First of all, we need to recover from the epidemic, not drastic reformsFirst of all, we need to recover from the epidemic, not drastic reforms
In a speech to the Alliance for a Stronger FDA (Alliance for a Stronger FDA) on April 14, Acting Director of the US FDA, Janet Woodcock said that the current environment is not the right time for the FDA to carry out drastic reforms, and discussed how the FDA will use it.
Newly obtained funds for the epidemic and the issue of re-examination of accelerated approval of drugs.
Center of ExcellenceCenter of Excellence
Woodcock said that because the new crown epidemic continues, it has put pressure on FDA staff and increased the workload, so it is not suitable for implementing structural reforms within the agency.
This topic was mentioned because Woodcock was asked if the FDA was interested in establishing other "centers of excellence" similar to the Oncology Center of Excellence (OCE).
OCE was established in 2017 and brought together experts from the FDA Product Center to accelerate the review of cancer treatment drugs, biological products and devices, and has achieved widespread success.
Woodcock said that the FDA is discussing and considering the development of other centers of excellence to take advantage of the "collection across different drug fields," but she also emphasized that now is not the time for institutional reform.
"The FDA is currently under tremendous pressure.
These major and even minor structural reforms will take several years to establish, and then the architecture must be adapted to the needs and ensure that everyone can collaborate well and learn to work in the new system.
Therefore, I think the one job that is currently at the bottom of our priorities is to do a lot of very destructive things.
Woodcock admits that the Center of Excellence is a “plus point”, “but we don’t want to do it in a destructive way, and we don’t want exhausted staff to take on more work plans immediately.
” Woodcock also pointed out that due to the OCE In some special cases, its success may be difficult to replicate.
For example, OCE Director Rick Pazdur is also the Director of the Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research (CDER).
Epidemic recoveryEpidemic recovery
Woodcock gave a similar assessment of the FDA's ability to implement the recommendations made in the Pandemic Recovery and Response Plan (PREPP).
She said, “We are currently unable to achieve all the recommendations in the PREPP report.
We are still in the pandemic and we must recover.
So, obviously, we will integrate some of them.
And some of them will be implemented as we push forward.
Previously, wider public feedback and discussion are needed.
” PREPP was published on January 13, written by an external third party, and introduced the FDA’s response from enhancing the transparency of emergency use authorization risk and benefit analysis to providing vaccine development guidelines.
Provides some suggestions for future work.
The FDA stated that it will first focus on several key areas in the PREPP report:
- Identify ways to improve the EUA review process;
- Identify ways to improve science-based communication with the public;
- Identify methods that can increase the scope of inspection by using next-generation technologies such as virtual and video platforms;
Identify potential gaps in the medical product supply chain by evaluating the FDA's tracking, monitoring, and evaluation capabilities.
As for how to continue to respond to the immediate crisis, Woodcock outlined how the FDA will use the US$500 million allocated to the FDA from the Coronavirus Assistance, Relief, and Economic Security (CARES) Act passed by Congress in March.
Woodcock said that pre-market surveillance would take up "a lot of" resources, and emphasized that emergency use authorization (EUA) is technically regarded as a pre-market product and requires continuous surveillance.
Woocock also said that it is worth noting that the new crown variant has affected the treatment and diagnosis of EUA, and the FDA is monitoring the vaccine and preparing for any changes required by the virus variant.
Woodcock also said that the funds will also be used to solve supply chain issues, especially advanced manufacturing that may be used to rapidly increase vaccine production.
"The pandemic clearly shows that we do not have sufficient funds and insights and foresight into various supply chains, and a large part of it is driven by IT.
Woodcock also made it clear that the FDA's backlog of inspections of pharmaceutical manufacturing facilities is a top priority.
When talking about the issues that the FDA will focus on after the pandemic, she said, “We have our own resilience to carry out facility supervision and inspections, but we may not have done so.
” The FDA released drugs during the epidemic last week.
The Guidelines for Remote Interaction Evaluation of Production Facilities introduces the remote interaction tools that the FDA may use, but it does not explain how the FDA intends to resolve the inspection backlog.
Accelerated approval re-examinationAccelerated approval re-examination
When asked whether the recent delays in the approval of some drugs and the re-examination of certain accelerated approval decisions indicate that the FDA is becoming stricter and less willing to adopt flexibility, Woocock said, “I don’t think so.
I think What's happening is that science is entering areas that are not usually seen in the past, so I think some adjustments must be made.
" She reviewed her experience at the FDA during the AIDS epidemic in the 1980s, when the FDA adopted some treatments as early as possible.
" This boldness is based on the forecast of such a large demand.
" She suggested that those who have questions about approval should have more conversations with Patrizia Cavazzoni, director of the new CDER, and Peter Stein, director of the FDA's Office of New Drugs.
SVB Leerink investment bank analyst Geoffrey Porges recently stated in an investor statement that the FDA may strengthen its position on the industry, especially on safety issues.
"Among investors, people feel that under the leadership of the new Acting Commissioner Woodcock, the FDA has become more active and more stringent.
If this is a huge change (rather than a coincidence), then it is wise to assume that there are any problems.
Certainty or problematic regulatory applications are at a higher risk than expected, and further requests for information and expert committee review will be received.
Other major FDA plans this year include technology and infrastructure modernization projects.
In addition, Woodcock also pointed out that “cell and gene therapies require the most urgent resources.
” New drug applications (IND) for new gene therapy research have soared from 32 in 2010 to 161 in 2019, and in the next few years, It is expected that there will be more rapid development.
Author: Lin know - blue fir