The Supreme Court v. Reality: FDA Version
Image has not been found. URL: http://www.washingtonindependent.com/wp-content/uploads/2008/09/law.jpgIllustration by: Matt Mahurin
Today the Supreme Court ruled 8-1 that you can’t sue a manufacturer for a defective medical device if the Food and Drug Administration has already approved the device. Legally, perhaps, the decision has its merits. But practically the decision ignores the myriad scandals surrounding the agency that call its core competency into question.
Justice Scalia wrote in his majority opinion that the agency spends 1,200 hours reviewing one device application before granting approval. But it also came to light this week that the agency spent zero hours inspecting a Chinese plant that produced the blood-thinning drug Heparin, distributed by Baxter International Inc. Heparin has been linked to four deaths and hundreds of accidents. The FDA says it mistakenly went to the wrong plant.
Both the House Committee on Oversight and Government Reform and Energy and Commerce Committee are pushing for an overhaul in the agency. Two weeks ago, heads of both committee’s wrote a letter to the President calling on the FDA’s science advisory board rip up the current budget and start all over again. And this morning Energy and Commerce Subcommittee on Oversight and Investigations Chairman Bart Stupak (D-Mich.) told the Wall Street Journal: “[If Americans] knew how little the FDA did to assure the food and drug supply, if the truth ever came out…people would be marching in the street.”
It’s, of course, not the Supreme Court’s fault that the F.D.A. is in crisis. But the high court may end up having a major impact in determining the the agency’s responsibility- they are considering three other cases that involve patients suing for drug and drug labeling.
Today’s ruling suggest that the F.D.A. is the final check on the health care industry. That’s a scary proposition for health care patients.