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 had an immediate and profound effect on the prescription and use of abortion-related drugs. While manufacturers, distributors, and dispensers of these products have experienced the most significant impacts of the changes in law that followed on the heels of the Dobbs decision, they are not alone. Other life sciences industry stakeholders also have been impacted, and there may be further potential challenges in the years to come.
Understanding the Immediate Impacts
Because of the Dobbs ruling, certain medical device developers and life sciences professionals may encounter 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.
Additionally, donor centers, biobanks, IVF centers, tissue banks, or other entities that collect, process, and distribute biological material or human tissues to other businesses for research purposes may see their operations restricted by laws in states that criminalize these activities.
Epstein Becker Green’s Checklist for Research Institutions, Medical Product Developers, and Research Services Providers outlines potential impacts on these companies as a result of the Dobbs decision and subsequent changes in state law.
Click here to download our checklist
“That 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 abortion-related products or fetal tissue obtained after an abortion procedure in any state where the research is performed. Epstein Becker Green attorneys Kate Gallin Heffernan, Marylana Helou, and Megan Robertson discuss this matter in detail on the Diagnosing Health Care podcast episode “Post-Dobbs Considerations for Clinical Trials and Research.”
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 abortion medications for the treatment of other conditions may face increasing 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 for abortion-related products is worth the risk under the new patchwork of state laws. As Epstein Becker Green attorney Delia Deschaine 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.” In addition, the outcome of ongoing litigation could impact the validity of available pathways to approval going forward, such as accelerated approval pathways and existing products on the market under those pathways.
Special Considerations Regarding Mifepristone and Other Drugs Used to Terminate Pregnancy
Many questions have surfaced regarding the effects of Dobbs on the ability to legally manufacture and distribute mifepristone, misoprostol, and other drugs used to terminate pregnancy where abortion bans are present. Although the FDA has approved mifepristone to be used as the first drug in a two-step protocol to terminate pregnancy through the first 10 weeks of pregnancy via telehealth, there is significant uncertainty as to its ability to be prescribed for “off-label” uses in some states. Twenty states’ attorneys general indicated a willingness to pursue state law claims against retail pharmacies that mail drugs used for the purpose of terminating pregnancies to patients, for example.
Specifically, manufacturers, providers, and researchers that conduct business related to potential abortifacients should closely monitor developments in any lawsuit challenging state laws on mifepristone, such as Alliance for Hippocratic Medicine v. FDA and related litigation, as it will determine whether drugs such as mifepristone are available at all and could serve as a lodestar for similar challenges that relate exclusively to access to FDA-approved drug products.
To read more about the legal battle over mifepristone, click here.
“There is significant uncertainty as to mifepristone’s ability to be prescribed for ‘off-label’ uses in some states.”
