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FDA Studying Approval of Drug Cocktails for Life-Threatening Diseases

Posted Mar 19 2010 12:00am

In a major policy shift, the FDA is opening the door for the future approval of drug cocktails to treat life-threatening diseases such as tuberculosis in a more effective way (see: FDA Is Easing Way for Drug Cocktails ; subscription required). Below is an excerpt from the article:

The Food and Drug Administration is devising guidelines that could accelerate testing and approval of multidrug regimens for some of the world's most deadly diseases....Many diseases, such as AIDS, tuberculosis and cancer, require multidrug combinations. Such drug cocktails can prevent the development of drug resistance, because the microbe or cancer cell needs to undergo more mutations to escape several drugs than to escape just one. By attacking the disease in different ways, drug combinations also improve the chances of therapeutic benefit. Traditionally, the FDA has required each new drug to be tested and approved individually. Afterwards, multidrug regimens are usually developed through additional, time-consuming clinical trials. At least since the mid-1990s, when cocktail therapies slashed the death rate from AIDS, the agency has been urged to streamline its approval process for multidrug regimens....Now the FDA is drafting guidelines on how testing and approving multidrug cocktails composed of new, experimental drugs—something the agency has never done before, according to an FDA spokeswoman.....The new guidelines would apply only to medications for life-threatening illnesses for which good treatment options do not already exist, and for which drug combinations—as opposed to single agents—are believed to be necessary....Testing drugs together can make it more difficult to tease out which drugs or drug interactions cause certain side effects.

This article mentions regulatory science, a term with which I was not familiar. It turns out that academic degrees are now being offered in this field. I am sure such graduates will be cordially welcomed by both the FDA and by the pharmaceutical companies on a much larger scale. One of the core competencies of such companies is the ability to maneuver through this complex bureaucratic pathway. Less time and effort to achieve drug approval equals less cost for them in bringing a drug to market. Knowing how difficult it is to gain FDA approval for new drugs, I can only imagine how complex a process it will be to study new compounds that are administered in combination with other agents. It's a bit of an understatement to say, as above: testing drugs together can make it more difficult to tease out which drugs or drug interactions cause certain side effects.

I can't resist pointing out the analogy of between multi-drug cocktails and the development of panels of biomarkers interpreted by a computer algorithm that the FDA refers to as IVDMIAs . The attempt by the FDA to regulate them has been challenging for the agency. The second draft version of guidance dates back to July, 2007 . In my mind, we are now facing a future with both therapeutic cocktails and diagnostic cocktails. This perhaps is a reflection of modern life and modern medicine whereby a single drug or a single biomarker no longer suffices. And the FDA is being forced to operate as a regulatory agency in this new environment. One of the gnarly issues associated with IVDMIAs has been proving diagnostic efficacy. Both efficacy and safety will be even a greater challenge on the drug side of this equation.

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