Criminalization of Medication Dispensing

Following the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, AMCP is concerned about potential negative repercussions for patient care that extend beyond the immediate scope of reproductive care. AMCP finds it unconscionable that pharmacists have been threatened with the loss of their licenses and, in some cases, imprisonment for dispensing safe, effective medication approved by the Food & Drug Administration (FDA). 

Certain proposed laws and regulations—as well as pending court cases—threaten to criminalize specific types of care, including the dispensing of FDA-approved products used for FDA-approved indications. These laws, regulations, and court cases undermine the FDA’s scientific review process for approving drugs and interfere with patient access to care.  

For example, some states have sought to criminalize the dispensing of drugs used to medically terminate a pregnancy.¹ These drugs, namely mifepristone and misoprostol, are approved by the FDA for the treatment of other conditions unrelated to pregnancy.² It is medically inappropriate to entirely prohibit the use of these products because they are also used to terminate pregnancies. In contrast, there are examples where state legislatures have acted to protect health professionals who prescribe, dispense, or administer FDA-approved medications. All but four states have enacted varying degrees of immunity laws to protect those who, either by act or omission, operate in good faith to dispense naloxone, an FDA-approved opioid overdose reversal medication.³ Twenty-nine states offer immunity from civil and criminal liability, and professional disciplinary action, with the remaining seventeen states offering varying—albeit lesser—protections.⁴ 

Recognizing the diversity of thought and beliefs within AMCP’s membership, we firmly contend that pharmacists and other health professionals have an ethical and professional obligation to their patients⁵ and should never be at risk of criminal prosecution for providing FDA-approved and standard-of-practice care. AMCP opposes any federal or state laws and regulations that impede these obligations. 

Certain states—including Idaho, Oklahoma, and Texas—have imposed civil liability on any actor who assists a patient in terminating a pregnancy.⁶ The remit of these actions is exceedingly broad and includes health insurance plans and pharmacy benefit managers (PBMs) who cover products or reimburse for services such as telehealth or travel related to the termination of a pregnancy. These laws are contrary to the bedrock legal principle of standing and allow any person to sue payers, health plans, and PBMs over coverage or reimbursement of this care, even if that individual has no connection to the patient or care being provided. Private healthcare decisions should be made by patients and healthcare providers rather than by public and legal entities. AMCP opposes these laws. 

The vague nature of these statutes is dangerous for patients across America, raising key questions about the provision of patient care unrelated to reproductive health.⁷, ⁸ For example, some drugs used in the treatment of cancer have the side effect of terminating a pregnancy. At this point, it is unclear whether dispensing these treatments would be considered a felony under multiple state laws. The potential legal jeopardy facing pharmacists providing such care could translate into significant health risks for pregnant patients with serious conditions like cancer. As such, AMCP calls on states with laws criminalizing the dispensing of FDA-approved drugs to clarify that it is not a felony to provide FDA-approved care for medical conditions, including potentially life-saving care that may have the side effect of terminating a pregnancy. 

Conflicting federal court rulings seek to overturn and uphold FDA’s authority regarding approval status and dispensing guidelines for mifepristone, a therapy repeatedly deemed safe and effective by FDA.⁹,¹⁰ Drug approval and related policies should be the domain of relevant scientific review bodies like FDA, not the courts. Furthermore, these pending court cases—and related legislation and regulations—could be precedent-setting and invite ideological or politically motivated challenges to established drug therapy standards. AMCP opposes lawsuits, legislation, and regulations that politicize FDA approval of therapies, which should be an impartial scientific process to evaluate safety and efficacy.  

AMCP respects the serious personal considerations that inform a wide range of perspectives on healthcare decisions. Though those views are deeply held, it is inappropriate to impose ideological standards that do not incorporate scientific evidence on medical and pharmacy care. AMCP urges policymakers and stakeholders to reject these dangerous laws and lawsuits in favor of rigorous scientific standards used to determine the safest and most effective care for patients. Failure to do so will hinder AMCP members from performing their professional obligations and threaten healthcare for millions of Americans. 

AMCP Legislative and Regulatory Positions

¹ As of May 11, 2023, the following states have enacted provisions expressly prohibiting pharmacist dispensing of these drugs: Florida SB 300 (2023), Indiana HB 1568 (2023), Texas SB 4 (2022), North Dakota SB 2150 (2023), and Wyoming SF 109 (2023). For interactive maps of state policies, see https://states.guttmacher.org/policies/ and https://www.kff.org/womens-health-policy/dashboard/abortion-in-the-u-s-dashboard/ 

² Mifepristone may be used to treat hyperglycemia in patients with Cushing syndrome and has shown efficacy with off-label uses for uterine leiomyomas, https://www.ncbi.nlm.nih.gov/books/NBK557612/, while misoprostol may be used to reduce the risk of NSAID induced gastric ulcers and to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers, https://go.drugbank.com/drugs/DB00929. 

³ https://legislativeanalysis.org/wp-content/uploads/2021/05/Naloxone-Access-Summary-of-State-Laws-Final.pdf  

⁴ https://legislativeanalysis.org/wp-content/uploads/2021/05/Naloxone-Access-Summary-of-State-Laws-Final.pdf  

⁵ For example, these ethical obligations include putting the patients' well-being first. The pharmacist code of ethics serves as the foundation of the practice of pharmacy. See, e.g.: https://www.aacp.org/sites/default/files/2021-12/oath-of-a-pharmacist-pdf-2021.pdf; https://www.ashp.org/-/media/assets/policy-guidelines/docs/endorsed-documents/code-of-ethics-for-pharmacists.ashx; and https://pharmacist.com/Code-of-Ethics.   

⁶ https://www.lexology.com/library/detail.aspx?g=4c56bb06-fe1e-4bac-98a6-eae89e2aa9fd  

⁷ https://www.ashp.org/news/2022/09/08/statement-on-state-laws-impacting-patient-access-to-medically-necessary-medications 

⁸ https://reproductiverights.org/maps/abortion-laws-by-state/  

⁹ https://www.justice.gov/file/1563091/download 

¹⁰ https://law.justia.com/cases/federal/district courts/washington/waedce/1:2023cv03026/102225/80/