When ‘Breakthrough’ Drugs Aren’t Actually Breakthroughs: FDA’s Approval Pathway Can Be Misleading, Study Finds
A new paper finds that some drugs approved under a special law to bring "breakthrough" treatments to market faster are not actually significant scientific advances. In other pharmaceutical news: Sen. Cory Booker (D-N.J.) lashes out at drugmakers for using tax windfalls to help shareholders; insurers are starting to pass rebates directly on to consumers; and the SEC and the FDA both launch investigations into two different clinical trials.
Stat:
FDA-Designated 'Breakthrough' Therapies May Not Be Real Breakthroughs
In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of the compounds are not actually scientific breakthroughs, which they say could be potentially misleading to the public. “You have newly approved breakthrough therapy drugs that may not be any better than existing treatments, and in some cases, it’s possible they could be even worse,” said Jonathan Darrow, lead author of the paper and faculty member of Harvard Medical School. (Swetlitz, 4/11)
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Senator Lashes Out At Drug Makers For Buying Back Stock, Not Cutting Prices
Amid ongoing debate over the effect of the recent tax law, one lawmaker complains that shareholders in the nation’s 10 largest drug makers will reap a “windfall,” but the average American will not share in the bounty because none of these companies is using tax cuts to lower prescription medicine prices. In a new report, Sen. Cory Booker (D-N.J.) noted that several of the companies have announced more than $45 billion in stock buybacks, but overall, there has been only “limited mention” of investments in ways that could benefit patients and workers, such as increases in R&D and capital investment for building new facilities and creating jobs. (Silverman, 4/11)
The Associated Press:
Insurers Look To Pass Drug Price Breaks Straight To Consumer
Some major health insurers plan to take a little sting out of prescription drug prices by giving customers rebates at the pharmacy counter. Aetna and UnitedHealthcare both say they will begin passing rebates they get from drugmakers along to some customers starting next year. They could spark a trend: The idea has been championed by President Donald Trump, and it's something other bill-payers like major employers might consider. (4/11)
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SEC Considers Civil Charges Against Clovis Oncology Over Trial Data For Discarded Drug
For investors in Clovis Oncology (CLVS), this may be a case of “Better late, than never.” Two years after an R&D expert publicly questioned the veracity of clinical trial data released by the drug maker, the company disclosed that the Securities and Exchange Commission may pursue a civil enforcement action or administrative proceeding against the company. (Silverman, 4/11)
