It appears the FDA has greater focus on deadlines than on public safety

When you give bureaucrats a choice between ensuring public safety and meeting deadlines, which of those do you suppose wins out?

Sure, you can see this one coming a mile away.

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

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, drugs that just squeaked under the deadline were much more likely to require FDA safety intervention after the drugs were on the market.

I guess those thousands of consumers who suffered serious adverse side effects can take comfort in knowing that deadlines were met.

Of course, every time we have a Vioxx fiasco or a Trasylol fiasco or some other drug safety fiasco, you can be sure a few congressmen will get up in arms and call for an investigation to find out what happened.

Hello! Earth to Congress! The trail of evidence leads straight to your door.

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