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Congress OKs FDA safety bill

Pharma Compliance Alert, September 26, 2007

Congress is giving the FDA more power to police prescription drugs already on the market as part of a bill passed last week.

Under the bill sent to President Bush for his signature, Congress gave the FDA the power to fine pharmaceutical companies for false or misleading ads without having to seek approval from the courts.

Other changes include:

• The fine for the first violation in any three-year period will be $250,000. Fines are not to exceed $500,000 for any subsequent violations in that period.
• Drug companies are required to submit television ads, but the FDA can only recommend changes to those ads.
• The FDA's fees to review drugs will increase. Part of that money will go towards monitoring drugs after they are in the market.

The new bill also solidifies the FDA's authority to mandate changes in drug labels, require additional safety studies, and limit a drug's distribution if safety concerns arise.

Click here to read Senator Edward Kennedy's remakes on the passage of the bill. Click here to read more in the Federal Register.

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