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Home » Topics » Regulatory » FTC

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US FTC zeroing in on exclusionary rebate schemes hurting biosimilars

June 20, 2022
By Mari Serebrov
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers  to crack down on some of those schemes.
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Website of The Federal Trade Commission

US FTC to open the black box on PBM dealings

June 8, 2022
By Mari Serebrov
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
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10-28-Boston-Science_Global-Headquarters_Marlborough,-Mass

FTC gives Boston Scientific a nod for updated divestiture plan

Feb. 24, 2022
By Mark McCarty
The U.S. Federal Trade Commission has signed off on an amendment to the divestiture plan for Boston Scientific Corp. (BSX), of Marlborough, Mass., related to the acquisition of British Technology Group plc (BTG).
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Payouts continue for Shkreli drug companies

Feb. 1, 2022
By Mari Serebrov
As part of a settlement in a class action suit, Vyera Pharmaceuticals LLC and its parent company, Phoenixus AG, of Baar, Switzerland, agreed last week to pay up to $28 million to a proposed class of third-party payers that covered Daraprim (pyrimethamine).
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World with digital overlay
A look back as we head into 2022

Top Med-tech Trends of 2021: Regulatory torpor adding drag to advances in artificial intelligence, machine learning

Dec. 17, 2021
By Mark McCarty
Regulatory agencies across the globe had their hands full in 2020 and 2021 in responding to the COVID-19 pandemic, but that is just one reason that regulatory frameworks for artificial intelligence are lagging. Several regulatory proposals have been floated, but one of these hints at a need for regulatory harmonization, a requirement that seems certain to add yet more drag to a process that is already years behind the technology.
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Woman using smartphone

FTC set to crack down on health apps under breach notification rules

Nov. 17, 2021
By Mark McCarty
The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk.
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Clinical trials are a regulatory danger zone for unregulated wellness apps

Nov. 12, 2021
By Mark McCarty

The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.


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Clinical trials are a regulatory danger zone for unregulated wellness apps

Nov. 11, 2021
By Mark McCarty

The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.


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Statue of man and horse outside of U.S. FTC building

FTC rule puts potentially anticompetitive mergers back in its crosshairs

Oct. 27, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
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Statue of man and horse outside of U.S. FTC building

FTC memo hints at less than holy reverence for Illumina’s acquisition of Grail

Oct. 26, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
Read More
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