FDA Extorts Congress for Funding; Shelves Important Sunscreen Advances

The Food and Drug Administration has been holding up approval of new, advanced sunscreens since 1999, in order to extort more money from Congress before approval — despite the explosion of medical knowledge about how the sun’s ultraviolet-A and ultraviolet-B rays damage skin cells.

Coppertone

I’ve had melanoma, and would like to believe that my government wasn’t preventing me from getting the protection I need.

This is as serious as a heart attack. Or melanoma.

A recent Wall Street Journal article, “Sunstroke at the FDA,” exposed U.S. drug regulators banning better sunscreens amid a serious skin cancer crisis in the United States. 

Congress just passed the “Sunscreen Innovation Act.” Before you laugh, the purpose is to reverse the “government-created public health hazard, and allow Americans to buy the same next-generation sunblocks that are on the market everywhere else on the planet,” the Wall Street Journal explained.

As I found out 20 years ago, skin cancer is common and preventable, but melanoma kills one person every hour in the U.S. 

The WSJ found one reason is that the FDAa refuses to approve superior prevention technologies. The FDA last blessed a new sunscreen in 1999. Eight new chemical ingredient applications are awaiting regulatory decisions—three of them since 2002, and another three since 2005.

It’s all political — the FDA wants more funding from Congress before the agency will approve advanced sunscreens.

Read on, or link to the story: http://online.wsj.com/articles/sunstroke-at-the-fda-1406762239 

The decade-plus purgatory has coincided with an explosion of medical knowledge about how the sun’s ultraviolet-A and ultraviolet-B rays damage skin cells. UV-A penetrates more deeply and contributes to the genetic mutations that lead to tumors, while older sunscreens were designed to block UV-B, which mainly causes sunburn. Modern compounds that better protect against both types of radiation have been ubiquitous in Europe, Asia, Australia and the Americas for many years.

On Tuesday the Surgeon General issued a “call to action” on a 200% climb in the U.S. incidence of skin cancer since 1973 and all but declared indoor tanning and Snooki Polizzi menaces to society. Yet the FDA justifies its call to sunscreen inaction, as always, on a supposed lack of safety information. Janet Woodcock, the director of the FDA Center for Drug Evaluation and Research, explained to a House hearing in April that “some sunscreen ingredients are absorbed through the skin, and that leads to systemic exposures that are chronic, that have not previously been understood or anticipated.”

These speculative risks don’t seem to trouble Dr. Woodcock’s overseas counterparts. But rather than accept this international consensus and the evidence of world-wide experience, the FDA is forcing sunscreen makers to somehow prove the negative that their products will never lead to long-term harm. An approval process in search of a safety problem for more than a dozen years no longer deserves to be called a scientific enterprise.

The House bill, sponsored by liberal dean John Dingell of Michigan and Kentucky Republican Ed Whitfield, tells the FDA to clean out the backlog by next summer, creates an 11-month-max review period for new compounds and matches the approval criteria to global norms. The measure passed by voice vote, and the Senate version also enjoys trans-ideological support.

Dr. Woodcock said it “may be self-defeating” to give the sunscreen advisory panel a deadline. “If it is not possible to identify all the problems and get to a considered opinion in that time frame, then it would be likely to turn something down rather than turn it loose on the public,” she threatened. So preserving the FDA’s culture of political control trumps the lives that could be saved or extended. Her mindset would be a scandal if weren’t routine.

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