The FDA Internet Dilemma

Source: DTC Perspectives eNewsletter
(Issue 383, November 20, 2009)
Written by: Bob Ehrlich, Chairman DTC Perspectives, Inc.

The 2 day hearings held last week aired all the issues related to drug marketing over the Internet. It is ridiculous that the FDA is using a promotional code written prior to the existence of web search. They know it is ridiculous and are trying to find a way to incorporate the Internet in a way that meets the regulations and satisfies industry.

That being said, Congress is not going to be overly accommodating in making DTC easier. This is not an environment where being kind to drug companies is in fashion. Most Democrats want to reduce use of brand name drugs not increase their exposure. In fact, most Democrats would support more restrictions on DTC if they could pass the free speech test.

In the context of runaway health costs and a likely cumbersome, complex reform structure; making things easier for drug companies will have a low priority. Just this week drug companies were vilified for raising prices about 9% this year with inflation at 1%. Drug companies say these price increases were justified by the increased cost of R&D. Critics say they are doing this in advance of health care reform to set a higher base for negotiations. In any case this price rise is sure to inflame critics in Congress.

FDA is in a tough spot. They know the Internet has a wealth of tools to educate potential Rx users. They know consumers will not see a one line mention of a drug and its indication and run to get an Rx without further investigation. They know artificial restriction of web search ads makes it harder for consumers to get educated.

Despite all this it will be hard for them to do anything that appears to be conciliatory to the drug companies.

What is likely is a long process of consideration of alternatives with market research testing to validate alternatives. FDA moves slowly and any changes will be glacial. Before FDA makes changes they will see what the final health reform bill requires on drug promotion. They are under enormous political pressure to be tougher on advertising and have new leadership that is supportive of that increased vigilance.

The net is hearings were useful to air the issues and propose alternatives. The reality is Internet media companies should not expect timely resolution. For those of you interested in the individual presentations and analysis from the hearings check our website. I am not expecting anything positive in terms of pragmatic solutions for at least a year.