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.

Choosing the Right Consultancy Firm

We’ve all been there. Crazy schedules, not enough resources, and timelines looming. We need to bring in the consultants. We bring in the consultants and then “meh,” widespread feeling we are better off doing it ourselves.

One of the significant problems is folks don’t look at consultant companies as part of a system, instead thinking bringing in an expert will just solve things. The other is picking the last company you used instead of properly vetting for the job.

Choosing the right fit is critical. I always look for an excellent systemic consultancy. Hard to find.

Aspect	Traditional Consultancy	Systemic Consultancy
Approach	Linear, top-down approach relying on “expert” advice	Process-oriented, viewing organizations as complex, interconnected systems
Problem-solving	Analyzes problems and proposes solutions based on expertise	Helps clients discover solutions by examining the entire system and its dynamics
Focus	Focuses on specific issues or departments in isolation	Looks at the whole organization and how different parts interact
Client Involvement	Positions consultants as outside experts delivering solutions	Involves clients deeply in the process, seeing them as co-owners of projects
Consideration of Social Factors	May overlook social and psychological aspects	Heavily considers social interactions, culture, and psychological factors
Implementation	Provides recommendations but may leave implementation to the client	Assists with implementation and provides ongoing support
Timeframe	Engagements can be lengthy, lasting months or years	Can be more time-efficient, sometimes requiring fewer sessions
Perspective	Relies more on logical-rational analysis	Expands the view to include aspects neglected by purely rational analysis
Adaptability	May be less flexible in adapting to changing circumstances	Designed to be more adaptable to complex, evolving situations
Outcome Focus	Aims for specific, predefined outcomes	Focuses on improving overall system functioning and adaptability
Industry Specialization	Often works across various industries without deep specialization	Often has deep excellence within a narrow corridor of competencies and roles
Real Solutions	May take time to understand the problem and suggest solutions	Can start work on day one, providing immediate, insightful solutions
Personal Skills	May require time to build rapport and understand the organizational culture	Often possesses the maturity to navigate difficult situations and build immediate rapport

To truly find a good fit, you must go through a robust selection process.

Define your needs and project scope clearly. Before evaluating a consultancy, clearly understand your project goals, timeline, budget, and desired outcomes. This will help you find consultants with the right expertise and capabilities.
Look for relevant experience and expertise. Seek out consultants with a proven track record in your industry and with similar types of projects. Ask for case studies and client references to verify their experience.
Assess their approach and methodology. Look for consultants who have a structured yet flexible approach that can be tailored to your specific needs. The above table can really help. Their methodology should align with your company’s culture and ways of working.
Evaluate their team and resources. Consider the qualifications of the specific team members working on your project. Also, assess whether the consulting firm has adequate resources and support to deliver successfully.
Check their communication style and cultural fit. The consultants should be able to communicate clearly and work well with your team. Their working style and values should align with your company culture.
Compare pricing and value. While cost is important, focus on the overall value the consultant can provide rather than just the lowest price. Consider their expertise, methodology, and potential ROI.
Assess their thought leadership and innovation. Look for consultants demonstrating forward-thinking approaches and staying on top of industry trends and best practices.
Consider the size and type of firm. Based on your project needs and budget, decide whether you need a large global firm, a boutique specialist, or an independent consultant.
Review their technology and tools. Evaluate whether the consultant has access to relevant technologies, data, and analytical tools that can benefit your project.
Trust your instincts. After evaluating all the factors, trust your judgment about which consultant you feel most confident partnering with for a successful outcome.

To select the right consultancy:

Create a shortlist of potential consultants based on the above criteria.
Request detailed proposals from your top choices.
Conduct in-person interviews and presentations.
Check references thoroughly.
Evaluate proposals against your key selection criteria.
Negotiate terms with your preferred consultant.
Ensure alignment on project scope, deliverables, timeline, and budget before finalizing.

A systematic approach to evaluating and selecting a consulting partner will help you find the right fit for your needs and set your project up for success.

Remember, criminal enterprises like McKinsey should be avoided.

Shortage Prevention and Mitigation Plans a Reality for Compliance

On June 18, 2024, the EMA issued templates for Shortage Prevention Plans (SPPs) and Mitigation Plans (SMPs). Marketing authorization holders (MAHs) in the European Union/European Economic Area are encouraged to create SPPs to minimize the risk of medicinal shortages. SPPs are already obligatory under Regulation 2022/123 for drugs listed in the list of critical medicines for that particular crisis, and the US has similar guidance.

Shortage Prevention Plans help to identify and manage potential risks in the supply chain and include information on the MAH, the supply and manufacturing chain, key data on stock, sales, consumption, and manufacturing, and an analysis of the history of supply issues. A SPP should be in place for each medicinal product marketed by the MAH. The minimum requirements for the SPP state that MAHs should analyze and evaluate weaknesses in the supply chain. The robustness of shortage prevention measures is to be evaluated. MAHs are obliged to assess the risks of supply interruptions for patients. A medicine shortage risk register should be developed to identify clinically significant products based on therapeutic use and availability of substitutes. Using available information, such as root cause analysis of shortages, the MAH must determine whether corrective and preventive actions or revalidation are needed nationally and internationally. Furthermore, MAHs should maintain minimum stock levels at national levels. Measures to prevent drug shortages should be reviewed regularly.

Shortage Mitigation Plans are designed to eliminate potential or actual drug shortages and minimize the impact on patients. The minimum requirements for the SMPs include procedures for dealing with shortages, from identification to resolution. These procedures should include measures to reduce the shortage’s impact, notification to regulatory authorities, and follow-up actions. MAHs should define roles, responsibilities, and escalation processes and maintain records of root causes and mitigation measures after resolving shortages.

Both should be readily available for submission upon request and can be subject to inspection during GMP and/or GDP inspections or inspections of MAHs. Thus, they should be living documents in the quality system together with the SMF, contamination control strategies, APQRs, and other similar apex documents.

Parental Leave

When I had my kids I was lucky to be able to take a week or two, and it certainly wasn’t easy coming back. As such I’m really invested in making sure my team gets the opportunity to have more breathing room around parental leave than I did. Here’s my checklist of activities.

Recommendation	Description
Plan early	As soon as you are notified of the upcoming leave, start discussing transition plans, coverage needs, and expectations.
Create a transition plan	Work with the employee to document key responsibilities, ongoing projects, contacts, and critical information.
Be supportive	Recognize this as an important life event and avoid making employees feel guilty about taking leave.
Maintain appropriate contact	Establish expectations upfront for communication during leave.
Plan for re-entry	Schedule a meeting before the employee returns to bring them up to speed on changes.
Be flexible upon return	Consider gradual return options and be open to flexible work arrangements.
Focus on outputs	Trust that the employee can still perform at a high level, even if their work style changes.
Provide mentoring support	Connect returning parents with other employees who have successfully navigated parental leave.
Review compensation fairly	Ensure taking leave doesn’t unfairly impact compensation or advancement opportunities.
Use leave as an opportunity	Identify ways to improve processes or develop other team members’ skills.
Communicate effectively	Be transparent about leave plans and delegate responsibilities clearly.
Trust and empower	Create growth opportunities for team members by delegating responsibilities.

Actions for Parental Leave

Thinking About the High Performers

I am blessed to have inherited a lot of high performers from my predecessor, who built and sustained a highly functioning team, often amid chaos.

I think about what that means to my team a lot. Being a bunch of high performers, they tend to get:

Stressful projects and goals: They often receive a lot of complex and risky projects and goals.
Meeting mania: Because my team is viewed as an essential part of the work (and they are) and can solve even the thorniest issues, their days are filled with back-to-back meetings.
Return-to-office pressure: Because they are “high profile,” my local team members are expected to work more from the plant, resulting in less flexibility. There are many good reasons for this, but that doesn’t make it more popular.

As I move through my 2nd quarter, here are the activities I am working to implement.

Establish a simple weekly team rhythm that drives intensity, not pressure. This is going to take a lot of effort with my peer teams. We need to build a rhythm where we know (to a much higher detail) the types of work we do. I want to move more to a model where we do prioritization on Monday, including defining projects, managing change controls, etc.; problem-solving midweek and a time we do a lot of execution (though frankly, that also happens on the weekend); and Friday is to review completed work, share feedback, and align on next steps. No matter what, we need to create a standardized calendar.

Measure the team’s motivation. As I get close to my 5-month mark, I will be asking the following questions:

What are teammates excited about working on in the second half of the year?
What might be causing them anxiety or pressure?
What habits does the team want to improve?
What are some specific ideas for improving those habits?
What did we do really well last quarter that we should maintain?

Continue to prioritize teaching. I will be scheduling a quarterly skill-check meeting with each of the team. During this conversation, I will help the individual reflect on their current skill goals and pick a new one if they don’t yet have any or have hit them all. We put a lot of work into this during my first quarter, and it is critical to continue to grow here.

Practice Joy. Practicing joy at work is important to maintaining a positive work environment and improving overall job satisfaction.

Cultivate gratitude: Start each day by acknowledging something you’re grateful for at work.
Celebrate small wins: Recognize and appreciate your accomplishments, no matter how small. This can boost your motivation and create a sense of progress.
Find purpose in your work: Connect your daily tasks to the larger goals of your organization or to your personal values. Understanding how your work contributes to a greater purpose can increase job satisfaction.
Find humor in daily situations: Look for opportunities to laugh and share light moments with your colleagues. Humor can help reduce stress and create a more positive work environment.
Practice self-care: Prioritize your physical and mental health by getting enough sleep, eating well, and exercising regularly. When you feel good, it’s easier to experience joy at work.