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Former head of FDA’s medical and scientific affairs on Covid: ‘FDA has never been tested like this’

Thought Leader: Anand Shah
April 14, 2021
Source: Link

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

The interview is lightly edited for clarity.

Endpoints News: I thought I’d start off by asking about this decision announced by the FDA and CDC on Tuesday to pause the administration of J&J’s Covid-19 vaccine. Can you offer any details on what goes into a decision like that behind the scenes? Who’s consulted at FDA, and how are different factors weighted in such a big decision?

Anand Shah: What’s important to note here is that this is a decision made by the career staff of the agency. [CBER director] Peter Marks works diligently with sister agencies across HHS and with industry — they are collecting data from a variety of sources and as they see signals that are concerning, that’s probably the impetus for issuing this pause. My sense is that this is basically an ask to hold on the vaccine, not a revocation of the EUA. It’s a tacit acknowledgment that it’s very few cases and for folks to keep an antenna up and report similar cases.

Endpoints: What kind of an impact might this pause have on vaccine hesitancy in general?

Shah: The public should have confidence that the FDA and CDC continue to surveil the performance of these vaccines, even after an emergency use authorization is issued. It’s a sign that the processes that the agency has in place are working. This is really no different than how we monitor other drugs, biologics, medical devices after they’ve been cleared by the FDA. I would say the public should have confidence that the processes of the agencies are working and the agency will communicate very clearly as it learns more about this J&J vaccine.

Endpoints: The FDA recently announced some of its top Covid-related priorities moving forward (based on the PREPP report from January) and I’m curious if you can explain how the agency might optimize the way sponsors move products through the EUA process? Would you say it’s more or less complicated or collaborative (in terms of sponsor-FDA interactions) than the standard drug approval process?

Shah: So during the first year of the Covid-19 pandemic, FDA received more than 3,000 EUA requests and FDA reviewed more than 2,300 of these requests and issued over 600 EUAs, the lion’s share on the medical device side of the house. Just to put that in perspective, FDA issued 65 EUAs in all previous public health emergencies combined.

So early last year, it became very clear the Covid-19 pandemic was and continues to be a once-in-a-lifetime public health emergency. FDA has never been tested like this during its history. Because EUAs are used in limited circumstances, the review of products requires some additional checks and balances during the review process and often the data are less mature than what you’d see in a regular submission. Throughout the pandemic, FDA staff have worked collaboratively with industry and academia — the great example of this is CTAP [the Coronavirus Treatment Acceleration Program], which was a special fit for purpose program to seamlessly review EUA requests and work more collaboratively.

It’ll be important to assess how programs like CTAP impact workload at the agency and how they work from a stakeholder perspective. It will take some time after the public health emergency to fully distill the impact of these programs and processes and then decide which learnings should be made permanent.

Endpoints: Overall, do you think this pandemic shows there’s room for the FDA to speed up its drug and biologic reviews further?

Shah: It’s important to note the EUA approval process is very different from FDA approval or clearance. The agency makes a product available to the public based on the best available evidence without waiting for all the evidence that would be needed for approval or clearance. So when evaluating an EUA request, FDA carefully balances benefits and risks, and during this pandemic, that risk-benefit profile has been dynamic based on what we continue to learn on the SARS-COV-2 virus.

Regarding non-emergency FDA approval times, like an organization, there’s always room for optimizing processes. The agency has always worked closely with stakeholders and continue to iterate on these expedited programs. User fees bring a high level of accountability around performance benchmarks.

It’s important to note there are programs like RTOR [Real-Time Oncology Review] to strive for more efficient reviews, ultimately to allow faster patient access while still preserving the integrity of the agency’s review. FDA will need to see support through user fees, appropriations or even both to scale these further across the medical product centers.

Endpoints: What does the FDA need to do to get on better footing with the general public in terms of transparency and explaining its decision-making for some products that have received EUAs?

Shah: There’s always more room for transparency, and it’s encouraging to see FDA prioritizing EUA transparency around the PREPP initiative. Both of these can go hand in hand in terms of educating the public on the FDA’s decision-making and the underlying science and data to support those decisions. An open and transparent approach bolsters public confidence.

During the pandemic, the agency has published risk-benefit assessments for many of the EUA decisions, and this is really helpful to all stakeholders, especially clinicians making decisions with their patients regarding potential testing or therapy or vaccination.

Another example of transparency is how the professional staff at CBER work closely with the public to ensure really the highest level of transparency on how vaccines are reviewed internally at FDA, to walk the public through our processes, and really explaining carefully how the advisory committee will function.

Endpoints: Thinking back on your time at FDA, former President Trump has made clear that he used political pressure to speed the FDA’s reviews of vaccines — is that consistent with what you saw? How intense was the political pressure from Trump and others at the White House? What did that kind of pressure do for morale at the agency?

Shah: FDA has always been guided by science and data. And really an agency that regulates such a large swath of the economy will always be a focal point for the public and subject to a variety of opinions. Despite the heightened public interest over the past one year towards FDA, the professional staff at the agency have demonstrated an unbelievable resilience during the pandemic despite the personal impact we’ve all encountered over the past year. Going forward, it’s critical FDA maintains regulatory independence in its decision-making. Other agencies like NIH or CMS or HHS can certainly be informative on larger policy items but individual medical product decisions must remain internal to FDA and more specifically, led by the career staff.

Endpoints: Did you hear anything from anyone in the White House who were trying to preempt certain decisions made by that career staff?

Shah: No.

Endpoints: Considering you’ve worked at the FDA, CMS and NIH — what are some cross-agency collaborations that you’d like to see moving forward? Are there collaborations that have been initiated at these three agencies since the pandemic began and that might continue afterward?

Shah: All of these agencies are focused on advancing public health. The pandemic has led to strong partnerships at many levels across these agencies. Early in the pandemic, the agencies worked very closely together on Covid-19 testing. A great example is, together with the CDC, there was a need for horizontal alignment between the agencies to ensure medical product development, review and authorization and CLIA considerations were lockstep.

FDA worked closely with the NIH’s National Cancer Institute to stand up an infrastructure to independently evaluate the performance of Covid-19 tests. This was an incredibly helpful backstop for the FDA to study tests on the marketplace, and notably, this was the first time the federal government evaluated tests itself to inform FDA authorizations. And so, this is a model for how we can drive all of government approach to tackle the most pressing public health issues of our generation.

I think a great opportunity going forward is to really tackle antimicrobial drug resistance, and that’s an area where we can really accelerate drugs from bench to bedside. AMR has complex scientific, regulatory and market access issues that are best solved when we’re all working together. And I think the frameworks that we’ve learned to develop over the past year, and specifically the collaborative frameworks, will serve as a lasting legacy for how we should move forward on non-Covid related issues.

Endpoints: Speaking of non-Covid related issues, drug pricing seems to be a major focus area for President Biden — do you think CMS is ready for what may come in terms of negotiating power? And what roles, if any, do you think the FDA and NIH will have with drug pricing?

Shah: I think we’re all watching very closely a lot of the activity on the Hill. And certainly, if there is new legislation, CMS will have to move quickly around implementation and working with industry and potentially putting forth guidance on what implementation will mean going forward.

Drug prices continue to be a concern for patients and consumers alike. It’s still early in the new administration and it remains to be seen how HHS, CMS and the White House will align on their policy goals, and the role of Congress driving these priorities forward. In terms of NIH and FDA, they don’t have a direct role in drug pricing, but they continue to advance objectives around drug discovery and increasing competition and choice for patients. We made great strides in improving access to generics and biosimilars at FDA and I expect that progress will continue at the agency.

Endpoints:  We’re seeing some high-level FDA officials, like yourself and Amy Abernethy, move on from the agency, and Patrizia Cavazzoni was recently named as the head of CDER. Do you think the FDA does enough to attract and keep top talent? What can be done other than more funding?

Shah: It’s been remarkable to see over the past five years the FDA really prioritized recruitment, retention, and promotion across the board at the agency. Like any other high-functioning organization, there are always challenges to cultivating a diverse, mission-driven professional workforce. Talent continues to cycle at the FDA, including among leadership. But there continues to be a healthy balance in terms of maintaining institutional perspective versus new talent and outside perspectives coming in.

FDA has to keep up with constantly evolving science, as well as the need to recruit and train people with highly specialized skills. Congress has recognized the importance of a stronger FDA for public health and in late 2016, Congress gave FDA new resources to achieve these objectives of bringing on talent.

The Office of Operations at FDA has been truly remarkable with talent acquisition, especially during the pandemic, where we’ve had record new hires over the past many months. But that said, FDA needs to explore new avenues for hiring other than increased funding. Perhaps there are ways to adapt best practices from other non-governmental agencies.

FDA has an opportunity to work closely with industry and academia to chart a path forward for continuing to cultivate professionals who are specialized in cell and gene therapy development and regulation. There may be opportunities for a program whereby the FDA can benefit from outside talent while finding ways to mitigate conflicts of interest. Alternatively, there may be opportunities for FDA to spend time on the front lines of novel therapy development and seek additional educational opportunities and continue to be informed on new science.

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