Tag Archives: Allergan

PMA Process Taking Longer and Longer

In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan Inc. 

“A decade ago we used to see a PMA approval time of 9-12 months,” Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine 2012. “In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It’s something that we are anxiously watching. We don’t see any signs of that abating.” 

The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, “is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market.” 

— Doug Brunk (on Twitter@dougbrunk)

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Filed under Dermatology, Drug And Device Safety, health reform, IMNG, Practice Trends

Is Counterfeit Botox a Terrorist Threat?

Image courtesy U.S. Army via Flickr Creative Commons

The U.S. Department of Defense and antiterrorist organizations are growing increasingly concerned about the trade in fake botulinum toxin because, and there’s a long string to this, it could somehow be at the root of production of a weapon of mass destruction (the Washington Post, “Officials Fear Toxic Ingredient in Botox Could Become Terrorist Tool,” Jan. 25, 2010).

Undoubtedly, United Nations inspectors and C.I.A. agents found vials of Botox (onabotulinumtoxinA) in Saddam Hussein’s arsenal, but my guess is that those were for personal use, not for carrying out his genocidal plans…

This post originally appeared on The Mole, the blog of Skin & Allergy News, an Elsevier Global Medical News publication. Please visit The Mole to read more.

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Filed under Dermatology, Drug And Device Safety, Health Policy, IMNG, Internal Medicine, Obstetrics and Gynecology, Plastic Surgery, Primary care