Friday, November 4, 2005 -- Our Recommendations to the FDA

The FDA earlier this week held two days of public hearings on DTC in Washington. DTC Perspectives was among several groups invited to provide comments at this hearing. Following is the text of our presentation.

Thank you for the opportunity to present our views today. We have tried to be an objective observer of DTC trends and issues over the past several years, and our position has always been that the DTC industry benefits most by understanding the points of view of both supporters and critics. Our weekly columns often take drug companies to task for actions we feel are not in the public interest.

First, let us say we think DTC has been a net positive for the American public. We must recognize that our health system is not objective and was not objective before DTC appeared. Physicians are not always neutral. They are influenced by drug companies through medical meetings, samples and detail reps. Insurance companies are not neutral and often try to influence drug choices to less expensive drugs, not necessarily the best drugs. OTC products try to influence consumers and compare themselves to Rx drugs. Therefore, consumers benefit by having all the facts available to them, even imperfect information containing a sales orientation that characterizes branded DTC.

Second, we think the industry has taken some positive steps in 2005. Drug ads are more straightforward, more sober and easier to understand. This trend is positive for consumers because risk information is now presented in many ads as part of the main actor portrayal, not as a voice over. In some ads, doctors provide benefits and risks. Drug companies have significantly increased disease education ads in 2005 in response to critics and FDA guidance.

We also see an attempt at self-regulation through the PhRMA code adopted this August. It is not perfect, but does provide two major changes. Most important is the end of branded awareness reminder ads and age appropriate advertising targets.

Now let us turn to what we think should still be done to improve DTC.

First, we were greatly disappointed that the PhRMA code did not deal with medicalese brief summaries. This is a major problem that still exists in about 50% of print ads. Despite the FDA draft guidance issued almost two years ago, few drug companies have changed to a patient-friendly format. We think this is absolutely wrong. Consumers, now more interested in understanding risk, deserve to have that information in understandable terms. Drug companies owe that to consumers any time they run ads in consumer magazines and refer to that information on television ads.

We urge DDMAC to seek the regulatory authority it needs to ban medicalese brief summaries. Many marketers at drug companies have told us they want these patient-friendly summaries adopted, but are vetoed by company lawyers who somehow believe a flood of incomprehensible information will protect them from liability lawsuits. I hope they are proven wrong and that American juries react negatively to medical brief summaries. Therefore, DDMAC should consider getting specific authority to mandate patient-friendly summaries or alternatively make the typeface requirement larger so these medicalese-type summaries are cost inefficient for drug companies.

One of the companies that deserve praise for making patient-friendly summaries available years ago is Merck. Given the negative press it has for Vioxx, at least Merck deserves credit for its brief summary policy.

Our second recommendation is to develop a guidance that encourages ads that deal with retention and compliance. Most DTC is for brand awareness. We are glad to see more disease education ads, but believe the public needs to see ads on proper use of drugs. We know that poor retention and compliance is a major contributor to hospitalizations, and other illness. We think a good use of reminder ads would be for this purpose. The 15- or 30-second ads would be impactful for current or lapsed users of brands.

Third, we recommend Congress or DDMAC develop a panel to oversee the PhRMA code. An independent assessment of self-regulation is critical to determine if drug companies have done the job well. This panel should issue a public report on how well the industry has followed PhRMA’s 15-point code.

Fourth, we do not think there is a need for additional regulation on use of celebrity endorsers. There is no evidence celebrities work better than non-celebrities and drug companies do not usually use them for branded ads. Clearly, the public identifies with celebrities who announce they too may have an embarrassing condition, and therefore celebrities can be effective in disease education.

Fifth, we would recommend that DDMAC not try to ban promotional ads, as DDMAC raised as a question in the background to this meeting. While we do not believe brands help their image through couponing or through buy a few/get free product type promotions, we do not think there is any harm to consumers by offering them. There is no evidence that these discounts lead to inappropriate use or result in physician pressure to prescribe. These discounts are usually small and not a major incentive to ask doctors to prescribe.

In sum, we think the industry has come a long way in 2005 toward making DTC more in the public interest. We believe no major changes are needed and 2006 should be a learning year on self-regulation and to determine if the industry will continue on its trend toward more disease education and less branded ads. We do, however, believe DDMAC should act on medicalese brief summaries through new regulations. We also support an independent panel to monitor self-regulation. DTC Perspectives would be happy to assist in that effort as we feel we are able to objectively review drug company compliance with the PhRMA code.

Thank you.

Bob Ehrlich, Chairman
DTC Perspectives, Inc.