Drug safety may be compromised by mandated FDA deadlines

Drug safety may be compromised by mandated FDA deadlines

We can file this one in the Sarcasm Cabinet, in the drawer marked “Gee – Ya Think?”

Harvard professor Daniel Carpenter conducted a study to see if congressionally mandated deadlines for drug approval might impact drug safety.

How do you suppose that went?

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), which established this directive for the FDA: When drug companies submit a drug for approval, the agency must complete its analysis and render a decision within 12 months. If 90 percent of all drugs up for approval are not approved or rejected within 12 months, funding for the agency will be reduced.

Wait – it gets better.

In 1997, Congress changed the deadline to 10 months. And the 10-month deadline was renewed in 2002 and again in 2007.

So when Prof. Carpenter examined data on drug approvals going back to 1950, he found that since 1992 a disproportionate number of approvals have been granted right before the deadline. And when he compared the long-range outcome for those drugs approved at the last minute to the outcome for drugs that were given a longer approval process (sure, you can see it coming a mile away), drugs that squeaked under the deadline were much more likely to require FDA safety intervention after the drugs were on the market.

In other words, meeting the deadline was more important than ensuring safety.

Of course, every time we have a Vioxx fiasco or a Trasylol fiasco or some other drug safety fiasco, Congress convenes an investigation to find out what happened.

Hello! Earth to Congress! The trail of evidence leads back to your house.

Source:
“FDA Deadlines May Compromise Drug Safety by Rushing Approval” Harvard University Press Release, 3/26/08, eurekalert.org