Impact on Life Sciences
Reevaluating the Full Life Cycle of Your Drug and Device Products
The U.S. Supreme Court's decision in Dobbs v. Jackson Women's Health Organization to overturn Roe v. Wade has had an immediate and profound effect on the prescription and use of abortion-related drugs. As your organization continues the development of new products, how must your research, clinical trial, and approval strategy adapt to state and federal law?
Understanding the Immediate Impacts
Because of the Dobbs ruling, medical device developers and life sciences professionals are encountering significant disruptions to the legal framework in which they operate.
Drug manufacturers and pharmacies that distribute medication abortion drugs now face legal restrictions that vary widely across states. Using these drugs in connection with ongoing clinical research may now also be restricted, depending on your state. Currently, there are more than 350 active/recruiting studies involving abortion and abortion medications that may be impacted.
Additionally, donor centers, biobanks, IVF centers, tissue banks, or other entities that make biological material or human tissues available to other businesses for research purposes may be subject to laws in states that criminalize these activities.
States where bans are in place may even encounter efforts to restrict access to certain contraceptives, like Plan B or other levonorgestrel pills, that prevent life after the moment of fertilization. Manufacturers and providers of such contraceptives will need to understand where such legal ambiguities lie across state lines, paying close attention to decisions that better define the law.
Epstein Becker Green’s Checklist for Research Institutions, Medical Product Developers, and Research Services Providers outlines topics that have an immediate impact on issues related to Dobbs and the overturning of Roe v. Wade.
“[T]hat [FDA approval] pathway is very costly and uncertain.”
Long-Term Effects on Research and Products in Development
Companies engaged in pre-clinical research should consider the impact of changing state laws on their ability to continue research involving these products/tissues in any state where the research is performed.
Existing template agreements related to research, such as material transfer agreements, may contain provisions that violate laws in states where abortion is completely banned. Additionally, clinical trials studying new indications for abortion medications for the treatment of other conditions (e.g., methotrexate for rheumatoid arthritis) may face exceeding scrutiny in states with full abortion bans in effect.
Beyond research, manufacturers will need to undergo a more rigorous process to understand whether or not pursuing the approval pathway is worth the risk under the new patchwork of state laws. As Epstein Becker Green attorney Delia Deschaine recently told Vox, “The incentives for developing U.S. Food and Drug Administration (FDA)-approved drug products are strong, but those start to erode the more fractured the regulatory scheme for these products becomes. … Indeed, even absent those restrictions, that pathway is very costly and uncertain.”
To better understand how the overturning of Roe v. Wade impacts long-term clinical research and development, review Epstein Becker Green’s Checklist for Research Institutions, Medical Product Developers, and Research Services Providers.
Special Considerations Regarding Mifepristone and Other Abortifacients
Many questions have surfaced regarding the effects of Dobbs on the ability to legally manufacture and distribute mifepristone, misoprostol, and other abortifacients where abortion bans are present. Although the FDA has approved mifepristone to be used through the first 10 weeks of pregnancy, there is significant uncertainty as to its ability to be prescribed for “off-label” uses in some states.
It is generally understood and backed through decisions in cases like Zogenix Inc. v. Patrick that FDA-approved drug products found to be safe and effective for use by the public cannot be impeded by state law. This doctrine, known as federal preemption, has come under the microscope since Dobbs, with various parties attempting to challenge that precedent in abortion ban states.
Manufacturers, providers, and researchers that conduct business related to abortifacients should closely monitor developments in any lawsuit challenging state laws on mifepristone, such as GenBioPro, Inc. v. Dobbs, as it may serve as a loadstar for similar challenges that relate exclusively to preserving access to FDA-approved drug products.
For an overview of topics pertaining to the legal status of mifepristone and other abortifacients, please refer to the Checklist for Research Institutions, Medical Product Developers, and Research Services Providers.
“This doctrine, known as federal preemption, has come under the microscope …”