The Problem with FDA Restrictions on Drugs
By David Henderson
Or, actually, one of many problems.
When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”
This is from Gardiner Harris, “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval,” New York Times, January 2, 2016.
Dr. Pazdur, according to the reporter, “has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.” Pazdur, the oncology chief at the FDA, is one of the key gatekeepers. So if cancer drug approvals are slow, he bears much of the responsibility. But now, partly because his wife got cancer and recently died from cancer, he has changed.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
I generally argue that people respond to incentives. But a careful reading of the piece suggests that that’s not what’s really going on here. In 2014, he approved a drug for ovarian cancer, against the wishes of an expert advisory panel that voted it down 11 to 2. But, as he pointed out, it was aimed at a cancer that was genetically different from that of his wife. So it doesn’t appear to be a narrow issue of incentives.
So why did Dr. Pazdur change? He hinted at it with his self-described move from regulator to regular-advocate. Good for him and I’m sorry for his loss. What he’s saying, I think, is that the lives of strangers for whom he was making literally life-and-death decisions have become more real to him.
But he should have always been that way. Do we count a regulatory system as good when the regulator has to suffer a personal loss in order to become an advocate for those whom his decisions are affecting? Is there some other way?
Yes, there is, and it’s a way that Alex Tabarrok, Daniel Klein, and a number of others, including Charley Hooper and me, have written about: strip the FDA of its power to make such decisions. Let it serve as an information provider and certifier. Let companies sell drugs that the FDA has not certified, as long as they say in big letters: THIS DRUG HAS NOT BEEN CERTIFIED BY THE FDA.Then we wouldn’t have to depend on personal losses of regulator to get them to care more about the lives of people they’re affecting.
One other interesting note. Many critics of FDA regulation, like Sam Kazman and the above-mentioned authors, have often pointed out that every month of delay in approving a drug costs lives. It’s refreshing to see the New York Times admit as much. Gardiner Harris writes:
Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.