FDA 2011年に35品目承認！

先ほどのケニアの記事よりもこちらの記事に「オッ！」と思われる方も多いかと思います…。

実は…、

2011年にアメリカのFDA（Food & Drug Administration）が承認した新薬の数が、この10年間でも最高レベルの35品目になることが分かった

ようです。




2009年の37品目には及ばなかったようですが、今年度の35品目というのは承認品目数としては非常に多い年のようで、特にC型肝炎に対する薬剤（2種類）、それに、末期前立腺がん、非ホジキンリンパ腫（30年ぶり初承認）、全身性エリテマトーデス（50年ぶり初承認）に対する薬剤が承認されたようです。

以前は医薬品の承認は非常に少なかったようなのですが、これほど多くの新薬が承認されて世に出てくるというのはPrescription Drug User Fee Act (PDUFA) 「処方箋薬ユーザー手数料法」というシステムのお蔭のようでして、「製薬会社側がFDAに新薬申請＆審査手数料を支払うことにより、審査手続きに関わる費用をバックアップする」ことで、新薬の承認が急速に増加したようです。

2011年10月には、小規模製薬会社が製薬開発研究をより積極的に進めれるような法的（？）枠組み を作ったようで、まずます新薬開発に拍車がかかりそうな感じかもしれませんね！

ちょっと期待したい気持ちですね…☆


【PDUFAについて】

私、銭形個人としては、このPDUFAに関しては「ちょっと複雑」な感情を持っています…。もちろん、新薬が増えるは喜ばしいことでしょうし、「抗HSV薬も早いうちに承認されてくれれば…」という思いもあるのですが、「ハーバード・ケネディースクールからのメッセージ」でも示唆されているように、

• 企業側が手数料を払って審査のスピードアップを図っている
  　　　　　　　　　　↓
• 最初のうちは良かったが、そのうち企業側の手数料が無ければ通常業務さえもできないようになってしまう
  　　　　　　　　　　↓
• FDAの自律性が無くなってしまい、製薬会社の思いのままになってしまう可能性も…

ということになってしまうのがやはり怖いですね…。

同ブログでも書かれているように、ひょっとしたらFDAって、

　　Funded by the Drug Industry At your Expense
　　（あなたの犠牲の上に立つ、製薬業界からの手数料で賄われるＦＤＡ）

かもしれないですね…。



FDA: 35 Innovative New Drugs Approved In Fiscal Year 2011

November 4, 2011

Report shows quick approvals of safe and effective medicines occur in the United States before other countries

Silver Spring, MD /PRNewswire-USNewswire/ - Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years.

In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.

The report shows faster approval times in the United States when compared to the FDA's counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.

"Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients," said Margaret Hamburg, M.D., Commissioner of Food and Drugs. "We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."

Among the new drugs approved in FY 2011, a number are notable for their advances in patient care and for the efficiency with which they were approved:

• Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
• Seven of the new medicines provide major advances in cancer treatment;
• Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
• Ten are for rare or "orphan" diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
• Almost half (16) were approved under "priority review," in which the FDA has a six month goal to complete its review for safety and effectiveness;
• Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
• Three were approved using "accelerated approval," a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program; and
• Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.

The Prescription Drug User Fee Act was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012.

"Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy."

In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies.

In a separate action, the agency also released a report this week on drug shortages, expanded its current actions to address the problem, and, at the direction of the President, will broaden early notification of drug shortages and work with the Department of Justice to prevent price gouging.

For information:

Report on FY 2011 Innovative Drug Approvals
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm

Driving Biomedical Innovation: Initiatives to Improve Products for Patients
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274333.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration