Monday, June 1, 2009

Off-Label Promotion of Prescription Drugs - Should Medical Writers Be Concerned?

By Cyndy Kryder  (Guest blogger)

In the prescription-drug industry, off-label use of prescription drugs is not that unusual. Health care providers are permitted to use a drug or device off label, that is, in an unapproved manner. Pharmaceutical companies, however, are not allowed to market or promote their products for any uses other than those approved by the US FDA.

In January, 2009, Eli Lilly and Company agreed to pay $1.415 billion to resolve allegations that it promoted its antipsychotic product, Zyprexa, for off-label conditions. This huge fine includes a criminal fine of $515 million and an additional $800 million in a civil settlement with the federal government and the states. Among health care cases, this is the largest fine on record, and the largest criminal fine for an individual corporation ever imposed in a criminal prosecution in the United States.

If you're a medical writer who writes content for pharmaceutical sales and marketing materials, should you be concerned? In my opinion, medical writers need to be aware of the regulations surrounding off-label use, and help clients by avoiding writing about off-label uses when that content will appear in promotional materials, since that is illegal. About the only places where writing about off-label uses may be acceptable is in continuing medical education (CME) programs, textbooks, and clinical study reports (CSRs).

When medical writers are hired by our clients, we are expected to create content that is accurate and well referenced. That means that writers need to be acutely aware of a product's approved uses. If you include information about off-label use in something you are writing, you need to state that this is an unapproved use. Once the content we create is out of our hands, however, we have no control over how that content is ultimately used. It is incumbent on the company marketing and promoting the product to ensure that all materials comply with government regulations.

Still, it's impossible to know what kinds of repercussions might follow a medical writer who creates content for materials that are later used illegally to promote prescription drugs. The ongoing investigation into the influence the pharmaceutical industry has on physicians has already resulted in the public naming of a reputable medical communications firm and the medical writers it hired. A year ago, most medical writers would have thought this impossible, but today I'm not so sure. The best strategy in the current environment is to write accurately, cite your sources, and keep copies of the final drafts as they left your computer, just in case.

You can read the Department of Justice press release about the case and its resolution here.

Cyndy Kryder, co-Author of The Accidental Medical Writer. The Accidental Medical Writer is for everyone who is frustrated with working for someone else. For everyone who wants the freedom and security that freelance medical writing can help them achieve. Visit our website at the link above for information, inspiration, strategies, lessons, and tips to help you become a successful freelance medical writer, too. Article source here.

No comments: