The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies.
Philips RS North America LLC, formerly known as Respironics Inc., has agreed to pay more than $24 million to settle allegations that the company violated the False Claims Act in relation to CPAP equipment, another hit on the company which has been dealing with a stream of FDA recalls for these products. The allegations include that Philips RS provided durable medical equipment suppliers physician prescribing data to help these suppliers market their inventory, an unusual vector for violation of the FCA.
The U.S. Federal Trade Commission (FTC) issued a final order in connection with the proposed reacquisition of Grail Inc. by Illumina Inc., in an action that might seem to finally conclude a matter that has stretched over several years. However, the FTC acknowledged that Illumina has 60 days to petition the order, which Illumina said it intends to do in conjunction with an effort to overturn a similarly adverse outcome in the EU.
With the public health emergency for the COVID-19 pandemic rapidly winding down, the U.S. FDA has published guidance for the transition of COVID-specific diagnostic tests and other articles to conventional premarket review mechanisms.
The U.S. FDA has released a final guidance for the agency’s refuse-to-accept (RTA) policy for cybersecurity measures in medical devices, a policy document that was required by Congress via the Consolidated Appropriations Act for the 2023 federal fiscal budget.
Developers of artificial intelligence (AI) and machine learning (ML) algorithms have found themselves returning repeatedly to the U.S. FDA for seemingly modest updates to their products, a problem that may soon be relieved by an FDA draft guidance on predetermined change control for AI and ML. However, Brad Thompson of Epstein, Becker & Green, P.C., told BioWorld that the terms of the draft “hugely increases the burden on developers to plan ahead” in order to obtain that postmarket relief from repeated 510(k) filings, a concession that device manufacturers and software developers may be more than willing to make.
The controversy over U.S. Medicare coverage of breakthrough devices is far from over as an administrative matter, but the House of Representatives is prepared to statutorily force the issue with a new bill that enjoys bipartisan support. The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 provides instant Medicare coverage upon FDA clearance or approval of the device, a feature of previous policy proposals that the CMS has found administratively problematic.
The Biden administration’s budget proposal for the U.S. federal government’s 2024 fiscal year is undergoing the usual vetting in Congress, and one hearing each in the House and Senate suggest the proposal will gain little or no traction on Capitol Hill. However, supporters of the National Institutes of Health (NIH) may be cheered by the fact that one of President Biden’s own party, Rep. Rosa DeLauro (D-Conn.), blasted the proposal for offering only a 2% increase in the NIH budget, a sign that the agency will receive a substantial boost in monies yet again in FY 2024.
Mergers and acquisitions in the U.S. have been under tremendous regulatory pressure over the past two years, a trend that seems likely to continue for the foreseeable future. However, Lina Khan, chairwoman of the U.S. Federal Trade Commission (FTC), said in a March 27 public forum that the agency will not wait for airtight cases to pursue legal remedies in part because the perfect case does not always arise, but also because the courts can be provoked into validating a novel legal theory even if the court does not ultimately side with the FTC.
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
