With dangers from antidepressant use in children, Ketek, Vioxx and now Avandia and Actos in the news, Congress has faced some pressure to address problems with monitoring safety of new drugs. A bill giving the FDA greater power to monitor such drugs seems to be moving toward approval. This week the House approved a bill that would set up a network to scan health insurance and pharmacy records looking for potential problems with newly released drugs.
The Senate, which passed a similar measure, has joined the House in giving the FDA the muscle to make drug companies put current risk data in prescribing literature. The bills also would give the FDA the ability to demand--rather than ask--that pharmas do follow-up safety studies on new drugs. If pharmas didn't conduct post-market studies, change labels or limit distribution of treatments as ordered by the agency, they could face a $250,000 fine for one violation and up to $1 million for several violations.
While the bills are moving along, it's not clear whether President Bush will sign them. The Senate, too, could attempt to include a proposal allowing the FDA to approve generic versions of biologic drugs, which could scuttle the deal.
To learn more about the bill:
- read this Los Angeles Times article
- read this Kaiser Daily Health Report piece
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