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Will FDA Safeguards Survive the Trump Era?

FDA hepatitis C

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Although the newly-passed 21st Century Cures Act contains provisions for expedited approval of certain life-saving medications and devices, those provisions may not be broad enough or expedited enough for President Trump’s liking.

Possible candidate for FDA commissioner: “Let people start using them, at their own risk.”

Late last month several high-ranking executives from major pharmaceutical companies met with Trump at the White House.

Trump summed up his vision for drug-to-market flow for the CEOs gathered this way: “When you have a drug, you can actually get it approved if it works, instead of waiting for many, many years.”

And the short list of names Trump is purportedly considering for heading up the United States Food and Drug Administration (FDA) reflects that push for speed and reduced regulation.

For instance, one potential pick to head the agency is Jim O’Neill, employed by the Health and Human Services Department (HHS) during the George W. Bush administration and currently managing director of Mithril Capital Management, an investment firm founded by Silicon Valley billionaire and Trump supporter Peter Thiel. O’Neill sits on the board of the SENS Research Foundation (a charity that underwrites anti-aging research); at a 2014 conference, he discussed the merits of what he called “progressive” approval for drugs, allowing products on the market shown to be safe but without demonstrated efficacy.

“Let people start using them, at their own risk,” O’Neill said at the conference. “Let’s prove efficacy after they’ve been legalized.”

U.S. has long history of a high bar for drug approval

The hurdles drug companies have had to clear before getting a product to market were established in 1962 when Congress passed a law that required approved meds to have efficacy as well as safety behind them. And it wasn’t the last piece of legislation that stressed the need for manufacturers to demonstrate that their product worked.

Since the ’60s and the dramatic tightening of drug approval protocol in part as a response to global thalidomide tragedies (babies born with severe birth defects after women had taken the drug during pregnancy), the regulatory climate has been strict. Indeed, the current system of FDA clinical trials is so thorough and exhaustive that only around one in ten of the pharmaceuticals that enter the starting gate cross the finish line.

Trump’s promise: “…cutting regulations at a level that nobody’s ever seen before…”

Although it’s likely that Congress would ultimately have to pass legislation that achieves deregulation, some in the industry have opined that an FDA commissioner intent on relaxing efficacy measures would possess the unilateral power to alter clinical trial requirements, thereby in effect dramatically scaling back drug approval protocol.

And Trump’s promise to the pharma execs made it clear that a much more FDA-hands-off approach is his goal: “We’re going to be cutting regulations at a level that nobody’s ever seen before.”

It’s a promise that might prove a boon to big pharma looking to sidestep a laborious, costly process in getting their product on the shelves, but it’s also one that has raised alarm in many individuals and companies alike.

Feedback from biotech professionals unambiguously anti-deregulation

Endpoints News, an independent organization that focuses on the biotech and pharmaceutical world, asked drug developers and biotech CEOs to weigh in on the news of the apparent direction the Trump administration plans to take the FDA approval process. The resulting feedback was published on the Endpoints site in a blog post entitled “Dear President Trump: Don’t destroy the FDA we know and respect.”

The overwhelmingly emphatic pushback to potential approval deregulation includes these highlights:

Biotech entrepreneur Michael wrote, “Lowering the bar for proof is inviting both catastrophe for patients and even more wasted money in a system that is forced to pay for drugs that don’t work — and may even inflict harm.”

John Maraganore, the CEO of Alnylam, said: “We need to maintain standards for both safety AND efficacy, and work with the FDA to identify novel pathways and clinical trial designs that can speed innovative medicines to patients. We’ve been doing this with FDA over the last decade with FDASIA, 21st Century Cures, and PDUFA VI [….] But the bottom line is that patients and physicians need to know that the medicines they take are safe AND effective.”

CEO of Ovid, Jeremy Levin, had this to say: “[W]ithout rigorous scientific and medical proof to establish that a drug is both Safe and Effective, we risk taking a step back into a time when people sold colored water for cancer treatments and patients became the unwitting tools of unscrupulous marketeers. Proposals that walk us back to that time, are counter to innovation and leadership in the world of medicine. They are not just bad for science and clinical medicine and dangerous to patients, they risk being unethical and bad for business and the industry.”

Bernard Munos, founder of the InnoThink Center for Research in Biomedical Innovation added: “If the president wants to cut costs and speed drug to markets – laudable goals – cutting corners on safety and/or efficacy studies is not the way to do it. Instead, he should look at cheaper/faster ways [to] collect the data needed to demonstrate safety/efficacy. As it happens, new technologies are emerging that do just that (e.g., biosensors, apps), and the US has a lead in them.”

And perhaps the best bottom-line, one-line statement comes from Bassil Dahiyat, CEO of Xencor, who wrote: “And we don’t want to market things that don’t work.”

 

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