U.S. Removed From Canada’s List Of Countries It Uses To Control Drug Prices
In addition to the United States, Switzerland was also kicked off the reference list the Canadian government will use to regulate prescription drug costs. Meanwhile, Allscripts, Rite Aid and Novartis are in the news. And Stat interviews the FDA's digital health chief about artificial intelligence devices.
Politico Pro:
Canada Kicks U.S. Off List Used To Regulate Drug Prices
Canada will remove the United States from the list of countries it uses as a reference point to regulate drug prices, saying the U.S. lacks policies to control costs. The Canadian government unveiled on Friday a long-awaited plan to reduce prices that includes striking the U.S. and Switzerland from the reference list. The briefing material released made a special point of explaining why the U.S. did not belong there. (Panetta, 8/9)
The Wall Street Journal:
Allscripts Reaches Tentative Agreement Over Federal Probes
Allscripts Healthcare Solutions Inc. has reached a tentative $145 million agreement to resolve civil and criminal federal investigations into the business practices of one of its recently acquired companies. The federal investigations revolve around Practice Fusion Inc.’s software certification, compliance with anti-kickback regulations and related business practices, according to securities filings. No additional details were given. Health-care information-technology company Allscripts acquired the electronic-health-records company last year. (Armental, 8/9)
The Wall Street Journal:
Rite Aid Names Heyward Donigan As CEO
Rite Aid Corp. appointed Heyward Donigan as chief executive, saying her experience leading health-care companies would help the pharmacy chain confront competition that has hurt sales and prompted job cuts. (Haddon, 8/12)
Stat:
Senators Blast Novartis Over Data Manipulation Before Zolgensma Approval
A group of senators, including presidential hopefuls Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), blasted Novartis (NVS) on Friday for failing to promptly disclose that falsified data were used to win approval for the company’s $2.1 million gene therapy, Zolgensma. The Food and Drug Administration earlier this week said AveXis, a subsidiary of Novartis, was aware of “data manipulation” involving Zolgensma, which was approved in May to treat spinal muscular atrophy, but failed to disclose it to the agency until months later. (Florko, 8/9)
Stat:
Q&A: The FDA's Digital Health Chief On How To Regulate AI Products
The Food and Drug Administration has allowed medical devices that rely on artificial intelligence algorithms onto the market, but so far, the agency has given the green light only to devices with “locked algorithms” — those that remain the same as the product is used until they’re updated by the manufacturer. Systems with algorithms that evolve and sharpen on their own, however, are already in development. (Joseph 8/9)
