If a consumer lawsuit claims that labeling is false and misleading, and FDA approved the labeling, doesn't that make FDA somewhat responsible for the false advertising?You would think that FDA would stick up for its jurisdiction and authority. If courts are second-guessing what is false and misleading, when Congress has expressly given that responsibility to FDA, you would think the agency would intervene with some kind of amicus curiae brief or some willingness to testify or participate. [An amicus curiae brief is a "friend of the court" filing in which an agency like FDA can intervene and deliver its point of view, which is intended to be preemptive.] But the one time we saw FDA try to intervene with amicus briefs was in some California cases. I think one was a Paxil case in which consumer groups were trying to get additional labeling that exceeded what FDA had approved. Dan Troy filed an amicus brief, and members of Congress went after him aggressively, saying, "You are a shill for industry," and "These were former clients of your law firm." Congress ignored the fact that FDA was trying to argue preemption to preserve its jurisdiction and eliminate the burden on interstate commerce and having separate labels in every jurisdiction.

On the question of accountability, do consumers have a legitimate complaint against pharma advertising if their doctor, who prescribed the medicine for them, thought it was the right thing to do? I haven't seen any accusations that doctors are prescribing drugs to patients that don't need them. I have seen some statistics in Prevention magazine and others that show if a patient is a candidate for a drug and there are several competing drugs available, the drug the patient asks for gets prescribed. But I think you would have to agree that doctors have the obligation to counsel their patients correctly. It's hard to believe that a doctor would be persuaded by a patient who saw a commercial if that patient either didn't need the drug or if a more effective drug was available. That's malpractice.

There used to be a defense called the "learned intermediary." It still exists even in the face of direct-to-consumer advertising because the patient cannot get the drug without the doctor being the intermediary. That line, so far, has been preserved.

Doesn't DTC advertising also affect drug prices? There is absolutely no evidence that the cost of advertising has had any effect on drug prices. Those are separate budgets that have to justify themselves through return on investment through selling more products. It's simplistic to think that you can increase drug prices based on those advertisements. If anything, the more drugs you sell, the lower your prices can be. Yet, one of the prime reasons that prices can be 30, 40, or 50 percent higher here in the United States is not just that other countries have managed-healthcare systems, but the cost of litigation here, which is totally unique to our wonderful, free-market system.

So DTC advertising is here to stay regardless of class action lawsuits against it? Clearly, we are in a direct-to-consumer revolution. The country has been built on the premise that consumers should have as much information as they can possibly get. Baby boomers, especially, want that information. As long as the information is truthful and balanced, most every regulator and government entity that has looked at direct-to-consumer advertising has supported it. So it would be a shame if harassing lawsuits that have no basis—in fact that are maybe even provoked by competitors that are being disadvantaged in the marketplace—cause a pullback in the communications that consumers are receiving. If compliance lawyers are allowed to sue freely without any limitations on damages, then certainly pharmaceutical companies should be allowed to advertise freely as long as their advertisements are truthful and not misleading.

Marc Scheineson is a former FDA associate commissioner for legislative affairs and now heads the food and drug law practice at Alston & Bird in Washington. He is the author of dozens of articles on FDA regulations and legislation, and he provides inhouse training for FDA’s drug reviewers and regulatory officials. Scheineson is also cochair of the American Bar Association’s task force on FDA reform. He earned his LLM degree from Georgetown University Law Center and his BA and JD degrees from the University of Cincinnati and its College of Law.