The New York Times reports this morning that the US Food and Drug Administration (FDA) has initiated “a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.”
A recent rash of court decisions have suggested that the FDA has gone too far in protecting the public by tightly regulating what manufacturers can and cannot claim about their products. Manufacturers have challenged FDA’s approach on First Amendment grounds, and increasingly seem to be winning.
There are not expected to be any changes in FDA procedures until it gets a new commissioner; Dr. Mark B. McClellan was nominated to the job by President Bush late last month and seems headed for Senate confirmation.
However, a former commissioner has attacked the notion that there should be any changes in the FDA’s mandate. “It represents a frontal attack on the fundamental responsibilities of the agency under the Food, Drug and Cosmetic Act," said Dr. David Kessler, who was the FDA commissioner from 1990-1997 and is now the dean of Yale's School of Medicine. “I have great concerns that this is simply an attempt to deregulate while doing it in the name of the First Amendment.”
A recent rash of court decisions have suggested that the FDA has gone too far in protecting the public by tightly regulating what manufacturers can and cannot claim about their products. Manufacturers have challenged FDA’s approach on First Amendment grounds, and increasingly seem to be winning.
There are not expected to be any changes in FDA procedures until it gets a new commissioner; Dr. Mark B. McClellan was nominated to the job by President Bush late last month and seems headed for Senate confirmation.
However, a former commissioner has attacked the notion that there should be any changes in the FDA’s mandate. “It represents a frontal attack on the fundamental responsibilities of the agency under the Food, Drug and Cosmetic Act," said Dr. David Kessler, who was the FDA commissioner from 1990-1997 and is now the dean of Yale's School of Medicine. “I have great concerns that this is simply an attempt to deregulate while doing it in the name of the First Amendment.”
- KC's View:
- What would concern us about any shift in the FDA’s mandate would be that consumers would still assume that the government was controlling what could and could not be said. Therefore, manufacturers’ statements could be viewed as having a government imprimatur, even when they do not.
