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Senator calls for outsourcing probe at FDA

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A new senator is leaping into the pharma fray. Sen. Sherrod Brown, an Ohio Democrat, is calling on the FDA to evaluate its oversight of outsourcing practices. In a letter to the agency, Brown cites a statement by CDER Chief Janet Woodcock at a recent Congressional hearing, when she said some drugmakers outsource their operations because of "lower, less stringent standards in some parts of the world," in addition to lower labor costs. At the same hearing, a Pfizer exec said 17 percent of its active ingredient and drug manufacturing is outsourced--and Brown wants an explanation for that number, too. He wants to know not only how much Pfizer saves through outsourcing, but also what, exactly, has it outsourced to countries with "less stringent oversight?"

It had to happen: Outsourcing has been a hot-button issue, and a highly political one ever since Ross Perot's famous "giant sucking sound" quote when he was running for president. And this is an election year, after all.

- see Brown's release
- read the Pharmalot post

Related Articles:
Pharma outsourcing continues to swell
IMS: Pace of outsourcing accelerating
Is Pfizer eyeing Chinese outsourcing?
AstraZeneca: Just a bit of outsourcing
AZ reaffirms whole-hog API outsourcing

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More stories about FDA   Congress   CDER   AstraZeneca   Active Ingredients   FDA regulation   Sherrod Brown   Pfizer   Pharma outsourcing   Janet Woodcock  

Comments

Wow, almost everything in this world have been outsourced. Pretty interesting..

outsourcing must be stopped. the fda's job is to protect us. they cannot do that when drugs are produced overseas. you can't buy drugs in canada but you can have them made in china? this is against the first admendment, the bill of rights, and the declaration. drug companies are interested only in profits not in performance. the fda is not assuring us our health. just recently a drug, mysoline, an anticonvulsant was pulled off the market abruptly leaving many people who require time to withdraw and adjust to a new anticonvulsant no alternative but a generic manufactured under the otiginal drug's name. valeant sent information stating it was the same formula. it is not. this is life threatening situation for some people and the fda gave permission for it to happen. this may result in some deaths but noone at the fda or at the manufacturers seems to care. the drug company valeant just happens to be in the third trial of a new epileptic drug. coincidence? i don't think so. if you load a gun it is premeditated murder. if you stop producing lifesaving drugs its business. the fda and valeant know the consequencesknow the consequences and should be held responsible by the attorney general.

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