FDA Preemption: Implications of Dobbs Decision for Uniform Access to FDA-Approved Drugs in the U.S.

Health Highlights

The Big Picture

On June 24, in Dobbs v. Jackson Women’s Health Organization, the Supreme Court held that the “Constitution does not confer a right to abortion. Roe [v. Wade] and Casey [v. Planned Parenthood] must be overruled, and the authority to regulate abortion must be returned to the people and their elected representatives.”1 And on that date, the ability to obtain an abortion immediately became dependent upon where one lives. All forms of abortion (medication and surgical) are now banned or mostly banned in 13 states, and several others are expected to follow suit in the coming weeks.

As disruptive as this ruling is for the provision of women’s health services in the United States, there are also lurking and potentially dire consequences for the United States’ internationally respected “gold standard” of Food and Drug Administration (FDA) approval of medical products.

As of 2020, 54% of all abortions in the United States were achieved via “medication abortion” using an FDA-approved drug called mifepristone, which has been on the market since 2000 and has a demonstrated track record of safety.2 In the wake of Dobbs, Attorney General Merrick B. Garland issued a statement asserting the Administration’s commitment to “protect and advance reproductive freedom” and declaring that “[s]tates may not ban [m]ifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”3

Garland’s statement is premised on the doctrine that federal law overrides or “preempts” inconsistent state law. In other words, the FDA’s decision to approve mifepristone based on its expert determination that it is safe and effective is a federal action that preempts state laws that would ban or prevent access to the drug based on a state’s contrary conclusion about the drug’s safety and effectiveness.

Although the statement is true as a matter of what is settled law today, as a practical matter, the extent and limits of FDA preemption in this area will ultimately be decided by the courts in the context of challenges to state laws that ban or limit access to medication abortion. These decisions should be closely followed, as they will establish important precedent with respect to the ability of states to enact legislation that could significantly interfere with the FDA’s ability to uniformly regulate drugs throughout the United States.

Background on FDA Preemption

The Supremacy Clause of the U.S. Constitution establishes that federal law prevails over any conflicting state law.4 This doctrine, called “preemption,” applies to federal actions that are in conflict with state actions. Under the Supremacy Clause, federal law can explicitly preempt an area of the law, foreclosing states’ ability to enact and enforce laws in that area. Federal law can also impliedly preempt an area (1) where compliance with both the state law and the federal law is impossible or where complying with the state law would undermine the purpose of the federal law (“obstacle preemption”), or (2) where the federal government manifests an intent to completely regulate a field (“field preemption”).

The Supreme Court has emphasized that courts deciding preemption cases must be guided by Congress’ intent with respect to the preemptive effect of a federal law. As the Court has noted, “the purpose of Congress is the ultimate touchstone in every pre-emption case.”5

In 1906, with the passage of the Pure Food and Drug Act, Congress established the FDA as the sole agency to approve and regulate drugs in the United States.6 The FDA is responsible for ensuring the safety and efficacy of drugs through a drug approval process and by regulating the usage of drugs.7

Congress did not expressly preempt state law with respect to drug regulation as it did in the area of medical device regulation. Section 521 of the federal Food, Drug, and Cosmetic Act (FDCA) states:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.8

The FDCA does not include similar language in its drug-related portions. Thus, in drug preemption cases, courts have evaluated state laws in the context of implied preemption under conflict preemption theories. The Supreme Court has upheld certain state laws that do not conflict with the FDA’s regulatory scheme, such as state tort laws under which so-called “failure-to-warn” claims have been brought. In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court agreed with the FDA’s longstanding position that state tort law “failure-to-warn” claims play an important role in complementing and supporting the agency’s regulation of drugs. The Court rejected the argument that it was impossible for Wyeth to comply with both state law duties to provide warnings about the drug and federal labeling duties, and noted that Congress did not intend for federal law to preempt state law “failure-to-warn” actions.

However, in two subsequent cases, the Supreme Court held that actions brought under state laws which imposed requirements that made compliance with the FDA’s requirements and the state law impossible were preempted under an impossibility preemption theory.9

One court has relied on a theory of conflict preemption to invalidate a state’s attempt to ban and impose additional requirements on an FDA-approved drug. In the 2014 case Zogenix v. Patrick, the U.S. District Court for the District of Massachusetts invalidated the state’s attempt to prohibit the prescribing, ordering, dispensing, or administration of Zohydro, an FDA-approved prescription painkiller, in light of concerns about opioid abuse.10 The court noted that “[i]f the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, [this] would undermine the FDA’s ability to make drugs available to promote and protect the public health.”11 When Massachusetts changed the regulation essentially to mirror the FDA’s approved label, the court upheld the law.12

State Laws Limiting Access to Mifepristone

Since mifepristone was first approved in 2000, states have taken steps to restrict access to the drug. After Dobbs, these efforts are likely to intensify, and courts will be faced with determining whether a state-based ban of mifepristone violates the Supremacy Clause and is therefore preempted. There is little precedent on these questions and therefore limited guidance on how courts are likely to rule.

It is clear that, under Dobbs, the federal Constitution alone does not prohibit states from banning or regulating abortion, including both medication abortion and procedural abortion. The Court concluded that, when challenged in court under the Constitution, state laws regulating abortion can be upheld if the state legislature had any rational basis for the law, with the Court noting a wide array of “legitimate” state interests, including “the elimination of particularly gruesome or barbaric medical procedures” and the “preservation of the medical profession.”13 In states that have taken this step, mifepristone is now effectively prohibited given that the only approved use of the drug is to terminate a pregnancy, though the ability of FDA preemption to protect mifepristone is unresolved.

Even prior to Dobbs, many states had enacted laws that placed limitations on the prescribing and dispensing of mifepristone that exceeded the conditions that FDA had imposed on its use, including prohibitions on off-label prescribing and physician-only prescribing. In Mississippi, GenBioPro, the only generic mifepristone manufacturer, is challenging a regulation that requires patients to see a doctor in person to obtain mifepristone.14 GenBioPro argues that the FDA’s approved Risk Evaluation and Mitigation System (REMS) for mifepristone permits patients to receive mifepristone without an in-person doctor’s visit, and therefore the FDA’s approved regimen preempts Mississippi’s state law. GenBioPro is now seeking to add allegations to its complaint regarding Mississippi’s trigger law banning nearly all abortions, which went into effect when the Supreme Court issued its decision in Dobbs. GenBioPro claims Mississippi’s trigger law is also preempted by the approved REMS for mifepristone.

Conclusions and Questions

State law bans on mifepristone raise the specter of a future in which state legislatures are free to ban FDA-approved drugs either on the basis of their own judgment of safety and effectiveness, or simply because they do not agree on moral, ethical, or other grounds that a particular drug should be available in their state. Imagine if Florida had legislated on the basis of the advice from its Surgeon General (and its Governor) recommending against pediatric COVID-19 vaccines and banned the vaccines in the state instead of simply opting out of pre-ordering the vaccines.15 Alternatively, state legislatures might also permit the marketing of a drug that the FDA has decided not to approve, because they disagree with the FDA’s assessment of the safety and effectiveness of the drug or believe the state’s citizens should have access to a drug for other reasons. This kind of state law patchwork, with requirements and restrictions that conflict with each other and with federal law on how FDA-approved drugs can be prescribed, dispensed, and distributed, should alarm manufacturers, providers, and patients alike.

Given the dearth of caselaw on state bans of FDA-approved drugs (few states have attempted it to date), there are many questions about the likely fate of state laws that ban mifepristone or other FDA-approved drugs. Courts will undoubtedly be faced with complicated decisions as challenges to these laws are mounted.

As the Supreme Court has noted, the “ultimate touchstone” in cases regarding the preemptive effect of the FDA’s drug regulatory system is the congressional intent underlying it. With respect to a state ban on an FDA-approved drug, as in the case of mifepristone, what was Congress’ “purpose” in establishing the FDA as the sole federal regulator charged with overseeing the safety and effectiveness of drugs? Did Congress intend for the FDA to only provide its judgment about whether a particular drug is safe and effective? Or did Congress also want the FDCA to act as a floor (and perhaps a ceiling) preventing states from enacting laws that inhibit uniform patient access to those drugs throughout the country?

Further, state laws banning or limiting access to mifepristone—or other FDA-approved drugs—may ultimately not be enacted based on a “disagreement” with the FDA’s scientific judgment about safety and effectiveness as alluded to in the Attorney General’s statement. Rather, given the politicization of the issues around abortion, states are more likely to justify these laws based on their own moral and ethical judgment about abortion. Indeed, Dobbs makes clear that “[a]bortion presents a profound moral question” and that states are now free to regulate—or prohibit—abortion on that basis.16 Thus, one of the key questions for courts will be whether, under conflict preemption principles, state laws that contradict federal law should be preempted regardless of the motivation underlying a particular policy. In other words, should it matter why a particular state banned mifepristone, or is it sufficient that the effect of the law is to create a conflict with federal law, i.e., the FDA’s approval of the drug?

It remains to be seen how the Biden Administration will respond to these state efforts to prevent or limit access to mifepristone. It will take a concerted initiative and significant resources from both the Justice Department and the FDA to engage in what will likely be protracted litigation with uncertain outcomes. It also remains to be seen whether additional challenges will be brought by other stakeholders, including pharmaceutical companies, providers, and patients.

It is clear that the stakes of these challenges are high, and the implications for the future of access to FDA-approved drugs regardless of where one lives are critical.

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1 Dobbs v. Jackson Women’s Health Org., 597 U.S. ___ (2022). For more on the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, see the Manatt newsletter.

2 Jones, R.K., Nash, E., Cross, L., Philbin, J., and Kirstein, M., Medication Abortion Now Accounts for More Than Half of All US Abortions, Guttmacher Institute, February 2022, https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions.

3 Attorney General Merrick B. Garland Statement on Supreme Court Ruling in Dobbs v. Jackson Women’s Health Organization, U.S. Department of Justice, June 24, 2022, https://www.justice.gov/opa/pr/attorney-general-merrick-b-garland-statement-supreme-court-ruling-dobbs-v-jackson-women-s.

4 See U.S. Const. art. vi, cl. 2.

5 Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996)

6 When and why was FDA formed? U.S. Food and Drug Administration, March 2018, https://www.fda.gov/about-fda/fda-basics/when-and-why-was-fda-formed.

7 See 21 U.S.C. 355.

8 In Riegel v. Medtronic Inc., U.S., No. 06-179 (2008), the Supreme Court held that Section 521 preempted common law claims that received approval through the premarket approval (PMA) pathway.

9 Pliva v. Mensing, 564 U.S. 604 (2011); Mut.Pharm.Co. vs. Bartlett, 570 U.S. 472, 475 (2013).

10 Zogenix, Inc, v. Patrick, No. 14-11689-RWZ (D. Mass. July 8, 2014).

11 Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 1454696, at *2 (D. Mass. Apr. 15, 2014).

12 Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 4273251 (D. Mass. Aug. 28, 2014)

13 Dobbs v. Jackson Women’s Health Org., 597 U.S. ___ (2022) at 77-78.

14 Memorandum in Support of its Motion for Leave to File Amended Complaint, GenBioPro, Inc. v. Dobbs, No. 3:20-cv-00652-HTW-LGI (S.D. Miss. July 21, 2022).

15 Sarkissaian, A., “Florida’s controversial surgeon general recommends against Covid-19 vaccination for kids,” Politico, March 7, 2022, https://www.politico.com/news/2022/03/07/florida-surgeon-general-covid-vaccines-00014702; “Florida isn’t ordering doses of the COVID vaccine for children under the age of 5,” NPR, June 16, 2022, https://www.npr.org/2022/06/16/1105633368/florida-isnt-ordering-doses-of-the-covid-vaccine-for-children-under-the-age-of-5.

16 Dobbs v. Jackson Women’s Health Org., 597 U.S. ___ (2022) at 78-79.



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