The U.S. Federal Trade Commission (FTC) has updated a 1998 compliance guidance for health care products, much of which reiterates the provisions of the legacy edition. However, this updated version calls for randomized, controlled clinical trials to substantiate any claims made in connection with medical devices.
The U.S. Federal Trade Commission (FTC) has once again waded into the question of whether medical devices should be included in the agency’s right-to-repair discussion, most recently in an advanced notice of proposed rulemaking ostensibly titled for energy labeling. The Medical Imaging & Technology Alliance (MITA) pushed back on the proposal by pointing to the draft’s required disclosure of proprietary information about a medical device system, a provision MITA said might detract from patient safety.
The latest U.S. Federal Trade Commission (FTC) hearing on the merger between Illumina Inc., and Grail Inc., highlighted some sharp disagreements over the impact of the transaction on the market for multi-cancer early detection (MCED) tests, but Illumina has vowed to take steps to blunt any such effects in an open offer.
The U.S. Federal Trade Commission (FTC) has moved decisively in the area of mergers and acquisitions recently, but the agency also has a footprint in the enforcement space for health data disclosure. The FTC’s Ronnie Solomon said in a Dec. 1 public meeting that the agency will begin “thinking outside the box about what health information is in the 21st Century,” adding that the FTC is eyeing a more stringent enforcement regime regarding personal health data disclosures in the coming new year.
A subcommittee of the Senate Judiciary Committee met recently to review the current state of antitrust enforcement in the U.S., and heard from both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) about their enforcement activities. FTC chairwoman Lina Khan acknowledged that the agency had coordinated with the European Commission about the transaction between Illumina Inc., and Grail Inc., activities which she claimed were nothing more than an attempt to promote regulatory efficiency.
The Biden administration’s views of mergers and acquisitions have veered sharply from those of the previous administration, but Jonathan Kanter, assistant U.S. attorney general, said recently that there is more to come. Kanter said the Department of Justice (DOJ) and the Federal Trade Commission (FTC) will shortly publish draft guidelines that would place the burden on the parties to these M&A transactions to prove the transaction is not anticompetitive, upending the historical presumption that the plaintiff is liable for demonstrating the anticompetitive nature of the proposed transaction.
Data privacy laws are springing up more regularly in the past couple of years, including in several U.S. states, but Congress seems inclined to step in to avoid a patchwork of regulations across the 50 states. The House Energy and Commerce Committee gave a ringing endorsement of new legislation via a 53-2 vote for H.R. 8152, a bill that would largely preempt the growing list of state privacy laws, but makers of health apps and other digital products might eventually be subject to private litigation under the terms of the bill.
The U.S. Federal Trade Commission (FTC) affirmed its proposed order to force Intersect ENT Inc., of Menlo Park, Calif., to divest itself of Fiagon AG before Dublin-based Medtronic plc., can complete its acquisition of Intersect. The announcement comes as no surprise, but serves as a reminder that the FTC is standing by previous threats to tightly control the mergers and acquisitions market in the U.S., a policy stance that has been duplicated in the European Union.
Intersect ENT Inc., of Menlo Park, Calif., picked up Fiagon AG Medical Technologies less than two years ago in a bid to expand its footprint in the ear/nose/throat (ENT) business, but that acquisition is about to be undone. The U.S. Federal Trade Commission (FTC) said Intersect will have to jettison Fiagon because of Dublin-based Medtronic plc’s acquisition of Intersect, thus unwinding a transaction that was valued at €60 million (US$62.4 million) in September 2020.
Pharmacy benefit managers (PBMs) were in the spotlight at a May 5 U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations.
