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A comment on The Mark Cuban Cost Plus Drug Company. Parent comment

Re:The Mark Cuban Cost Plus Drug Company by wincy on Wednesday January 27, 2021 @10:46PM (#25937898)
The Wikipedia page [0] says piracetam has been around since the 1950s, and was used to treat epilepsy as early as the 50s. Our daughter’s PEAC [1] is a rare complication of a relatively rare disease.

From my very limited understanding of the regulations, a company would have to spend the million+ dollars it costs to get FDA approval, but then wouldn’t be able to recoup that cost by selling the drug exclusively because the patent has long since expired. The US has this class of drugs that just never got approved and no drug company will ever pay to get approved, even if they are commonplace in other nations.

[0] https://en.m.wikipedia.org/wiki/Piracetam

[1] https://medcraveonline.com/JPNC/peac-prolonged-expiratory-ap...

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Re:The Mark Cuban Cost Plus Drug Company by shkkmo on Wednesday January 27, 2021 @10:58PM (#25937962)
It sounds like we need a mechanism for a company to be granted short term exclusive distribution for drugs that are out of patent but not approved if they sheppard that drug through the approval process.
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Re:The Mark Cuban Cost Plus Drug Company by jcims on Wednesday January 27, 2021 @11:24PM (#25938153)
I believe that's in part what the Orphan Drug Act does - https://en.wikipedia.org/wiki/Orphan_Drug_Act_of_1983
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Re:The Mark Cuban Cost Plus Drug Company by desine on Wednesday January 27, 2021 @10:54PM (#25937944)
I had to check if it would fall under Trump's Right to Try Act [0], but sadly it doesn't seem like it would meet the requirements. Perhaps this is something we can continue pushing for more freedom enabling legislation though.

[0] https://www.fda.gov/patients/learn-about-expanded-access-and...

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Re:The Mark Cuban Cost Plus Drug Company by foolinaround on Wednesday January 27, 2021 @11:10PM (#25938040)
In the short term, how are you getting access to this medicine? Having your friends ship it in from abroad?
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Re:The Mark Cuban Cost Plus Drug Company by wincy on Thursday January 28, 2021 @12:29AM (#25938567)
I’m hesitant to reveal how as the FDA had been cracking down recently, but racetams are very popular in the nootropics community. It’s sad too because there’s a huge difference between her with this medicine and without.

A few times we’ve missed a day and it’s not a fun experience. Something as innocuous as a diaper change can mean giving her getting upset, turning blue, pulling out the a bag and mask, and giving her oxygen and hoping she’ll come to. Then she’ll sleep for hours. If it’s especially bad, like it was before, she’ll forget words which is super scary.

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