Monday, February 16, 2009
More on the proposed ban on prescription drugs direct to consumer advertising
Here is a link to a comment by the folks over at Drug and Device Law Blog on the proposed ban on direct to consumer advertising of prescription drugs. Remember that some legislators want Congress to pass a bill barring direct-to-consumer advertising for the first two years that a new drug is being sold based, at least in part, on the argument that marketing "increases the number of consumers exposed to safety risks of new products long before those risks are truly understood.” As you would expect, drug manufacturers strongly oppose the idea; but perhaps more surprisingly, D&DL Blog reports that, at least, some generic drug manufacturers oppose it too. Their point does make sense: "Generic manufacturers want the innovators [the drug companies that manufacture the original drug] 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." What is even more surprising, though, is that the D&DL Bloggers admit they have "mixed emotions" about the proposal. See their reaction here. They start by stating that "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." Then they counter, "On the other hand, . . . [i]f 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." It is an interesting approach. But I wonder why is there a need to worry so much about people getting exposed to the product if we can be so confident that if the FDA has approved it, it is "sufficiently safe." I think this exposes a weakness in the first premise, upon which the argument for preemption is also based, by the way. I think it is fair to say that history has shown that we don't necessarily want to place so much faith on the FDA's ability to perform (or efficiency in performing) its function.