Regulatory Focus™ > News Articles > Viehbacher: Diet Pill Guidance Needed To Ensure Investment

Viehbacher: Diet Pill Guidance Needed To Ensure Investment

Posted 20 January 2012 | By Alexander Gaffney, RAC 

Speaking to Reuters on Thursday, Pharmaceutical Research and Manufacturers of America (PhRMA) Chairman and Sanofi SA CEO Chris Viehbacher said that the US Food and Drug Administration (FDA) needs to offer more guidance on their risk and benefit determinations for diet pills.

"To make sure we're not ignoring unmet needs in primary care, we need a lot more clarity around the risk-benefit so there's predictability when we invest in these products," said Viehbacher.

FDA issued Complete Response Letters (CRLS) to several diet pill manufacturers recently, including Arena Pharmaceuticals, Orexigen Therapeutics and Vivus Incorporated. CRL's notify companies that their drug application is not approvable in its current form. Orexigen's diet drug, Contrave, was seen as a particularly puzzling setback by some industry watchers because it uses a combination of two already-approved therapies-naltrexone HCI and bupropion HCI.

After meeting with FDA, Orexigen agreed to conduct a new $100 million clinical trial involving 10,000 patients. So long as the trial doesn't increase the risk of heart attack by more than 40% at the end of the study, says FDA, the drug should have a good chance of being approved.

The prohibitive cost of the trial and the uncertainty around the product class has led to hesitancy to invest in the product class, according to Viehbacher. "You're starting to see primary care diseases becoming somewhat neglected," says Viehbacher.  "I don't think anybody has to sacrifice. I think there just has to be a lot more science."

Viehbacher's comments come in advance of hearing on the Prescription Drug User Fee Act V (PDUFA V), which funds FDA activities through marketing application fees paid by pharmaceutical companies. The legislation typically attracts a flurry of lobbying efforts from industry and consumer groups alike.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.