Mr. Thiel, a Silicon Valley mogul and entrepreneur, believes the FDA’s long and complicated regulatory process hinders drug innovation. He — along with FDA candidates like Jim O’Neill and Balaji Srinivasan — think the agency should drop its requirement that drugs must be proven effective before hitting the market.
While technology leaders believe bringing the same speedy and disruptive approach to medical regulation that Silicon Valley brought to many other industries would make new treatments available faster, Ms. Belluz said they fail to understand one crucial point: manipulating biology isn’t the same as manipulating computer code.
Derek Lowe is a pharmaceutical scientist with 28 years of experience developing drugs. For every 5,000 compounds discovered in the preclinical phase of drug development, only about five are promising enough to be tried in humans, representing a success rate of 0.1 percent, Mr. Lowe told Vox.
“It’s very tempting for someone who has come out of IT to say, ‘DNA is code, and cells are the hardware; go in and debug it.’ But this is wrong,” said Mr. Lowe. “We have 3 billion years of spaghetti-tangled gibberish to deal with. And unless you’ve done [drug development], it’s very hard to get across how hard it is.”
Therefore, fast-tracking medical innovation will take more than just removing regulations — advancements in the understanding of biochemistry and the body must also be made, said Ms. Belluz. Plus, removing regulations on the efficacy of drugs could be a threat to patients, as consumers can’t effectively judge the safety and quality of medical products on their own, according to Ms. Belluz.
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