FDA Approval Rate for New Drugs Drops Dramatically after Major Recalls like Vioxx


Now years removed from the backlash over the infamous defective drug Vioxx marketed by drug giant Merck and nearly one year from the massive $485 billion settlement that Merck agreed upon to compensate the heart attack and stroke victims and surviving family of those who wrongfully died from that drug, the FDA seems to be treading ever more carefully in its approval of new drugs.

The mistakes involving Vioxx certainly proved the devastating public safety consequences of rushing through drug trials or maintaining lax enforcement on drug standards.

Though it publicly denies that it has implemented tougher standards since the Vioxx recall in 2004, the FDA has overseen a drastically decreased passage of new drugs over 2006 and 2007.

In 2006, the FDA approved only 22 new drugs, and only 19 in 2007, its lowest amount in a single year since the major prescription drug boom in the 80s and 90s.

As all reports indicate, 2008 is shaping up to be much the same.

Currently, only 18 drugs have been approved, and individual pharmaceutical manufacturers have plenty of anecdotes of seemingly more rigorous approval measures that are beginning to hamper business.

Drug giant Eli Lilly & Co., maker of Prozac, Cialis, Methadone and controversial preservative Thiomersal, reported that the FDA wants to take an extra three months to approve its much-anticipated heart drug prasugrel.

Merck itself has been asked to wait for approval of a cholesterol drug named Cordaptive, pending the results of a clinical trial that could set its entry into the market back as much as five years.

With the caution in passing new drugs onto the public market comes an increased retroactive awareness of new side effects discovered. The FDA calls these revisions "black box warnings," since the warning is printed within a thick black border to catch the consumer's attention.

In 2007, the FDA issued 75 new or revised black box warnings, a stark increase from previous years and double the 2004 number, when Vioxx was king of the pharmaceutical market to the tune of $2.5 billion in revenues.

For sure, the fact that the FDA may be moving more cautiously when it comes to consumer safety is a big benefit.

A recent article on defective drugs by Total Injury staff writer Gerri Elder outlines the enormous problems that come from the FDA rushing too many drugs through the process, and argues that so few of new drugs approved are needed, that the FDA may be flooding the market with too many choices.

However, the upshot of the restrained numbers of drug approvals is that companies are tightening down research and development work, a tragic consequence.

Sick folks may need what the latest drug to be approved offers; if it can't get through the approval process in a timely manner, it could even cost lives. One man, in fact, is fighting the FDA to try to get unapproved drugs that may help into the hands of dying patients as a last-resort method.

One thing's for sure: the FDA and drug companies have made their bed. They might be kicking a little, but they're sure having to lie in it.

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