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zoom RSS FDA新長官を指名/米国医療事情 アメリカ食品医薬品局 オバマ政権

<<   作成日時 : 2009/03/16 00:13   >>

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 オバマ大統領はFDAの新長官を発表するとともに、ピーナッツバターとトマトなどの食品・ヘパリンのような医薬品から国民を保護するために10億ドルの投資を含めたFDAの大幅な改革計画を立てている。
 「食品安全性は、大統領としてだけではなく親として深刻に考える。今年のはじめピーナッツ製品が汚染されていたと聞き、たぶん1週間に3回昼食にピーナッツバターサンドイッチを食べる7歳の娘、サーシャについて、直ちに考えた。どの親も、どの家族も、買う薬が害を起こすと心配する必要があるべきでないように、子供が昼食から病気になるだろうと心配する必要があるべきではない。」
画像 前ニューヨーク市保健局長官Margaret Hamburg を新FDA長官に指名した。大統領の計画では、食物検査官数を増やし、食品供給を監視するために検査を現代化する予定である。また、病気の牛が食品として供給されないことを保証する対策を講じる。今までの方法では「公衆衛生上の危険があり、受け入れがたい。Dr. Margaret Hamburg のリーダーシップで変革する」。旧式のガイドラインから食品安全性システムの弱点が一部生じている。法律がルーズベルト以来のままで食品安全性を制御している規則が変更されていない。
 ボルチモア保健局長官Joshua Sharfstein がFDA副長官に指名された。大統領は公衆衛生局として食品医薬品局を再活性化することを求めている。しかし、批評家によれば、二人に公衆衛生上の豊富な実務経験があるとはしていない。
 FDAほど難しく重要な政府の役所はない。Dr. Hamburg はバイオテロのエキスパートでもあり、ビル・クリントン大統領の医療政策アドバイザーでもあった。1991-97年にニューヨーク市の保健長官として勤務する前に、彼女はNIH国立予防衛生研究所の国立アレルギー・伝染病研究所で副部長として伝染病が専門だった。
 Sharfstein は小児科医で、乳幼児への市販かぜ薬の販売禁止に貢献した。また、ホワイトハウスと連邦議会への直接的なつながりを持っている。ボルチモアの保健チーフになる前に、カリフォルニア民主党下院議員ヘンリーワックスマンのもとで喫煙問題に関して働いていた。FDA長官の候補にもなっていたが、製薬産業の猛烈な反対が起こる可能性があった。
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FDAの科学者が管理体制を批判/米国医療事情 FDA食品医薬品局
http://kurie.at.webry.info/200901/article_20.html
FDAは医薬品の安全性保証はできない
http://kurie.at.webry.info/200711/article_4.html
汚染ヘパリン製剤問題の核心はFDAにある/米国
http://kurie.at.webry.info/200803/article_28.html
FDA「食の安全」計画の失敗/米国
http://kurie.at.webry.info/200806/article_23.html
上院委員会 ピーナッツ由来のサルモネラ菌感染で連邦の監督局を非難/米国 食品安全
http://kurie.at.webry.info/200902/article_13.html
安全の落差
http://kurie.at.webry.info/200811/article_2.html
サルモネラ 1000人以上、最大規模の食物由来流行感染に/米国
http://kurie.at.webry.info/200807/article_23.html
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Obama Taps Ex-NYC Health Commissioner to Lead FDA
President Invests in Food Safety, Names Margaret Hamburg to Oversee Agency
By KATE BARRETT
March 14, 2009
http://abcnews.go.com/Health/story?id=7059201&page=1

As he announced a new head of the Food and Drug Administration today, President Barack Obama laid out plans for an extensive overhaul of the agency, including a billion-dollar investment to keep tainted peanut butter and tomatoes out of the food supply and to protect patients from contaminated medications like the blood thinner heparin.

"Food safety is something I take seriously, not just as your president, but as a parent," Obama said in his weekly video address. "When I heard peanut products were being contaminated earlier this year, I immediately thought of my 7-year-old daughter, Sasha, who has peanut butter sandwiches for lunch probably three times a week. No parent should have to worry that their child is going to get sick from their lunch, just as no family should have to worry that the medicines they buy will cause them harm."

Obama tapped former New York City health commissioner Margaret Hamburg to be the new FDA commissioner. The Senate must confirm the appointment.

The president's plan would boost the number of food inspectors and modernize labs to better keep tabs on the nation's food supply. It would also take steps to ensure sick cows don't enter the food supply.

Of the past way of doing things, Obama said, "That is a hazard to public health. It is unacceptable. And it will change under the leadership of Dr. Margaret Hamburg."

Obama said vulnerabilities in the food safety system stemmed in part from outdated guidelines.

"Part of the reason is that many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt," he said.

Baltimore health commissioner Joshua Sharfstein was named principal deputy commissioner of the FDA, the No. 2 slot.

By putting two public health officials in charge of the organization, the president is seeking to revitalize the FDA as a public health agency, health experts said.

Commenting on the Hamburg and Sharfstein picks, Sid Wolfe, director of Public Citizen's health research group, told ABC News this week that he couldn't think of two people with more extensive on-the-ground experience in public health.

Challenges That Await the FDA

If confirmed by the Senate, Hamburg will take the reins of an agency dogged by controversy.
Hamburg or Sharfstein possible FDA head
Doctors Margaret Hamburg and Joshua Sharfstein are President Obama's picks to head the Food and Drug Administration.
(NHI/Landov)

"There are few jobs in the federal government that are as tough or important as FDA commissioner," Consumers Union director of food policy initiatives Jean Halloran said in a statement this week.

"Dr. Hamburg would first have to help the FDA get the budget and authority it needs so it can visit food processors every year, instead of once every 10 years, and can inspect their records and impose meaningful penalties on violators," Halloran said.

Widely reported to have been the frontrunner for the post, Hamburg is an expert in bioterrorism and served as a health policy adviser to President Bill Clinton. Before serving as New York City's health commissioner from 1991 to 1997, she specialized in infectious disease as an assistant director at the National Institutes of Health's National Institute of Allergy and Infectious Diseases.

"She has been forward-thinking in her approach both to medical and food security issues -- a quality that should enable her to return the FDA to its role as a trusted, effective regulatory agency," said Michael Jacobson, executive director for Center for Science in the Public Interest in a Saturday statement.

Sharfstein, a pediatrician, helped lead the charge to ban over-the-counter cold medication for young children.

He also has direct ties to the White House and Capitol Hill. He worked as an investigator for Rep. Henry Waxman, D-Calif., now chairman of the powerful House Energy and Commerce Committee, before becoming Baltimore's health chief. Under Waxman, Sharfstein investigated tobacco companies, and in Baltimore he has fought to reduce smoking, experience that could be vital with Congress considering giving the FDA authority to regulate cigarettes as drug-delivery devices.

Sharfstein had also been floated as a possible commissioner of the agency but vigorous opposition to his nomination was possible due to his reputation as a crusader against drug companies. The deputy position does not require confirmation.

Obama Announces Working Group to Update Food Safety Laws

Ensuring the safety of the country's food and drug supply is a daunting task. Many observers have said the FDA does not have enough people or money to do the job well.

"The system is not set up to catch bad actors, at least not until the problem has already erupted, really on a nationwide level," Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, told ABC News in January during a peanut recall.

"I believe it is broken, I believe it needs to be fixed," Tom Nassif, president and CEO of Western Growers, told ABC News in July 2008 when the FDA was trying to determine what was contaminating tomatoes. "I know that FDA and CDC must be tremendously frustrated by their inability to trace back the source."

David Acheson, FDA's assistant commissioner for food safety, explained the enormity of the job in January during the peanut recall.

"Clearly in the context of a global food supply, the more integrated the system is, the more standardized it is, the better," Acheson said. "And there's definitely significant moves in that direction. Not just from the FDA but from the states as well. So we're moving in that direction, but FDA doesn't have a mandate to require every state to do exactly what FDA tells it to do."

Consumers and lawmakers alike have also worried the FDA is not doing enough to inspect foreign food and drug plants. In addition to domestic health scares, the FDA has recently dealt with blocking the import of Chinese milk products and zeroing in on where along its international supply chain the blood thinner heparin became tainted.

The agency has also confronted controversy about the safety of diabetes drug Avandia and recalls of the painkiller Vioxx -- flaps that left some wondering whether the FDA is effectively regulating drugmakers.

"We want to work with Dr. Hamburg to reform the way FDA approves medicines," said Consumers Union health analyst Bill Vaughan in a March 11 statement. "Between contaminated imports and the use of dishonest research results, the American medicine cabinet has become a little shop of horrors. In recent years, the agency has been too slow to protect consumers and too willing to give industries a pass on safety."

Lawmakers have repeatedly voiced their frustrations with the FDA.

"Either you don't have the resources, or you are incompetent to do the job you're supposed to do," Rep. John Dingell said to FDA food safety director Stephen Sundlof at a February hearing on the peanut recall. "Which conclusion am I to arrive at?"

Some in Congress have even said the challenges are so enormous that food and drug oversight needs to be completely reorganized. They support creating a separate food safety agency, in part because responsibilities are currently split between the Department of Agriculture, which monitors meat, poultry and eggs, and the FDA, which monitors all other food.

At a hearing this week on Capitol Hill, however, Waxman said that isn't going to happen just yet, citing a need to first clean up the current structure before taking on a more extensive overhaul.

Today Obama called for the creation of a Food Safety Working Group, to be jointly led HHS and agriculture secretaries. He said he expects the group to report back on upgrading food safety laws as soon as possible.

"We need to be reactive when problems occur," Acheson said in January. "We need to do that faster. We need to recognize the problems earlier. But more importantly we need to establish preventitive controls."

"No one can inspect and test everything," Acheson said. "It's just not humanly possible. So we've gotta be smart about what we test, where test it. What we look for."

ABC News' Brian Hartman and Lisa Stark contributed to this report.

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FDA新長官を指名/米国医療事情 アメリカ食品医薬品局 オバマ政権 医師の一分/BIGLOBEウェブリブログ
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