Engineer Says FDA Stifles Pharmaceutical Innovation
Aerospace engineer Robert Zubrin says FDA is a “federal bureaucracy gone mad” that stifles drug innovations and should face significant cutbacks in its regulatory authority. In a National Review article that was picked up by Yahoo News, Zubrin says he started looking into the agency because FDA was blocking businesses from using cheap, fast tests that could enable them to identify and send home Covid carriers. “FDA is stopping us from employing a technology that would allow us to stay open while crushing the pandemic,” he writes.
Zubrin draws many of his conclusions from the 2018 book Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It by former Upjohn researcher Mary Ruwart.
He says that by expanding the paperwork, testing, and other legal and regulatory requirements to bring a new drug to market or treatment to practice, FDA has caused the development time for new drugs to triple since 1962 and has caused the cost to multiply 40-fold and the number of new drugs introduced each year to be cut five-fold.
Among the issues he discusses are FDA’s failure to approve AIDS drugs used in Europe, the refusal to allow aspirin manufacturers to promote off-label use to avert heart attacks, forbidding the dissemination of the knowledge that folic acid could prevent a large class of birth defects, user fees, enforcement activities against dietary supplement manufacturers, and increases in animal testing.
He supports remedies in Ruart’s book such as reforming FDA to limit its power to banning drugs proven to be unsafe. In other words, he writes, any drug not proven to be unsafe should be legal for sale, with FDA offering certification of those it has found to be effective, but no authority to ban drugs it has not, or to ban speech it has not verified.
“Uncertified drugs should be legal for sale,” he concludes, “provided their label carries the caveat that ‘the effectiveness of this drug has not been demonstrated to FDA.’ It could, however, carry endorsements from other authorities such as the American Medical Association. People would be free to take or leave such advice, as they prefer, but no one would be denied the right to defend their health as they see fit. Looking at our current pandemic situation, such measures could not be more timely.”