FDA is finding difficulty in hiring & maintaining employees; how will this impact the drug approval process? — 5 notes

The FDA is finding it difficult to hire and maintain staff, as pharmaceutical companies offer employees a higher salary, according to Kaiser Health News.

Here are five notes:

1. The FDA has faced criticism for its lengthy drug approval process, with its center for drug evaluation and research division having 711 open positions. The division is charged with approving new drugs.

2.  Janet Woodcock, the CDER director, said the many openings are due to new laws or initiatives boosting the agency's workload and creating new positions within the division. With the influx of openings, the FDA has had issues keeping pace in the hiring process, especially because pharmaceutical companies can offer higher salaries.

3. The agency's biologics evaluation and research division has 96 vacancies, which may pose difficulty for the agency to quickly approve orphan drugs. Peter Marks, director of the center for biologics evaluation and research division, said, "We move rather slowly — like a snail might be a better analogy. A young person with a family can't wait four months for us to get through some of the federal hiring process. So if they have something else that's more . . . expedient, they will take that."

4. The Senate has yet to approve the 21st Century Cures Act, which would work to make  FDA postgraduate degree requirements less strict for certain postiions. The House passed the legislation last year.

5. A Pharmaceutical Research and Manufacturers of America spokesperson said the trade group is concerned with the FDA's staffing issue and the agency has struggled to move drugs through the approval process. Joshua Sharfstein, a former principal deputy commissioner said the FDA could try to amend its staffing issue by offering higher salaries.

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