August 19, 2015
By Shannon Brownlee, MSc
Last week, an American heroine died. A family doctor who went to work for the U.S. Food and Drug Administration (FDA) in 1960, Frances Oldham Kelsey prevented thalidomide from being marketed in the U.S., a decision that saved thousands of children from terrible birth defects.
Thalidomide was already being sold in Europe to pregnant women for morning sickness under the brand name Kevadon. But when the manufacturer, the William S. Merrell Company, of Cincinnati, applied to the FDA for marketing approval, Kelsey refused, citing a lack of safety data.
“Thus began a fateful test of wills,” as her New York Times obit put it. Kelsey kept requesting more information. The company stonewalled. They went to her superiors, complaining that she was a fussy, stubborn, petty bureaucrat who was blocking them from bringing relief to American women.
Not until the following year did reports begin coming from Europe of the terrible birth defects in thousands of children born to women who took thalidomide. By then, only a few hundred pregnant women took the drug in the U.S., thanks to Frances Kelsey.
A public servant like her wouldn’t have much of a career in today’s FDA. This is an agency under siege, whose power to protect the public from bad science and dangerous or ineffective drugs is being steadily eroded by Congress and the courts. The latest assault on public safety, reported ironically enough in the same issue of the Times as Kelsey’s death, is a recent Federal District Court ruling against the FDA’s enforcement of regulations prohibiting drug companies from off-label marketing.
The case against the FDA was brought by four doctors and Amarin Pharmaceuticals, the maker of Vascepa, which is basically high-power fish oil in a pill. The FDA approved Vascepa in 2012 for patients with a genetic condition that causes extremely high cholesterol. Two years ago, the company applied for permission to market the pill to patients at lower risk for heart attacks and strokes, and the FDA turned them down, citing a lack of evidence.
What does a company do when it isn’t allowed to peddle its fish oil? It sues, claiming that the agency’s refusal to let it market its drug off-label is a violation of free speech.
Seriously? Since when is drug marketing the equivalent of me being allowed to stand on a street corner and criticize the government? Gosh, and here I thought the First Amendment was supposed to protect we, the people, not corporations.
 Many if not most patients are probably unaware that their doctors are permitted to prescribe drugs “off-label,” for conditions other than the one approved by the FDA. And they almost certainly don’t know that companies aren’t allowed to market for off-label uses.