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We spoke recently to an in-house lawyer at a generic drug company.
(Aw, c’mon, innovator clients! You can’t fire us for that! Surely we’re allowed to talk to the guys, even if we can’t represent ’em.)
The generic guy was outraged that Representative Waxman wants Congress to pass a bill barring direct-to-consumer advertising for the first two years that a new drug is being sold. (Here’s a press report on that effort.)Waxman’s worried that aggressive DTC marketing “increases the number of consumers exposed to safety risks of new products long before those risks are truly understood.”
Why was the generic guy disturbed about a statute limiting advertising by innovators? You’re not thinking hard enough: Generic manufacturers want the innovators to spend a ton of money on catchy musical jingles and celebrity spokespatients so there’s plenty of demand for the product when it goes generic years later. The innovators’ advertising expenses redound in part to the generics’ benefit.
But how should the innovators themselves feel about banning DTC ads for the first two years of a new drug’s life?
As a rule, we never have mixed emotions at the Drug and Device Law Blog. We’re making an exception here.
On the one hand, the FDA weighs the risks and benefits of new drugs. If a drug is approved, then the FDA has decided that the drug is sufficiently safe and effective to be made available to the public. Is there a reason to limit that decision?
Moreover, we’re big believers in the First Amendment, and drug companies shouldn’t lightly be barred from making truthful statements about the risks and benefits of their products.
And, on a completely non-legal front, if sales of new drugs are artificially depressed for the first two years of a new product’s life cycle, there will be less revenue available for investigating and developing new drugs. That’s a substantial cost to impose on society.
On the other hand, your dynamic blogging duo basically works in legal, not marketing. That makes us naturally conservative. If the company sells less of a product, then there are fewer people exposed to the product, and fewer potential plaintiffs. That would make mass torts less massive and all litigation easier to defend.
And, of course, if the law barred DTC advertising for two years, we could explain to juries that the law requires not just FDA approval of a new drug, but also an intentionally slow introduction to the market to help protect public safety, even if that slow introduction reduces corporate profits.
So we’re of two minds on this issue.
But we can’t stop there: Remember the decision in West Virginia ex rel Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), which rejected the learned intermediary doctrine? (If you don’t remember it, you can refresh yourself by reading one of our outraged earlier posts here.)
Karl reasoned in part that direct-to-consumer advertising “obviates each of the premises upon which the [learned intermediary] doctrine rests.” If Congress bans DTC ads for the first two years of a drug’s life, then Congress may help to undo Karl, which we deemed one of the worst decisions of 2007.
By passing what purports to be a consumer protection bill, Congress may unintentionally help to undo a purportedly consumer-friendly decision from West Virginia’s Supreme Court.
Even if your emotions are mixed on other issues, you’ve gotta be tickled by the irony in that possibility.