There would likely be very little up-front financial support for any studies, said FDA pharmacology adviser Sudharshan Hariharan, Ph.D. No pharmaceutical companies have volunteered, and they probably won’t, because there is very little money to be made from a medication consisting of three very inexpensive generic drugs. Any company that did market such a pill would have exclusivity for 3 years, after which the prospect of any profit virtually disappears.
"There is no commercial backing for this at all. Doing these trials would consist entirely of writing grants and pleading with friends to do them for next to nothing. Drug companies have said that if they thought something like this could make it through regulatory hurdles, then they might start to invest in creating it. But right now it’s a chicken-or-egg situation," Dr. Hariharan explained.
No committee member had any relevant financial disclosures.
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