Pharma execs back FDA divorce

Could splitting the FDA in two actually speed up drug approvals? Industry observers think so. And they say that pharma executives are pushing for the idea--off the record, for fear of offending the powers-that-be at the agency. "Every CEO that I know in health care is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA," drug-company analyst Steve Brozak told the Associated Press.

According to Brozak and other pharma-watchers, the seemingly unending series of food-safety scandals has taken its toll on FDA. Already spooked by high-profile drug withdrawals in the recent past, the agency has grown even more gun-shy because of the food-recall publicity. And that makes it more difficult for drugmakers and investors to predict which drugs FDA will bless, they said.

But splitting FDA into a food regulator and a drug regulator could be intensely political, the AP points out. Changes in agencies translate to changes in which Congressional reps oversee them. And we all know that an elected official with oversight power doesn't want to give it up, even if government is streamlined in the process. Rep. Rosa DeLauro has been backing the creation of a separate food-safety agency--and she still does--but rather than advocating the consolidation of food-related activities spread over a handful of agencies into one, she's now proposing a simpler carve-out of the FDA.

Whatever the approach, it's clear that any split will take time. So it'll be business-as-usual--or something like that--until then.

- read the AP article

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