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25 Billion in Generic Drug Savings Underscores
Need to End Generic-Approval Backlog at FDA


A report finding consumers could save nearly $25 billion this year by switching to generic prescription drugs underscores the need for the Food and Drug Administration to remove roadblocks that are keeping more affordable generics from reaching the market quickly, Consumers Union said.

“It’s been estimated that up to 800 generics have yet to reach the market because the FDA has a three-year approval backlog. When generics aren’t available, consumers are forced to pay for equivalent higher-priced, heavily advertised brand-name drugs,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

“The Federal Trade Commission and the FDA also need to do more to stop the outrageous, but growing practice of brand-name companies manipulating the generic market through so-called ‘authorized’ generics, and by actually paying generic manufacturers to delay bringing lower-cost drugs to market,” Vaughan added.

The analysis released by Express Scripts, Inc., one of the largest pharmacy benefit managers in North America, found that Americans could save $24.7 billion this year if they were prescribed more generics in six major drug classes for treating conditions such as heart disease, ulcers, pain, depression, high blood pressure and high cholesterol. The company said the savings reflected in part the introduction of two new generics this year – the cholesterol-lowering drug simvastatin (generic Zocor) and the antidepressant drug sertraline (generic Zoloft).

The report is the second in recent months to quantify generic savings. An analysis released in April by the Pharmaceutical Care Management Association – the trade group for pharmacy benefit managers (PBMs) – projected $26.4 billion in savings between now and 2009 if optimal use is made of 14 generic drugs scheduled to become available over that period. Much of the savings would accrue to people over age 65, and thus reduce expenditures in the new Medicare drug program.

Consumers Union’s free public education project on prescription drugs, Consumer Reports Best Buy Drugs (www.CRBestBuyDrugs.org) has identified the most effective, safe and affordable medicines in 13 drug classes, with most of the “Best Buys” being generics.

“Switching to generics whenever possible is, quite simply, one of the clearest paths to reducing health care spending in the years ahead,” said Steve Findlay, Best Buy Drugs managing editor. “But we need government policies and practices in the marketplace to make sure the obstacles on that path are removed.”





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