How the FDA’s new head affects agency policy


Dr. Robert Calif is Nominate The Food and Drug Administration was led by President Joe Biden last week. If confirmed, Califf will lead an organization that is still battling the COVID-19 pandemic, while working on innovation.

Califf served as an FDA commissioner for nearly a year at the end of the Obama administration. Stakeholders say that he knows how the agency works and can start work quickly. According to Howard Sklamberg, a partner at Arnold & Porter, Califf’s leadership style revolves around setting key priorities and implementing them. He served as Deputy Director of the FDA during Califf’s first term.

As the FDA enters a new leadership stage, the following five policy themes are worthy of attention.

1. Keep an eye on COVID-19

Califf may be prioritized Coronavirus disease The FDA has always given priority to public health emergencies in the past two years. Heather Pierce, senior director of scientific policy and regulatory questions at the Association of Academic Medical Schools, said the agency needs to continue to focus on vaccines, tests, and drug development related to COVID-19.

New COVID-19 therapies are still under development, such as Pfizer’s pill The FDA authorization was submitted earlier this week. Susan Lee, a life science practice partner at Goodwin Proctor, said Califf may be involved in these decisions.

Some stakeholders hope that the FDA will improve the way it communicates pandemic-related policies to providers and patients. Mark Howell, Senior Associate Director of Hospital Standards and Drug Policy of the American Hospital Association, said that the organization has discussed with the FDA to simplify communication around emergency use authorization and believes that the agency is trying to move in this direction.

2. As the pandemic gradually ends, transition from EUA

FDA has used EUA Howell said that bringing multiple devices and drugs to the market during the pandemic would be very helpful to hospitals.

But these approvals expired in response to a public health emergency. Howell said the FDA needs to create a transition period so that when the EUA expires, the hospital will not suddenly leave unauthorized products.

The agency has also exercised enforcement discretion on pre-market approval requirements for different products. It must figure out what and how to phase out some of these temporary policies.

3. Additional attention and innovation to clinical trials

Sklamberg said that Califf is considered an expert in clinical trial research and he is keen to improve clinical trials and evidence development. Califf may make the trial process more open to real-world evidence.

Lee said the pandemic forced the FDA to allow flexibility and innovative clinical trial design, especially in remote monitoring. She hopes Califf will continue to promote this process.

By bringing therapies to market faster, clinical trial innovation can also benefit patients and practitioners.

4. More FDA policies to control drug costs

The FDA is not responsible for drug price regulation.But Calif has speak out Opposing unsustainable drug costs shows that he can instruct the agency to control prices more aggressively.

Lee said that enthusiasm for innovative clinical trial design may lead to lower drug costs because the high cost of drug development leads to high prices for consumers.

As a way to control costs, the FDA can also work hard to strengthen competition in the drug market. Sklamberg expects Califf to ensure that the first and second generation generic drugs on the market have the right resources. He said that Califf may continue with former FDA Commissioner Scott Gottlieb’s push to submit anti-competitive practices in the industry to the Federal Trade Commission.

AHA wants to see the FDA continue its work BiosimilarsHowell said-drugs that are almost the same as the original drugs-and interchangeable products under Califf’s.

“What we care about is whether we can bring more generic drugs to the market, especially when we consider high-cost biologics,” he said.

5. Fighting the pressure of the epidemic of opioids and substance use disorders

Opioids And substance use disorders continue to destroy the United States, with overdose increasing during the coronavirus pandemic. The US Centers for Disease Control and Prevention announced this week that for the first time in the 12 months ending in April 2021, there have been more than 100,000 drug overdoses.

Califf dealt with the same crisis in 2016 and 2017 with the FDA Commissioner and previously as Deputy Commissioner for Medical Products and Tobacco.The agency began to require its Strongest warning label On the opioid packaging under Califf.

But some lawmakers and advocates believe that Khalif’s connections to the pharmaceutical industry make him a poor choice for commissioners. According to reports, Califf’s financial disclosures show that consulting fees or funds received from pharmaceutical companies (including some companies that manufacture opioids) support his salary at Duke University.Four senators opposed Califf’s nomination in 2016, and Senator Joe Manchin (DW.V.) has already Said He will not vote to confirm Califf this time.

Together, these factors may bring additional pressure and energy to the agency to deal with the epidemic.

Pierce said AAMC hopes that the FDA will use the lessons learned from the pandemic to solve the opioid crisis.

“We will look forward to the FDA becoming a partner in addressing the opioid epidemic, and continuing to truly continue our progress through COVID, public trust, community involvement, key issues related to health equity, and how the data may be handed over to the FDA that may affect the results. ,”she says.



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