|
|
|
|
|
|
by inetsee
881 days ago
|
|
|
One of the things I spotted in my casual looking around is this statement: "Therefore, as part of the FDA approval process, Gilead was required to develop an alternative form of the chemical — known as a “prodrug”— that could be taken by mouth." [1] If Gilead agreed to develop an alternative drug that had fewer adverse side effects in exchange for FDA approval of their preferred (more expensive) drug, then I think the lawsuit has a great deal of merit. [1] https://lawandcrime.com/lawsuit/federal-court-rejects-drugma... |
|
|
"To create a usable medication from tenofovir, Gilead was required to develop an alternative form of the chemical, known generally as a “prodrug,” that would be safe and effective when administered orally. Gilead eventually created TDF, a prodrug form of tenofovir, and focused its development efforts on that compound. TDF was approved by the FDA for sale as a treatment for HIV/AIDS in 2001. At some point during its work, Gilead developed a second prodrug form of tenofovir, TAF, that also showed promise in the treatment of HIV/AIDS"
The FDA does not engage in horse trading like saying we will approve this Dangerous Drug if you promise to develop a safer one in the future. Drugs either meet clearly established legal criteria, or they don't.