Woodcock on tougher FDA drug reviews: ‘I don’t think so’

 Following a recent string of setbacks for some drug developers, acting FDA commissioner Janet Woodcock said Wednesday that she does not think the FDA is getting more stringent in its reviews of new drugs even as the agency hosts a 3-day advisory committee next week to take a closer look at several accelerated approvals.

“I don’t think so,” Woodcock said when questioned about the tougher stance at a webinar for the Alliance for a Stronger FDA. “I think that what’s happening is that science is moving into fields that typically haven’t seen advances that we’re seeing in other areas, and so I think there is some adjustment that has to be made as people deal with that.”

She noted her experience at the FDA during the HIV epidemic in the 1980s when the FDA took some chances early on with treatments.

“That kind of boldness is predicated on the need being so great that you can take those chances,” Woodcock said. “I think people asking these questions should have more conversations with [newly minted CDER director] Patrizia Cavazzoni and [head of the FDA’s Office of New Drugs] Peter Stein.”

She also noted that CDER was trying to finish a major reorganization just as the pandemic took off, and they haven’t been able to finish that work and to fully staff up.

“I wouldn’t read too much into the tea leaves over this, but it’s worth having more conversations with the center,” she said.

The comments come as SVB Leerink analyst Geoffrey Porges recently said in an investor note that the FDA may be hardening its stance against the industry, particularly with respect to safety issues.

“There is a perception among investors that the FDA has become more active and demanding under new acting commissioner Janet Woodcock,” Porges wrote. “If this is a sea change (rather than a coincidence of timing), then it seems sensible to assume that regulatory applications with any uncertainties or questions have a higher-than-expected risk of being delayed and will be subject to further information requests and advisory committee reviews.”

Woodcock also made clear that the FDA’s inspection backlog of drug manufacturing facilities is a priority. The pandemic has forced the FDA to forgo more than 1,000 of its planned fiscal year 2020 inspections and the agency will likely face a backlog of future inspections for years to come, according to Mary Denigan-Macauley, director of health care at the Government Accountability Office.

“We have our own recoveries to make on facility surveillance and inspections and things that we may not have gotten to,” she said in reference to a question on what the agency will focus on following the pandemic.

The FDA on Wednesday unveiled new guidance on remote inspections, explaining how they will be requested by the FDA and conducted for the duration of the Covid-19 public health emergency at any facility where pharmaceutical products, including biologics, are manufactured, processed, packed or held.

The FDA is also prepping to decide where to spend an additional $500 million from Congress that came as part of Covid-related stimulus funds.

She said a significant amount of those funds will be spent on surveillance in its premarket work and that surveillance must be stepped up across the agency.

“We are also going to invest in supply chain. This pandemic made clear we don’t have enough visibility into supply chains, and much of this is IT-driven,” Woodcock said.

Other major programs at the agency this year include tech and infrastructure modernization projects, initially led by Amy Abernethy, who’s now departing the agency later this month.

And as the next iteration of PDUFA negotiations has indicated, Woodcock also noted, “Cell and gene therapy is the most pressing resource need.” The push comes as INDs for new gene therapies have catapulted from just 32 in 2010 to 161 in 2019, and many more are expected in the coming years.

https://endpts.com/janet-woodcock-on-if-the-fda-is-getting-tougher-on-drug-reviews-i-dont-think-so/