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FDA approves new drugs without complete data

New and improved? We’re not really sure

Most people probably assume that, when a new drug hits the market, that drug is an improvement over what’s already out there.

I mean, isn’t that what doctors — and patients — want to know? Whether or not this new drug is the best choice? And isn’t that why, in 2009, Congress put $1.1 billion into comparative effectiveness research (research that compares the benefits and risks of alternative treatment methods)?

Well, sure. But that doesn’t mean Big Pharma really cares — especially when drugs are getting FDA approval anyway.

A study published in the May 4 issue of JAMA reveals that 51 percent of the new drugs approved in the last decade had comparative effectiveness data available at the time of their FDA approval. So the FDA, for the past 10 years, has been approving drugs without knowing if these drugs actually improved upon what was already out there.

Researchers took a look at approval packages that are publicly available in a database of FDA-approved drugs. They found that just about half of the drugs approved between 2000 and 2010 had comparative efficacy data available at the time of market authorization.

Once they excluded orphan products, which is the term for drugs that may be useful but are not considered commercially viable, they found that the drugs with available comparative effectiveness data increased to 70 percent. An improvement, yes, but that’s still walking the line between a C and a D — not too reassuring when we’re talking about people’s health.

The researchers also didn’t look at how informative the comparative effectiveness data actually was — all that was required for their check was at least one head-to-head trial with an approved alternative.

So what’s the result here? A market flooded with drugs that may or may not be better than anything else out there. How can we even begin to navigate that particular mine field?

We need to demand more from these pharmaceutical companies — and from the FDA. Why should a drug be approved if it hasn’t been proven to be more effective than what’s already out there? Especially if an attempt at finding out hasn’t even been made? It’s absolutely outrageous.

You may or may not know this, but the FDA has joined the Facebook craze. And they actually allow consumers to leave comments on their page. Why not take advantage of this feature? Everyone who visits the page will see your comments.

Right now it’s covered with people expressing outrage at the FDA going after Amish farmers selling raw milk — but that’s a whole different e-Tip. Curious about raw milk? We’ve covered the debate before — search the archive at, or click here for more on the truth about raw milk and how it could it be the very key to your health.

“Many New Drugs Did Not Have Comparative Effectiveness Information Available at Time of FDA Approval,” Newswise (