gretedudek@cis-partners.com
Although the current healthcare reform discussion has been in the spotlight recently, there is also a less visible battle taking place for restrictions on direct to consumer drug (DTC) advertising. Currently, there are a number of different proposed ideas and methods to restrict DTC ads, but since a number of similar bills have stalled in the past, there is uncertainty regarding whether or not any legislation will be passed. One idea (as discussed in Judy Fox’s article, The Definition of Indecent Could Become Ridiculous), from Representative James P. Moran, a Democrat from Virginia, is to ban prescription drug ads for erectile dysfunction during prime time hours on decency grounds.[1] Representative Henry Waxman, a Democrat from California, would like to see a ban on prescription drug advertising for the first few years the drug is on the market. He said,
“It is in these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products, long before those risks are truly understood.... That is why I have supported legislation that would grant FDA the authority to restrict direct-to-consumer advertising for an initial period for new drugs on a case-by-case basis.”[2]
The drug Vioxx is one example of a drug with risks that weren’t immediately clear. In long-term studies undertaken after the drug’s approval, an increased risk of cardiovascular events was seen after taking the drug for 18 months. The pain drug was removed from the market over these safety concerns, but had extensive usage and patient exposure due to DTC advertising campaigns.[5] Meanwhile, Representative Jerrold Nadler, a Democrat from New York, has introduced a bill to the House that would deny tax deductions for direct to consumer advertising.[4]
Critics of these restrictions have the right to free speech on their side, which is one reason similar bills have stalled in the past. Studies have found that DTC advertising can make consumers aware that their conditions have effective treatment, and that ads “can help people who do need treatment to start taking, and stay on, appropriate drugs.”[3] The ads can lead to increased patient visits to doctors that detect treatable diseases, and increase the quality of discussions between patients and doctors.[6]
It is also interesting to note that the US and New Zealand are the only two developed countries that allow direct to consumer drug advertisements. However, that almost changed a few years ago, when lawmakers in New Zealand tried and failed to ban DTC advertising. What does the future hold for DTC advertising in the U.S? We will have to wait and see.
Sources:
1. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2175:
2. http://www.prescriptionproject.org/tools/conference_remarks/files/0003.pdf
3. http://www.nytimes.com/2009/07/27/business/media/27drugads.html
4. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2966:
5. http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf
6. http://roomfordebate.blogs.nytimes.com/2009/08/04/should-prescription-drug-ads-be-reined-in/
2 COMMENT ON THIS ARTICLE:
I agree that DTC should be more tightly regulated. I have worked in this space for almost 30 years and have never seen such a dysfunctional medium for promotion. It has the merit of information on disease state and that's where it should stop. The fact alone that only New Zealand shares this medium with us is a hint we are over doing again. Since it started in 2000, doctors have been inundated with requests for brands often not appropriate for the particular patient and as mentioned in your article, more importantly, the agressive marketing can lead to severe consequences...
Sufficient time is not taken in this country to prove safety and efficacy, rather the rush to recoup investment has taken priority over the value of human life...
TV advertising is expensive and has taken the money spent on sampling directly to doctors, and having the rep actually getting the time to disucuss and explain usage and dosing of the drug to the physician. Go back to common sense, and forget the commercials which disclose side effects that sound worse than the disease you are hoping to fight. We are in dire need of reform not only in healthcare/insurance, but in the way we market to the lay public.
What happened to "Do no harm"?
Diane Rich
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