By a vote of 93 to 1, the Senate yesterday approved a bill that would expand the size of the staff at the Food and Drug Administration that monitors drug safety. It would also provide for fines of up
to $2 million for pharmaceutical companies that do not comply with the new system for monitoring the risks of new and high-risk drugs in the first few years after they become available.
Drugmakers would also have to include clear warnings of possible negative side effects of drugs in radio and television ads. And they would be required to register clinical trials of new drugs in a
publicly available database.
The bill also would enable the FDA to fine companies that fail to report contaminated food, and would require the government to establish labeling standards
for pet food and create a system to detect tainted pet food and notify the public of recalls. The provisions are all part of a bill to reauthorize the current system that charges drugmakers hundreds
of millions of dollars in fees each year to pay for speeded-up reviews of prospective new drugs.
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