COULD US drug regulators be feeling the heat of government scrutiny? On 13 June, federal health advisers unanimously declined to approve a new weight-loss drug because of concerns that it might cause suicidal thoughts and other psychiatric problems.
In studies presented to a panel of independent experts convened by the Food and Drug Administration (FDA), the drug Acomplia had twice as many psychiatric side effects as a placebo.
鈥淭he drug Acomplia had twice as many psychiatric side effects as a placebo鈥�
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The US House of Representatives is holding hearings on the reauthorisation of the Prescription Drug User Fee Act (PDUFA) which may change the way new medicines are approved and subsequently monitored. Some think the FDA is being overly cautious about approving new drugs for this reason. Clifford Rosen, who chaired the panel, says that while the FDA always presents panels with evidence on drug safety, the amount for Accomplia was 鈥渁 bit unusual鈥�. 鈥淚 think they鈥檙e being very cautious right now.鈥�
The FDA says the amount of evidence considered was set many years ago and not influenced by the PDUFA. The FDA is expected to make a final decision by 27 July.
