Jonathan Leff, partner of Deerfield Management, told attendees that although the environment hasn’t necessarily changed “across the board,” the number of times where a company didn’t get clear input from FDA “has been reduced over the past several years.” He specifically points to the breakthrough therapy designation as the “most tangible policy change,” noting that it’s a “way of saying let’s start with early data and figure if there’s a way to streamline the development process.”
Leff also praised the FDA leaders who drove the breakthrough therapy initiative because of the way it can “cut through red tape and procedures that might stifle development.”
Paul Hastings, CEO of OncoMed, offered a less encouraging perspective, noting that one of the main frustrations is the inconsistency across the various levels of the FDA – from the upper management to the division directors and down to the reviewers. Hastings cites the variability in the responses from various agency officials, noting that informal communications is an area were there might be room for more consistency.
“In some of the informal conversations, officials say now I’m going to send you a letter and 30 days is when you have to respond. It takes the wind out of the sail of that informal communication,” Hastings said, noting that often times a company won’t know what’ll happen – “will you get a letter, and will it come in a couple days, or will it come on the 29th day of the 30 days that they’re required to respond by?”
As far as where the FDA might be headed in the future, none of the experts on the panel agreed with a survey finding shifting attitudes around the FDA weighing a new drug’s value as part of its decision to approve a new drug. All said the FDA has enough on its plate trying to gauge the science of developing drugs.
“The biggest thing we can strive for is clarity,” Michael Narachi, CEO of Orexigen Therapeutics, told attendees. “We should hold the agency accountable for clarity – onus is on us to provide really clear questions. And if you want clarity, in most cases you can get it.”
Preliminary results from a new survey from BIO also found that FDA’s CBER (Center for Biologics Evaluation and Research) received higher ratings when compared to other divisions in terms of interactions. But all three of the experts praised the work of CDER (Center for Drug Evaluation and Research) director Janet Woodcock, as well as outgoing FDA commissioner Margaret Hamburg.