Drugmakers prefer to have their products go through the FDA approval process. “At the end of the day, [companies] control their products. It’s their property. You can pass a law saying people can try things, but unless you obligate companies to give something, there’s no right to gain access,” said Arthur Caplan, who heads the division of medical ethics at the NYU School of Medicine.
Stat: Right To Try ‘Remains A Bust,’ As Many Drug Makers Prefer FDA Reviews
Despite the hubbub over the “right-to-try” law, a recent survey found that nearly half of drug makers indicated they would require regulators to review a decision to provide an experimental treatment to a person with a life-threatening disease. Specifically, 13 of 29 drug companies indicated they want a relevant regulatory authority to review requests that are granted to such people. Of these, six specified they would ask the Food and Drug Administration to conduct a review and five stated they require a research ethics committee or institutional review board, according to a report from the Government Accountability Office. (Silverman, 9/12)
In other pharmaceutical news —
Stat: Consultant Sues Nocion For Allegedly Passing Him Over For CEO
Connecticut pharma consultant claims he was offered the CEO job at a well-connected biotech startup — and now he’s suing the company because they didn’t ultimately give it to him. Terence Kelly, who spent 20 years at Boehringer Ingelheim before running a California biotech startup, is suing Nocion Therapeutics, a Boston-based company with big-name investors that’s hoping to take aim at the common cough. (Sheridan, 9/13)
Politico Pro: ‘Pay For Delay’ Bill Targeting Drug Maker Deals Heads To Newsom
CA AB824 (19R) by Assemblyman Jim Wood (D-Santa Rosa) would codify the presumption that so-called pay-for-delay deals — when brand name drug manufacturers pay generic companies to keep lower-price drugs off the market — are anti-competitive if “something of value” is exchanged. Sponsored by state Attorney General Xavier Becerra, the bill seeks to speed the entry of generic drugs on the market. (Hart, 9/12)
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