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