Well this was a dizzy ride – thanks SCOTUS for everything (not)

The 2024 U.S. Supreme Court decisions have had significant impacts on the Food and Drug Administration (FDA) and other federal agencies. I don’t think we will truly understand the impact for years as matters move through the courts. This increased uncertainty has led to new questions arising as we assess risk.

Overturning the Chevron Doctrine

A significant decision was made to overturn the Chevron doctrine, a longstanding precedent that mandated courts to defer to federal agencies’ expertise when interpreting unclear statutes. This doctrine has played a crucial role in enabling agencies such as the FDA to establish and enforce regulations based on their specialized knowledge.

Reduced Authority: With the Chevron doctrine overturned, the FDA’s ability to interpret and enforce regulations without judicial interference is significantly curtailed. This change makes it easier for regulations to be challenged in court, potentially leading to increased litigation and uncertainty in regulatory enforcement.

Challenges to Regulatory Actions

The decisions made by the Supreme Court have made it harder for federal agencies to effectively carry out their regulatory functions. The court’s rulings have extended the time frames for challenging agency actions, leading to delays in implementing new regulations and enforcement actions. This could particularly affect the FDA’s ability to respond promptly to emerging public health issues.

Specific Cases Affecting the FDA

Several other cases have also directly impacted the scope of FDA regulations:

Environmental and Safety Regulations: Recent court decisions have impacted the FDA’s ability to enforce regulations concerning food safety and environmental protection. For example, the decision to block certain EPA regulations on cross-state pollution indirectly affects the FDA’s responsibility to ensure the safety of food and drugs that might be affected by environmental factors. It’s still uncertain how significant this impact will be, but I am more concerned about this issue than I am about the weakening of the Chevron defense.
The Supreme Court’s decision to protect access to the abortion medication mifepristone is an important exception. The court upheld the FDA’s regulatory decision, which ensures that the FDA can continue to regulate and approve medications important to public health. However, it’s worth noting that this ruling was specifically about the legal standing of the case, so it’s not an entirely straightforward situation.

Broader Implications

The recent decisions signal a change in the balance of power between the judiciary and federal agencies. The Supreme Court’s decision to limit the deference typically given to agencies such as the FDA has altered the federal regulatory landscape. This change could result in a more restricted and litigious regulatory environment.

Laboratory diagnostic testing regulations

The recent Supreme Court rulings, especially the overturning of the Chevron doctrine in Loper Bright Enterprises v. Raimondo, will first impact the FDA’s new laboratory diagnostic testing regulations.

Increased Legal Challenges: The removal of Chevron deference means that courts will no longer automatically defer to the FDA’s interpretation of ambiguous statutes. This change might result in more legal disputes regarding the FDA’s power to regulate laboratory-developed tests (LDTs) as medical devices. The American Clinical Laboratory Association (ACLA) has already filed a lawsuit against the FDA over the new LDT rule, and this Supreme Court decision could strengthen their case.
Uncertainty in Regulatory Framework: The FDA’s final rule, published on May 6, 2024, regulates Laboratory Developed Tests (LDTs) as medical devices, similar to in vitro diagnostics. However, due to a new Supreme Court ruling, the FDA’s authority to regulate LDTs may face greater scrutiny by the courts. This could lead to uncertainty in the regulatory framework for clinical laboratories.
Potential Delays in Implementation: The Supreme Court’s decision in Corner Post v. Board of Governors extends the timeframe for challenging agency rules. This could lead to delays in the implementation of the FDA’s LDT regulations because stakeholders may now have more time to challenge the rules in court.
Stricter Scrutiny of FDA Decisions: The new ruling emphasizes that courts should exercise independent judgment in deciding whether an agency has acted within its statutory authority. This could lead to stricter scrutiny of FDA decisions regarding LDT approvals and regulations.

Keep in mind that although these potential impacts are meaningful, the complete effects of the Supreme Court’s rulings on FDA regulations will likely become more apparent over time as cases are presented in court and as the agency adjusts its approach. The situation is still evolving, and those of us involved in FDA regulated industries should be prepared for significant changes ahead.

FDA CDER Quality Management Maturity White Paper

FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) recently published a white paper proposal on the development of a rating system to measure a firm’s quality management maturity (QMM) as a way to mitigate drugs shortages and enhance the quality of finished drug products. These ratings would be publicly available. This is very aligned in thought to the recent NAS study recommendations in a paper commissioned by Congress.

This fits nicely within the recent draft guidance on metrics, and the two are definitely meant to fit together.

I am a big advocate of this work. I definitely want to see the particulars, but this is a long time coming and greatly needed. Frankly, the best way to make them happen is to require the QMM to be a factor in purchasing decisions for Medicaid/Medicare and the Veterans Hospitals (and more if possible).

The agency will be holding two workshops on quality management maturity, on May 24 and May 25. The first workshop will address CDER’s QMM program and the second will discuss quality ratings.

FDA Prescription Drug User Fee Renewals

Senators grill industry groups over FDA user fee agreements to fund the agency through 2027

I am not a huge fan of PDUFA. It puts the wrong cast on things. Fees are something I pay for a service, and it should put me in the driver’s seat (well except for airlines and everyone hates that). We tax for government services. Making the FDA dependent on pharma creates an imbalance in power that quite frankly shouldn’t exist.

The extent of statutorily required industry input in the drug regulation and reauthorization processes has increased as a result of the PDUFA reauthorization. The centrality of user fees to the modern FDA has led some observers to express concern that they have contributed to “corrosive capture” of the agency (i.e., a weakening of regulatory independence and of the ability of the agency to uphold traditional efficacy and safety standards) by shaping discourse about how drugs should be regulated or by enabling an unhealthy culture of closeness between the FDA and industry. Each successive PDUFA has required the FDA to be increasingly responsive to industry concerns.

The FDA plays a crucial role in protecting the health of the public while approving new treatments in a timely fashion. Thirty years of experience with user fees has shown that, in the face of inadequate public funding of the personnel budget of the FDA, increased funding by its egulated industries can indeed improve regulatory timelines. This increased speed has also raised questions related to the decisions being made and the growing reliance of the agency on financial support from the companies it regulates, as the user-fee model has fundamentally changed the way that the FDA interacts with industry. In a different political climate, adequate public funding in place of user fees would allow the FDA to continue its current performance levels while adding further confidence that the public remains the primary client of the FDA.

Descriptive versus Prescriptive Regulatory Guidance and Quality

There are two different ways that language is discussed and taught: descriptive grammar vs. prescriptive grammar.

Prescriptive grammar describes when people focus on talking about how a language should or ought to be used. Prescriptive grammar tells you how you should speak, and what type of language to avoid. This is commonly found in English classes where the aim is to teach people how to use language in a very particular (typically described as ‘proper’ or ‘correct’) way.

Descriptive grammar, on the other hand, focuses on describing the language as it is used, not saying how it should be used. For example, think about a prescriptive rule like Don’t split infinitives. A descriptive grammarian would see a sentence like “To boldly go where no man has gone before” and would try to describe how the mental grammar can cause that ordering of words, rather than saying that the surface form is faulty due to prescriptive rules (which would require the sentence “To go boldly where no man has gone before”). Linguistics takes this approach to language.

We have a similar thing in pharmaceutical regulations, often seen by how the FDA looks at certain issues and how the EMA and PIC/S looks at them.

For example, the FDA is proceeding with draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint. This is mostly a descriptive approach, as it sets a lot of desirable outcomes but you few strong requirements for how to get there.

The EMA has a draft Annex 1 which lays out a pretty strong set of requirements for exactly how to perform contamination control, telling you exactly what to have and what it should look like.

The difference can be pretty evident when you hear the different regulators discuss their approaches. I’ve certainly heard more than one present or former FDA regulator say that adopting Annex 1 isn’t necessary because the GMPs already have the requirements built in.

You see a similar approach when it comes to QPs or the GCPs.

The prescriptive versus descriptive difference even comes up during inspections. Most people will talk about how the FDA focuses on artifacts and the EMA goes deep on the process.

A similar divide can happen in your quality system where you see different approaches (often a hodge-podge) between controlling the bad and promoting the good.

Being a pragmatist I often see benefits in both approaches (the same way I find value navigating between FDA and EMA approaches). The key thing is being deliberate about it.