Thursday, July 31, 2008

The elephant in the pill bottle

A US Senator is hot and bothered about outsourcing by big pharma, says a piece at Outsourcing-Pharma, and the Congressional Record may shortly feature some interesting info:

Sen Brown has asked for specific information on the mechanisms Merck uses to track the chain of custody for reach ingredient used in its products, procedures to check that each facility in the supply chain adheres to its operating procedures and standards, and whether the US Food and Drug Administration (FDA) “periodically inspect every facility” that makes ingredients for the company.

He also asks for a detailed breakdown on the percentage of production that is outsourced to US providers, a ranking of the top 10 countries the company outsources to, and the estimated average and median wages paid at companies producing active pharmaceutical ingredient s(APIs) for Merck in each country.

He's done the same thing to Pfizer, apparently scandalized by something he found in the 2Q results, specifically a big hike in profits “due in part to cost-cutting measures,” Outsourcing-Pharma notes. Maybe he can't be blamed. According to the website, an FDA official made a serious accusation.

In April at a meeting of the Senate Health, Education, Labor and Pensions (HELP) Committee, says Brown, an FDA official “acknowledged that American drug companies outsource operations due to cost factors and the existence of weaker drug safety standards abroad.”

Or maybe Brown just didn't understand what he was being told at the time. He certainly doesn't seem to understand the drug industry. He seems to think that Pfizer's 17% outsourcing should be called "heavy reliance". Has he looked at the generics industry? Obviously no, because he probably would have had a stroke over 100% outsourcing.





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