump administration is launching a new private health tracking system with Big Tech’s help. Associated Press. July 30, 2025. Accessed August 1, 2025. https://apnews.com/article/trump-ai-rfk-jr-health-tech-fa73703bd1fd557c787ef0b590e151f1