Drugs companies scarred by US watchdog’s tougher stance

This article is from Marianne Barriaux in today’s Guardian.

US regulators are taking an increasingly tough stance on approving new drugs after a series of safety scares.

Wyeth, the US pharmaceuticals company, said four out of five attempts to launch new medicines on the US market had been delayed by the US food and drug administration (FDA). Regulatory problems are hitting firm’s share prices. On Thursday, for example, AstraZeneca’s market value fell by £1.3bn after the FDA said it was reviewing the safety of its biggest seller, Nexium, and Prilosec.

GlaxoSmithKline had £4.6bn wiped off its value in one day after safety scares over its Avandia diabetes drug came to light.

Instead of issuing final approvals, the FDA is giving companies more and more “approvable” letters, which set conditions. This leads to delays to the launch of a drug, which can significantly affect a company financially.

Bob Ruffalo, Wyeth’s head of research, said: “At least four out of five standard review NDAs [new drug applications] go through an approvable stage.”

He was speaking after Pristiq, a Wyeth drug awaiting approval to treat menopausal hot flushes, was delayed by regulators for at least a year over safety concerns, pending a further trial.

Analysts say the number of approvable letters given out by the FDA has risen dramatically since its reputation was hit by a series of drug safety scares. The withdrawal of Merck’s painkiller Vioxx in 2004 and safety concerns about Glaxo’s Avandia also led to criticism of the FDA.

Navid Malik, a Collins Stewart analyst, said: “The FDA has become more risk-averse to safety and vocal on issues it believes need to be brought to the attention of the public.”

Some say the caution is overdone, and is the result of political pressure before a key piece of US legislation that will decide some of the funding for the FDA. Mike Ward, a Nomura Code analyst, said: “Politicians are snapping at their heels.”

But all agree that the FDA’s safety stance is having an impact on the pharmaceutical industry. Mr Malik says investors should focus on biological drugs, such as proteins and vaccines, which are less risky.

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