FDA Hiring Freeze Could Slow Down Biosimilar Approval Process

Christina Mattina

President Donald Trump's executive order freezing hiring for federal jobs could apply to the already-understaffed FDA, which would extend the waiting time for biosimilar approvals.

The hiring freeze order issued January 23, 2017, specifies that federal agencies can exempt any positions it deems necessary to meet “public safety responsibilities,” but it remains unclear whether drug reviewer positions at the FDA would fall under this category. Bob Pollack, former acting deputy director of the FDA Office of Generic Drugs (OGD), wrote in a blog post after the announcement that he did not anticipate the exception would apply to FDA staff, grimly noting that “we could be in for a long, unpleasant haul.”

There are currently around 850 vacant positions within the FDA Center for Drug Evaluation and Research, 150 of which are for generic drug reviewers. This dearth of staff combined with a backlog of over 4000 pending generic drug applications has raised concerns that approvals of new generics and biosimilars could slow to a crawl. OGD expects to receive a record-high 1600 abbreviated new drug applications in the 2017 fiscal year.

“A fully-resourced FDA is critical to reducing the backlog and making sure that patients have timely access to medicines,” the Generic Pharmaceutical Association (GPhA) said in a statement. “The agency itself has recognized the need for more resources to expedite the approval of generics and biosimilars.”

STAT news reported that 8 congressional Democrats sent a letter on Monday to acting FDA Commissioner Stephen Ostroff, cautioning of the potential ramifications of a hiring freeze at the FDA. A main concern was that the freeze could thwart a component of the recently passed 21st Century Cures Act that would fund the hiring of new drug reviewers.

“A hiring freeze at the FDA would conflict with and do significant damage to these bipartisan efforts to fill vacant positions and expand the scientific and technical workforce needed for a robust review of drugs and medical devices,” they wrote.

If the freeze does in fact stall the review and approval of biosimilars, it will eliminate a promising avenue for controlling the cost of prescription drugs. Evidence from Europe suggests that biosimilar competition can drive down prices across an entire class of drugs, resulting in cost reductions of up to 60%. A slowdown of biosimilar approvals in the United States would prolong the financial struggles experienced by many patients facing skyrocketing drug prices.