The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not.
In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage. In the years that followed, the company invested in research leading to additional TDF-based regimens critical to the fight against HIV. It had also done preliminary work on a similar but different drug — tenofovir alafenamide fumarate (TAF) — for which it had early, although not definitive, evidence for safety and efficacy.
Ultimately, this medicine was shown to have a better side effect profile than TDF. Starting in 2018, plaintiffs began suing Gilead for negligently failing to develop TAF earlier, on the theory that it wanted to protect the profits from TDF. Now, the California court has agreed to let the suit proceed.
Click this link for the original source of this article.
Author: Dan Troy
This content is courtesy of, and owned and copyrighted by, https://www.statnews.com and its author. This content is made available by use of the public RSS feed offered by the host site and is used for educational purposes only. If you are the author or represent the host site and would like this content removed now and in the future, please contact USSANews.com using the email address in the Contact page found in the website menu.