What Can the Shirley Sherrod Story Tell Us All About Judging the FDA

In June, the FDA sent letters to consumer genotyping companies—the companies that analyze your spit and tell you what diseases you’re most at risk of contracting—telling them that their tests could not be marketed without FDA approval. The rationale was that the agency wanted to prevent consumers from being “misled by incorrect test results or unsupported clinical interpretations.”

There was a strong reaction against the FDA, as demonstrated by the public’s feedback to this CNN article. Some sample comments:

• “It’s not a food, it’s not a drug, it’s outside the FDA’s purview.”

• “Who is running the FDA and exactly what is their agenda?”

• “As a consumer of 23andme’s product I am deeply ashamed of the FDA and their inability to let these tests alone.”
“The Police State marches on.”
“Another example of the FDA protecting big business.”

• “The FDA is just like every other bloated, massively unreliable government entity.”

Then a month later, on July 23, 2010, the Government Accountability Office conducted a “sting.” They ordered tests from four genotyping companies and found that the results were misleading and sometimes even contradictory.

To wit, according to the Wall Street Journal, “one man who actually had a pacemaker implanted for atrial fibrillation was told by 23andme and deCODE that he was at below-average risk for the condition.”

Maybe like those who criticized Mrs. Sherrod, some have been too hasty to pass judgment on the FDA.