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The head of the US Food and Drug Administration has sought to reassure biotechnology companies that drug approvals will not be delayed following the Trump administration’s drastic workforce cuts, despite industry concerns that medicine approvals could be stuck in gridlock.
“We are hiring scientists at the FDA,” said Marty Makary, the agency’s commissioner, speaking at a biotech conference in Boston on Tuesday. “I have reinstated people at the FDA.”
Makary, who was confirmed in late March, said “it was a challenge” for him to start work at the agency following the axing of staff by Elon Musk’s so-called Department of Government Efficiency, but he said “morale is good and improving”. While he said the people who were fired were support staffers, he acknowledged there were “tremendous redundancies” at the agency.
However, the biotech community remains sceptical that the FDA is running at full speed. “There have been a lot of delays across the industry [stemming from the FDA],” Moderna chief executive Stéphane Bancel said on June 11. Biotech company Solid Biosciences warned investors in May that “delays at the FDA” could hurt its business.
Biotech companies rely on the FDA to approve new medicines, and following President Donald Trump’s inauguration, share prices have languished throughout the sector. The Nasdaq biotech index dropped after the FDA’s top vaccine regulator Peter Marks abruptly resigned on March 28. The index is down 3 per cent for the year.
Vaccine makers like Moderna have been particularly hard hit since Trump took office. Health and human services secretary Robert F Kennedy Jr last week fired all of a top vaccine committee panel that makes recommendations to the government.
The panel’s first meeting with Kennedy’s newly selected experts is scheduled for later this month, and it remains uncertain how hostile they might be to the US vaccine schedule.
Makary said the FDA recommendations for Covid-19 vaccines “are moving closer to the European model”, which are less aggressive than the US. In the UK, Covid vaccines were recommended for people 75 or older and individuals with high-risk health conditions, he said.
The US, meanwhile, has recommended “that every 12-year-old healthy child in America needs another 60 doses for the rest of their life — one every year,” Makary said. “[That] is not supported with good clinical data for young, healthy people — the repeat booster strategy, in my personal opinion.”
Separately on Tuesday, the FDA announced a programme to speed up drug development for certain medicines. The timeframe for review could be cut to 1-2 months from almost a year for these medicines, the FDA said. Although parts of the programme were already established, the announcement is likely to please those in the biotech industry.