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Week in Review Editorial: 10 to 16 August

Over the last week, the FDA has not won many friends in the pharmaceutical industry as it continued to demonstrate that drug safety was at the top of its regulatory agenda

Over the last week, the FDA has not won many friends in the pharmaceutical industry as it continued to demonstrate that drug safety was at the top of its regulatory agenda.

The origin of the FDA's augmented safety profile can be traced back to the time it approved Merck & Co's Vioxx, which as we all know resulted in injury and death in some patients prescribed the drug.

Under heavy criticism from Federal government, the FDA has slowed its rate of drug approvals and a number of high profile pipeline drugs have suffered regulatory setbacks or marketed treatments have had their existing labelling changed.

Wyeth seems to have suffered the most this week, as its new antipsychotic licensed in from Solvay, bifeprunox, was judged to be not as effective as existing marketed treatments, such as Bristol-Myers Squibb and Otsuka's Abilify. The FDA has already rejected Wyeth's Pristiq, an antidepressant that was being tested for menopausal symptoms, demanding clinical trials on the drug's heart and liver side effects.

Earnings continue to be eroded by regulatory delays on products and safety concerns of widely used marketed treatments, such as GlaxoSmithKline's Avandia diabetes pill and Takeda's rival, Actos. Also suffering is AstraZeneca, whose blockbuster acid reflux treatments, Nexium and Prilosec, came under FDA scrutiny after two studies linked the drugs to heart attacks and death. Novartis's Galvus diabetes pill, which analysts said could have generated USD 1bn in sales, was rejected by the agency as well.

And it's not just the FDA. The European Medicines Agency rejected Elan's Tysabri to be used against Crohn's disease, while Novartis' Prexige analgesic was pulled from the market by Australian regulators on concerns that it could damage the liver.

The FDA approved 38 new drugs through July of this year, down 31 per cent from 55 per cent in the same period of 2006, according to Friedman, Billings and Ramsey (FBR) analysts. They say that 2007 approvals have so far only included seven new molecular entities (NME), which is the lowest level in ten years.

On the surface, the FDA may not be entirely to blame for the reduction in NME approvals. Lack of innovation from pharmaceutical companies, whose pipelines continue to suffer from a paucity of NMEs, must also be considered.

However, Fran Hawthorne, the author of "Inside the FDA" says that there was nothing new about the reduced levels of innovation: "It's true that the pipelines are pretty dry at the drug companies, but the pipelines were dry five years ago when the FDA was approving more."

16th August 2007

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