Senator calls for outsourcing probe at FDA

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 [1]
- read the Pharmalot post [2]

Related Articles:
Pharma outsourcing continues to swell [3]
IMS: Pace of outsourcing accelerating [4]
Is Pfizer eyeing Chinese outsourcing? [5]
AstraZeneca: Just a bit of outsourcing [6]
AZ reaffirms whole-hog API outsourcing [7]