Filed under: advertising, pharmaceutical marketing | Tags: Big Pharma, brands, drugs, FDA, healthcare, patient education, physicians, products, relationship, safety, trust
What needs to be done? Start here.
Filed under: pharmaceutical marketing | Tags: advertising, agency, Big Pharma, FDA, marketing, pharmaceutical
In pharmaceutical advertising, we find ourselves in a state of constant regulation as everyone tries to ensure each piece created meets FDA requirements. This struggle between advertising the benefits of a drug and satisfying the necessity to indicate the risks (in increasingly larger quantity and size) is one we face daily. With the recent release of the draft form of Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion , a set of non-binding recommendations for print and broadcast promotion, the FDA is attempting to help us along. The stated goal of the draft guidance is to clarify the factors the FDA considers in evaluating ads and promotional labeling for prescription drugs and restricted medical devices.
Overall, the FDA is clarifying the presentation of risk information so that it is equivalent to the presentation of benefit information, which is nothing new. But they are doing this by including more detail and examples. Their examples and occasionally vague language indicate how tricky this situation can be, not only for advertisers but also for the people doing the regulating.
One of the most exciting aspects of the draft guidance is the fact that the FDA will be accepting comments and suggestions for a 90-day period. Though no one can say for sure if the FDA will implement the suggested changes they receive, now is the time to review these draft recommendations and share your thoughts. If you think the examples they provide are not sufficient, you should request more, better examples. If you think their recommendations aren’t practical, you should tell them that and explain why. Maybe they’ll agree. We now have the opportunity to perhaps gain some control over a situation that affects pharmaceutical companies and advertisers daily. We shouldn’t let that opportunity pass without at least trying to make a difference.
Comments and suggestions can be submitted until August 24, 2009. Be sure to include the docket number, FDA-2008-D-0253, from the notice of availability that came out on May 27, 2009.
Send comments to
Division of Dockets and Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Filed under: Uncategorized | Tags: AMWA, clinical study, communications, content, data, drugs, EMWA, FDA, ghost writing, guidelines, healthcare, ICMJE, medical journals, pharma, pharmaceutical, physicians, WAME
The debate over who should write medical journal articles has been raging for years. Although heated and passionate at times, these debates are often imprecise about what constitutes ghostwriting or what possible benefit there is in employing a professional medical writer. Let’s clear up some half-truths and misconceptions.
He’s not a ghost if you can see him.
There are definitely ghostwriters among us. At its most extreme, ghostwriting is the use of an invisible writer hired by the marketing department of a pharmaceutical company to produce a selectively favorable report of their product, with authorship attributed to a high-profile investigator whose sole participation is cashing their honorarium check. This extreme example is shunned by most who are responsible for producing medical communications. More often than not, journal articles are written by medical writers who adhere to rigorous ethical guidelines (EMWA, ICMJE, WAME, AMWA). Central to appropriate medical writing is close collaboration of the professional writer with faculty authors who direct and control content.
Who are you going to call?
Another crucial aspect of professional medical writing is transparency. Successful medical publications are a team effort. Just as physicians investigate, statisticians calculate, and peer reviewers authenticate, the job of the medical writer is to communicate. Skilled medical writers perform the time-intensive tasks involved in clarifying and translating data into a submission-ready manuscript. Full disclosure of the contributions of all members of the team is essential to restore trust in medical literature.
Is it time to give up the ghost?
Investigators cite limited time as the most common reason why they do not convert clinical trial data into publishable manuscripts. A 2005 study of publication rates of oncology clinical trial data found that up to one third of clinical research in oncology remains unpublished. A recent survey for the Food and Drug Administration found that encouraging the participation of medical writers would help reduce the non-publication rate associated with industry-sponsored clinical trials.
And now a word from our sponsor…
Much of our medical literature is funded directly or indirectly by the pharmaceutical industry. We need them and they need us. At our best, the collaboration results in significant advances in healthcare. A final step toward eliminating hidden biases and restoring trust in medical literature is full disclosure of industry support and open access to clinical study data.
Filed under: physician, representative | Tags: FDA, pharma, pharma company, pharmaceutical rep, research, s&r communications group, web
Physicians have spoken and reps DO have a pivotal role in keeping physicians informed. According to a recent survey of physicians, 74% of respondents said they rely on pharmaceutical companies and their reps to stay informed about medications to treat certain conditions. The online survey conducted by S&R Communications Group also found that physicians considered gaining insightful information from representatives to be a higher priority than searching for relevant information on the web or through the FDA.
More results from the survey can be found here.