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FDA may ease restrictions on off-label information

Pharma Compliance Alert, December 4, 2007

The FDA may soon make it easier for pharmaceutical and medical device manufacturers to distribute medical journal studies about unapproved uses for drugs.

As part of draft guidance, the FDA would permit pharmaceutical and medical device manufacturers to distribute unabridged reprints of peer-reviewed studies published in respected medical journals. The reprints cannot be written, edited, or significantly influenced by the manufacturers or people with financial ties to them.

All off-label communications were prohibited until the FDA Modernization Act of 1997 allowed pharmaceutical and medical device manufacturers to distribute reprints that were submitted to the FDA for approval and they asked the FDA to approve the new use. Other exceptions to the off-label prohibition were created by the Washington Legal Foundation's litigation against the FDA.

In a letter to the FDA, Rep. Henry Waxman (D-Calif.) claimed the draft guidance poses multiple risks, including creating a "disincentive for drug and device manufacturers to seek approval for unapproved uses."

Click here to read the draft guidance. Click here to read Rep. Waxman's letter to the FDA.

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