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製薬業界で 12 年以上キャリアを持つ Sharon 先生による医療コラムをお届けします。

特集:医療英語 > 第 3 回:The FDA in 2004: Highs and Lows (2004 年度の FDA 総括)

Sharon BeltrandelRio 先生 Sharon BeltrandelRio 先生

12 年以上製薬業界の第一線で活躍する Sharon 先生が 2004 年 12 月より不定期でコラムを持つことになりました。最近の製薬業界の動きや医療に携わる日本人が英語を話す時に注意すべき点等、比較的自由に書いてもらおうと思っております。書いて欲しい記事などございましたらレッスン中に Sharon 先生にお伝え頂くか までご連絡ください。

Based on recent headlines, it may appear that the U.S. Food and Drug Administration (FDA) had a rough year in 2004. On September 30th, Merck withdrew its blockbuster cox-2 inhibitor Vioxx? from the market. On October 16th, the FDA ordered pharmaceutical companies to include a "black box" warning on the labels of antidepressants, linking the drugs to an increased risk of suicide or suicidal thoughts among young people. A "black box" warning is the FDA's strongest safety alert and is one step below banning the drug. In both cases critics have been vocal in saying that the agency is not doing enough to safeguard public health.

In an attempt to improve the situation, President Bush has recently increased the FDA's funding (but only moderately) and a new oversight board has been created to supervise safety issues. The agency has not had a permanent leader for more than a year, but President Bush's nominee, Dr. Lester Crawford, who has been the acting commissioner for the past year, is undergoing confirmation hearings in the U.S. Senate this week.

A bright spot in the FDA's 2004 activities is the large number of new drug approvals. Last year the FDA approved more new medicines than in any of the previous eight years. In 2004, a total of 113 new drugs were approved, compared to 87 approvals in 2003. The last time that the FDA approved more than one hundred drugs in one year was in 1997, when 121 drugs were approved.

Very importantly, 31 of the new drugs are new molecular entities (NME), nearly double the number of NME's approved in 2003. A new molecular entity is an active pharmaceutical ingredient in a dosage form that has never been approved for marketing in the U.S. NME's often represent novel treatments for diseases. Some of the most promising new drugs approved in 2004 include:

  • Avastatin (Genentech) - The first angiogenesis inhibitor to be approved for marketing. Avastatin is for the treatment of first-line or previously untreated metastatic cancer of the colon or rectum.
  • Cymbalta (Eli Lilly) - The first drug approved to treat the pain caused by diabetic peripheral neuropathy. Cymbalta was also approved for the treatment of major depressive disorder in 2004.
  • Spiriva HandiHaler (Boehringer Ingelheim Pharmaceuticals) - The first once-daily inhaled drug to improve lung function for patients with chronic obstructive pulmonary disease.
  • Tysabri (Biogen Idec and Elan) - The first humanized monoclonal antibody approved for treating multiple sclerosis. The drug works by inhibiting adhesion molecules on the surface of immune cells.

All medicines have risks and benefits. One of the most important parts of the FDA's mission is promoting public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner. Hopefully the FDA will soon obtain a permanent commissioner to provide the agency with the additional strength and stability it needs to overcome and learn from the low points of 2004, and to continue carrying out its mission of promoting public health.

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