Fw: NYTImes : Many Surprised By Bold Moves At the F.D.A.

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From: " ilena rose " <ilena2000@...>

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Sent: Monday, January 26, 2004 4:48 AM

Subject: NYTImes : Many Surprised By Bold Moves At the F.D.A.

>

http://www.nytimes.com/2004/01/25/national/25FDA.html?ei=5062 & en=d130e935be6

9c006 & ex=1075611600 & partner=GOOGLE & pagewanted=print & position=

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>

>

> EXCERPRT: Dan Cohen, the new vice president for global government

> affairs at Inamed, which the F.D.A. told this month to do more

> research if it wanted to return its silicone breast implants to the

> market, said Dr. Kessler was " overly political, capricious, and didn't

> seem to have science at heart as opposed to an agenda. "

>

> ~~~~~~~~~~~~~~~~~

>

> Inamed's New PR Flack has it all upside down and backwards ... LOL ...

> like Inamed doesn't have an " agenda. " Dr. Kessler certainly did ...

> protecting the public's health against dangerous medical devices.

>

>

>

>

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>

> January 25, 2004

> Many Surprised By Bold Moves At the F.D.A.

> By GINA KOLATA

>

> Some people thought they knew what to expect of the Food and Drug

> Administration under President Bush: It would be attuned to business

> and sensitive to religious conservatives. It would put off difficult

> decisions and issue fewer regulations.

>

> Its commissioner, Dr. Mark B. McClellan, is a Republican and the

> brother of Mr. Bush's press secretary. Traditional Republican

> supporters, like large drug companies, praise him, so it might seem

> predictable that he would take a strong stand as he is doing this week

> against importing prescription drugs from Canada, a practice that

> undercuts prices here. But the decision has also put him in conflict

> with several governors - some of them Republican - and legislators who

> want cheaper drugs from Canada.

>

> A number of other decisions by Dr. McClellan have kept the Food and

> Drug Administration in the spotlight as one of the more activist

> agencies in the Bush administration. Granted, critics say that some of

> the rulings - like banning ephedra - were years in the making, but

> other people note that unlike, say, the Environmental Protection

> Agency, the F.D.A. has not seemed in retrenchment on regulatory

> matters.

>

> The agency's announcement last month that it would prohibit the sale

> of ephedra was a move sought by liberal Democrats like Senator

> M. Kennedy and consumer groups like Public Citizen's Health Research

> Group. That tough stand was just the beginning of a crackdown on

> supplements, Dr. McClellan promised.

>

> " While most supplements are probably safe in the dose people take

> them, we are concerned about a number of other dietary supplements

> that are currently on the market, " he said in a speech Tuesday. " And

> we intend to do more to take a closer look at them. "

>

> In another move that could be construed as hindering business, Dr.

> McClellan deferred a decision on whether to allow silicone breast

> implants back on the market after more than a decade-long hiatus. He

> said the F.D.A. needed more data on safety, especially on ruptures,

> how to detect them and what to do when they occur.

>

> " I've been pleasantly surprised, " said Pearson, executive

> director of the National Women's Health Network, which wanted ephedra

> banned and more safety data on implants.

>

> Other F.D.A. watchers were surprised when the agency signaled a

> willingness to consider allowing a prescription morning-after pill to

> be sold over the counter. The pill, called Plan B, can prevent

> pregnancy after unprotected sex.

>

> Women's groups, like the National Women's Health Network, strongly

> support making Plan B available over the counter, but some religious

> groups strongly oppose it. Believing that pregnancy begins with

> fertilization, they say the pill can prevent a fertilized egg from

> implanting, and so it induces abortion.

>

> But the agency put on its advisory committee people known to support

> offering the pill over the counter. And the committee voted

> overwhelmingly to make the drug available without a prescription. A

> final decision is expected by mid-February.

>

> " Miraculously, I was appointed to the committee, " said Dr.

> Trussell of Princeton University, who has always wanted the drug to be

> offered over the counter.

>

> Some consumer groups argue that the Food and Drug Administration is

> too cozy with the industries it regulates. In fact, even industry

> groups that appear to have been hurt by some of Dr. McClellan's

> decisions speak well of his approach to the job.

>

> He " isn't what most people would have expected from a Republican

> administration, " said Dr. Annette Dickinson, president of the Council

> for Responsible Nutrition, a trade group for the dietary supplement

> industry. But, she said, " he's been a breath of fresh air. "

>

> She said her group wanted the agency to stop supplement makers from

> making false health claims or flouting good manufacturing practices,

> and supported the ephedra ban.

>

> Others regulated by the F.D.A. like the attention they are getting.

>

> Dr. Rhona Applebaum, the executive vice president and chief scientific

> officer of the National Food Processors Association, said that in her

> 20 years in the industry, she had never seen an F.D.A. commissioner

> pay so much heed to food. " So yeah, we're pretty excited. "

>

> Part of Dr. McClellan's success, said Dr. Alan M. Garber, an internist

> and economist at Stanford, is that he is a pragmatist, not an

> ideologue.

>

> He also has a style that can be immensely appealing.

>

> " McClellan is so personable and comes across as a person of such great

> integrity that it's hard to find somebody who says something

> negative, " said Wayne Pines, who was the agency's associate

> commissioner for public affairs under Dr. A. Kessler, who is now

> a consultant to companies dealing with the F.D.A.

>

> The same cannot be said of Dr. Kessler, who served under President

> Bill Clinton and the first President Bush and angered industry

> officials by halting the sale of silicone breast implants and seeking

> to regulate tobacco as a drug.

>

> Dan Cohen, the new vice president for global government affairs at

> Inamed, which the F.D.A. told this month to do more research if it

> wanted to return its silicone breast implants to the market, said Dr.

> Kessler was " overly political, capricious, and didn't seem to have

> science at heart as opposed to an agenda. "

>

> Dr. Kessler would not discuss how his management style differed from

> Dr. McClellan's, but he did compliment his decisions on breast

> implants and supplements. " He got it right, " Dr. Kessler said.

>

> In a telephone interview, Dr. McClellan said he was surprised to be so

> roundly praised.

>

> " I thought I managed to tick everybody off, " he said. " It's one of the

> things that's kind of freeing about this job. We get criticized no

> matter what we do. " But, he said, he wants to continue the agency's

> long tradition of " getting the science right. "

>

> " A lot of people have a pretty cynical view of Washington, but I

> really don't, " Dr. McClellan said. " It's a little corny, but it's

> focusing on the right thing to do. "

>

> Some find him hard to pigeonhole.

>

> For example, consumer groups objected and large drug companies

> applauded when he warned that it was illegal to import prescription

> drugs from Canada. But just the opposite happened when he changed

> regulations to make generic drugs available sooner when a drug's

> patent expired. Both drug companies and consumers approved of the

> agency's investigations and prosecutions of drug counterfeiters.

>

> With foods, Dr. McClellan and his staff examined whether nutritional

> science could justify new claims. In the first change to food labels

> in a decade, last year he announced a proposal for labels to list

> so-called trans fats, which can increase cholesterol levels, a move

> that angered some companies. But, in an action favored by food

> manufacturers, he would allow them to list qualified claims about the

> health benefits of foods and nutrients.

>

> In the case of dietary supplements, Dr. McClellan's proposal last

> month to ban ephedra got most of the attention.

>

> But that, he said, " was just the tip of the iceberg. " He said he had

> also issued 75 warning letters to supplement makers - a fivefold

> increase from 2002, before he took office - and seized millions of

> dollars worth of supplements that made false health claims or that

> were unapproved drugs masquerading as supplements. The agency also

> stopped the importation of 664 shipments of potentially dangerous or

> fake diet supplements.

>

> At the same time, the agency's actions on contentious women's health

> issues have been watched closely from all sides.

>

> For example, Dr. McClellan insisted that all hormone pills to

> alleviate symptoms of menopause include hard-to-miss warning labels

> about their risks for cancer and heart disease.

>

> He also has not bowed to pressure from groups that say that

> mifepristone, a drug once known as RU-486 and approved in 2002 to

> induce abortions early in pregnancy, is unsafe.

>

> But for all the examples of his attention to regulation, some consumer

> advocates say he should be doing more.

>

> Dr. F. son, the executive director of the Center for

> Science in the Public Interest, a consumer advocacy group, said he saw

> " a real pattern of actions that undercut the public's health. " He said

> of the plan to allow more health claims on food labels, for example,

> that Dr. McClellan was " just ignoring the law. " His group and Public

> Citizen, another advocacy group, have sued the agency over such

> labeling, saying it would violate the current food labeling law, which

> requires health claims to be substantiated by " significant scientific

> agreement. "

>

> Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,

> has a litany of complaints in addition to the food labels that are, he

> said, " a flagrant violation of the Nutrition Labeling and Education

> Act. "

>

> Among the complaints, the F.D.A. did not propose banning ephedra until

> the major manufacturers had stopped making it, because they could not

> get product liability insurance, Dr. Wolfe said. The delay " was just

> inexcusable. "

>

> Mr. Pines, the former assistant commissioner, said that while advocacy

> groups had raised objections and sued the agency no matter who was

> commissioner, the striking and reassuring fact was that " the F.D.A.

> continues to make decisions based on the public health. "

>

> " Any administration coming in can certainly change some of the

> nuances, " Mr. Pines said. " But it's too big a ship to turn in a new

> direction. "

>

> ~~~~~~~~~

>

> www.BreastImplantAwareness.org

>

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