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FDA Approvals and Healthcare Marketing
By: Cindy Wendland
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There are so many issues to take with healthcare that it is hard to focus on just one. Drug approvals by the FDA are the current focus, so let’s talk about the limited approval of Praluent. Praluent is a new injectable cholesterol-lowering drug. The FDA gave the manufacturer, Sanofi and Regeneron Pharmaceuticals, approval to market it only to patients with unusually high cholesterol due to an inherited disorder. The issue at hand is whether this drug can truly lower the risk of heart problems.

Our father has had numerous heart issues, which have resulted in a quadruple bypass and a pacemaker. The number of medications he takes is quite astounding. Before another drug is swapped or added to his regimen, we would like to know that the FDA and his medical team are confident it will make a difference. We learned from past visits to the hospital that a patient’s family has to be the advocates and never leave a patient’s side to ensure adequate or hopefully quality care. We feel like the approval committee making recommendations to the FDA is acting in this capacity for all of us.

Pharmaceutical drugs are big business and have helped save and prolong many lives. For that, we can be grateful. The marketing of some big brands does cause concern when you see commercials asking you to join a group of injured people in a lawsuit. Marketing and branding of drugs is done by skilled experts and is a class of marketing all its own. 

Imagine if your brand had to go up before a committee outside your company to see if they would give you approval to market it as you planned. You have to have the plans in place ready to go, but the committee can reject or modify your marketing plan, making your plans ineffective. That is what could be happening with Praluent. 

The long-time assertion that high cholesterol causes heart problems is being questioned. Until the approval committee sees more data, they are not willing to have the product marketed in that way. Although the initial data did not state it, inflammation may be more of the cause of heart problems. If this drug does not affect inflammation, it cannot be marketed as widely as the manufacturer had hoped. This limited acceptance puts quite a wrench in their marketing plans, although they might have already had marketing plan B ready to go. Be thankful your marketing plan only has to get approval within your own company!

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About the Author
Cindy Wendland has a background in marketing and finance. She is the creative director for an online men's health magazine, BrainBrawnBody.com, and she gets to write their leisure/travel blog. She is also a web designer helping her clients with online community engagement, websitesbywendland.com. Prior to her web years, she worked in pharmacy consulting.
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