trending Market Intelligence /marketintelligence/en/news-insights/trending/v6QGFDRcL-wYZQG-0UGG1g2 content esgSubNav
In This List

US FDA seeks to overhaul drug office to boost efficiency, scientific expertise

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


US FDA seeks to overhaul drug office to boost efficiency, scientific expertise

The science of drug development is changing rapidly, and the U.S. Food and Drug Administration aims to keep up by overhauling both the office that evaluates new medicine applications and its review processes.

The new alignment and processes would improve drug review efficiency by at least 20% overall, said FDA Commissioner Scott Gottlieb, citing the agency's internal assessment. That means new innovative medicines could get to the U.S. market much more quickly.

The FDA is seeking to create many new therapeutic-specific divisions with greater ability to engage in discrete areas of medicine, which would "ultimately flatten the overall matrix of our review process," the commissioner stated.

"We believe this will deepen internal collaboration and enhance external scientific exchange," Gottlieb said.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said she envisions growing the current 19 divisions within the Office of New Drugs to 30.

The FDA wants to staff its new drug review divisions, which consist of about 1,000 employees, in a way that matches its manpower to the flow of applications and critical tasks, like postmarket safety, Gottlieb said.

The agency also would like to have its reviews more tightly integrated around a common review process and a common review template "that's more easily collaborated around," the FDA chief said.

"We want to make the entire review process more integrated across the discrete areas of science and regulatory expertise that are critical components of informing our overall mission," he said.

Over time, many of the FDA's new drug divisions have developed procedures specific to their areas of review, Woodcock noted.

With a single and consistent process, the FDA's scientific and clinical experts would be able to "focus on what they know best — science and medicine" and its regulatory experts would be able to manage the many processes the agency conducts, she said in a June 4 blog.

A more integrated approach across the discrete areas of science and regulatory expertise would also involve having better-organized review memos, "so that our medical staff can document their findings more efficiently and spend more of their time on advancing scientific work in their fields," Gottlieb said.

An FDA spokeswoman emphasized that the ideas from Woodcock, which Gottlieb said he is fully committed to and supports, are only proposals for now, and the agency must gain congressional approval to implement them.

The two FDA leaders have been hinting for months that the overhaul plan would soon be disclosed, with Gottlieb revealing June 2 it would be released this week.

More time for elevating expertise, engaging

In her blog, Woodcock said the proposed changes to the drug review process are intended to "free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities."

One principal aim of the proposed changes is to elevate the role of the FDA's scientists and medical officers to take on even more thought leadership in their fields, Gottlieb said, adding that the professional staff members are the "backbone of our process and the heart of our public health mission."

The changes would result in the new drugs office staff having more time for reviewing and providing feedback to companies on clinical trial protocols, he said. Staff would also be able to devote more time to engaging with drugmakers earlier in the development process to ensure that trial designs are efficient and structured in the most effective way to identify risks and measure benefit, Gottlieb added.

In addition, drug reviewers would have more ability to reach out to external stakeholders, like disease specialists, academic researchers and regulatory partners at other agencies.

They also would have more time to interact with patient groups, which Gottlieb said are "becoming an important part of our regulatory practices."

"Patients are the FDA's most important stakeholder and our vision includes incorporating the patient voice in modern patient-focused drug development," Woodcock said. "Patients depend on the FDA to do what is necessary to provide access to safe and effective drug therapies. They take FDA-approved drugs because they trust us."

She said her modernization plan also calls for enhancing the FDA's information technology capabilities and access to information to better enable the storage and management of the collected experience of its scientific review staff.

"Accurate historic information from many past drug reviews is essential to informing current and future reviews and to assure consistent regulatory decision-making," Woodcock said.