It was inevitable: All the chit-chat [1] about drug safety and the FDA's shortcomings had to result in legislation. Rep. John Dingell's House Energy and Commerce Committee released a "discussion draft" yesterday, planning to convene hearings over the next few weeks and draw up the real bill after that. Here's a primer:
- Drug and device plants making products for the U.S. market would register annually with the FDA.
- FDA would have to inspect all drug and device facilities every two years; no drug, ingredient, or device could be sold until its plant had been inspected at least once--and FDA approval could be yanked if this rule was violated.
- Importers without documentation that they'd complied with all safety rules could only ship into ports with federal testing labs.
- Drug and API makers would have to test their products for contaminants.
- Drug labels would identify the source of active ingredients and specify where a drug was made.
The bill would give the FDA stronger enforcement powers, including the ability to recall drugs unilaterally and destroy counterfeit [2] or contaminated imports. The agency would also be able to issue fines for violations.
And to pay for it all? Drug and device registrations would include new fees to cover the cost of inspections. That's sure to be a popular provision, don't you think?
- see the USA Today story [3]
- check out the item [4] at Pharmalot
- find the Associated Press article [5]
ALSO: The Raleigh News & Observer sat down with FDA commish Andy von Eschenbach for a chat about overhauling the agency. Here's what he had to say. Report [6]
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FDA wants satellite offices overseas. FDA report [7]
Planning for the FDA's overhaul. FDA report [8]
FDA pleas for funding gaining traction? Funding report [9]
FDA chief admits need for funding, reform. FDA report [10]