Duckworth Calls for an End to Generic Drugs Backlog

DUCKWORTH CALLS FOR AN END TO GENERIC DRUGS BACKLOG

Tammy Duckworth, who has made health care the centerpiece issue of her campaign for Congress in Illinois' 6th District, called today for steps to reduce a massive backlog holding approval of generic drugs. Doing so could result in considerable savings to consumers who rely on prescription medications.

Currently, an estimated 800 generic-medication applications are awaiting approval from the Food and Drug Administration, the largest such backlog is history. The approval process is now taking about 20 months for each drug; the normal time is 6 months.

"We need to act swiftly to get these drugs to market— to save people's lives and save Americans billions of dollars in health care costs," she said.

The backlog is attributable to several factors. Historically, the pharmaceutical industry has used regulatory loopholes to keep generic drugs off the market—forcing patients to use their brand name equivalents.

Additionally, the Bush administration has consistently under-funded the FDA's Office of Generic Drugs.

In recent years, many brand-name drugs have lost their patent protection, making generic alternatives an option if they were approved and available to the public. That trend will continue this year, as generic alternatives become available for at least 15 brand-name drugs, and drugs which account for $11 billion in sales lost their patents.

Duckworth called on Thursday for three steps that could speed-up generic drugs reaching the market:

* A modest—but effective—investment in funds. Industry experts point out that approximately $15 million per year in additional funding to the FDA's Office of Generic Drugs could solve the backlog problem—a small investment considering the potential savings. One study estimates that wider generic drug use could have saved consumers $20 billion in 2004 alone. Experts claim that Americans spent about $250 billion on prescription drugs in 2005; but that using generics can cut costs by about one-fifth.

* Limiting drug companies' ability to block new generics. One tactic that the pharmaceutical makers have used is to file numerous patent infringement challenges that delay the entry of generic medications. Duckworth said that she would support legislation limiting companies' use of such challenges.

* Expanding the number of antibiotics that are eligible for generic versions. A loophole currently exists that blocks competition among original uses of an arbitrary subset of antibiotics. Duckworth would fight to cancel that loophole.

Duckworth said that it was logical to close loopholes that drug companies have exploited to block generics from reaching the market.

"These are the same companies who are set to make an additional $140 billion in profits from the new Medicare Part D bill that their lobbyists help draft. The price tag for this new program has included higher costs and confusion for seniors—and higher deficits for all of us," she said.

"Closing these loopholes would be a small—but fair and effective—price for the pharmaceutical companies to pay," she said.

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