With the preemption arguments raging on in the Supreme Court and in circuit courts around the country, we have yet more evidence that making the FDA the gatekeeper for product liability claims is tantamount to naming Roger Clemens the new performance enhancing drug czar. The FDA is under fire for approving the sale heparin, Baxter’s blood-thinning drug, without bothering to inspect the plant in China that manufactured the heparin’s active ingredient. Peter Barton Hutt, a former top FDA lawyer, said that since 1980 the FDA has had a policy requiring that plants be inspected before drugs are approved for sale. “It was obviously a glitch” that the FDA didn’t bother to inspect the site, said the F.D.A. through a spokesperson.
On Monday, Baxter announced that it had temporarily halted production of its version of the anti-clotting drug heparin because of about 350 bad reactions linked to heparin, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery. The active ingredient used to produce heparin was sold by Baxter International until sales were suspended after the aforementioned fatalities and complications.
I love the FDA’s response. “While no FDA inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible. We have already requested expedited access to the facility, facilitated through a recently signed agreement with the Chinese State Food and Drug Administration. FDA also has requested the facility’s inspectional data and adverse event reports connected to the product.” Thanks guys. Now that the horse is out of the barn, we are so grateful for you to take the time to close the door. United States Supreme Court? Are you there? I hope you are paying attention.