GDUFA Success Story: FDA Exceeds Hiring Goals, Names OGD Director

By mid-December, the agency had hired more than 1,000 new employees for the generic user fee program, and now adds one more to the tally – Kathleen Uhl as permanent director of the Office of Generic Drugs.

FDA already has surpassed is hiring goals for the generic drug user fee program, which should be a welcome site for industry as it waits for review times to decrease and other promised improvements.

The agency’s authority to quickly bring new employees on board may not last much longer, but officials did not think it would affect their ability to fill any remaining positions.

The agency released a memo to CDER staff on Jan. 15 stating that as of Dec. 14, more than 1,000 employees had been hired under GDUFA.

As of Nov. 19, 2014, FDA had hired 952 new employees for GDUFA-related positions, according to presentation slides for a Dec. 16 meeting between FDA and the Generic Pharmaceutical Association that were posted Jan. 13. The two parties meet quarterly.

Almost all of the new hires, 777, went to the Center for Drug Evaluation and Research. Another 115 went to the Office of Regulatory Affairs, and 60 were slated for the Office of the Commissioner, according to the slides.

FDA also announced Jan. 15 that Kathleen “Cook” Uhl had been named the permanent director of the Office of Generic Drugs. Uhl had been the acting director for nearly two years following Gregory Geba’s resignation in March 2013 (Also see "FDA Generics Office Gets Third Director In Three Workdays; Uhl Brings Policy, Pharmacology Experience" - Pink Sheet, 19 Mar, 2013.).

The move was not a surprise, given that Uhl has shepherded OGD during most of the growth and transformation spurred by the user fee program (Also see "GDUFA Success Depends On Industry Changes As Much As Review Improvements, FDA Says" - Pink Sheet, 4 Nov, 2013.).

FY 2014 A Key Hiring Year

It appears much of the recruiting was completed in FY 2014. The agency added 190 more new employees that year than its target. The cumulative total of GDUFA hires increased from 291 at the end of FY 2013 to 882 a year later (see chart below).

GDUFA Hiring Totals
Fiscal Year	Cumulative Hires	Congressional Target		Difference
2013	291	231		60
2014	882	692		190
2015 (through Nov. 19, 2014)	952	923		29
GDUFA Hiring By Location
Location			Number
Center for Drug Evaluation and Research			777
Office of Regulatory Affairs			115
Office of the Commissioner			60
Note: All data as of Nov. 19, 2014 Source: FDA-Generic Pharmaceutical Association quarterly meeting slides

GDUFA, enacted as part of the 2012 FDA Safety and Innovation Act, allowed FDA to charge user fees for several generic drug applications as part of an agreement with industry to improve review times and make other changes.

Both sides agreed FDA would need additional employees to handle the new program. One quarter of them were scheduled to be hired in FY 2013, followed by half the total in FY 2014 and the remainder in FY 2015 (Also see "GDUFA Hiring Ahead Of Pace But Still Faces A Long Road" - Pink Sheet, 30 Sep, 2013.).

But it quickly became clear that the GDUFA workload was larger than the employee count estimated to help FDA meet its new responsibilities (Also see "GDUFA: FDA Struggles Under Higher-Than-Expected Submission Volume" - Pink Sheet, 3 Mar, 2014.). The situation reached a head in June 2014 when OGD received more than 600 ANDA submissions, a record for a single month (Also see "ANDA Avalanche: How Will FDA Deal With The 600 Received This Month?" - Pink Sheet, 30 Jun, 2014.).

Submission levels have decreased dramatically since the peak, but the number of pending applications caused some in industry to worry. One industry executive warned that the median ANDA review time could exceed 40 months by the end of 2014 (Also see "Can ‘I Love Lucy’ Help Calm FDA/Generic Industry Tensions?" - Pink Sheet, 28 Oct, 2014.).

In its effort to meet its new review goals, OGD has instituted a number of changes to improve review efficiency and communications (Also see "FDA/Generic Communications Plan Restoring Best Of Past Practices" - Pink Sheet, 18 Dec, 2014.).

As part of GDUFA, FDA was allowed streamlined hiring authority to make the necessary additions faster. GPhA officials asked whether it will become more difficult “to hire for the hard-to-fill positions” when that authority expires, according to minutes of the quarterly meeting.

FDA said it will not and that CDER used the streamlined authority “in a very limited way to help quickly get staff on board.” The center has used LinkedIn, Twitter, the FDA website, existing employees and an onsite hiring event to find candidates, according to the minutes. The agency said in the slides that the job fair drew more than 3,000 people to its White Oak headquarters.

The nature of the federal hiring process has hindered FDA recruitment, in particular agency efforts to fill senior executive positions. However, the agency still would like to bring in talent from outside the agency (Also see "FDA Searches Small Industry Candidate Pool To Fill Executive Vacancies" - Pink Sheet, 24 Mar, 2014.).