FDA denies it is risk-averse on drugs

The newly appointed head of medicine approvals at the US Food?&?Drug Administration has insisted that science rather than politics or pricing is behind the growing difficulties facing new pharmaceuticals attempting to reach the market.

Janet Woodcock, head of the Centre for Drug Evaluation and Research, one of the most senior jobs at the FDA, rejected claims from drug companies that her unit was rejecting new medicines because the agency was too risk-averse.

Ms Woodcock's spirited defence follows intense criticism of the FDA in recent months. With a large number of new drugs rejected or delayed, pharmaceutical companies and a number of patient associations have accused the agency of being toorisk-averse, partly in response to politicians and consumer groups which have attacked it for approving medicines and failing to identify dangerous side effects, such as with the painkiller Vioxx.

She acknowledged that the rate of success in bringing new drugs to market had declined in recent years in a way that is putting pressure on pharmaceutical company executives and depressing investor interest in the sector as existing medicines come off patent.

She said that when the FDA rejected new medicines, it did so based on an assessment of their safety and ­efficacy, not as a result of political pressure or greater conservatism.

She told the Financial Times: "We have a different story from the companies. We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions."

Ms Woodcock conceded that the size and length of clinical trials had grown substantially in recent years but argued that was a result of better understanding by regulators of how best to identify risks. "We're smarter now [but still] humbled by what we don't know."

She said the FDA would unveil proposals this autumn on reducing drug development costs by standardising the format and content of clinical trial data. "We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it."

While endorsing a recent move towards greater post-marketing surveillance studies – with continued obligations on companies to study safety risks even after a drug has been launched – she allayed concerns about their extent.

"The fear that there will be a huge number is misplaced. We think very hard about every case," she said.

She denied industry claims that the FDA was turning down experimental drugs simply because they were more expensive or less cost effective than existing treatments but said: "If there are choices out there and a new drug is less safe, we will not put it on the market unless there is some advantage."

Ms Woodcock acknowledged that FDA staffing and funding for the inspection of foreign manufacturing sites for medicines remained "thin", warning of the ­dangers of globalisation highlighted by concerns over Chinese-sourced ingredients for the anti-clotting agent Heparin.

"We now rely on a risk-based approach. Regulators share information but that does not totally compensate. There has been no increase [in inspectors] to the field."

She also defended the use in many instances of the FDA's gold standard ofplacebo-controlled trials, where a new drug is tested against a sugar pill rather than an existing approved medicine for the same disease. "If you compare with a treatment that is not proven to be effective, you don't know if either drug is effective," she said.

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