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Overview

Viewpoint

Last reviewed: November 2010

Here, a monthly perspective from Consumers Union on the latest challenges—and possible solutions—facing U.S. consumers today. See archived letters.

 

Long waits for generics

Pharmacist surrounded by shelves of pills
Held up
Approvals of generic drugs have been delayed, costing consumers money.
Photograph: Getty Images

Switching from name-brand drugs to their generic versions is one of the easiest ways for consumers to save money on health care. And they can save a lot.

A recent check on Medicare.gov showed that a person could spend some $3,500 to $5,000 less per year by switching to generic versions of three widely used brand-name drugs: Pravachol (for cholesterol), Zoloft (for depression), and Flomax (for enlarged prostate). Consumers Union's free website, BestBuyDrugs.org, which compares the cost and effectiveness of medications, often finds that older, less expensive generic drugs are as effective and as safe as newer medicines.

So it's maddening that thousands of applications for new generic drugs have piled up at the Food and Drug Administration's Office of Generic Drugs, in part because the agency doesn't have the staff to process them. That's costly to consumers, insurers, and taxpayers, who foot the bill for a large part of the nation's drug costs through Medicare and Medicaid.

Fees from pharma?

Consumers Union believes that the FDA should receive substantially more funding from Congress to move quickly through the backlog. What it actually gets, though, most likely won't be enough.

One option is to charge generic-drug makers a "user fee" to pay the costs of processing applications. Brand-name drug makers already pay hefty user fees to help speed their applications through the FDA. That money is expected to provide about a third of the agency's budget this year.

In general, we oppose user fees that allow a regulated industry to fund the regulators. A government agency can become dependent on the companies it's supposed to objectively regulate, which can influence decisions. In a 2006 survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, many FDA employees said they felt pressured to hastily and perhaps improperly approve user-fee drugs. And at least one felt the agency viewed industry, not the American public, as its client.

If user fees are truly the only option to break the logjam, strong consumer safeguards are essential: Ban timelines for approval or rejection of applications to give regulators enough time to make good decisions; require FDA staff who work on an application to publicly sign off on the safety of approvals; and resort to generic-drug user fees only until the backlog clears.