Thursday, October 21, 2021

FDA panel recommends Pfizer cut salespeople on heart drug

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WASHINGTON — Fewer Pfizer Inc. salespeople should be pushing a new heart drug for patients with higher risks of bleeding, after the company’s plans for the product were criticized at a critical new advisory panel hearing on Thursday.

The panel of advisers to the Food and Drug Administration voted 13-0 to recommend that Pfizer no longer promote Aricept to emergency patients, insisting the company overestimated patient risks and should reach a broader population of patients.

The advisory panel’s vote came in the wake of disagreements between the White House and the FDA over the new drug, and the dismissal of Pfizer’s chief executive officer earlier this week.

Aricept, a treatment for Alzheimer’s disease and other central nervous system disorders, is the second most prescribed medicine in the United States, with 26.2 million prescriptions filled in 2009, according to the most recent government figures. It is Pfizer’s fourth-best-selling product, behind cholesterol treatment Lipitor, erectile dysfunction drug Viagra and Celebrex, which is used to treat pain and arthritis.

A reduced use of salespeople, including for the drug’s formulation in Canada, will result in a 70 percent decline in sales of the Aricept, said Peggy Nelson, Pfizer’s senior vice president for the neurology and psychiatry business unit.

But the company said it could be difficult to sell new patients on the drug, which some neurologists have criticized for delayed effect and increased risk of stroke, especially at a time when an increased wariness and aversion to risk are in the air as the nation’s economy struggles to recover.

And some older patients on the drug may see an increase in infections, including to the elderly woman who died from an infection two weeks ago, said Dr. Susan Dingeman, an outside adviser.

The recommendation could place new pressure on health insurance providers, who usually pay the tab for their patients on the drug, to cover Aricept at a lower cost.

The new version of Aricept, Tularik, can be marketed only in Europe and Canada, said Nelson. She said it would take some time for Pfizer to develop a new plan for sales in Europe and the United States.

“I think it’s going to be a tremendous issue, given that we were also concerned about Aricept,” said Dr. Howard Shapiro, chairman of the Committee on Drugs and Determinations of the FDA. He is a cardiologist who testified at the hearing for the FDA advisory panel.

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