FDA commissioner calls for more onshoring of clinical trials

FDA Commissioner Robert Califf took to the stage twice in the last 12 hours in San Francisco, lining up his priorities and digging in on vaccine misinformation, accelerated approval reforms, and a renewed interest in onshoring more clinical trials where companies may be trying to save money, particularly in oncology.

Taking the stage early Tuesday at the JP Morgan conference, Califf told attendees that the recently passed omnibus spending law is “really important” for the agency to more quickly help sponsors verify or disprove the benefits of accelerated approvals.

He said the message to biopharma companies is that the sooner they consider initiating confirmatory trials for their accelerated approvals, the “better off you’re going to be.”

Another major piece of legislation — the recently passed user fee legislation — will allow the FDA’s biologics center to hire more talent and tackle cell and gene therapies better than ever before. CBER director Peter Marks is creating an internal think tank at FDA “to try some new things to work collaboratively with industry in early stages,” Califf said, noting the agency is “not so worried” about the larger companies.

“But with startups — the really bad thing to do is hide something. Lots of pressure when you have one tranche of investment,” Califf added. “But hiding things from FDA — that’s not a good idea.”

Richard Pazdur

Meanwhile, Califf also touched on an issue that’s become more prominent for FDA’s top cancer doc Rick Pazdur, who is railing against companies that offshore trials to lower-income countries to save money, but that data may not translate to the US population.

“I’m 100% in favor of globalization,” Califf said. “But 100% opposed to offshoring as a financial arbitrage. Pazdur is on fire about this — much more enrollment from low-income countries. We need to onshore this.”

In a follow-up comment to Endpoints News, Califf said he thinks this is particularly problematic in oncology, and it’s a growing issue (although it’s been an issue for at least a decade).

“It’s not good for our economy or our national security,” Califf said in his Q&A.

In November, Pazdur and Califf discussed the issue at another event in Washington, DC, with Pazdur noting that sometimes companies move trials outside the US because of cost issues, which “might be a reasonable issue,” but “one of my problems” is when companies will use single-country trials because they can test the investigational product against an inferior therapy and that trial wouldn’t be ethically run in the US.

“These companies are not Mother Teresa here, they’re using patients here, and we have to always make sure patients aren’t considered commodities,” Pazdur added.

Califf on Tuesday also touched on misinformation around Covid-19 vaccines, noting that close to 10% of the US population incorrectly thinks these vaccines have tracking chips in them.

He also said he thinks direct-to-consumer advertising for medical products “is terrible, but I’m not changing that.”

While noting the industry “has consistently pushed that boundary” on marketing and advertising, he said Tuesday that if FDA loosens the reins too much, “good marketing people can go a long way with things on the edge.”

Meanwhile, Califf took to the stage last night at a private Stat News event where he was grilled by Matthew Herper on what transpired with FDA’s cozy relationship with Biogen before approving its controversial Alzheimer’s drug Aduhelm.

The FDA was recently lambasted by two congressional committees for its work in tandem with Biogen, but Califf stood by the process and said there were no surprises in the report, noting that he found the language was inflammatory but that that’s to be expected because it’s Congressional committees.

He also said he continues to support Billy Dunn, head of FDA’s neuroscience office, and others who were at the heart of this Biogen controversy.

vaccines
biologics
medical
fda
clinical trials