lundi 23 mars 2015

2- HEALTHCARE SOCIAL MEDIA by PHARMAGEEK - Using Social Media in the Healthcare Fields



The very nature of social media is informal. Companies of all types use it to promote the products or services. As well they should! However, companies need to realize that what they distribute via social media can have some serious repercussions.

I recently went through a webinar designed for companies in healthcare and how they use social media. The main point that the presenters tried to convey was that the Food & Drug Administration (FDA) is watching social media (and other places) to make sure that what companies provide via social media cannot recommend any use of the product that is considered “off label”.

While most companies themselves are likely to adhere to posting only approved uses of their products, there is a significant concern over what an employee/salesrep might say on social media. Part of the webinar involved what employees may have said at a tradeshow or in advertisements. The common thread here is making sure that EVERY communication that is created by a company &/or one of its employees adheres to what a company is allowed to say based on claims made in its 510K clearance or similar regulatory requirements.

For example, if a new product called “Wonderdrug” is designed for a specific purpose, maybe to eliminate extreme perspiration, but a salesrep suggested that it would also be great at reducing wrinkles from aging and that has not been proven and approved by the FDA, that’s a problem.

Years ago, one of the birth control pills (I can’t remember which one) conducted a study that proved that its product helped clear up acne. It could tell doctors about it, but other companies could not do the same thing until they cleared it with the FDA even though the active ingredients were virtually the same. That did not stop doctors from using competing products to their patients for either/both reasons.

The webinar presenters took a “gloom and doom” approach, I was sorry to see. They were almost recommending that companies forbid employees that work in the healthcare fields from using social media, even personally. The risk was that an employee to inadvertently post something that was not in following with any regulatory requirements. Can you imagine telling every employee that works for Merck, Pfizer or any other manufacturer of healthcare items. Please note that this only pertains to manufacturers, not to healthcare providers, who are not restricted the same way that the companies that make the products are by the FDA.

The FDA itself posted a Q & A regarding what companies should be doing via social media. When asked if the FDA would be actively monitoring social media to ensure manufacturers are correcting misinformation according to FDA’s draft guidance, their response was: “…monitoring for compliance with underlying statutory and regulatory requirements, where applicable, is one component of FDA’s multi-faceted program for the oversight of prescription drugs and medical devices.”












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