Tag: Administrative law

Inter-Loper: Loper Bright and Judicial Intrusion on Agency Prerogatives

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by Nathan Cortez

If you wanted quick medical advice, you’d ask your friend with an MD or BSN. Not a JD. Likewise, if you wanted to know how to regulate nitrogen oxide under the Clean Air Act, you’d probably trust the scientists at Environmental Protection Agency (EPA) over the judges on a court that referred to the gas as nitrous oxide (laughing gas). But under the Supreme Court’s recent opinion in Loper Bright Enterprises v. Raimondo, a 6-3 conservative majority ruled that courts get the final say on such matters.

Loper Bright was a blockbuster decision, though not unexpected. Here, I’ll discuss what it might mean for health agencies like the EPA, U.S. Food and Drug Administration (FDA), and Department of Health Human Services (HHS).

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“Hubris Squared”: What SCOTUS Decision Gutting Deference to Public Agencies Means for Health Care Protections

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This post originally appeared on Health Care in Motion, published by the Center for Health Law and Policy Innovation.

The last days of the Supreme Court of the United States’ (SCOTUS) term brought some blockbuster decisions with far reaching implications for federal agencies charged with regulating health care. In an expected but still monumental move, SCOTUS issued a decision in Loper Bright vs. Raimondo overruling decades of precedent under which courts gave deference to agency interpretation of federal statutes the agency was charged with enforcing.

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The Impetus for a Neutered Chevron

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by Barbara Pfeffer Billauer

Legal pundits are predicting the imminent demise (or at least substantial enfeeblement) of the Chevron doctrine. Until recently, that case afforded substantial judicial deference to decisions made by administrative agencies if a statutory provision under its purview was ambiguous. Now two cases are before the Supreme Court challenging an agency interpretation regarding funding of statutorily required monitors on fishing boats. This development signals a “sea-change” is in sight for agency autonomy, as deference to agency decisions is being threatened.

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Supreme Court of the United States.

The Federal Judiciary Is Broken — But Not for the Reason You Think

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By Jennifer Bard

Recent events, including the discovery that Justice Thomas has been accepting luxury vacations from and selling real estate to a billionaire, and the Fifth Circuit’s finding in Alliance for Hippocratic Medicine v. FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. But they’re not. Both involve a threat to our constitutional government and both highlight the need to shield all federal decision makers from entities with billions at stake and a fiduciary interest in increasing the value of their company for the benefit of shareholders. And while issues of influence affecting Supreme Court Justices attract the most attention, the factors that make Justices targets extend across the entire federal judiciary.

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rendering of luminous DNA with gene being removed with forceps.

Mainstreaming Reproductive Genetic Innovation

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By Myrisha S. Lewis

Despite religious and ethical objections, assisted reproductive technology (ART), including in vitro fertilization and egg freezing, manages to flourish in the United States, with some states and companies even creating regimes for its insurance coverage. However, reproductive genetic innovation — a term I use to refer to the combination of assisted reproduction with genetic modification or substitution — has yet to receive the same acceptance. Examples of reproductive genetic innovation include mitochondrial transfer, cytoplasmic transfer, and germline gene editing.

Moreover, while many scientists, regulators, and members of the public have called for societal discourse or consensus related to individual reproductive genetic innovation techniques, these calls rarely include an explanation as to how these discourses would be conducted. In a recent article, Normalizing Reproductive Genetic Innovation, I offer four potential avenues for structuring a societal discourse in the U.S. on the topic.

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Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

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By Matthew Chun

In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.

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Supreme Court of the United States.

The Bind We’re in — And How the Supreme Court Put Us There

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By Jennifer Bard

As the COVID-19 pandemic rages into its third year of global death and destruction, the Supreme Court of the United States has effectively thwarted every measure by federal or state government to implement the public health tools that for hundreds of years have been used to stop the spread of contagious disease. They have done so by operationalizing what were previously fringe and relatively harmless academic views in ways that extend their powers beyond any previous boundaries. These include, but are not limited to, extending the protection for religious exercise past any previously imagined, and limiting Congressional authority to respond to emergencies by imposing impossible standards of specificity on its delegation of authority to the agencies which it creates, funds, and directly oversees.

In so doing, the Court has not only undermined the health of the nation, and pushed millions of people into unnecessary long-term disability, which our fragmented health care and social security system is unequipped to handle. It has also threatened our national security by infecting what is already more than half of the children in the country with a virus that has the potential to damage every organ in their bodies, from heart to brain.

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It’s Time for Biden to Scrap Trump-era Junk Plans

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By Cathy Zhang

Open enrollment for the health insurance marketplace begins on November 1.

Among the options available to consumers will be short-term, limited-duration insurance (STLDI), also known as junk insurance plans. The Trump administration facilitated the proliferation of these cheap, underprotective plans in an attempt to undermine the marketplace, and the Biden administration has yet to reverse that policy.

As part of the Biden administration’s public effort “to restore and strengthen Americans’ access to quality, affordable health care,” the administration needs to take executive action to protect consumers and eliminate junk plans.

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The Patent Trial and Appeal Board Again Survives Supreme Court Review

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By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

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