FDA's efforts to increase personnel levels are hindered by the practicalities of finding, hiring, training and retaining qualified applicants, as much as by inadequate resources, according to agency observers.

Even with additional user fees authorized by the FDA Amendments Act and made available to the agency by an omnibus appropriations package, FDA's capacity to add staff quickly is "very limited," Pfizer VP-U.S. Regulatory Affairs Robert Clark noted at Windhover's third annual FDA/CMS Summit for Biopharma Executives, Dec. 13.

CDER had about 50 openings last year and filled fewer than half, he pointed out. This year, the agency can hire 340 full-time equivalents at CDER and CBER. The question not only is, "Where are they going to put them, but how are they going to find that many qualified people in the time period they have?"

In addition, Clark said, new hires "need to be trained, and you can't let them loose on some of these delicate issues immediately."

FDA Needs Direct Hiring Authority

HHS regulations that "took away from the FDA the ability to hire its own staff" have resulted in "a very difficult time for the FDA, in terms of making new hires," former FDA Commissioner Mary Pendergast told the conference.

The departmental hiring system takes so much time "that most competent people will have found a new job by the time FDA" makes an offer, she said.

Hiring at FDA is "a very cumbersome process," former FDA Deputy Commissioner Scott Gottlieb agreed. Qualified applicants often "have multiple job offers and when you have a six- to eight-month hiring process, they'll go elsewhere," he said.

"This is a real opportunity for the pharmaceutical executives to go to [the Office of Management and Budget] and see if they could get direct hiring authority at the agency," Gottlieb suggested. "It would be a good test to see just how politically potent this industry is with the Bush White House."

Fewer Applicants With Specialized Skills

Gottlieb also pointed out that while there is still a large pool of applicants for FDA jobs, the applicants' skills and backgrounds are shifting. There are fewer people coming from academia and drug development programs and more from suburban clinical practices, he said.

"You start to get concerned when you see people without the broad academic drug development experience composing a significant portion of the applicant pool. It starts to raise the question whether or not you can be able to attract the people with the requisite specialized knowledge that you need."

This could be a particular problem at the Office of Surveillance and Epidemiology, where staff must be increased and clinical pharmacologists, as well as epidemiologists, will be needed to implement the safety provisions of FDAAA, Gottlieb said.

"That's going to be hard to do ... if the applicant pool doesn't start to reflect those kinds of people expressing interest in coming to work at the agency."

A recent report from FDA's Science Board Subcommittee on Science and Technology identified gaps in scientific expertise as a major weakness of the agency. In addition to more resources, the panel suggested the creation of an Incubator for Innovation in Regulatory and Information Sciences (¹ Also see "FDA Should Look Through IIRIS To Improve Science, Panel Says; Funding Is Worry" - Pink Sheet, 10 December, 2007., p. 15).

Lower Salaries Affect Retention Rates

Higher compensation in industry is an issue that affects staff retention at FDA, Gottlieb said. FDA recently backed away from giving both retention bonuses and Title 42 pay [for those with relevant clinical experience] to the same person.

Salaries in industry and for medical specialists "usually are far in excess of what people at the FDA make," he concluded.

Industry should support the agency leadership and "perhaps instead of raiding the agency for talent, you should get out there and leave them there longer in order to help the agency develop and get through this period of time," Arnold & Porter Senior Counsel William Vodra admonished conference attendees.

He also stressed the importance that leadership and management skills will play in implementing FDAAA.

Consensus On Safety A Major Issue

Their importance is underscored by the lack of internal consensus at FDA on "how much safety is going to be required [and] what benefits are worth having." This lack of consensus extends to the medical profession, Congress, the media and the public, Vodra added.

As a result, FDA operates in "a climate in which every decision can be challenged as being improperly made."

This raises the question of "how, as a manager, as a leader of the agency, do you get the agency to make decisions and come together and reach consensus ... listen to disagreements and then come to a collegial judgment, when Congress and the media want to escalate every sign of dissention they can."

Power is moving lower and lower in the agency as staff "are not accountable to leadership," and go public with complaints "because they didn't get their way," Vodra said.

These leadership and management issues are "not necessarily going to be resolved in the next 12 to 18 months because a new party comes into power," he concluded.

Pendergast suggested that "the culture of the whistleblower and the lack of sense of professional courtesy and top-down decision making ... has really complicated things completely at the agency."

Internal Dissent Undermines Public Confidence

When FDA goes to an advisory committee meeting with dissenting views and no single agency position, "that's not a terribly helpful way to do it. ... Why would I, as an American John Q. Public, trust an agency that doesn't even know what it thinks? ... A lot of work needs to be done around that. It's a managerial question," Vodra said.

Internal dissent at FDA has become more public during the safety era ushered in by the withdrawal of Vioxx . Merck will pay more than $4.8 billion to settle claims arising from the drug's cardiovascular issues (² Also see "Merck’s Novel Vioxx Settlement May Set Standard To Resolve Litigation" - Pink Sheet, 12 November, 2007., p. 11).

Most recently, the Office of New Drugs and Office of Surveillance and Epidemiology sparred over the meaning of cardiovascular risk data reported for GlaxoSmithKline's diabetes drug Avandia (³ Also see "CDER Offices Go Public With “Fundamental Disagreement” Over Avandia" - Pink Sheet, 6 August, 2007., p. 6).

Silos that have been built up around specializations are part of the reason for the dissent, Gottlieb suggested. "You rarely see whistleblowers emerge where there was a conflict within a review division. ... Often the whistleblowers emerge across different areas of specialization. ... So thinking about how to embed specialization within the process better could be an important step forward."

Problems associated with isolating specialists within their own sphere argue against creating a separate drug safety center, he said. Separation "is what breeds some of the internal strife inside the agency."

In the device arena, the Center for Devices and Radiological Health has escaped contentious safety issues by getting the reviewers involved in examining postmarket information, Gottlieb noted.

Whistleblower Protections May Be Expanded

While the speakers lamented FDA's inability to reconcile scientific differences, Congress is deliberating legislation that would expand federal whistleblower protections. The Senate adopted S. 274 on Dec. 17, setting the stage for a conference with H.R. 985, which passed the House in March (⁴ 'The Pink Sheet' March 19, 2007, In Brief).

Both measures would bar retaliation against federal employees who disclose information about policy decisions based on discretionary authority, if the employee believes the information to be evidence of "gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety."

The House bill also would protect federal employees from managers' efforts to suppress the publishing of scientific findings by government scientists.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

FDA Staffing Problems Extend Beyond Funding Shortfalls; Culture Shift Sought

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