Heparin snafu prompts call for legislation

Pharma's favorite dynamic duo, Reps. John Dingell and Bart Stupak [1], are threatening to force the FDA to inspect foreign plants before drugs or ingredients are exported to the U.S. You'll recall that an FDA staffer mistook the Chinese plant that supplied Baxter with raw heparin for another plant with a similar name [2], which had been inspected. So the Baxter supplier's facility wasn't ever checked out by the agency. As yet, there's no conclusive evidence that the plant was the source of problems with the heparin, which Baxter first recalled and then stopped making altogether [3].

To the Congressmen, the FDA's clerical error is bad enough. But it's "the further assertion by FDA that it is free to ignore its own preapproval policy [that] raises concerns" about the safety of our drug supply, Stupak said in a statement. So the two men are considering introducing a bill that would make preapproval inspections not just a matter of policy, but mandated under law.

Dingell and Stupak also wrote Baxter CEO Robert Parkinson, asking for detailed records about its heparin supply chain and any adverse events associated with the med. (The FDA has said that it received 350 reports of adverse reactions; four patients died after taking the drug.) Did the FDA mislead Baxter into thinking the supplier's plant had been inspected? If not, the letter states, "then we are concerned that your company was knowingly distributing an unapproved drug." Of course, Parkinson has said that his company wouldn't have known whether the Chinese plant had been FDA-inspected because it doesn't keep that close a watch on its supply chain.

All of this raises at least two questions. First, will Congress put its money where its mouth is and fund any new mandate for foreign inspections? Second, can we expect drug makers who aren't watching their supply chains for possible problems overseas to start doing so?

- read the press release [4]
- check out the letter [5] to Baxter's CEO
- see this story [6] in the International Herald Tribune
- find the Wall Street Journal piece [7] in the
- get more [8] on the committee's correspondence with FDA at Pharmalot

Related Articles:
Heparin supply chain full of loopholes. Report [9]
Baxter tests point to Chinese problem. Report [10]
FDA inspected wrong Chinese plant. Report [2]
Baxter stops making multidose heparin. Report [3]
Baxter recalls heparin on adverse events. Report [11]