The marketing model for US prescription pharmaceuticals is often debated for its direct-to-consumer (DTC) advertising as the United States is one of the few jurisdictions globally which allows this type of marketing. Yet equally debated is promotion directly to physicians, key decision makers in the prescription process. Physician promotion comes in many forms, ranging from one on one visits with sales representatives to educational sponsorship to the ubiquitous branded pen. (more…)
Last month saw the conclusion of the FDA’s public hearing on the internet promotion of drugs. This was the first time the agency has directly addressed and engaged key stakeholders in regards to online policy and guidelines since 1996, when the 16.7% of Americans who had web access spent an average of 30 minutes online each month.
Following on from last week’s conversation, I left off with the issues surrounding the off-label prescriptive habits by physicians and the implicit role of the sponsors. The Academy of Managed Care Pharmacy (AMCP) supports off-label use of FDA-approved drugs when medically appropriate and necessary, but opposes government-mandated coverage of specific pharmaceuticals, whether for FDA-approved or off-label uses.
Mentioned last week was the original definition of off-label use as the use of a drug for clinical indications other than those stated in the labelling approved by the US Food and Drug Administration (FDA) and other regulators. An example would be the use of a drug for oncological treatment (e.g. pancreatic), where the drug would originally have been approved for treating other maladies of the same class (e.g. ovarian, bladder and genitourinary cancer).
Today, and in the coming weeks I shall review the increasingly complex phenomenon in the pharmaceutical industry called off-label drug use.
In February 2008, the FDA issued a statement in which it said that it “recognises that the public health can be served when healthcare professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products”. Senator Henry Waxman (Democrat), chairman of the House of Representatives Energy and Commerce Committee, implied that the Bush administration had given drug companies a long desired “parting gift”.
While we firmly believe at Clinuvel that communication and online dialogue is a most valuable tool to inform shareholders, prospective patients and physicians, the boundaries of drug promotion are being drawn as we speak.
When it comes to marketing and selling drugs, digital media present the lifescience industry with a plethora of new opportunities. However, the traditional principles of good practice in pharma still apply. In other words, the same guidelines and regulations need to be used when deciding to promote products online. Regulators seem to have followed suit and closely look at online announcements and interpret wording carefully. The best case is presented by the US FDA issuing warnings earlier this year to 14 major pharmaceutical companies in relation to fair balance language and paid search activities.
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