Allergan is suing the FDA on free speech grounds. The company wants to ability to provide information on off-label uses of Botox to physicians. FDA regulations allow promotion only for FDA approved indications. Physicians, however, can prescribe medications for any use they see fit. Allergan wants to fill the information gap that exists today. Those that oppose that view off-label promotion believe that the drug industry will have no incentive to test their drugs for new indications once the medication is approved, would over-promote their medicines and would hinder the FDA’s ability to protect human health.
Natasha Singer wrote a good overview of the story in the October 3, 2009, New York Times. The suit, if Allergan were to win, threatens to overturn a regulatory structure that has existed for quite a while. Allergan claims that it is protecting its First Amendment rights of free speech and its ability to inform physicians about all the information that is available on a product. What are the communications implications of this case?
If Allergan were to win, pharmaceutical companies would be able to promote their products off-label. From the Russo Partners perspective, such a right would be both an opportunity and a responsibility for our clients. The opportunity to discuss the broader literature beyond FDA-approved indications with physicians is clear. However, the risk to a company’s credibility by promoting a product beyond what can be concluded from the literature is high. We would recommend to clients to develop transparent promotion guidelines that are communicated to all interested parties. In this way, the risk of over-promotion is mitigated and the client’s credibility remains intact.
The changing and challenging environment of journalism is a topic we always discuss with our clients. Traditional media (broadcast and print) has been under siege by a new medium (the internet) and outlets (blogs). Their revenue-generating business models have failed to adapt to the new environment resulting in slashed budgets and staff and the disappearance of many print publications. Journalists that survive are now often responsible for multiple beats and have access to reduced resources to investigate stories. Media outlets inevitably depend on third party sources for a significant part of their news.
In many cases the new environment helps our clients disseminate their stories as they can help journalists understand the significance of news relevant to our clients. Our clients can help journalists reach out to experts in a particular field who can add color and perspective to their stories.
In some cases, however, the new environment can lead to the dissemination of misinformation. This was highlighted in an article by Mark Bowden in the October issue of The Atlantic. The article, entitled The Story Behind the Story, describes how a political activist blogger, looking for information to challenge the nomination of Judge Sonia Sotomayor to the U.S. Supreme Court, found archived speeches and panel discussions that included significant material from the Judge. He downloaded segments that he believed made the case against her and sent them to numerous broadcast outlets. The outlets, apparently without identifying the context in which the comments were made, broadcast them on national television. The segments, taken out of the context in which they were found, put the judge in a negative light. Media has a responsibility to act as arbiters of the news and to critically evaluate a story that is submitted to them. Unfortunately, possibly due to journalism’s challenging environment, the outlets did not do their job vetting the story and putting the comments in the correct context so that their viewers would have a better understanding of what she said.
There is not much that we, as public relations counselors, can do about the post-journalistic environment. What we advise to our clients is to manage it by focusing on what they can control, which is the key messages they want to communicate about their company.
An article by Robert Weisman in the Boston Globe on Oct. 1, 2009, discussed a general concern by life sciences executives regarding the funding squeeze in drug research. As large pharmaceutical companies consolidate and capital availability for biotechnology start-ups shrinks, funding for innovation has become more scarce.
A large amount of capital is necessary to develop a drug and bring it to market which has traditionally been raised through venture capital firms and private investors. However, these backers have become increasingly concerned with prolonged drug development periods and decreased IPO activity. The financing pool has also been shrinking since big pharmaceutical companies have been acquiring each other. As a result, interest in small and mid-sized biotechnology companies has decreased, hindering the funding of drug research.
Since an increasing number of biotechnology companies compete for a smaller pool of money, scaling up public relations and investor relations activities help companies reach the appropriate investors. At Russo Partners, we apply a rigorous corporate communications program that assists our clients achieve their financing objectives.