What We're Reading: FDA and Medical Devices; CVS–Aetna Merger to Close; GAO Probe of Trump Associates

Medical Device Approval Process to See Overhaul by FDA

The FDA will revamp the process for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and related products, a day after the publication of a global investigation into medical device safety by more than 50 media organizations. The Associated Press said the FDA’s new system is aimed at reflecting up-to-date safety and effectiveness features. Under decades-old rules, manufacturers can launch new products based on similarities to older products, not new clinical testing in patients. The probe by the International Consortium of Investigative Journalists found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the FDA over a 10-year period.

CVS—Aetna Deal Set to Close

The $69 billion merger between CVS and Aetna is expected to close Wednesday after New York signed off on the deal Monday, The Hill reported. The merger means that there will no longer be any independent pharmacy benefit managers. The 2 companies said the merger will improve healthcare outcomes and reduce costs immediately. They have plans to turn CVS’s 10,000 pharmacies and clinics into community-based sites of care with nurses and other health professionals available to give diagnoses or do laboratory work. The deal was cleared by the Department of Justice in October, and New York was the last state regulatory approval that the companies needed.

GAO to Probe Trump Associates for Undue Influence in VA EHR Contract

The Government Accountability Office (GAO) will investigate whether members of President Donald Trump’s private club in Florida improperly influenced the Department of Veterans Affairs (VA), Politico reported. At issue is a $10 billion contract to modernize veterans’ electronic health records (EHRs), according to a letter from the watchdog office released by Democratic Senators Elizabeth Warren, D-Mass, and Brian Schatz, D-Hawaii. They had requested an investigation following reports that Trump confidant Ike Perlmutter, chairman of Marvel Entertainment, and Bruce Moskowitz, a West Palm Beach doctor, used their access to Mar-a-Lago, and the president, to delay and shape a plan to overhaul EHRs at the VA. Moskowitz, an internist, objected to the VA contract with Cerner Corp because he didn’t like the company’s software in use at 2 Florida hospitals, and his concerns effectively delayed the agreement for months.