Critics of drug ads have been calling for restrictions ever since the ads hit the airwaves back in 1997.  The pharmaceutical industry has always been able to block any Congressional attempts at putting meaningful regulation into place.  This past year, a number of Congressional Reps and Senators tried to put in place a “moratorium” in which new drugs would not be able to advertise to consumers for a certain length of time (say, two years).  Even that modest reform was removed from the final bill, which became the FDA Amendments Act of 2007. (FDAAA, which we prefer to pronounce as though it’s “open wide and say FDAaaaaaa….”).

One reform did make into the final legislation, however.  But don’t fret — the ad agencies that produce drug ads won’t be showing up on your street corner with “Will Shill for Food” signs anytime soon. The FDA has never had the power to require drug companies to submit their ads before they hit the airwaves, and they still don’t.  But, now, drug companies can voluntarily submit drug ads to the FDA for “pre-broadcast review.” If they choose to do so, they have to pay a fee for that review. And the FDA has just announced that the fee for each ad in 2008 will be $41,390.  That’s a pretty modest fee – most ads no doubt cost much more than that to produce and to air.

How did the FDA arrive at this seemingly odd number? Why $41,390 and not $57,642?  The FDAAA called for the FDA to raise $6.5 million for the program in the first year. The FDA asked drug companies to estimate how many ads they’d submit in 2008, and then divided $6.5 million by that number.  Which means that drug companies estimated that they’d be submitting 157.04 ads for pre-broadcast review in 2008 (I, for one, look forward to seeing the .04 ad – I imagine it won’t get past “Ask you doctor ab…”).

What if a drug company goes over its estimate?  It pays a 50% surcharge.

Now one might reasonably ask “Why would a company submit an ad for pre-broadcast review if it’s voluntary?”  And that’s a good question.  Arguably, many won’t.  Those that will are hoping to avoid the FDA later issuing an enforcement letter citing violations in their ads. Better to get “clearance,” if you will, beforehand, than a rebuke after the fact.  This is the reverse of the old saw that it’s better to seek forgiveness than permission.

Here’s what’s unclear:  What legal status will an FDA pre-broadcast approval of an ad have? What if, for instance, consumers are deceived by an ad that overstates a drug’s effectiveness or understates its risks, despite the FDA’s pre-broadcast review, and file a lawsuit claiming that the ad violates state consumer protection acts?  I have no doubt that drug companies will argue that an FDA pre-broadcast approval of an ad “preempts” any claims under state law that an ad was unfair or deceptive.  The industry has been arguing that virtually any claim under state law that a person was harmed, deceived, injured or even killed is “preempted” by the FDA’s authority to regulate prescription drugs. (We’ve written about the preemption issue ad nauseam on this blog — see archived posts on the topic here).

Arguably, the standards that the FDA will apply in its pre-broadcast review are different than those that are relevant to state consumer protection laws, which aim to protect the public from “unfair or deceptive” conduct in the marketplace. The FDA is primarily concerned with making sure that drug ads do not “misbrand” drugs a term from the Food, Drug and Cosmetics Act and the FDA’s regulations.) Conduct that is “unfair or deceptive” under state law is arguably broader than conduct that constitutes “misbranding.”  But conduct that constitutes “misbranding” is most likely also “unfair or deceptive” under these state laws. This is a good example of how state consumer protection law and the FDA’s authority are complementary, rather than contradictory.  So I would argue that an FDA pre-broadcast approval should not insulate a drug company from liability under state law. Whether or not courts will agree is an open question — the jury, as they say, is still out on the issue.  The Supreme Court just recently took up the preemption issue generally in the case of Riegel v. Medtronic, a case that concerned medical devices, not drugs.  (PAL joined an amicus brief in that case, and we’ve blogged on it here before.)  The Supreme Court’s ruling on preemption in that case is likely to have some effect on how Courts address drug preemption issues, although not as much as if the Supreme Court directly addressed the question of preemption in the realm of drugs.

It will be interesting to see how the FDA pre-broadcast review program shakes out in its first year.  Will it result in fewer enforcement letters being issued? Will it change the tone and tenor of drug ads in any meaningful way?  To find out, all you’ll need to do is stay tuned to your TV, where drug ads will continue to bombard you on a regular basis. Enjoy!

To see the FDA’s notice on these new fees, go to