Behind the Bill: August 7, 2024

Welcome back to “Behind the Bill,” and today I will be taking a special deep dive into June’s bombshell Supreme Court decision. As some of you may know, I’m defending my thesis on this very topic today (wish me luck!), so as tribute, I wanted to dig into the implications of overturning the Chevron doctrine for drug law and regulation.

Last month, I gave you the cliff notes on SCOTUS overturning Chevron in Loper Bright Enterprises v Raimondo and its companion case, Relentless, Inc. v Department of Commerce. Today, we’re going to unpack what this seismic shift really means for the US Food and Drug Administration (FDA), drug manufacturers, and ultimately, public health.

In a 6-3 decision split along ideological lines, SCOTUS overturned the long-standing Chevron doctrine. This landmark precedent, established in 1984, had given federal agencies like the FDA the authority to interpret ambiguous statutes. Although SCOTUS hasn’t applied Chevron in their rulings since 2016, lower courts have relied on it in over 21,000 opinions.¹

The Importance of Congressional Intent

With Chevron out of the picture, courts will likely place greater emphasis on discerning congressional intent when interpreting ambiguous statutes. A perfect example of this occurred as a result of the 2000 SCOTUS case, FDA v Brown & Williamson Tobacco Corp. In this case, the FDA attempted to assert authority over tobacco products under the Food, Drug, and Cosmetic Act (FDCA) by concluding that nicotine is a drug, and cigarettes and smokeless tobacco products are considered devices. As a result, the FDA announced several regulations concerning tobacco products’ advertising, promotion, labeling, and accessibility to minors.²

The Supreme Court ruled that Congress did not provide the FDA that authority, so their interpretation of the FDCA’s definition of “drug” and “device” was not considered. This decision highlighted 2 key aspects of congressional intent:

1. Did Congress speak directly to the issue?
2. Or, as many law experts have clarified, did Congress intentionally use vague or ambiguous language to allow expert agencies to provide clarity?
   1. In the case of FDA v Brown, it ended up being the latter; Congress eventually passed the Family Smoking Prevention and Tobacco Control Act (TCA), granting the FDA the authority to regulate tobacco products under the FDCA.^2,3

This is a perfect example of how congressional intent can clarify agency authority over time. Post-Chevron, we might see more instances where courts defer to Congress rather than agencies to resolve ambiguities, though the case of FDA v Brown should be considered an outlier and not standard practice (it took Congress nearly a decade to pass the TCA and grant the FDA the authority to regulate tobacco products).

The Role of Precedent

At first glance, SCOTUS appeared to protect case law through the principle of stare decisis—or the principle of adhering to precedent. Stare decisis does not compel continued support for the Chevron doctrine, but the holdings of prior cases that relied on this framework are still considered lawful and subject to precedence. It’s basically like saying, “We’re changing the rules going forward, but we’re not erasing the scoreboard.”¹

However, this part of the decision is considered “dicta,” meaning it is non-binding commentary that other courts may choose to follow but are not obligated. So, while longstanding interpretations of the FDCA might be safe for now, they could be vulnerable to fresh challenges if deemed “unworkable” or “unreasonable.” Supreme Court Justice Elena Kagan articulated this in her dissent and suggested that motivated courts “can always come up with something to label a ‘special justification.’ All a court needs to do is look to today’s opinion to see how it is done.”¹

What This Means for Drug Law

• FDA's Interpretive Power Takes a Hit: Without Chevron, the FDA's ability to interpret vague statutory language is on shaky ground. Terms like "active ingredient" and "active moiety" in the FDCA might become battlegrounds for interpretation.
• Congress in the Spotlight: Expect more pressure on Congress to provide clear, specific language in drug laws. The days of leaving it to the FDA to figure out the details might be over.
• Litigation Windfall: We're likely to see an uptick in lawsuits challenging FDA regulations and decisions. Plaintiffs might argue that the FDA's interpretations don't align with congressional intent.
• A Regulatory Agility Test: The FDA might struggle to adapt regulations quickly to address new health issues not explicitly covered by existing statutes. Gene therapies, novel drug delivery systems – these could end up in regulatory limbo.
• Public Health on the Line: The FDA's ability to respond swiftly to health crises or emerging safety concerns could be hampered if its decisions are constantly challenged in court. Similarly, the FDA may struggle to defend statutes that expend beyond explicit authority and new administrations might hesitate to reinterpret governing statutes.

The Bottom Line

The overturning of Chevron marks a significant shift in drug law and regulation. While the full impacts will take time to unfold, it's clear that the FDA faces new challenges in exercising its authority. The emphasis on congressional intent and the uncertain future of stare decisis add layers of complexity to an already intricate regulatory landscape.

Join me every Wednesday as I highlight key court decisions, review notable health policies, and analyze what's behind the bill in health care.

References

1. Chevron Inc v NRDC Inc, 467 US 837 (1984).

2. FDA v Brown & Williamson Tobacco Corp, 529 US 120 (2000).

3. 21 USCS § 321