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.
“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.
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.
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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