Supreme Court Decision On EPA Could Have Implications For Other Regulatory Agencies, Like FDA

Healthcare Supreme Court Decision On EPA Could Have Implications For Other Regulatory Agencies, Like FDA Joshua Cohen Contributor Opinions expressed by Forbes Contributors are their own. I write about prescription drug value, market access, healthcare systems, and ethics of distribution of healthcare resources New! Follow this author to improve your content experience. Got it! Jul 5, 2022, 08:13am EDT | Share to Facebook Share to Twitter Share to Linkedin WASHINGTON, DC: Associate Justice Elena Kagan, with Associate Justice Clarence Thomas and Chief .

. . [+] Justice John Roberts in front of her, stands during a group photo of the Justices at the Supreme Court in Washington, DC on April 23, 2021.

On June 30th, 2022, Kagan issued a dissenting minority opinion in the West Virginia v EPA case. in which she asserted that “to keep faith with that Congressional choice, courts must give [regulatory] agencies ample latitude to revisit, rethink, and revise their regulatory approaches. ” (Photo by Erin Schaff-Pool/Getty Images) Getty Images Last week, in a case brought to the Supreme Court – West Virginia v EPA – in a 6-3 decision the Court restricted the Environmental Protection Agency’s (EPA) ability to regulate greenhouse gases.

This sets a precedent that could limit government agencies’ capacity to establish certain new regulations. The Court’s decision is grounded in the “major questions doctrine” which was deployed in this case for the first time. The upshot of this doctrine is that government agencies, such as EPA, have little leeway in setting new regulations of “major economic and political importance” that rely on powers not clearly spelled out in detail by Congress.

The major questions doctrine holds that in such instances federal agencies must be able to point to specific Congressional authorization for their actions. In the West Virginia v EPA case, the Court’s decision substantially limits the EPA’s rulemaking authority. Throughout history, when Congress established federal regulatory agencies, it purposely adopted wide-ranging language that wouldn’t narrow the agencies’ mandate to specific sets of rules and regulations.

Indeed, regulatory agencies have always been meant to interpret laws, carry out their intent, and create regulations in an ever-changing societal dynamic that involves evolving challenges. In this context, Congress relies on the expertise of federal agencies, such as the EPA and others like the Food and Drug Administration (FDA), to implement new rules and regulations as they see fit. This is partly due to lawmakers not being as knowledgeable, or at least not sufficiently so, to regulate the specifics of issues which may impact the public.

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Before the FDA Clinical or Safety Reviews Have Been Made Public In the West Virginia v EPA case, Justice Kagan wrote a dissenting minority opinion , in which she asserted that “Congress makes broad delegations in part so that agencies can adapt their rules and policies to the demands of changing circumstances. ” Kagan concluded: “To keep faith with that Congressional choice, courts must give agencies ample latitude to revisit, rethink, and revise their regulatory approaches. ” How could the Court’s decision affect other agencies, such as the FDA? In light of acute and ongoing public health challenges there are new regulations that the FDA might try to formulate and implement.

The major questions doctrine is not fully defined or delineated, so it’s unclear which of the regulations would be a target of the doctrine. Nevertheless, if new regulations go against existing practice and conflict with certain stakeholders’ interests, they could be subsumed under the major questions doctrine. Accordingly, these regulations could be subject to litigation.

The precedent created by West Virginia v EPA could then be used to legally challenge such regulations. Here, we’ll focus on a potential new regulation; the FDA possibly forcing prescription to over-the-counter (OTC) switches, using as an example the opioid antagonist naloxone. The U.

S. is contending with a major ongoing public health crisis with large numbers of overdose fatalities, especially from illicit fentanyl. Naloxone is an opioid antagonist that rapidly reverses an opioid overdose.

All 50 states allow individuals to purchase naloxone at the pharmacy without a prescription. However, states don’t have the authority to designate naloxone as an OTC medication. While they’ve created workarounds , these are cumbersome and don’t apply to organizations that purchase naloxone in bulk from drugmakers.

The fact that the utilization of naloxone dipped in 2020 while overdoses soared suggests there may be an access problem. Harm-reduction groups are calling on the FDA to allow naloxone to be sold OTC so that it can be accessed more easily. In turn, the FDA has blamed the companies which manufacturer naloxone for dragging their feet on applying for a prescription to OTC switch.

Pharmaceutical firms that make naloxone are reluctant to initiate switch proceedings, ostensibly because this could lead to insurers denying coverage of the product. Insurers tend not to cover OTC products. But, the real reason may be less innocuous, as an OTC switch will encroach upon drug makers’ ability to set high prices.

After all, post switch, products’ prices tend to decline significantly. Harm-reduction advocates now say that the FDA should make the prescription to OTC switch itself, which the FDA may be considering. Policy experts and harm-reduction advocates have argued that there is a statute which allows a drug’s prescription status to be removed “when such requirements are not necessary for the protection of the public health.

”Drug companies have countered that the government doesn’t have the authority to unilaterally designate a prescription drug as OTC. Suppose the FDA were to force a switch, as it appears it might do soon . This could be rebuffed by the courts, with the FDA’s action deemed to constitute regulatory overreach, based on the precedent established by West Virginia v EPA.

The public health argument may not be sufficient, as courts could decide that Congress must first pass targeted legislation allowing for the FDA to impose OTC switches. At a certain point, Congress may do just that. But, we know how slowly Congress works.

Bills that seem very reasonable on the surface either go nowhere, or wind up taking years to enact. In the meantime, tens of thousands of Americans are dying of overdoses every year. As Professor Lawrence Gostin of Georgetown University maintains, the West Virginia v EPA case has repercussions that extend beyond the EPA’s ability to regulate the environment.

The decision could in fact impact the authority of all federal agencies that issue regulations, such as the FDA. Follow me on Twitter . Joshua Cohen Editorial Standards Print Reprints & Permissions.