DEERFIELD, Ill. —Adopting a tougher and more interventionist tone with the U.S. drug and medical device market, the Food and Drug Administration signaled in May that it was closely scrutinizing a plan by Pathway Genomics to sell its saliva-based genetic test kits in thousands of drug stores operated by the nation’s two largest pharmacy chains. In response, both Walgreens and CVS Caremark announced May 18 that they would delay any move to offer the products until questions posed by the federal agency were resolved.
Those questions arose following published reports that Pathway would begin selling its genetic test kits in most of Walgreens’ 7,500 stores last month, and in CVS stores beginning in August. The reports triggered new scrutiny from the FDA, which indicated in mid-May that it has no record of having approved the kits for sale.
The federal agency may be adopting a more assertive stance to product reviews and approvals under commissioner Margaret Hamburg. Hamburg, who was confirmed by the Senate as head of the FDA on May 18, 2009—exactly one year prior to the drug chains’ decision to suspend their sale of the test kits—told Reuters news service that her agency would “take a hard look at any claims made by [Pathway].”
Fast on the heels of the FDA’s announcement, the House Energy and Commerce Committee, chaired by U.S. Rep. Henry Waxman, D-Calif., revealed it also is scrutinizing genetic test kits sold online by three manufacturers, including Pathway and two other kit makers, 23andMe and Navigenics.
Both Walgreens and Pathway originally asserted that FDA approval is not needed for the sale of test kits in a retail setting. But FDA spokeswoman Erica Jefferson told Reuters, “If a company is making claims about a product that hasn’t been reviewed or validated by the FDA, we want to make sure the information to consumers is accurate, and the test will do what it says it will do.”
In response, both pharmacy retailers reversed course and announced that they had shelved, for now, plans to go ahead with a rollout of the kits. “In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” said Walgreens spokesman Jim Cohn.
“We are not moving forward until we understand the outcome of the suppliers’ discussions with the FDA,” CVS said.
The Pathway tests involve a saliva-based sample of a patient’s DNA, which is mailed to a laboratory for analysis. The tests are intended to assess genetic markers for such potential conditions as diabetes and cancer. The kits themselves retail for $20 to $30, but users would pay several times that much for a full set of lab analyses.
In a statement, Pathway said it was “communicating with the FDA about the Pathway Genomics Insight collection kit.”