Pharmacy Policy, July 2024

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July 17, 2024

Pharmacy Times

July 2024

Volume 90

Issue 7

Pharmacy Policy, July 2024

Supreme Court Rejects Challenge to Limit Mifepristone Access for Abortion

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The Supreme Court has rejected a lawsuit challenging the FDA’s regulations of mifepristone, a common abortion pill. With the new ruling, the pills will continue to be mailed to patients without an in-person visit with a physician.¹

Mifepristone is used to block progesterone, thereby terminating a pregnancy. Despite the body of evidence, opponents of abortion sued the FDA over its expanded access. The case began 5 months after the decision in Dobbs v Jackson Women’s Health Organization, which overturned the precedent set in Roe v Wade.

Abortion opponents initially won a ruling in Texas that would have entirely revoked the FDA’s approval of mifepristone, but the US Court of Appeals for the Fifth Circuit upheld the approval.² It reversed changes in 2016 and 2021, which were designed to ease access by allowing its use through 10 weeks’ gestation and mail-order delivery without an in-person appointment with a physician.³ The Supreme Court took up the case, putting the appeals court’s ruling on hold.²

The lawsuit argued that physicians would be unduly required to handle a greater number of emergencies related to the wider use of mifepristone by patients who had obtained it via mail order, regardless of their personal objections to abortion care. In addition to finding that the plaintiffs did not have the standing to bring the lawsuit, the justices were not swayed by this argument.¹

With the Supreme Court decision, the justices ruled that the opponents of abortion lacked the legal right for the lawsuit, enabling the drug to remain available through 10 weeks’ gestation and via mail order.¹ Despite the ruling, the FDA’s ability to regulate drugs will come up again in the future.

Illinois Moves to Expand Pharmacists’ Scope of Practice

The Illinois Legislature is taking steps to expand pharmacists’ scope of practice, potentially allowing pharmacist prescribing. For instance, Illinois Gov J.B. Pritzker has signed into law new legislation including an amendment to the state’s Pharmacy Practice Act, allowing pharmacists to test, screen, and prescribe treatments for influenza, COVID-19, group A Streptococcus, respiratory syncytial virus, adult-stage head lice, and “health conditions identified by a statewide public health emergency.”⁴

Like much of the country, Illinois is facing major shortages of physicians and other health care providers. According to data from the Cicero Institute, 89 of the 102 counties in Illinois are health professional shortage areas (HPSAs), and low-income residents are disproportionately affected. The HPSA designation indicates areas where there are 3500 or more patients for every 1 health care provider. Furthermore, primary care in Illinois is projected to be short 1063 providers. Compared with other states, Illinois’s doctor to patient ratio is 34% worse for preventive medicine.⁵

All of these findings highlight the crucial role pharmacists could play both in Illinois and across the country. As accessible health care providers, pharmacists can step in to fill gaps in care for patients.

Pharmaceutical Companies Counter State Laws on Hospital Contract Pharmacies

Several pharmaceutical companies have filed lawsuits challenging multiple state laws requiring drug manufacturers to offer discounts on drugs dispensed by third-party pharmacies that are contracted with hospitals and clinics.

Most recently, Novartis and Pharmaceutical Research and Manufacturers of America (PhRMA) filed suits in West Virginia and Maryland, and PhRMA filed suit in Mississippi. All of the lawsuits argue that state laws conflict with federal legislation governing the 340B Drug Pricing Program. According to reporting by Reuters, manufacturers have argued that the use of multiple contract pharmacies by a single health system leads to a lack of transparency. Therefore, drug companies have aimed to restrict 340B drug sales using contract pharmacies, such as Novartis’ policy that it would work only with contract pharmacies located within 40 miles of a 340B provider.⁶

However, advocates for contract pharmacies within the 340B program argue that these pharmacies are crucial to maintaining patient access to affordable medications, particularly for low-income patients. Approximately 40% of retail pharmacies in the US have at least 1 contract with a 340B-eligible health care provider, giving these pharmacies a significant role in the program.⁷

Importantly, pharmaceutical companies have succeeded in previous cases against federal guidance that would have required manufacturers to work with contract pharmacies in the 340B program. In response, multiple states, including Maryland, West Virginia, Mississippi, Kansas, and Louisiana, passed legislation requiring manufacturers to offer 340B discounts on medications dispensed by contract hospitals.⁶

References