Advice for Makary’s FDA: Get Out of the Way

The government isn’t the only arbiter of product quality

Letter to The WSJ. 

"Your editorial “The Spin Doctors at the FDA” (Oct. 28) rightly urges the agency to speed up its drug approvals. Years ago Milton Friedman identified the FDA as Exhibit A in America’s overregulation problem. A medication that saves 100,000 lives kills a million when the agency sits on it for a decade.

About 86% of U.S. healthcare spending is outside the realm of prescription drugs and benefits us without any “help” from insulated bureaucrats determining its quality. More important, a large share of drug spending doesn’t require FDA approval. That is because “off label” use—taking a drug for a disease not approved by the FDA after the agency has accepted it for another purpose—is legal. This practice allows for robust private-sector research, all without government’s explicit say-so. For oncology, the largest drug class in the FDA pipeline, off-label use is often the norm.

If the private sector can determine effectiveness for subsequent uses of a drug not approved by the FDA, why can’t it handle the initial use too? The government isn’t the only arbiter of product quality. Insurance companies, providers and patients will all demand evidence before use but will accomplish it more efficiently.

Countless drugs have been stuck for years in the FDA quagmire. One shows great potential in slowing memory loss of early-stage Alzheimer’s. Another one is for the neurological disease ataxia that has been delayed for many years. Zynquista offers hope for type 1 diabetes—an important potential adjunct to insulin—and yet the FDA is dragging its feet in giving it the green light.

Congress could save lives and reduce suffering by relaxing or repealing the 1962 mandate that the FDA assess drugs for efficacy. It would be a humane solution for those afflicted with cancer, Alzheimer’s, diabetes, epilepsy, Parkinson’s and multiple sclerosis, among others. Call it Operation Warp Speed Part II and let the private sector get to work.

Tomas J. Philipson

Chicago

Mr. Philipson was a member of the White House Council of Economic Advisers, 2017-20, and its acting chairman, 2019-20."