If the FDA Wore a Uniform

February 25th, 2010. By Hunter West

You gotta love the good ol’ FDA (US Food and Drug Administration) for its renewed stance on oversight on things such as drug advertising. Four months into the Obama Administration, the FDA gets a new leader—Margaret Gamburg—and all of a sudden things start happening.

Among other crackings of the whip, the FDA issued draft guidelines designed to clarify what is appropriate in drug ads. You know, things like upping the music volume when all those nasty, ‘adverse reaction’ bits appear. Or the use of distracting images and visuals to take the focus away from what you are hearing. 

The renewed focus on what consumers are seeing in medicinal TV ads—which seem to take center sponsor stage on the major network television newscasts each night—stems from a few well-placed cat calls from John Dingell and Bart Stupak. Back in 2008 the two congressmen openly questioned if drug advertising properly presented product benefits and risks. 

Among other complaints, Stupak criticized Pfizer for using the inventor of an artificial heart, Robert Jarvik, to promote its cholesterol drug Lipitor because he isn’t licensed to practice medicine and the ad didn’t disclose he was paid for his endorsement. 

And so the FDA got busy. Things really got rolling when the new FDA commissioner was put in place in May, in tandem with a President who promised greater FDA oversight in the wake of a tidal wave of bad news on the drug front during the last several years. 

Here’s the question… 

What would happen if our police forces operated like the FDA? 

That’s what the FDA is, isn’t it? The drug police for the pharmaceutical companies? The agency has to vet new drugs to make sure they’re safe—no, check that—to make sure the benefits outweigh the risks, and to keep Big Pharma on their toes for the benefit of the people. 

So why does the commitment on oversight filter down from the Oval Office? 

During the Bush Administration the FDA was criticized for being too soft on the pharmaceutical companies. (For that matter, the National Highway Traffic Safety Administration was also criticized for not looking hard enough when problems with Toyotas first began surfacing years ago). 

Trasylol was allowed to stay on the market even though there was good evidence that it was killing people. It wasn’t until a clinical study in Canada was halted because too many trial participants were dying. Then the medical authority in Bayer’s native Germany told the Trasylol manufacturer that under no circumstances would Trasylol be welcome any longer on the pharmacy shelves of Deutschland. 

And so Bayer agreed to stop marketing Trasylol. The FDA thought it would be a good idea, too. 

Well things are different, now. There’s a new President in the White House promising to help everyone pull up their socks. He has placed a new leader at the helm of the FDA to facilitate just that. 

And what is being facilitated? Standards that were already there, according to Thomas Abrams, who told Bloomberg News in late January in a conversation about pharmaceutical advertising that “our standards haven’t changed, but we are trying to do a better job at reaching the industry.” 

John Busbice, a principal in commercial effectiveness at IMS Health Inc., a Norwalk, Connecticut-based market research company, said of the US drug regulatory watchdog, “The FDA has now developed a reputation of being an active governing body.” 

Oh, goody. But why shouldn’t this be a constant? Why must it depend on influence from the top? Are there no such things as laws, and regulations that require enforcement regardless of who is running the show? 

Perhaps a police force is only as good as the chief, but that’s an over-simplistic statement. The laws of the land must be enforced, and that goes for everybody. Imagine the chaos if police operated like the FDA? Sure, we’ll leave this known drug pusher who is selling OxyContin tabs to our kids because he also happens to do well financially and contributes scads of cash to the Police Benevolent Fund. 

And we’ll let Kiefer Sutherland walk away from his DUI because we’re a fan of ’24.’ Oh yeah, the chief is a fishing buddy of the mayor and they’ve worked out a sweet deal where anybody who drives a GM car can ignore the speed limits. Cops will look the other way. The mayor says there’s a reason why he favors GM, but he isn’t saying… 

A rule is a rule. A law is a law. It’s bad enough that various statutes of limitations, and the capacity for plea bargains in courts of law can achieve diminished punishments, but that’s a whole ‘nother matter. If there is a regulation, it should be enforced—regardless of who is sitting in the executive suite. Deals are for card games, or when negotiating the price of a car. A deal should never impede, or get in the way of law. 

So the FDA is enforcing the rules now. Good. It never should have stopped in the first place. Let’s just hope that whoever takes over from Obama in three, or seven years from now will dictate similar positions. And should someone come into the White House who says, “hey boys, go easy on those nice folks at the drug companies now…” let’s hope the FDA flips the bird and walks the other way…     

Tags: Dingell, DUI, FDA, Gamburg, OxyContin, Stupak, Trasylol

This was posted on Thursday, February 25th, 2010 at 4:31 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.