• Mon, Feb 11 2013

FDA Postpones Approval Of Novo Nordisk Diabetes Drugs; Reports Focus On Stocks, Not Health

novo nordisk diabetes drugs
Novo Nordisk is the star of today’s health news right now, because the Food and Drug Administration didn’t approve two of their new diabetes drugs as expected. But practically all headlines and articles are focused on one thing: What this means for the value of Novo Nordisk shares. Am I crazy, or should the failure a massive diabetes drug manufacturer to properly test prescription drugs before putting them on the market be of concern to a wider audience than shareholders?

The company (which is the same one who signed Paula Deen to be a spokesperson for their already-approved diabetes treatment) expected their new diabetes medications–Tresiba and Ryzodeg–to gain approval, after an FDA panel of endocrinologists voted 8-4 in favor of allowing the drugs to move forward last fall (side note: FDA panels provide recommendations that are more often than not followed by the FDA, but the U.S. administration isn’t required to act in accordance with their advice). Although the panel shared concerns over the drugs’ cardiovascular side effects, they recommended that the company conduct a trial study…after the approval of the drug.

Unfortunately, this isn’t unprecedented; plenty of drugs get approved on the condition that they provide further research and information about the drugs after they’ve gone on the market (scary, right?). But the FDA didn’t agree that this one should: Their final ruling was that the company should provide data to address cardiovascular issues before they go on the market, which some say could delay drug production up to five years.

The news is kind of great for consumers: It’s nice to know that the FDA is willing to put a hold on drug production when they’re not sure the drugs are safe for human consumption–even if it means that a big drug company isn’t happy, or has repercussions in the market. But most of the reporting isn’t about consumer health at all: It’s about the politics and finances of what happens when a huge company doesn’t get to sell whatever they want, with or without the right kind of medical data to prove that it’s safe. And here I was skeptical that Novo Nordisk’s top priorities were patient health.

Photo: Getty Images

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