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BioWorld - Thursday, February 12, 2026
Home » Topics » Regulatory » FTC

FTC
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Website of The Federal Trade Commission

FTC moves aggressively on mergers, non-OEM servicing of devices

July 22, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) had previously reported it would more tightly scrutinize mergers and acquisitions with an eye toward the impact on competition, and voted July 21 to expand its authority to review these activities. The agency also voted to eliminate restrictions by original equipment manufacturers (OEMs) on servicing of their devices, thus putting both drug and device makers on alert that much more rigorous FTC enforcement has arrived.
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Website of The Federal Trade Commission

FTC continues to increase pressure on life science companies

July 6, 2021
By Mark McCarty
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice.
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One dice with a green checkmark, red X and gray question mark.

FTC throws up antitrust hurdle to Illumina’s planned acquisition of Grail

March 31, 2021
By Meg Bryant
The Federal Trade Commission (FTC) is seeking to block Illumina Inc.’s $7.1 billion purchase of Grail Inc., claiming the deal will “diminish innovation in the U.S. market” for multicancer early detection (MCED) tests, which could be used to flag dozens of tumor types when they are still treatable. Illumina has vowed to “pursue all legal options” to complete its acquisition of Grail, arguing that it does not compete with Grail and is committed to providing “unfettered access” to its NGS technology.
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Regulatory front for Jan. 27, 2021

Jan. 27, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Canada updates list of recognized standards; FTC posts draft consent agreement for Flo Health; Two more snared in PGx testing scam.
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Digital illustration of U.S., coronavirus

FTC active in litigation over advertising, promotional claims during pandemic

May 8, 2020
By Mark McCarty
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.
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Hurdles to robust U.S. biosimilar market in the eye of the beholder

March 9, 2020
By Mari Serebrov
“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
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Hands holding torn contract

Illumina, Pacific Biosciences abandon $1.2B merger over FTC opposition

Jan. 3, 2020
By Mark McCarty
Two players in the gene sequencing space, Illumina and Pacific Biosciences, have scotched their planned $1.2 billion merger roughly two weeks after the U.S. Federal Trade Commission (FTC) posted a 5-0 vote to seek an injunction against the merger. While Illumina is consequently liable for nearly $100 million in termination fees, it could recoup those monies under some circumstances. The $1.2 billion merger between Illumina Inc., of San Diego, and Pacific Biosciences of California Inc., was formally announced by the two companies in November 2018, but the deal faced substantial regulatory difficulty from the outset.
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FTC enforcement aside, disclosure is vital to trust for DTC gene testing firms

April 30, 2019
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has been active for some time in enforcement of its regulations for direct-to-consumer (DTC) gene testing firms, but Linda Malek, a partner at the New York office of Moses & Singer LLP, told BioWorld MedTech that while FTC compliance is becoming a bigger lift for DTC gene testing firms, the controversy in 2018 over a gene testing firm's sharing of data with a drug maker suggests that DTC gene testing companies might want to "hold yourself to an even higher standard in order to maintain trust in your product."
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