The FDA’s Big…Free-Speech Challenge?
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When word got out that Medtronic Inc. (MDT ) was working on a product that could quell a rare form of severe nausea, patients began clamoring for more details. But the Minneapolis medical-device maker couldn’t tell them anything. The Food & Drug Administration prohibits companies from talking about products before the agency approves them, for fear that patients’ hopes could be dashed if the claims didn’t hold up. According to court documents recently unsealed in a Massachusetts whistleblower case, drugmaker Parke-Davis (now a division of Pfizer [PFE ]) put profits ahead of the public health by deliberately breaking FDA rules against promoting unapproved uses for drugs. Parke-Davis got FDA approval for its drug, Neurontin, for a very narrow use — as an add-on treatment in some cases of epilepsy. But the whistleblower lawsuit alleges that Parke-Davis boosted sales by illegally marketing the drug for pain, anxiety, depression, and other more lucrative uses. The drugmaker even wrote articles on how Neurontin worked for the larger uses and paid scientists to “author” the papers and publish them in professional journals. Subsequent studies suggest the drug may not be effective for those uses. CHALLENGE NO. 1. These stories illustrate the two sides in the fight over a company’s right to talk about its products. And now, the FDA, in a landmark reexamination of its approach to the advertising and marketing of food, drugs, and medical devices, is putting the issue up for debate. Stung by losses in court, in May the agency invited anyone to comment on its rules, which govern everything from how much fine print has to be included in drug ads to what health claims can be made for breakfast cereal. With the comment period now over, the reevaluation is shaping up as one of the first major controversies that will confront Dr. Mark B. McClellan, the highly regarded former Stanford University health economist who was just sworn in as the new FDA commissioner. More : businessweek.com |