FDA May Lack Money to Carry Out Hiring Envisioned in ‘Cures’ Bill

Posted June 19, 2015 at 3:40pm

The Food and Drug Administration’s ability to hire senior staff would be enhanced under a bipartisan House package to speed new medical cures, but the cash-strapped agency still may not have enough resources to pay higher salaries and support the hiring permitted under the measure.

The so-called 21st Century Cures bill (HR 6) aimed at overhauling the FDA’s drug approval process and enhancing biomedical research at the National Institutes of Health was unanimously advanced out of the Energy and Commerce Committee last month. Tucked into the 300-page bill is a section addressing the hiring and retention of FDA staff — an effort to put the agency on more equal footing with the private sector as it is asked to do more with limited resources.

Energy and Commerce Chairman Fred Upton, R-Mich., said on June 16 he and fellow sponsors are working to secure the strongest vote possible and signaled they are open to adding amendments to the measure before bringing it up for a floor vote.“We are not quite ready to tell the leadership that we’re there yet. … We are very close,” Upton said.

The legislation would abolish the hard cap on the number of senior biomedical research staff that FDA can hire, which is presently limited to 500 for those in the Silvio O. Conte Senior Biomedical Research Service.

Energy and Commerce ranking member Frank Pallone Jr., D-N.J., championed the hiring language, saying it was necessary to get more innovative and life-saving products to patients faster. “We have given FDA many new responsibilities. Along with those responsibilities must come new resources, including more staff,” Pallone said.

The bill also would permit the agency to pay staff a salary as high as the president’s, currently $400,000. The provisions would also extend to the NIH, bill sponsors noted.

“We don’t have enough of those individuals, our pay is not competitive and hiring a biomedical research person can take nine months,” said Republican Rep. Chris Collins of New York in an interview. “The salaries aren’t even close to what folks are making in the pharmaceutical industry.”

According to a 2012 report by the Congressional Budget Office, federal workers with a doctorate or other professional degree are paid 23 percent less per hour, on average, than similar workers in the private sector. The difference in pay can amount to several hundred thousand dollars, according to experts.

“I do not believe the government should be the highest-paid employer, but it shouldn’t be the lowest either,” said John M. Palguta, vice president for policy at the nonprofit Partnership for Public Service. “The government will always get warm bodies because there are always people looking for work, but FDA is a great example of where we need people with qualifications. They are being hired to oversee drug applications and are doing cutting edge science.”

Palguta’s group termed the current pay scale classification system that governs federal workers — known as the General Schedule — a “relic of bygone era” in a 2014 report on civil service overhauls. The group said the system, which has 15 grades to determine salaries, is not market sensitive or flexible enough to be competitive, although some agencies have received various exceptions over the years.

One of the biggest hurdles for the FDA is in retaining talent, because the agency often invests significant time and money training junior level workers, only to see them lured away by the private sector. The agency is also facing gaps in leadership and scientific expertise as senior members retire and FDA struggles to replace them.

Competitive Pay

Supporters of the Cures bill said the language would allow the FDA to attract senior level staff with more competitive pay. Collins said such individuals are more likely to make swift and accurate decisions about medical products, which fits in with the measure’s concept of getting new cures to patients more quickly.

But there is still no guarantee the FDA will be able to pay higher salaries or hire more workers. The agency has not reached the current cap on senior service staff it can hire. The FDA would receive $550 million in mandatory funding under the Cures legislation, which is about $250 million less than what it has estimated carrying out the bill’s various mandates would cost.

One Energy and Commerce Committee aide said there are always concerns over providing adequate resources for the FDA, but added that Cures would produce additional savings by making the agency more efficient. The aide acknowledged the language doesn’t necessarily mean the FDA will hit the hiring cap and said the bill doesn’t mandate how high salaries must be.

Even if the agency is able to pay an employee $400,000, the sum does not match some salaries in the private sector, where individuals are given stocks and other compensation.

Collins pointed out that the language would at least place more emphasis on quality over quantity. The hope is the FDA could redirect its resources so it could have the flexibility to hire a worker with senior expertise over several more junior staff to do the same job.

“A senior level person can make these decisions on a wealth of experience, and FDA would rather have one of these than two of the other,” he said. “It’s not like they’re going to be hiring hundreds of these people, given their budget. But they could easily prioritize.”

Not all solutions require extra cash. The Cures bill would grant the FDA more direct hiring authority — something the NIH already has — in an effort to cut down on some of the time and bureaucratic hoops involved in hiring new staff, which can be a turn off for prospective employees. The measure also would expand the pool of senior service applicants by allowing individuals with master’s degrees in engineering or related fields to be hired for clinical-research evaluation or biomedical-product assessment, as opposed to just those with doctorates.

FDA officials — who have repeatedly outlined many of the agency’s hiring and retention challenges in congressional hearings — are happy with the new workforce policies outlined in Cures, according to Collins. 

“They came up to me at that [Energy and Commerce] hearing and were very pleased,” he said. “They thanked me profusely for hearing them out.”