After a backlash from the pharmaceutical industry to the Food and Drug Administration’s capricious approachto drug approvals under the second administration of President Donald Trump, the agency last month abruptly changed course.
On June 22, Health and Human Services Secretary Robert F. Kennedy Jr. unveiled a broad initiative to speed up both the clinical trial and drug approval processes, citing a need to maintain the country’s leadership in new drug development.
“America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas,” Kennedy said in announcing the reforms.
Flip-flop on Atara drug
The capricious nature of FDA drug approval decisions was on full display earlier this year with a drug developed by Thousand Oaks-based Atara Biotherapeutics that targets a rare and often fatal blood cancer that can occur after organ or stem cell transplants.
The agency initially rejected the drug in January of last year, citing issues with the third-party manufacturing process. Atara Biotherapeutics and its drug development partner, Paris-based pharma giant Pierre Fabre Laboratories, took steps to correct the deficiencies and resubmitted the drug for FDA approval.
But in January of this year, the FDA rejected the drug again, citing the clinical trial design, an issue that had never come up before.
News of this second denial was devastating: Atara’s share price plunged by more than two-thirds over two days.
In May, the FDA reversed course after a meeting with executives from Pierre Fabre.
The agency agreed to accept the clinical trial approach used by Atara and Pierre Fabre in exchange for some additional data and invited the companies to submit the drug for a third time.
Cutting time for clinical trials
Among the reforms the FDA announced last month: In certain cases, allowing for only a single late-stage clinical trial instead of at least two; allowing the use of artificial intelligence models (similar to what Atara did) in the clinical trial process; and steps to speed up recruitment of patients for clinical trials.
“I feel a lot of this has been a long time coming,” said Stephanie Hsieh, chief executive of BioscienceLA, a Culver City bioscience industry catalyst organization, who had previously helmed a drug development company. “I’ve watched drug development timelines get longer and longer over the years, and time is money, so it translates into more expense.
“Amen to this!” she added.
