Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. has agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.
Nearly three years after being terminated as president and CEO of Cytodyn Inc., Nader Pourhassan was convicted June 9 by a U.S. federal jury for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab. The jury also convicted Kazem Kazempour, the CEO of Amarex Clinical Research LLC, a contract research organization hired by Cytodyn, for his part in the scheme.
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists.
Azon Medical LLC, a supplier of medical products such as durable medical equipment, is on the hook for slightly more than $1 million for promoting the P-Stim device as eligible for Medicare coverage.
The U.S. Department of Justice reported that THD America Inc., and its Italian corporate parent company agreed to pay $700,000 over inducing physicians to use incorrect payment codes in Medicare and Medicaid claims.
The recent conviction of Ontrak Inc. CEO Terren Peizer for insider trading was conspicuous on two counts, including that it was the first time such a conviction had been obtained solely for trading conducted under a government-approved insider trading policy. More worrisome for industry, generally, is the case is another example of federal prosecutors’ ever-growing use of data and analytics to root out violations of SEC law. This is a trend that seems destined to grow with advances in artificial intelligence.
U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.
Companies that buy other companies know perfectly well that they may acquire a few headaches in the process, but recent enforcement trends are making the acquiring companies more careful about acquisitions. Regulatory attorney Jennifer Bragg told an audience at this year’s meeting of the Medical Device Manufacturers Association (MDMA) that the smarter companies are doing their due diligence before approaching the target company, an exercise that could ultimately dissuade the would-be acquirer of the wisdom of the transaction.
Kevin Dills, who the U.S. SEC said secretly controlled Oncology Pharma Inc., consented to a final civil judgment in federal district court related to a fraudulent stock-selling scheme.
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
