Response to DDMAC Warning Letter to Alcon Research, Ltd.
- Case Date: 9/27/2005
- Project Name: Health Care Project
On September 27, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Alcon Research, Ltd. on September 22, regarding Alcon's allegedly improper promotion of Travatan, 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 were inappropriate because the First Amendment protects the right of manufacturers to make truthful statements concerning studies published in a reputable journal regarding a drug's effectiveness, and that FDA may not ban such statements simply because it has concerns regarding the manner in which the studies were conducted. DDMAC alleged that in making its superiority claims, Alcon relied on studies that FDA did not deem "well-controlled." WLF said that, at most, FDA may require a manufacturer that cites truthful information from reputable journals to include disclaimers pointing out potential shortcomings in the studies.
|Awaiting FDA response.|
More Information and Downloads:
Press Release: WLF Calls On DDMAC To Withdraw Untitled Letter On Travatan