President Donald Trump’s move to instate a federal hiring freeze quickly set off concerns in the pharmaceutical industry as experts said a handcuffed FDA might not be able to keep up with an influx of drug applications.
Following Trump’s order to halt hiring on Monday, former FDA official Bob Pollock noted in a blog post that the FDA is already struggling to “keep pace” and meet its deadlines.
“While hiring freezes and restrictions of new regulations are not uncommon during a change of administration, with the new President’s pledge to reduce government and cut regulations by 75%, we could be in for a long, unpleasant haul,” he wrote.
A White House spokesperson told Regulatory Focus the freeze “has exemptions for public safety, which certainly could include public health.” Pollock’s opinion is that the exemption won’t include FDA staff.
The FDA is set to receive 1,600 abbreviated new drug applications this fiscal year, Pollock said. Already, the generics industry, which counts on strong FDA staffing to green light cheap alternatives to branded drugs, has voiced its concerns.
In total, there are 4,000 generic applications pending at the FDA, according to GPhA, and 850 open positions at the agency’s Center for Drug Evaluation and Research. Among that group are 150 openings for generic drug reviewers.
“A fully resourced FDA is critical to reducing the backlog and making sure that patients have timely access to medicines,” GPhA said in a statement. “The agency itself has recognized the need for more resources to expedite the approval of generics and biosimilars.”
What’s more, the FDA will collect user fees as normal during the freeze, GPhA said. Those “should be fully available for their dedicated uses, including hiring,” according to the group’s statement.
GPhA has regularly argued that increased competition from generics are a solution to the United States’ drug cost woes, with CEO Chip Davis saying last fall that egregious price hikes were rare among copycats. He pointed out that specialty drugs accounted for 31.8% of spending on 1% of the population in 2014, with the spending figure headed to 50% by 2018. Alternatively, generics make up 88% of prescriptions but account for 28% of costs, he said.
For its part, pharma’s trade group said it’s still reviewing the executive order. The group described the FDA as the “gold standard.”
“A stable and sustainable workforce is crucial to the agency’s ability to keep pace with scientific advances in biopharmaceutical drug development while ensuring safe and effective medicines reach patients in a timely manner,” PhRMA said in a statement.
By Eric Sagonowsky
Source: Fierce Pharma
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