Monday, February 16, 2009

We Finally Show Mixed Emotions: Banning DTC Ads For Two Years

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. And another, more recent, one.) 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.


Anonymous said...

Your Television Is Far From Your Health Care Provider

Not long ago, usually on television, one viewing will often at times see an advertisement for some type of medication- usually it is a drug involved with the treatment in a large market disease state. Such commercials are sponsored by large pharmaceutical corporations for particular networks on television. This is called direct to consumer advertising, and both doctors and citizens largely prefer that they do not exist.
Since 1997, when the FDA relaxed regulations regarding this form of DTC advertising for the pharmaceutical industry, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry has spent around 5 billion annually on this media source. The industry ranks number two on their spending of media campaigns- next to automobiles, I believe. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns typically associated or possible with newer medications, as history has shown.
The purpose of DTC ads are not to educate and inform the viewers, in my opinion, as others have claimed. Any advertising of any type shares the same objective- which is to increase sales and grow their market for a particular product and, in this case, for a particular perceived medical condition or disease state that may or may not exist, as a television is not by definition a health care provider for the viewer.
The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment soon for what may be an unconfirmed medical condition or disease suggested with such DTC advertisements. Furthermore, the FDA has admitted that they are ignorant as far as the content of such DTC ads before they are presented to the public, in relation to their accuracy and clarity, as well as possibly their effect on the health care system, as the FDA allows the DTC advertising to continue, yet now it is becoming more restricted, I understand.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe should be medical flaws, and illustrated by the creators through exaggeration and embellishments through such media sources as an avenue for what appears to be propaganda often, as is often seen with DTC advertising. The content of the advertisements appear to be medically absent, yet realistically they are in fact corporate creations of these questionable human ailments that do not or may not require treatment, possibly, and may be attempts by the makers of certain drugs to develop or embellish a particular medical condition to acquire additional profit.
One of my favorite DTC advertisements is the new concept for the use of an anti-depressant for a social disorder. Social disorders appear to be another phrase for what are known as introverts- a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease, many believe. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators of these commercials again wish to grow the market for a particular, and possibly fictional, disease state. Then there is also baldness treatments advertised, as another example by the advertisers who attempt to create a need for treatment.
Lifestyle medications are not treatment options for illnesses, and should not be portrayed as such in certain direct to consumer advertisements. Then there are the Viagra commercials with the happy man who is fully energetic on the advertisement for this drug is not your typical man who has erectile dysfunction. So DTC advertisements are intentionally deceiving to grow the markets for the benefits of the makers of the drugs advertised.
Also, DTC ads discuss only one treatment option normally, so it seems, when likely there are several treatment options that exist for authentic medical disorders. The options for treatment should be left to the discretion of the health care provider, as they are the ones who assess your health, not your television or another media source. That’s why most of the world does not allow DTC advertising, with the exception of our country and New Zealand.
Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the creators of direct to consumer advertising. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome if not awkward for the health care provider chosen by the viewer of a DTC ad for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription. Also, in some situations, the sponsor will speak and acquire a dormant/inactive actor, perhaps, or a former athletic celebrity, to fuel their intent.
Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world utilizing media outlets such as television. Perhaps this will save some over-prescribing of expensive medications that progressively has been occurring recently, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which should be far from financial prosperity. This elimination of DTC advertising would only be a start to achieve control in the U.S. Health Care System as it exists today.
“Ignorance is not innocence but sin.” --- Robert Browning
Dan Abshear
Author’s note: What has been written was based on information and belief
Published on

Supremacy Claus said...

DTC ads are great. They educate the public about bad conditions.

So a drug is approved for restless legs syndrome. During the two years of the ban by the biased, left wing ideologue, sure some rare side effects are not known. Meanwhile the thousands of people who have not heard about the condition nor about its treatment, are falling asleep at the wheel and killing hundreds of people a year, including themselves.

The left should leave us alone. At this time, all patients have access to the internet, can read specialist level information, and have an affirmative to Google anyway. Because there is no informed consent in real life, patients have a duty of ongoing self-education. This has yet to get asserted in a court decision. However, it is certainly true in life.

Ron Miller said...

I agree with Supremacy Clause. (What? Did I just say that? Take pistol to mouth.) But the play can't be to keep new drugs on the down and low so we can test market them on a smaller population and create less injuries and of course the all important societal goal of decrease tort exposure for drug and device companies by protecting them from themselves).

Instead, we have to find a way (1) make sure there is adaquate testing, particuarly for drugs and devices that are not expected to make remarkable improvements in the patient population (e.g. a thinner lead wire to a defibrilator) and focus on post market adverse reports without rose colored glasses.

I'm not saying this can all be done with ease: it it was easy to put in the proper controls, it would have already been done. There are a lot of systemic problems. But the answer is not limiting information about the availablity of a drug.

Lily said...

Any DTC ads for generics? No. Of course not. The ads are for what the drug companies are pushing. New and expensive. Let the doctors do the prescribing please.