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Covid, Tobacco Policy at Risk After High Court Emissions Ruling

July 1, 2022, 9:15 AM

The HHS will have a significantly harder time responding to public health threats and addressing a host of other policy issues following the US Supreme Court’s decision to block the Environmental Protection Agency from curbing power-plant emissions.

The justices’ 6-3 precedent-setting ruling endorsed a legal approach called the major questions doctrine, which states that agencies need precise Congressional authorization to address issues of major financial or political importance in novel ways. The court’s conservative members have lamented the power agencies have to create and enforce their own rules, and Thursday’s opinion will have lasting implications on every agency’s ability to regulate.

Now, the Department of Health and Human Services will have “a much more narrow scope to work within,” said Katie Keith, director of the health policy and the law initiative at Georgetown Law’s O’Neill Institute.

The ruling could slow or halt future Covid-19 public health regulations, threaten the Food and Drug Administration’s attempts to ban menthol in cigarettes, and thwart the Biden administration’s efforts to protect reproductive health-care and LGBTQ rights, health-care scholars and lawyers said.

“There’s almost nothing you could think of for which this wouldn’t have some implication,” said Lindsay Wiley, a professor at UCLA School of Law. The decision will be considered in “any situation where an administrative agency is trying to solve a problem using authority given to it by Congress in more general terms,” Wiley said.

The health-care industry is highly complex and highly regulated, which is why statutes like the Affordable Care Act are written broadly, said Erica White, a research scholar for the Center for Public Health Law and Policy at Arizona State University.

The opinion is “thick with health-care examples"—from the court’s decision to strike down the Centers for Disease Control and Prevention’s eviction moratorium to its ruling throwing out the Occupational Safety and Health Administration’s vaccine mandate for employees at large businesses, said Allison Hoffman, a professor at University of Pennsylvania Carey Law School.

Those examples make clear that “this doctrine will be used in all kinds of corners of health-care regulation going forward,” Hoffman said.

Covid-19 Mandates

The endorsement of the major questions doctrine will make it difficult for the HHS to enact any major response to the Covid-19 pandemic that isn’t clearly authorized by Congress. Vaccine and mask mandates have been challenged by opponents contending they exceed the agency’s authority, and “today’s decision re-invites lower courts to view agency action across the board skeptically,” White said.

“Lower courts are going to strike down federal regulations left and right citing this decision, whether it’s appropriate to do so or not,” Keith said.

The HHS will struggle with both speed and adaptability when it needs to “not just take swift action but also make nimble adjustments over time” to rapidly evolving threats, Wiley said.

Congress isn’t known for quick decision making, so if the HHS needs “an explicit, step by step word from Congress to do anything at all,” it will “hinder them from making a lot of decisions,” White said.

Cigarettes, Cigars

The Supreme Court’s decision also puts greater pressure on the Food and Drug Administration to prove it’s authorized by Congress to propose its draft ban on menthol in cigarettes and cigars and other major rule changes, said Marc Scheineson, a former FDA associate commissioner. The Biden administration also recently announced its intent to propose limits on nicotine in cigarettes and certain other tobacco products—a move likely to be contested by the tobacco industry.

“At least for major transformational rules, the burden shifts to the agency to prove that Congress specifically gave it this authority,” he said.

Scheineson, now a partner and co-head of the food and drug group at Alston & Bird, said that Thursday’s ruling “dramatically weakens” the high court’s decision in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. That case held that the court gives deference to an agency when ambiguity exists in a statute.

But Scheineson also noted the FDA has the advantage of the Tobacco Control Act, in which Congress explicitly gave the agency the authority to adopt product standards though notice and comment rulemaking, including on the content of cigarettes.

Joelle Lester, director of Commercial Tobacco Control Programs at Mitchell Hamline School of Law’s Public Health Law Center, said she agrees the FDA has clear authority from Congress to propose rules on tobacco product ingredients.

She added, though, that Thursday’s decision will likely embolden tobacco manufacturers to challenge the menthol ban and other policies once they’re finalized.

“It definitely provides a roadmap that the industry will follow trying to attack the menthol regulation with everything they can come up with,” Lester said.

Abortion, LGBTQ Rights

Abortion is another politically significant issue on the Biden administration’s agenda where it will need to tread carefully if it “acts in a space where Congress hasn’t given clear authority,” Hoffman said.

The HHS so far has been hesitant to unroll any substantively new policy agenda in response to the high court’s decision last week to overturn Roe v. Wade , but Secretary Xavier Becerra has assured reporters that the administration is exploring its options.

“One of the biggest threats of a decision like this is the chilling effect that it will have on agency decision makers,” Wiley said.

The court’s definition of an issue of profound importance “would definitely include mifepristone,” the most popular abortion drug in the US, so the doctrine could be invoked in that context, White said.

The administration hasn’t yet said whether it will support an ongoing lawsuit in Mississippi from generic mifepristone maker GenBioPro. The case deals with whether the FDA’s regulations on the pill preempt state laws limiting its access.

The administration could also run into trouble trying to regulate health-care discrimination against transgender and LGBTQ people, Hoffman said. The HHS is expected to release a rule strengthening LGBTQ protections.

To contact the reporters on this story: Allie Reed in Washington at areed@bloombergindustry.com; Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Brent Bierman at bbierman@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com