The Corner

Has the FDA Seen the Light on Expediting Its Drug-Approval Process?

The New York Times has a story about how an FDA regulator’s wife’s tragic fight against cancer opened his eyes to the need to speed up the process for drug approval:

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.

As it turns out, if there was one guy at the FDA to convince about the need for reforms, Mr. Pazdur was the guy. As the article notes, he happens to be the ”oncology chief for the last 16 years . . . a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.”

 How have things changed?

Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a years long 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.

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.”

I have somewhat mixed feelings about this. On one hand, I am delighted that this regulator has come to realize the frustrations with the FDA terrible slow and inefficient drug approval process that many people have expressed for years are well founded. It is a big deal when delays in drug approval can mean death for patients waiting for treatments that could have helped them. The FDA process also slows down innovation in health care. On the other hand, it is truly sad that being faced with such an ordeal is what it took to commit Mr. Pazdur to make this inefficient process evolve even a little. 

Now, to be fair, there were other factors behind Mr. Pazdur’s commitment to reform:

Many factors are driving him, he continued. “Was Mary’s illness one of them? Yes,” he said. But in 2012, he added, Congress also passed a law that gave the F.D.A. more money and a new pathway to work more closely with drug makers when a medicine may save lives. Another important change in the same period, he said, was a surge in advances in genetic research that made some medications more effective and easier to test.

“The drugs simply got better,” Dr. Pazdur said.

Some are unhappy about the development because it has the potential to make the FDA less risk-averse (imagine that!). I think the recent development may indeed soften the agency’s risk aversion a bit. However, the problems will continue as long as the underlying philosophy at the FDA is precautionary principle as opposed to the permissionless innovation. That’s why as laudable as the efforts by Congress to reform the FDA and the evolution of Mr. Pazdur are, they fall far short of what needs to be done to allow tech innovators to work their magic in health care and allow consumers and their doctors to decide what is best for them when they are sick. As I have suggested before, that can be achieved only by a private alternative to FDA

We should treat people like adults who are better suited to know their own best interest than bureaucrats in Washington. I think Mr. Pazdur’s experience and transformation shows that. To be fair, I am sure that the bureaucrats who work at the FDA are mostly well-meaning people. Unfortunately, they work in an environment that suffers from perverse incentives. These incentives are the same ones that produced the VA scandal, the CDC scandal, and a raft of other potentially deadly government failures. 

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