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Speedy Drug Approvals Put Patients at Risk

Dec 3, 2008 | Parker Waichman Alonso LLP

A prominent researcher has charged that pressure to quickly bring new drugs to market may be endangering patients.  To often, quick approval means a drug's dangerous side effects  are missed, and only discovered years after a medication has been on the market.

In an article he wrote for The British Medical Journal, Dr. David Kao of the University of Colorado Health Sciences Center points out that the U.S. Food & Drug Administration (FDA) had instituted new procedures over the last decade or so aimed at speeding up drug approvals. As an example, Kao points to the 1992 Prescription Drug User Fee Act, or PDUFA.  This act allows the agency to impose user fees on drug companies to help speed drug approvals.  The act is credited with reducing the average time to approve a drug from  33.6 months during 1979-86 to 16 months by the 1997-2002 period.

But Koa writes that the focus on approving new drugs quickly takes the focus off of dangerous side effects. Under the current system, Koa said new drugs are only tested on a few thousand people at most.  The FDA and drug makers then use post-approval surveillance to watch for  side effects that didn't become apparent during pre-approval clinical trials.

Koa points out that previous research has shown that drugs approved in the U.S. close to a mandated deadline are more likely to need additional safety warnings later, or even be withdrawn for safety reasons. This can lead to public health disasters, such as what happened with Vioxx.  According to Koa, 20 million patients had taken the dangerous drug before it was withdrawn in 2004 - five years after its approval - because of its link to heart attack and strokes.

To protect patients, Koa said he believes that the systems for reporting adverse drug reactions must be improved.  He suggests drug makers could play a role in this by using the types of aggressive techniques they already employ to market a new drug. For example, laws in the U.S. already compel TV  drug ads to instruct patients experiencing negative side effects to report their symptoms to the FDA.  Koa says that  the use of  other multimedia techniques - such as websites and direct mailings - could be expanded to include campaigns dedicated to drug safety monitoring.