Drugmaker Accuses FDA Of ‘Arbitrarily And Capriciously’ Approving A Rival’s Treatment That’s Priced Significantly Lower
There's been an unusual and heated war being waged between Catalyst Pharmaceuticals and small, family-run Jacobus Pharmaceutical over their rare drug. The battle is being closely watched to see if incentives for developing such drugs may be jeopardized. Other pharmaceutical news focuses on GSK's investment in CRISPR, privacy and drug importation.
Stat:
Catalyst Sues FDA Over Rivals' Drug Approval, Warning It Undermines Incentives For Rare Disease Meds
The next chapter in an unusual saga involving a high-priced, rare disease drug will play out in a federal court, where Catalyst Pharmaceuticals (CPRX) has accused the Food and Drug Administration of violating the law when it recently approved a similar medicine made by a small, family-run company. And the battle is being closely watched for clues that incentives for developing such drugs may be jeopardized. (Silverman, 6/12)
Stat:
GSK Partners With CRISPR Pioneer Doudna To Find New Drugs
The drug maker GlaxoSmithKline announced Thursday that it would team up with some of the nation’s most prominent CRISPR researchers to use the gene-editing technology in a search for new medicines, establishing a new lab in San Francisco and spending up to $67 million over five years. Jennifer Doudna, the University of California, Berkeley, researcher who co-invented the CRISPR enzyme technology, will help lead the effort, along with Jonathan Weissman, a UC San Francisco researcher who has been using CRISPR to understand the function of individual human genes and how they work together. Both are Howard Hughes Medical Institute investigators. (Herper, 6/13)
Stat:
Amazon's PillPack Is Accused Of Violating Patient Privacy
As Amazon ventures further into health care, the online giant may have to work harder to gain consumer trust in a market characterized by a heavy emphasis on patient privacy, at least based on recent actions allegedly taken by its PillPack subsidiary. Over the past year, PillPack has been accused in different lawsuits of violating federal law by calling or texting consumers to solicit business, a practice that has prompted regulators to take a tougher stand against unwanted marketing. And in one suit, PillPack is attempting to force a consumer to settle her claim in arbitration, a stance that is unlikely to be seen as friendly toward potential customers. Both claim privacy was invaded. (Silverman, 6/12)
Health News Florida:
Drug Importation Plan Signed As Questions Remain
Gov. Ron DeSantis, acting on one of his top priorities during his first year in office, signed into law Tuesday a measure that gives the state the go-ahead to pursue approval to import prescription drugs from Canada and other countries. But the Republican governor acknowledged at a bill-signing ceremony that the program won’t be up and running any time soon because of a requirement that it receive approval from federal authorities, including U.S. Health and Human Services Secretary Alex Azar. (Sexton, 6/12)
