How the FDA plans to modernize new drugs review process

Less than a month after President Trump announced his plans to address the high cost of medicines in America, the U.S. Food and Drug Administration (FDA) has said it wants to shorten approval times for life-changing generic drugs.

The new steps are part of a proposed “modernization of FDA’s drug review office,” better known as the Center for Drug Evaluation and Research (CDER).

In a written statement, FDA Commissioner Scott Gottlieb said the primary aim of the proposed changes is to empower the agency’s scientists and medical officers to take on more “thought leadership” in their respective fields.

Functional and structural changes to the CDER proposed

Speaking at the American Society of Clinical Oncology (ASCO) meeting in Chicago, the world’s biggest cancer conference, Gottlieb acknowledged that it’s only fair that those firms investing a lot of money in a breakthrough should have an opportunity to maximize their return on investment. But, he’s quoted by Reuters as saying that market monopolies “shouldn’t last forever.”

The commissioner believes the proposed changes would speed up approvals of cheap generic medicines, providing greater economic incentive for companies to be the second, third or even fourth to market.

The proposals include both functional and structural changes to CDER, with the aim of improving organizational efficiency and streamlining the agency’s review process.

One of the changes being considered is the creation of new therapeutic-specific divisions “that’ll have more ability to engage in discrete areas of medicine,” Gottlieb said in his statement. This aims to provide greater scientific leadership to academic, industry and patient groups.

“We’ll then staff these different divisions in a way that matches our manpower to the flow of applications and critical tasks, like post-market safety,” he said.

It is the functional changes, however, that will ultimately drive the improvements, the commissioner anticipates. The starting point is a common review template that’s “more easily collaborated around.”

“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 the statement.

He suggested that simply ensuring key review memos are better organized will drive significant improvement, as it will free-up experts to spend more time on advancing scientific work in their fields.

The FDA estimates that the proposed new alignment and processes will improve organizational efficiency by a minimum of 20% – a result of better workflow and workforce management and greater internal collaboration across the different review functions.

Pharma industry’s reaction

Following Gottlieb’s speech at ASCO, Reuters spoke to a number of cancer drug executives who expressed some uncertainty about whether the changes are entirely necessary.

Liz Barrett, former global president of oncology at Pfizer Inc., who heads up Novartis’ cancer operations, suggested that oncology has been “very competitive” in each class over the past few years.

Roy Baynes, head of global clinical development at Merck & Co., agreed that competition was not a problem in the field of cancer treatment. “If you’ve got good data, there is no barrier to getting approved,” he said. “It is in everyone’s interest to get medicines as quickly as possible.”

As the Reuters article notes, however, choice does not always drive down prices, with the cost of new cancer immunotherapies remaining high despite intense competition.

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Author: Ryan Clark

Ryan Clark is a strategic client director working on partnerships between CCC and commercial clients. Ryan has been with CCC over five years and has worked in rightsholder relations and business development prior to joining the strategic client group. Ryan enjoys spending time with his family, and following Bruins hockey and Ireland rugby in his time away from work. 
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