Sanofi CEO challenges FDA to clear up regulatory pathway for new meds

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Drug developers have had it with FDA reviews of new meds for major diseases such as diabetes and obesity. U.S. regulators have shot down or stalled a slew of applications for such drugs because of safety concerns, and Sanofi ($SNY) CEO Chris Viehbacher has called for the agency to clear up how it weighs the risks and benefits of the treatments or risk a drain on the industry's investment in developing them, Reuters reported.

"You're starting to see primary care diseases becoming somewhat neglected," Viehbacher told Reuters, wearing his hat as the chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA). "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."

Developers in the obesity and diabetes fields are likely to applaud Viehbacher's stance. In June, Orexigen CEO Michael Narachi blamed the FDA's lack of clarity on ways forward for obesity treatments as a threat to his and other companies' investments in diet pills. Last year the FDA wouldn't approve San Diego-based Orexigen's ($OREX) weight-loss drug Contrave because of potential heart-safety risks to certain patients, but the company is trying again to get the agency's nod for the treatment after meeting with regulators about data it would need to gain approval.

With obesity and diabetes weighing on the U.S. healthcare system, drug lobbyists are likely to make a strong case for getting the FDA to shed greater light on what companies need to prove in order to bring new treatments for the conditions to market. And if the regulatory waters remain murky for such meds, expect drugmakers to play it safe and divert funds toward safer bets in oncology, where drugmakers have had lots of success getting the FDA's approval stamp for new therapies.

- read the Reuters article

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