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To: sim1 who wrote (944)	7/27/2001 7:26:13 AM
From: Icebrg	Read Replies (1) \| Respond to of 7143

FDA chief denies changing drug approval standards By Adrian Michaels in New York Published: July 26 2001 19:28GMT \| Last Updated: July 26 2001 19:32GMT A senior regulator has hit back at pharmaceutical company suggestions that the Food and Drug Administration has become more conservative, saying the agency has not tightened standards for drug approvals. Dr Janet Woodcock, director of the FDA's Centerfor Drug Evaluation and Research, said the statistics did not bear out any change in attitude, despite industry criticism that the agency has become too cautious. The FDA has established itself as the leading pharmaceuticals regulator in the world. It approves drugs before companies are allowed to sell them in the US, by far the largest and most lucrative market. But most of the world's largest drugs companies - including Pfizer, Roche, Novartis, Eli Lilly and Amgen - have suffered regulatory setbacks this year. Drugs expected to be approved were sent back for more clinical trials, or held hostage while the FDA sorts out other disputes with their manufacturer. A year's delay in approval of a new "blockbuster" drug could cost a company billions. For investors, a perception that the FDA has raised the bar on drug approvals has put a cloud over the sector. It has rocked share prices and increased nervousness. There have been large modifications to earning and revenue forecasts as well as company behaviour. This week Novartis, the Swiss drugs group, voluntarily pulled a schizophrenia drug from the approval process to conduct more clinical trials. It cited evidence that the FDA had become more concerned by safety issues. Of US groups, both Pharmacia and American Home Products voiced uncertainty this week over drug approval timetables because of "the current environment". But Dr Woodcock said that companies were submitting fewer applications for approval, particularly in "new molecular entities" - the medical breakthrough drugs that are most eagerly awaited by patients and investors alike. While statistics cited by companies show that approval times for NMEs are up, and that fewer NMEs are being approved, Dr Woodcock said: "The percentage submitted that we approve of new molecular entities has not gone down. We feel we're implementing consistent standards." Pharmaceutical equity analysts say the FDA has become more concerned with drug safety and tightened up. Rachel Leheny at Lehman Brothers said: "Trends confirm a significant slowdown in approvals . . . as well as broad concerns about drug safety." Dr Woodcock conceded: "If I was a financial analyst, I would be concerned about why submissions have slowed down." Some in the industry have suggested that because companies are finding fewer potential blockbusters, each one has assumed a greater importance. If they are to keep growing sales and earnings at high rates and satisfy investors, the industry's leaders can ill afford regulatory stumbles. Some of the noise could be industry posturing while it campaigns for a new FDA head. George W. Bush sacked the previous FDA commissioner, Dr Jane Henney, in January, and has yet to appoint a replacement. The result has been a rudderless agency, the industry says. Another factor behind the industry's complaints may be a Congressional review of the FDA next year, and the chance that legislators may change regulations in the companies' favour. The largest companies have certainly succeeded in bringing criticism of the way the agency works to the fore. The European Commission, sensing an opportunity, last week announced plans to streamline its approval process, in a move that it hopes will entice companies to bring research and development back to Europe and threaten FDA supremacy. Dr Woodcock said she was flattered by the moves from Brussels. She said the FDA had pioneered much of what Europe was planning to do, for example in helping generic copies of drugs reach the market faster. But she said the FDA's status would not be threatened unless Europe started to work closely with companies on drugs long before they were submitted for approval. By consulting with companies throughout the drug discovery process, their R&D is made more efficient. "For companies, the real advantage [with the FDA] is our consultation with industry," Dr Woodcock said. "We had over 1,000 meetings last year about drugs that had not yet been submitted. That is a unique resource." One reason cited by analysts for the heightened sensitivity of the FDA is campaigning by consumer safety and patient advocacy groups. Over half of the drugs withdrawn from the market over safety fears in the past 20 years have been pulled since 1997. The FDA says that it now has more scientific knowledge to judge the safety of drugs - particularly on their effects on heart rhythm and interaction with other medicines. But Dr Woodcock said the rising numbers of withdrawals was just a reflection of the vast increase in drugs that had been approved. While withdrawals had increased, it was still the same percentage - a little over 2.5 per cent - of approved drugs. Still, the steep rise in absolute terms has contributed to the debate on the FDA, and sentiment has so far proved stronger than statistics. news.ft.com