Home » Allergan Drops Suit Challenging FDA’s Off-Label Enforcement
Allergan Drops Suit Challenging FDA’s Off-Label Enforcement
The device industry may have lost its best shot at challenging how the FDA regulates off-label use when Allergan agreed to drop its First Amendment lawsuit seeking the right to tell physicians how to safely use a product off label. The company dropped the suit against the FDA last week as part of a $600 million settlement with the Justice Department over its promotion of Botox for off-label uses. Had Allergan successfully pursued the case, device companies would be able to discuss off-label uses as long as they did so honestly and had safety and efficacy data to support the uses, James Beck, an attorney at Dechert, said.
Devices and Diagnostics Letter
Devices and Diagnostics Letter
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