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FDA Delays Burn Americans

Monday March 31st, 2014   •   Posted by K. Lloyd Billingsley at 8:15am PDT   •  

FDAlogo_200Summer will soon be here, and with all the fuss about global warming one would think Americans could avail themselves of the most protective sunscreens, like those used by their counterparts in Europe. They won’t be able to do that because, as this Washington Post report notes, “applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers.” Dermatologists find this delay distressing.

Darrell S. Rigel, clinical professor of dermatology at New York University and past president of the American Academy of Dermatologists, told the Post, “These sunscreens are being used by tens of millions of people every weekend in Europe, and we’re not seeing anything bad happening. It’s sort of crazy…. We’re depriving ourselves of something the rest of the world has.”

FDA bosses say the sunscreen issue is a high priority. If so, why must Americans make due with dated, inferior products? Doctors worry that FDA lethargy will have a chilling effect on innovation. Wendy Selig of the Melanoma Research Alliance told the Post, “We have a system here that’s completely broken down, and everybody knows that it has broken down.” And it’s not just broken down on the sunscreen issue.

The meningitis B vaccine Bexsero is approved in Europe, but the FDA approves it only on an ad hoc basis. Limited approval generally comes after an outbreak, such as those last year at Princeton and the University of California at Santa Barbara, where lacrosse player Aaron Loy had to undergo amputation of both feet.

The FDA should immediately approve the widely used MenB vaccine for general use in the United States while final testing proceeds. The FDA should also approve the more effective sunscreens already used in Europe. A pound of prevention is better than an ounce of delayed bureaucratic response.

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March 2014