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Home » Topics » Regulatory » FTC

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US FTC challenge leads to terminated Maze-Sanofi deal for Pompe

Dec. 12, 2023
By Karen Carey
Sanofi SA backed out of its $750 million effort to advance Maze Therapeutics Inc.’s oral Pompe disease candidate, MZE-001, after the U.S. FTC filed a federal lawsuit to block the deal, claiming the Paris-based firm was seeking to eliminate a nascent competitor.
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OIG asked to take deep dive into US vertical integration trend

Nov. 27, 2023
By Mari Serebrov
With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in the high list prices facing American patients.
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US FTC hits gene testing firm for claims related to ancestry testing

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
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US FTC seeks yet more broad AI investigative authority

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
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FDA Orange Book

US FDA letting FTC decide if Orange Book listings ‘improper’

Nov. 17, 2023
By Mari Serebrov
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
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US FTC delivers on Orange Book threat

Nov. 8, 2023
By Mari Serebrov
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
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M&A cityscape

Biopharma unites to remind US FTC that M&As are the PULSE of innovation

Oct. 5, 2023
By Mari Serebrov
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over.
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US FTC prepares for more scrutiny of Orange Book patents

Sep. 14, 2023
By Mari Serebrov
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.”
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US GAO says data on medical device advertising lacking, but stakeholders wary of ads

Sep. 11, 2023
By Mark McCarty
Direct-to-consumer advertising (DTC) for medical devices does not present the same policy footprint as DTC ads for drugs, but Congress recently asked the U.S. Government Accountability Office (GAO) to investigate device advertising to evaluate whether reforms are needed. GAO responded to the effect that while the literature lacks any useful studies on the question, some stakeholders believe that DTC device ads give short shrift to risk information, a finding that may prompt Congress to enact new legislation on the question.
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Gavel and FTC logo

US FTC and DOJ garner mixed reviews of proposed merger regulation framework

Sep. 7, 2023
By Mark McCarty
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions.
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