Stories like this would be a game changer for this new company. I genuinely hope they go for it. In a way, it's surprising that there isn't a charity dedicated to this type of effort for drugs considered safe.
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.
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.
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.
wincy|5 years ago
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...
shkkmo|5 years ago
desine|5 years ago
[0] https://www.fda.gov/patients/learn-about-expanded-access-and...
foolinaround|5 years ago