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Case Detail


Response to DDMAC Warning Letter to Allergan, Inc.
(Regulatory Proceeding)
On September 9, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw a Warning Letter sent to Allergan, Inc. on September 6, regarding Allergan's allegedly improper promotion of Lumigan, a drug used to reduce elevated interocular pressure in patients with open angle glaucoma or ocular hypertension. WLF's letter to DDMAC alleged that DDMAC's actions inappropriately faulted Allergan for making "unsubstantiated superiority claims" for Lumigan even though Allergan cited articles from reputable medical journals to support its claims. DDMAC alleged that in making its superiority claims, Allergan relied on studies that FDA did not deem "well-controlled." WLF's response charged that FDA is violating the First Amendment in attempting to prohibit all mention of the studies, whose truthfulness FDA does not challenge. At most, FDA may require a manufacturer that cites truthful information from reputable journals to include disclaimers pointing out potential shortcomings in the studies, WLF said.
Case Status:
Awaiting FDA response.
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