Janet Woodcock slams calls for FDA 'firewall' amid aducanumab debacle, citing need for collaborative drug development
The FDA has long taken a collaborative approach to working with drugmakers on approval applications, all in the interest, it says, of bringing the best molecules to market. But when the drug is a lemon, the cozy relationship between regulators and industry courts easy blame.
Could a “firewall” between regulators and drugmakers prevent lousy drugs from getting the agency’s backing? Acting commissioner Janet Woodcock says no way.
In December, the advocacy group Public Citizen issued a scathing statement on the agency’s review of Biogen’s snakebit Alzheimer’s med aducanumab, saying neuro chief Billy Dunn and his crew formed an “inappropriate close collaboration with Biogen.” The group proposed creating a firewall between agency staff to prevent similar relationships from occurring in the future, but Woodcock shut down that idea in a Feb. 11 letter to Michael Carome, director of Public Citizen’s health research group.
“The firewall you propose would significantly reduce the efficiency of FDA’s review process and cause delays in drug development,” Woodcock wrote in part. “Nor is a firewall necessary to ensure the integrity of FDA’s decision-making.”
Not only would a firewall be needed, Public Citizen said at the time, but also a complete investigation of the aducanumab review process by HHS. That included scrutinizing the relationship between Dunn and Biogen execs and asking then-FDA commissioner Stephen Hahn to remove Dunn from his role until an inspector general probe could be completed.
Woodcock did not address any other specific demands or suggestions made by Public Citizen, but she emphasized that the delays caused by such a firewall could seriously hamper the development process as well as prevent patients from getting timely access to the drugs:
Not only do FDA’s interactions with sponsors help ensure that pre-clinical and clinical development programs are appropriately designed to yield the data that would be needed to support an application, but also these interactions reduce the potential for duplicative or otherwise unnecessary testing in humans and animals. For FDA to make its expectations clear, staff involved in the review of applications must have a thorough understanding of the development program, from the pre-clinical phase through the clinical phase.
Carome called Woodcock’s letter “very defensive” in an emailed statement to Endpoints News. He said Woodcock “offers full-throated support for the FDA’s interactions with pharmaceutical companies during the drug development process. She extols the benefits of these interactions and ignores their potential downsides, which were readily apparent in the agency’s review of aducanumab as presented at the FDA advisory committee meeting for the drug last November.”
He went on:
Her rejection of our proposal that a firewall be created between FDA staff involved in any pre-submission interactions with sponsors and FDA staff involved in the post-submission new drug application (NDA) or BLA review and decision-making is not surprising given that she has fostered the ever closer relationship between the FDA and the pharmaceutical industry since the early 1990s when PDUFA was first enacted.
Woodcock, who ran CDER during the aducanumab review, is now considered a front-runner to take the reins at FDA on a permanent basis. In an Endpoints poll conducted in mid-January, roughly two-thirds of our readers want her to stay in her position.
This all started back in November when an adcomm reviewing aducanumab surprisingly voted against the experimental drug by a near unanimous margin. The panelists also took the unusual step of criticizing the FDA and Dunn, saying their presentation was heavily weighted in Biogen’s favor and excluded discussion of the harshly critical statistical review from FDA staffers.
Billy DunnDunn offered a full-throated endorsement of the drug despite the statistical review concluding that the data were conflicting and made the case that the drug didn’t work. That endorsement, however, outraged some on the panel including Johns Hopkins professor Caleb Alexander, who said the FDA presentation was “strikingly incongruous” and open to eliciting selective information.
Adcomm members also wanted to know why Dunn was willing to ignore the typical standard and enthusiastically back a drug that failed one of two pivotal studies.
Aducanumab has long been one of the most controversial programs in pharma, with analysts going back and forth over its purported efficacy. Biogen has maintained that the drug would be the first to reduce cognitive decline in Alzheimer’s patients, but the company’s approach to the data — including co-authoring FDA review documents — disturbed many scientists and outside observers.
The candidate’s PDUFA date was delayed last month to June 7, a move that sent Biogen $BIIB shares spiking about 13% at the time.
