The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the Food and Drug Administration’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture, and may inadvertently remove medications that simply can’t complete confirmatory trials within the narrow timeframe allowed.
Abbott Laboratories will pay $160 million to resolve claims that two of the company’s units submitted false claims to Medicare by providing kickbacks to diabetes patients, including “free” or “no cost” glucose monitors, the U.S. Department of Justice said.
The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.
Gilead Sciences agreed to pay $97 million to resolve claims from the U.S. government that the company violated the False Claims Act.
Novartis AG agreed to pay more than $729 million to settle U.S. government charges that the company paid illegal kickbacks to doctors and patients to boost drug sales, the U.S. Department of Justice said.
Regeneron Pharmaceuticals said the company will vigorously defend federal charges of being involved in a kickback scheme to bolster sales of the blockbuster macular degeneration drug Eylea.
A look at how the California Consumer Privacy Act put into effect in 2020 will impact the pharmaceutical industry.
Sanofi reached a civil settlement with the U.S. Securities and Exchange Commission fully resolving the SEC’s investigation into possible violations of the U.S. Foreign Corrupt Practices Act.
