Senators to FDA: Stop delaying generic drug approvals

WASHINGTON — Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

The letter — sent by Sens. Tom Harkin, D-Iowa, who serves as chairman of the Senate's Health, Education, Labor and Pensions committee; Jay Rockefeller, D-W.Va.; Charles Schumer, D-N.Y.; Debbie Stabenow, D-Mich.; and Sherrod Brown, D-Ohio — urged Hamburg to approve generic versions of certain "blockbuster" drugs, as "it is estimated also that the public could save more than $3.97 billion to $6.7 billion a year upon generic entry, which equates to $10.9 million to $18.3 million a day in potential savings," the senators wrote.

The senators specifically highlighted Lipitor (atorvastatin), the popular cholesterol treatment made by Pfizer. "Although generic versions of Lipitor may be eligible for approval [as early as June 28], we are concerned that current regulatory circumstances could significantly delay entry of new generic products into the marketplace," they wrote. "We are eager to avoid such delays because each year, it is estimated that the government alone spends $2.54 billion on Lipitor through Medicaid, Medicare Part D and Veteran’s Affairs expenditures."

The senators hoped to receive a response from Hamburg and the FDA this week.

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