I had never heard the term "non-inferiority trial" before. So I have to thank the Pharmalot blog and Outsourcing-Pharma.com for educating me a bit on the subject. It seems one avenue to gain FDA approval is to show your product is NO WORSE than the next guy's licensed product for the same indication.
Except, you can actually be a little bit worse if your drug is cheaper, or perhaps safer, or has fewer drug interactions or maybe is just easier to take. If taken to the extreme, I suppose over time that you could see downward drift in "same performing" drugs using this route if you offer it cheap enough for 3rd party payers. Not too cynical a view - couldn't help myself.
Well, it turns out the maybe someone woke up at the FDA in March and the agency has decided (and in fact is) getting tougher on the use of non-inferiority trials. In a new report by the GAO, the FDA is cited as setting more limitations on the types of trials where these studies can be applied. Secondly, the agency is reportedly being more rigorous in its review of trial data.
Congress has accepted the fDA has imporved of late but still believes there is work to be done in the non-inferiority arena. Some have called for a placebo to be included in all non-inferiority trials.
"The GAO report shows that these so-called 'non-inferiority' trials have often proved to be an inferior means of reviewing the safety and efficacy of new drugs," said Congressman Ed Markey, MA.
"...no one benefits from ineffective drugs---and so I encourage FDA and industry to continue to collaborate to do everything possible to ensure that safe and effective drugs are developed, " said Congressman Henry Waxman, CA.
It's funny. I would think Congressmen would be experts at non-inferiority trials given their campaign proclivities. Maybe someday we can focus on superiority trials?
Posted by Bruce Lehr August 30th 2010.