What if the Free Market Decided Whether or Not Drugs Work?
Would patients and drug companies be better off if the FDA didn’t regulate drugs?
During a meeting with leaders of the pharmaceutical industry on Tuesday, President Donald Trump said he wanted the U.S. Food and Drug Administration to speed drug approvals.
“We’re going to get the approval process much faster,” Trump said, adding that he has an unnamed “fantastic person” in mind to lead the agency.
Just how Trump will do that isn’t clear. But some of those with the president’s ear have embraced a radical free-market view. They want the marketplace, not the FDA, to determine how good drugs are.
For instance, one name floated in December as a potential FDA pick was that of Jim O’Neill, managing director of Peter Thiel’s investment firm Mithril Capital. O’Neill is a libertarian who has said he thinks drug makers shouldn’t have to prove their pills actually work at all, but only that they are safe. “Then let people start using them at their own risk,” he argued in a 2014 speech.
The idea is that the market itself will find ways to judge the best drugs, just as it rates restaurants, books, or software programs. It’s been a popular argument for years in some quarters, notably on the Wall Street Journal’s editorial page, but Forbes pointed out why the argument makes little sense. The reason is that many drugs aren’t safe at all. Instead they’re given when the benefits outweigh the risks.
Still, it’s tempting to think a Consumer Reports-type rating (or a “Yelp for drugs” as another rumored candidate for the FDA job put it) could be a 21st century solution to the low rate of new drug approvals. Others think the FDA should instead change its standards for approving new drugs. Joseph Gulfo, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, has said he thinks the FDA should approve some medicines based on whether they produce positive trends in biological markers associated with disease, even if they haven’t shown that they change patients’ long-term health. Gulfo is said to be in the running for the FDA job, too.
We asked some experts what “safety only” drug approvals would mean for various stakeholders.
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Would patients and drug companies be better off if the FDA didn’t regulate drugs?
During a meeting with leaders of the pharmaceutical industry on Tuesday, President Donald Trump said he wanted the U.S. Food and Drug Administration to speed drug approvals.
“We’re going to get the approval process much faster,” Trump said, adding that he has an unnamed “fantastic person” in mind to lead the agency.
Just how Trump will do that isn’t clear. But some of those with the president’s ear have embraced a radical free-market view. They want the marketplace, not the FDA, to determine how good drugs are.
For instance, one name floated in December as a potential FDA pick was that of Jim O’Neill, managing director of Peter Thiel’s investment firm Mithril Capital. O’Neill is a libertarian who has said he thinks drug makers shouldn’t have to prove their pills actually work at all, but only that they are safe. “Then let people start using them at their own risk,” he argued in a 2014 speech.
The idea is that the market itself will find ways to judge the best drugs, just as it rates restaurants, books, or software programs. It’s been a popular argument for years in some quarters, notably on the Wall Street Journal’s editorial page, but Forbes pointed out why the argument makes little sense. The reason is that many drugs aren’t safe at all. Instead they’re given when the benefits outweigh the risks.
Still, it’s tempting to think a Consumer Reports-type rating (or a “Yelp for drugs” as another rumored candidate for the FDA job put it) could be a 21st century solution to the low rate of new drug approvals. Others think the FDA should instead change its standards for approving new drugs. Joseph Gulfo, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, has said he thinks the FDA should approve some medicines based on whether they produce positive trends in biological markers associated with disease, even if they haven’t shown that they change patients’ long-term health. Gulfo is said to be in the running for the FDA job, too.
We asked some experts what “safety only” drug approvals would mean for various stakeholders.
…
