Meaning of Prasad’s Departure Debated
A Heartland Institute online newsletter quotes several experts with differing opinions on why CBER director Vinay Prasad is leaving FDA for a second time. The post says that during his tenure, Prasad, in his dual role as CBER director and agency chief medical and scientific officer, “raised concerns about drugs that were marginal in effectiveness or had a higher risk profile than drugs currently on the market.”
Cato Institute director of health policy Michael Cannon said, “People have a fundamental right to take whatever medicines they wish. When the government keeps medicines off the market, it denies that right and makes patients less safe. The particular medications in question were perhaps ineffective, but the form of regulation Prasad employed is definitely ineffective.”
However, University of Texas law professor Charles Silver sees Prasad’s departure as a triumph of the pharmaceutical industry and a defeat for effective regulation of efficacy and safety. “I think Prasad was fired because he wanted to raise standards and wasn’t shy about telling people their standards were too slow,” Silver says. “The last thing the industry wants is an FDA with high standards.”
To Jane Orient, executive director of the Association for American Physicians and Surgeons, there is a way to have some regulatory safety testing while keeping taxpayers and health insurance policyholders from paying millions of dollars on drugs that don’t work.
“The regulatory system does harm in imposing outrageous costs that delay approval of important drugs while serving as an insurmountable barrier to drugs with no prospect of turning enormous profit,” she says. “We would be much better off with a caveat emptor policy, with FDA’s role restricted to removing adulterated products, with transparency and excellent after-market surveillance. There should also be private industries testing products for purity, correct dosing, and honest reporting. This would be a valuable service for which most would be willing to pay. Insurance subscribers should have the right to elect coverage without mandates for such products.”