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 slow, measured, and usually triggered by major drug crises.
In the early 1900s, fraudulent “patent medicines” led to the 1906 Pure Food and Drugs Act, which prohibited “false and misleading” statements on drug and food labels and created the FDA.
After sulfanilamide killed more than 100 people in 1937, Congress passed the 1938 Food, Drug and Cosmetic Act, which required the manufacturer’s proof of product safety.
In 1961, the drug thalidomide caused more than 10,000 severe birth defects in children worldwide. Consequently, Congress passed the 1962 Kefauver-Harris Drug Amendments and the FDA began to require two adequate and well-controlled clinical trials.
In 1969, the two-trial protocol was codified in the U.S. Federal Register.
This FDA requirement — two clinical trials — has been the gold standard of pharmaceutical proof for more than 50 years. But now in 2026, the FDA suddenly embraces the greatest reduction of drug protection in the history of its existence.
“I don’t understand what this does, other than ratchet down the expectation that the FDA will seek high quality trials for the drugs that are being approved,” said Aaron Kesselheim, a professor of medicine and member of the Center for Bioethics at Harvard Medical School. “It’s self-disempowerment.”
One other thing it will do is allow drug companies to slash years of testing and save billions in R&D costs: leading one industry analyst to call it “the biggest jailbreak in biotech history.”
Another outcome will be an increased use of costly drugs rather than vaccines, for the maintenance of public health. This shift will deeply affect children and infants — especially since, as of January 2026, the CDC will no longer “universally recommend” the following childhood vaccines: influenza, respiratory syncytial virus (the leading cause of US infant hospitalizations), COVID-19, hepatitis A and B, rotavirus, and meningitis.
Finally, this new drug paradigm will strike one of our most vulnerable populations: foster children. There are roughly 400,000 foster children in the U.S., and 70,000 of them are confined to Residential Treatment Centers (RTCs) which mandate and monitor the children’s daily medication.
U.S. pharmaceutical revenue was $679 billion in 2024. This mountain of money and relaxed FDA regulations will create a powerful incentive for the use of pliable foster children and cooperative RTCs to smoothly engineer — and fast-track — the approval and sale of new drugs.
This scenario is not far-fetched. The 2004 BBC film documentary “Guinea Pig Kids” uncovered precisely this use of foster children as lab rats in a New York City RTC.
The Vera Institute documented multiple cases of foster children enrolled — without notice, information or consent — in undisclosed HIV/AIDS trials which violated federal rules on the treatment of human subjects.
Another published report exposed in great detail, “orphanages and institutions that supplied medical researchers with powerless human subjects” throughout the United States.
Back in 1994, Eileen Welsome won the Pulitzer Prize for her articles about the U.S. government’s human radiation experiments conducted on unknowing and unwilling Americans during the Cold War.
Hopefully a Pulitzer Prize will not be required, to save an entire generation of abandoned children, from becoming guinea pigs.
Denis was a New York State assemblyman and board member of the Boriken Neighborhood Health Center.
