NAPOLITANO: It is well known that the state of Masachusetts is the most highly-regulated state in the union, with the government that is most in your face. It has a government that is physically present at the plants of the people and entities that they regulate…I don’t know if they have a person physically present in this facility, but they have the right to do so. So it is obvious that the state cannot keep its people — and others, when [the shots were] shipped outside the state — safe.
CAVUTO: So what’s the alternative?
NAPOLITANO: The alternative is to have insurance companies do the regulating because they would be on the hook.Hear me out. When someone is injured because the state drops the ball, the state can’t be sued. when someone is injured because an insurance company drops the ball, the insurance company can be sued. So you darn well believe that they are going to be certain that every batch of chemicals that is mixed in that facility is safe because if it is not, they are going to pay for it.
The root cause of the deadly meningitis outbreak was not too much regulation, it was too little.
The thousands of pharmacies across the country that practice compounding, a method of remixing medicines to cut down on prescription costs, are currently outside of the FDA’s regulatory power. If the FDA had the authority to oversee compounding pharmacies, the agency could ensure that compounded products — like the contaminated steroid shots that were produced in Massachusetts and shipped to over 20 states — adhered to the same safety guidelines they uphold for drug manufacturers’ products. But the pharmaceutical industry has resisted further regulation, even as health advocates have called for increased FDA oversight into a sector of the drug industry they say is ripe for a public health disaster.