The federal government may be in the midst of a shutdown, but Janet Woodcock isn’t going anywhere anytime soon.

That was the message from FDA’s venerable Center for Drug Evaluation and Research director Oct. 10 in a bid to tamp down suggestions in a same-day Reuters story that her retirement from the agency was on the horizon.

“I want to assure you that I am not planning to retire as erroneously reported in the media today,” Woodcock said in the statement. “In fact, quite the opposite is true. I am becoming more deeply involved in many of the center’s issues, including the proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.”

“The inaccuracy of the media has unnecessarily raised concerns among center staff, and even among my own family,” Woodcock said.

Under the headline “Big Pharma Braces for Retirement of Favorite Regulator,” the Reuters article describes concern among industry stakeholders about the lack of a clear successor to Woodcock as head of FDA’s drugs center.

The story, based on interviews with two dozen people inside and outside the agency who have worked with Woodcock, discusses her stewardship of efforts to reshape the drug approval process, including speeding the development and approval of innovative new drugs. The piece never mentions a retirement date for Woodcock, 65, although the first paragraph states that her departure is “at least a year away.”

The main takeaway is that Woodcock has been a formidable presence as CDER’s director and filling her shoes when she ultimately does retire will be difficult, particularly since there is no obvious internal successor.

The piece includes a list of potential in-house candidates. Among the names are Richard Moscicki, a former Genzyme Corp. executive tapped by Woodcock earlier this year to fill the newly created post of deputy center director for science operations Also see "CDER Taps Genzyme Exec As Deputy Director For Science Operations" - Pink Sheet, 13 February, 2013..

Among the CDER veterans whose names appear on the list are Office of Medical Policy Director Rachel Sherman, Office of Hematology and Oncology Products Director Richard Pazdur and Office of Antimicrobial Products Director Edward Cox. Center for Biologics Evaluation and Research Director Karen Midthun also is mentioned.

The challenges of bringing in someone from the outside also are highlighted in the story, complete with a quote from FDA Commissioner Margaret Hamburg. Given the management, scientific and regulatory skills needed for the CDER director’s role, “it’s very hard to parachute into these jobs,” Hamburg said.

Rumors Raise “Unnecessary Concerns”

The Reuters story was published on day 10 of the partial government shutdown (see related story,Also see "Shutdown Week Two: Could Sponsors Find A More Focused FDA?" - Pink Sheet, 14 October, 2013.).

Federal closures notwithstanding, CDER’s new drug review engine has continued to hum along despite the lapse in appropriations, thanks to carry-over user fees from fiscal 2013.

In the shutdown’s first eight days the center approved three new drugs, two of which are, or consist of, new molecular entities: Bayer HealthCare LLC’s vasodilator Adempas (riociguat) for pulmonary hypertension and Pfizer Inc.’s Duavee (conjugated estrogens/bazedoxifene) for treatment of hot flashes and prevention of postmenopausal osteoporosis ([A#14131014001] and Also see "Pfizer’s Duavee Approved For Hot Flashes, Osteoporosis Prevention" - Pink Sheet, 4 October, 2013.).

The third drug, Baxter Healthcare Corp.’s intravenous feeding product Clinolipid (lipid injectable emulsion), was cleared following a priority review to help alleviate a drug shortage.

So routine were the late stages of the Adempas review, which was approved on its Oct. 8 user fee date, that a Bayer executive described the review division’s approach as “business as usual.”

Yet, the Reuters story, talk of which quickly spread through social media sites such as Twitter, apparently struck such a nerve both inside and outside the agency that Woodcock felt compelled to publicly respond. Her email was directed at CDER staff but subsequently distributed to the media.

While the intent of the two-paragraph email was to reassure, Woodcock’s memo in some ways underscores the Elizabethan concerns regarding her role at CDER – she is incredibly effective, but a completely singular force.

“The inaccuracy of the media has unnecessarily raised concerns among center staff, and even among my own family,” Woodcock said. “My daughter emailed me this morning to ask if I’m retiring! I continue to be fully committed to the important work CDER does and to its staff who work so diligently to protect the health of the American public.”

CDER’s Woodcock Retiring? Rumors Never Go On Furlough

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