Jerry Gundersheimer 0

The Faulty, Flawed Decision by the FDA Regarding Probuphine; a Real Setback in the Battle of Opioid Addiction

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Dear President Obama, I am very disturbed by a recent FDA decision to fail to approve Titan Pharmaceutical's new drug application for Probuphine on April 30th. Titan has developed a novel implant to aid those who are addicted to opioids to eliminate their dependency and resume normal and productive lives. With the current epidemic state of opioid addiction in the United States and the current emphasis being placed on finding ways to combat this addiction while reducing the extreme risk of diversion of these medications, Titan has emerged as a champion, pivotal in the process of change.Probuphine met the criteria for approval which the FDA themselves established for the drug to meet- the ADCOM on March 21st rendered a positive vote of 10 members For Approval, 4 Against,with 1 Abstaining-yet the drug was not approved by the FDA on April 30th. The reasons for non-approval make little to no sense, given what the FDA agreed to at the outset of Titan's study in order for approval. Why did the FDA all of a sudden move the goal-posts as Titan lined up and prepared to kick the ball straight through? Everything the FDA was asking for in their Complete Response Letter to Titan Pharmaceuticals could have been determined post-approval, and Titan could have proceeded forward in changing and saving people's lives immediately. The decision onApril 30thby the FDA would suggest something more than mere trepidation on their part, and even borders on impropriety. This is a huge step backwards in your pledge to combat and eradicate this scourge on the American people. I would urge you to look into this matter at your earliest possible convenience. A delay of 6-30 months to gain approval on this drug can cost the lives of many people who could otherwise be saved here and now by its approval. The opioid addiction epidemic has been well-documented and has become a focus of your administration- right here, right now is a viable answer and alternative to what is woefully, inadequately available currently. Thank you for your prompt consideration in this matter.

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Dr. Jerry Gundersheimer


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