In what was more of a campaign speech accompanied by frequent chants of “four more years,” U.S. President Joe Biden loaded the annual State of the Union address March 7 with what sounded like campaign promises for a second term. Among those promises were calls to Congress to expand the prescription drug price provisions of the 2022 Inflation Reduction Act.
Superhuman soldiers. Designer babies. Genetically tailored weapons. Mind-control. A foreign database containing the DNA of every person on the planet. The list reads like the plot of a science fiction horror story, but there’s no fiction involved. These are real threats from China raised by members of the U.S. House Select Committee on the CCP (Chinese Communist Party) at a March 7 hearing on the growing stakes of the bioeconomy and American national security.
A heads up for the biopharma and med-tech industries: The U.S. government is going beyond warning letters to slap companies for violating the FDA’s good manufacturing practice (GMP) regulations. KVK Research Inc., a U.S.-based generic drug manufacturer, pleaded guilty March 6 to two misdemeanor counts of violating the Federal Food, Drug and Cosmetics Act by introducing adulterated drugs into interstate commerce. As part of the plea, the company agreed to pay a proposed fine and forfeiture amount of $1.5 million.
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
Is the U.S. Inflation Reduction Act with its Medicare drug price negotiation provision the new legislative sacred cow that cannot be tweaked? Debate over whether the orphan drug carveout included in the negotiation provision should be extended to drugs with more than one rare disease indication was the major discord in an otherwise bipartisan discussion the House Energy and Commerce Subcommittee on Health had in a hearing held Feb. 29 in observation of Rare Disease Day.
“The market stinks,” Brian Johnson, a partner and vice chair of Wilmerhale’s corporate practice group, told a U.S. SEC advisory committee Feb. 27, as he painted a gloomy picture of last year’s IPO landscape in the U.S. While the scene was a little brighter than in 2022, a few key indicators could be worrisome, especially the median offering size, which is predictive of the strength of the IPO market, Johnson said
More than a year and a half after the U.S. FTC launched its investigation into how pharmacy benefit manager (PBM) practices and consolidation impact patients’ ability to access and afford their prescription drugs, the six biggest PBMs in the country have yet to fully comply with the agency’s June 2022 order to provide data and documents pertaining to certain business practices.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.