BIO filed a new “friend of the court” brief Tuesday against a California lawsuit questioning Gilead’s decisions about drug development.
The background: The Food and Drug Administration (FDA) approved Gilead’s HIV/AIDS drug made from tenofovir disoproxil fumarate (TDF) in 2001. FDA approved Gilead’s second drug, made from tenofovir alafenamide fumarate (TAF), in 2015.
What’s happening now: Though both drugs are effective and still in use, a lawsuit maintains Gilead should have developed TAF sooner because it has fewer side effects. Gilead is appealing to California’s Supreme Court after their request for summary dismissal was denied in January.
Why it matters: “Bringing a new medicine to market is a lengthy and expensive process,” says the new amicus brief filed by BIO and other industry groups. “Manufacturers should not be punished if it turns out with hindsight that the company could have pursued a different development path.”
BIO’s view: “Just one out of every 5,000 to 10,000 compounds under development, and less than one out of every eight medicines entering clinical trials, ultimately obtains FDA approval,” says the amicus brief. “Companies must make complicated strategic decisions about where to devote resources based on limited information about which medicines may have the most promise.”
The impact: Fear that drug development decisions will be “second-guessed years later,” even for drugs deemed safe and effective, “harms patients by disincentivizing pharmaceutical development and stifling innovation in the life sciences,” the amicus brief says.
What’s next: Given the issue’s importance to California patients and the state’s life sciences industry, the court is expected to grant Gilead’s petition and review the case on the merits.
