FDA experiments with America’s children |
The U.S. Food and Drug Administration may soon convert an entire generation of U.S. children, especially children in foster care, into guinea pigs. Here is how:
Commissioner Marty Makary recently announced that the FDA will soon lower its own standards — requiring only one clinical trial, not two, for most drug and medical product approvals.
Selected therapies will see even greater fast-track approvals under a “Commissioner’s National Priority Voucher” program, which truncates the FDA’s own drug review period from the traditional 10-12 months to 1-2 months.
This newly “permissive” FDA will simultaneously build obstacles to new vaccines: requiring reams of data, often redundant, from new shots for diseases ranging from flu to pneumonia.
The sudden fast-tracking of drug approvals, and suppression of new vaccines, is no mere hiccup in our public health system. It is a tectonic shift with deep implications for our entire population, deeper consequences for children and — deepest of all — for children in foster care.
History is important here: for more than a century, the evolution of U.S. drug regulation has been........