Evolving our communications channels, digital in particular, was an obvious and necessary next step. The launch today has provided us with a dynamic and flexible new platform from which we can continue to innovate online.
2010 is an important year for Clinuvel, as we progress afamelanotide in clinical trials across three continents.
A large part of our year is the refinement of our communications online. Feedback from many interested parties and stakeholders, and their constructive and excited responses have led us to develop digital communication opportunities and channels that:
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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.
Allergan’s lawsuit filed against the FDA presents a relatively novel case in addressing the requirements of drug developers in relation to off-label use of drugs by physicians.
Allergan may be one of the many companies to follow suit in time. Allergan’s concern is the FDA’s stance – prohibiting communication to the medical community in regards to the common off-label uses of Allergan’s lead product – poses a violation of the first amendment rights under the US constitution. A pharmaceutical company should be able to exercise its rights under freedom of speech to provide truthful and relevant information to its users: physicians.
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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