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Banning “pay-for-delay” deals that postpone the production of less-expensive generic drugs is a key action point in Hillary Clinton’s comprehensive plan to lower prescription drug costs. Eliminating these deals, she says, could save Americans billions of dollars on medications. But an even more productive strategy would be to stop drug makers from producing so-called authorized generics. (I tried to examine Donald Trump’s thoughts on this issue. While his website says he will remove “barriers to entry into free markets for drug providers,” no details are provided and no mention is made of pay-for-delay deals.)

A patent on a new therapeutic molecule is granted for 20 years, though its validity can be challenged at any time. Much of that 20-year window is often spent formulating the drug and testing it in animal studies and clinical trials. Acknowledging this delay, the Hatch-Waxman Act provides an incentive for drug development by granting the patent holder five years of market exclusivity during which no competitor can file to produce a generic variant. Not surprisingly, the price of the drug is high during this period.

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  • Dr. Bokhari: I do not agree with somethings you have suggested. Most of them have been written about and have been hashed over by many others.

    US Patents if granted are granted from 20 years from the date of filing. Also pay for delay has been challenged in court and FTC has done many cases. Even authorized generics are and have been scrutinized.

    Somehow you did not do your homework that I would have expected from an economics professor. My sentiments are echoed by others also.

  • The writer is ALSO a paid Big Pharma consultant, who makes a living spouting gibberish like this in front of government panels. Shame on STAT and Ed for not disclosing this man’s MANY ties to Brand Manufacturers.

    • In preparing for this article, Farasat Bokhari told STAT he had nothing to disclose. He just told me “I have never consulted for any pharmaceutical firm or received any payment from them or worked for them in any capacity. I am listed as an academic expert for economic consulting firms, but to date have never received any payments, nor have I testified on behalf of a pharmaceutical in front of any government panels.”

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