David Rosen Highlights FDA's Accelerated Drug Review Pathway

Foley & Lardner LLP partner David Rosen assessed the U.S. Food and Drug Administration’s push for quicker drug reviews in the PharmaVoice article, “FDA’s new accelerated pathway could open pharma up to risks, as well as benefits.”

Rosen said the consideration of drug affordability as among the FDA’s priorities is “a new factor.”

“We’ve not seen pricing taken into consideration for priority vouchers,” he explained. “It will probably be subject to some challenges — companies don’t necessarily have pricing structures during the development program. And so it may be that [the FDA] grants a voucher, and then all of a sudden they revoke it based on the pricing.”

“It’s an aspirational goal,” Rosen said of the effort to speed review. “But if there’s a new drug application they are working through and have other aspects of the application that have been determined to be acceptable and meet FDA requirements, and the review has been progressing and all they have to do is make a final decision, anything is possible.”

He highlighted that the accelerated pathway may expose pharmaceutical companies to litigation risks in cases where a drug is pulled from the market or issues arise following its approval.

“If the studies don’t bear out or people do get additional safety issues, the companies open themselves up to potential product liability class action lawsuits,” Rosen explained. “Sometimes they can open themselves up to shareholder lawsuits, depending on what kind of things they disclose.”

Overall, as the new process plays out, Rosen emphasized the importance of clear, timely communication with the FDA. “I’m a big believer in having early and [frequent] discussions with FDA, making sure that we have a sound rationale and a well thought out development plan and a good basis to bring these products into the marketplace through an accelerated process,” he added. “Because that benefits the FDA, and it benefits the companies, but mostly it benefits patients.”

Rosen’s commentary also appeared in BioPharma Dive.