Senator urges FDA to step up on foreign APIs

Sen. Sherrod Brown wants the FDA to focus its microscope on pharma outsourcing. For several years, Brown has been raising the flag on potential quality problems posed by outsourced manufacturing. And now, he's calling on the agency to look more closely at outsourcing APIs for drugs made at home.

The impetus is a new report that found a large majority of APIs are made abroad. According to a statement from Brown's office, the API report found that more than 80 percent of the ingredients were made overseas, mostly in plants rarely inspected by FDA. One of the most obvious--and frightening--examples was the heparin scare of 2007, when more than 100 people died after using contaminated heparin. Raw materials for the blood thinner, sourced in China, were found to be tainted.

"When drug companies outsource pharmaceutical ingredients, they also outsource drug safety standards," Brown said in the statement. "It's simply unacceptable to allow drug companies to skirt existing regulations by importing ingredients from countries with lax safety standards." The GAO has recommended that the FDA boost foreign inspections, but moves in that direction have been slow, and improvement will take years if FDA follows current strategies, Brown notes.

Brown cited all these things in a letter to FDA Commissioner Margaret Hamburg, commending the agency for digging into the API quality issue, but posing some additional questions. For example, are FDA inspectors ever denied access to foreign API plants? And if so, could FDA bar the products from those plants?

The letter hints at potential new rules to keep the API supply safe. Brown asks Hamburg about the feasibility of charging fees when pharma companies move operations overseas to help pay for FDA inspections of those foreign facilities. He suggests other fees to help pay for stepped-up oversight.

- see the release from Brown's office