This Week at FDA: Woodcock’s irreplaceable legacy and an averted shutdown

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The major news this week is FDA’s announcement that Janet Woodcock is retiring from the agency early next year, capping a 37-year career at the agency, where she has served in many different roles.

Woodcock’s retirement was announced in a post on X, the social media platform formerly called Twitter. In the post, FDA Commissioner Robert Califf called Woodcock a “legend,” adding that “Janet has made an indelible mark on so many of us, and on public health. There isn’t enough space or time here to properly capture her accomplishments, sing her praises and most of all, thank her.”

Howard Sklamberg, a partner with the Washington-based law firm Arnold & Porter, spoke about Woodcock’s legacy in an interview with Focus. Sklamberg worked with Woodcock for seven years in his role as deputy associate commissioner in the Office of Regulatory Affairs (ORA) and director of the Office of Compliance (OC).

“I would say it is not an exaggeration to say she is one of the most consequential public health figures over the last 30 years,” Sklamberg said. Her accomplishments include designing and putting into effect the modern drug approval system and developing the current framework for evaluating drug safety and efficacy.

She “moved the agency forward” on real world evidence, he said. Additional achievements include redesigning FDA’s food program and developing its pharmacy compounding program in 2013.

“Basically, almost anything related to how Americans use drugs and rely on pharmaceuticals is something that Janet Woodcock would have led or had participated in putting into place,” he said. “You can’t overstate her significance.”

Sklamberg noted Woodcock’s mixed style of management. “I’m not sure I would call her quiet. Janet has a very powerful public voice that she has used. She has been a public facing leader on a range of issues including before Congress and talking to the public about public health risks. She definitely has a very, very public face. She is no shrinking violet.”

Sklamberg acknowledged that she is a powerful presence behind the scenes as well. “She also does a lot of stuff behind the scenes that people don’t see. She is one of those people that can not only envision and design a program but knows how it can be done. A lot of what she does is making sure that good ideas get implemented in a timely fashion.”

When asked to comment to critics who say Woodcock was overly cozy with industry, Sklamberg said “the critics of Janet Woodcock who say she is too close to industry is interesting. She is communicative with industry. Sometimes that message is something that industry likes and sometimes it is a message that industry doesn’t like.”

He noted that “I have seen her pick up the phone with a drug company CEO and tell them that they had disappointed her and that they need to do better. I have seen her praise the development of important drugs. I think whether you think she is too cozy with industry or too critical of industry, I think depends on your experience with her. There are plenty in industry who think that she’s too tough. An active regulator who communicates a lot as she does is a necessarily going to be making some decisions that people like and some people don’t like and there will be some criticism based on that.”

Woodcock is “an absolutely fantastic witness at congressional hearings,” Sklamberg said. “She has an ability to explain very complicated scientific information in a way that people can understand.”

This was on display at a recent hearing about a major recall involving glass particles found in tablets. Woodcock was able to frame the discussion in a realistic way that allayed these concerns. “She said have you ever gone to the beach and there is some wind, and you swallow one grain of sand. That is what this is. It not like you are swallowing a broken champagne glass….We have to do a recall here but we also have to keep this in perspective and not go crazy.”

Sklamberg acknowledged that she will be hard to replace. “Given the breadth of her skill set, it will take several people to fill her shoes. I always say that with important people leaving government, everyone is replaceable…but some people are harder to replace. That will be true of Janet Woodcock.”

He added that “all the stuff she does, from the clinical to the policy area to the management to dealing with stakeholders and Congress, the public, those are all gaps that FDA must fill, and they will not be filled by one person. The agency will continue to do this work, but it will take several people to do the work that she did.”

This week’s other big news is yet another averted government shutdown. The House approved H.R. 6363, a continuing resolution that will fund the government through early next year. The Senate followed suit on Wednesday, with President Biden signing it on Thursday. According to the Alliance for a Stronger FDA, the spending measure uses a “laddered” approach which sets the first spending deadline for four bills on 19 January. These bills include Agriculture/FDA, Military Construction and Veterans Affairs, Transportation and Housing and Urban Development, and Energy and Water appropriations, while the remaining eight bills are funded through 2 February.

Drugs & biologics

President Biden announced plans to appoint Kimryn Rathmell, a cancer researcher and physician, to lead the National Cancer Institute (NCI). According to STAT, Rathmell will assume leadership of the $7.3 billion agency and plans to relaunch Biden’s Cancer Moonshot initiative.

AstraZeneca announced that FDA has approved Truqap (capivasertib) for certain patients with HR-positive, HER2-negatve advanced breast cancer. The drug is to be used in combination with the company’s Faslodex, reports Fierce Pharma.

FDA entered into a consent decree against Smart Women’s Choice, a Arizona-based company for unlawfully distributing unapproved contraceptive drugs and claiming the product is a safe and effective contraceptive. The consent decree prohibits the company from distributing products until they are in compliance with federal law.

FDA also released a new batch of  product-specific guidances (PSGs). The latest batch includes 22 new and 18 revised PSGs, 30 PSGs for products with no approved ANDAS, and 22 PSGs for complex products.

Medtech
 

FDA’s Center for Devices and Radiological health announced the approval of the first  test for chlamydia and gonorrhea with at-home sample test. “This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said CDRH director Jeff Shuren.

FDA also announced the Class I recall of B. Braun Medical’s Infusomat Space Large Volume pump due to a faulty occlusion alarm.