I find the FDA’s new plan to have pharmaceutical companies directly fund the agency’s review of drug commercials — through so-called “user fees” — strangely amusing. But then, I always found Orwell amusing, too.
The FDA positions the plan as a toughening of previously lax regulations in response to public complaints about direct-to-consumer ads. The reality is, the projected $6 million in annual fees for FDA review would primarily serve to keep the drug ads coming at a blistering pace. As one observer sums up FDA priorities:
[FDA officials] behave as if their job is to get as many “good products” to the American public as quickly as they can. The focus should be on public safety rather than on facilitation of the drug availability process.
In this respect, it occurred to me that the FDA has become to Big Pharma what the MPAA is to the movie business: a sham regulatory body whose chief purpose is to run interference against consumer complaints.
Let’s follow the analogy through. The big studios created the MPAA rating system as a way to regulate film content in response to complaints from theater owners (and their patrons) about the rising level of sex, violence and profanity in the movies. The MPAA’s objective wasn’t to “clean up” movie content; it was to keep the flow of product moving into as many theaters as possible. (As we know, the ratings system has done little to stem the industry’s race toward more explicit content.)
Similarly, we now have public complaints about drug advertising. But unlike the movie industry, Big Pharma doesn’t have to create its own organization to “police” ads. Why not? Because it can outsource the job to the FDA!
That’s right – for a mere $6 million per year, Big Pharma has its very own government agency to approve its ads and blunt public pressure for real regulation.
What a deal, huh?
What is true now, regardless of what may have been heard, is that any big pharma company can put anything on TV or distribute any material to prescribers without authorization from the FDA, until they get busted. That’s the way it is.