Prescription Drug User Fee Act Needs Reform

It is no secret that Americans are bombarded with pharmaceutical advertisements from every media front. As a result we take more prescription drugs than any other society in the world and many of the drugs Americans take are highly addictive. It seems like every year the FDA approves a new prescription painkiller, even if the doctors on FDA panels are against such approvals - as was the case with Zohydro ER (pure hydrocodone).

How does this happen? The answer has to do with a law that was passed in 1992 that allowed the FDA to speed up the trial and approval process of new drugs - called the Prescription Drug User Fee Act. Since the law went into effect, pharmaceutical companies had the option to pay the FDA fees to speed up the approval process. Drug companies have no shortage of cash and are more than happy to use their bottomless pockets to get a drug out on the market as soon as possible. What could possibly go wrong?

As you might imagine, a new study has found that more prescription drugs than ever before have received black-box safety warnings or have been completely withdrawn from the market, almost 27 percent, since the Prescription Drug User Fee Act went into effect, reports CBS. When you compare that number to the 21 percent of drugs that received black-box safety warnings and/or were withdrawn before 1992, it is easy to see that not enough research is being conducted on drugs before they are released on the market.

“New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval,” the researchers wrote in Health Affairs. “We believe that the ultimate solution is stronger U.S. drug approval standards.”

Researchers note that after the law was passed, median drug approval times were reduced from 33.6 months in 1979-1986, to 16.1 months in 1997-2002. 

“Our findings suggest the need for reforms to reduce patients’ exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently,” the researchers wrote.