Kathleen “Cook” Uhl, director of FDA’s Office of Generic Drugs, has returned to her regular duties after taking a leave to fight cancer.

Uhl returned to work full-time on Sept. 9, the agency told “The Pink Sheet” DAILY.

Uhl was gone more than five months after announcing that effective March 30 she was taking an extended medical leave in order to be treated for colorectal cancer.

John Peters, head of the OGD Office of Bioequivalence, was named acting director in the interim Also see "FDA Generics Office To Be Managed By Relative Unknown" - Pink Sheet, 31 March, 2015..

However, Uhl still seemed to remain somewhat connected to work while she was away, attorney Kurt Karst, of Hyman, Phelps & McNamara, said in an interview.

While Uhl certainly will be welcomed back at FDA’s White Oak campus, she also should help restore a measure of normalcy for OGD’s rank-and-file, which has seen a number of leadership changes in recent years.

Kathleen Uhl

Source: FDA

OGD has had several directors over the last five years since the departure of long-time director Gary Buehler Also see "FDA's Buehler To Join Teva" - Pink Sheet, 12 October, 2010..

Uhl became acting director following the departure of Gregory Geba in 2013 and in January was named permanent director ([A#14150115001]).

Stakeholders have said repeatedly that having a permanent director allows an office to perform better.

That includes the top of FDA’s hierarchy.

Deputy Commissioner for Medical Products and Tobacco Robert Califf was nominated for FDA commissioner on Sept. 15. Despite the fact that he may have one of the shortest terms in agency history if confirmed, he could be in a better position to push FDA’s agenda than an acting commissioner ([A#00150921019]).

Uhl already is scheduled to speak at the Generic Pharmaceutical Association Fall Technical Conference in November.

Peters had been slated to speak at the event in his acting director capacity. He has tended to stay out of the public spotlight during his time at the helm.

Peters spoke on behalf of OGD at a June public meeting gathering comments on the upcoming reauthorization of the generic drug user fee program.

He was also quoted in an agency press release explaining FDA's reasoning for approving generic versions of Otsuka Pharmaceutical Co. Ltd.’s Abilify (aripiprazole), despite court challenges ([A#00150504016]).

Performance Improved During Uhl’s Absence

Uhl is returning to an office that has seen its performance improve dramatically during the months she was on leave.

From April through July, OGD reported a large increase in ANDA approvals compared to previous months.

The office approved 200 ANDAs during the four-month span, which was more than the previous six months combined. It now appears the benefits of new employees, infrastructure and other additions made with GDUFA resources are beginning to show ([A#14150915002]).

The turn-around came after a near record low number of approvals were reported in March ([A#14150504004]).

OGD also approved its first ANDA with a formal review goal in August ([A#14150819008]).

Uhl had asked repeatedly for industry patience as tension and frustration related to problems with changes to the OGD review and communications systems increased.

She argued that improvements would not happen overnight and that industry also bore some of the responsibility for GDUFA success ([A#14141028005]).

Uhl also has set high goals for OGD staff. Rather than striving to meet the goals in the GDUFA commitment letter, which center on actions, she wants to focus on approvals ([A#14141212001]).

A Timely Return With User Fee Talks Starting

Uhl’s return also coincides with the beginning of formal negotiations to renew GDUFA.

Talks with industry representatives are expected to begin soon and last several months Also see "GDUFA Stakeholder Deadline May Come After Negotiations Conclude" - Pink Sheet, 12 August, 2015..

As OGD director, Uhl likely would be expected to help the agency negotiating team set its bargaining position and determine what industry proposals are feasible and desirable.

A new association representing contract manufacturers will join the three industry groups that helped negotiate GDUFA I Also see "GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table" - Pink Sheet, 6 July, 2015..

FDA Generic Office Director Uhl Returns From Medical Leave

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