Low number of approved new drug liability company, or wandering FDA-drug, FDA-pharmaceutical industry trade

Low number of approved new drug liability company

, or wandering FDA-drug, FDA-pharmaceutical industry trade

Over the past year by the U.S. FDA approval on new drugs all the discussion of the situation finally Panlai the answer. According to preliminary statistics, the FDA in 2007 approved only 18 drugs listed, including 16 new chemical entities, Vaccine And two biological products. This figure makes the following 14 in 1983 and 2002, 17 new drugs approved after the low number of reoccurrence.

2007 of hot-selling pharmaceutical raw materials, intermediates, equipment, product inventory and 2008 Market Forecast

However, FDA spokesman said that this data is not the final version, the final results will be announced in March this year. In any case, the 53 drugs and 1996's "Golden Age's" compared to today's pharmaceutical industry can only lament "an unlucky year."

The choice of pharmaceutical companies Investigate the reasons for the sharp reduction from the number of new drugs, FDA and pharmaceutical companies are divided on. GlaxoSmithKline FDA and other pharmaceutical companies claim to raise the standards for approval of new drugs. For this argument, FDA naturally be rejected. As a first-line drug development researchers, Tufts University (theTufts University) Drug Development Research Centre KennethKaitin said, pharmaceutical companies focus shifted to transforming existing drugs, trying to expand indications for existing drugs, which at the expense of development of new products as the price.

As Pfizer And Merck large companies rely on such "blockbuster" drug of profits each year to maintain double-digit growth in all but two years ago, Pfizer's Norvasc, Merck's Zocor and other over 400 billion U.S. dollars market, patent medicine patent expiry to growth exist, with the U.S. FDA to delay or reject Sanofi - Aventis, Wyeth and other big pharmaceutical companies "blockbuster" drugs for more makes this situation even worse. Therefore, many pharmaceutical giant had to take cuts of 2007 and other means to fend off the pharmaceutical industry, the trend of slowing profit growth.

Although the core mission of the pharmaceutical company is to new drugs and new treatments to market, but pharmaceutical companies are in the direction of the grim reality of making a deviation from R & D?? Will focus on the extension has been sale of drugs on the life cycle. This trick, just in new drug development for pharmaceutical companies to save a lot of money. The face of R & D, promotion, upward pressure on operating expenses, major pharmaceutical companies have taken massive layoffs and other cost-cutting measures, coupled with such a scourge will come rushing to generic competition, the company can maintain its original selling drug's market share is also a problem. Therefore, increasing indications for existing drugs and develop new drugs both directions, drug companies worry more effort chose the former.

However, there are indications that pharmaceutical companies are pouring on the development of new drugs to re-warm, the next few years, the number of new drugs approved each year should be increased. New drugs approved in 2007, the treatment with GSK and Novartis Breast Cancer Of Tykerb, the treatment of leukemia drug Tasigna and other pharmaceutical companies, the largest of all the winners.

FDA said the approval did not raise the standard

2007 years, including Sanofi - Aventis and Novartis, including many pharmaceutical companies suffered some setbacks. An FDA advisory panel in question rimonabant may allow users to produce suicidal thoughts and Depression After Sanofi - Aventis withdrew only Lose weight Drug listing applications. In addition, Novartis painkiller Prexige is also developed by FDA turned away.

Last year, Wyeth has three new products are FDA to postpone approval, including drugs used to prevent bone loss Viviant. FDA asked Wyeth to submit more likely to cause the Viviant Stroke And the risk of thrombosis research data. Wyeth expects to defer approval of these three drugs were once listed, create an annual sales income could reach 40 billion U.S. dollars.

Since 2004, Merck recalled painkiller from the market since Vioxx, FDA has been facing from the pressure from U.S. lawmakers, who asked FDA on Drug Safety For more stringent control.

October 24 last year, with analysts at the meeting, GlaxoSmithKline CEO Jean-PierreGarnier said: "There is no doubt that the threshold for approving new drugs has improved. We are try to introduce in the next 3 years, 25 new products, but some products will be delayed. If placed on two years ago, this may not happen. "

In a response to the problem Electronic Message, FDA Deputy Secretary JanetWoodcock said, FDA has not changed on the new drug approval standards, with the pharmaceutical company submitted new drug applications in recent years, the number dropped, FDA will be able to work better for the monitoring of drug risks. JanetWoodcock said: "We determine whether new drugs are a safe and effective standard has not changed. However, research on new drugs to analyze the data to identify possible security issues, our capabilities have greatly improved. In for the treatment of Chronic Disease when evaluating new drugs, we are particularly high degree of vigilance, because once the sale, patients taking these drugs every day the time will be up for many years. "

RobertRuffolo Wyeth R & D president, said in an e-mail: "FDA's leaders are enlightened, they talk with us and published in the announcements made by the new drug approval environment occurs changes. In fact, the number of new drug approval is indeed declining. As innovators, our job is to find the best way to ensure the success of this new environment. "

Internal reasons? To reduce the number of approved new drugs, not all pharmaceutical companies are directed against FDA. Martin, president, Pfizer Global R & D

Mackay said in an interview on the new drugs can reduce the number of the main reasons for the pharmaceutical company to start looking.

Tucson, Arizona Institute of important ways (the Critical PathInstitute) has been working with FDA Cooperation , On the new drug approval process for reform. The RaymondWoosley director, said pharmaceutical companies are increasingly focused on drug development will be concentrated in the treatment of disease causes, rather than the often more easily treated

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