Payoffs to FDA for new drug apps now just a part of doing business

The insane law that’s giving us more dangerous drugs every year

Let’s say you’re applying for a job.

You’ve submitted your resume, scored an interview, and as you’re shaking hands with your potential new boss you slip him a few hundred dollar bills. You know, just to process your application and all.

Sounds kind of fishy, doesn’t it?

Well that kind of thing goes on all the time with the FDA.

Only it decides the amount that a drug company must “slip” the agency to get a new application in the door.

The FDA figures out each fiscal year how much it wants. And it’s not cheap.

But for Big Pharma, it’s well worth the price.

It’s called the Prescription Drug User Fee Act (PDUFA), and since 1992 it’s been the way the FDA does business.

And when you see what it charges, it appears that it’s a very successful business. For this fiscal year, each new drug application that requires clinical data cost Big Pharma over $2 million to submit!

The FDA even gets to increase that each year. Sort of a cost-of-doing-business raise to itself.

But drug companies must get something in exchange for all that money. I mean $2 million has to buy you something, right?

When one of them sends in a new drug to be approved, the FDA must make a decision within 10 months. And everyone who works at the agency is under big pressure to meet those deadlines.

Investors, financial analysts and especially the drug company that’s waiting for its drug to be put on the market are all breathing down its back.

But what has all this done for us — the people who take these drugs?

A group of researchers just took a look at what that high-priced, fast paced process has given us over the past 22 years.

And what they found were more black box warnings and more dangerous drugs being approved — and then later being removed from the market.

In fact, since the PDUFA went into effect 20 different pharmaceuticals — ones approved by the FDA — have been recalled.

“The FDA is under constant pressure to rush new drugs through the pipeline to approval,” said the study’s lead author Dr. Cassie Frank, a professor of medicine at Harvard.

“In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” she added.

The researchers said that patients should be “wary” of new drugs rushed through the gate by the FDA.

Of course, Big Pharma just loves the PDUFA, and so does the FDA. It’s sort of like a dream come true for both of them. And drug companies don’t mind those big payments to the agency either. When you stand to make billions on something, what’s a few million?

But as cozy as this relationship is between industry and our government “watchdog” agency, it looks like things might go downhill even more.

This year, FDA head Margaret Hamburg gave a talk before a group of over 300 drug company bigwigs. And she promised “swifter, more efficient” review and approval.

She said that the FDA sees a “new era of partnership” where “we don’t just wait for an application to come to us.”

And that “new era” sounds like it will be focusing even more on drug company profits.

And even less on human lives.

Sources:
“Have faster FDA drug approvals caused more safety problems?” Ed Silverman, August 5, 2014, The Wall Street Journal, blogs.wsj.com