Pete Petit, former Mimedx Group Inc. CEO, was sentenced Feb. 23 in U.S. federal court to one year in prison and fined $1 million for orchestrating a multimillion-dollar scheme to fraudulently inflate Mimedx’s revenue – a scheme that cost shareholders about $35 million, according to the U.S. Attorney’s Office for the Southern District of New York. Following a four-week jury trial, Petit and Bill Taylor, the company’s former chief operating officer, were found guilty in November. Taylor was scheduled for sentencing late Feb. 24. After consistent quarter-over-quarter revenue growth and meeting or exceeding revenue guidance in 17 consecutive quarters beginning in 2011, Mimedx, of Marietta, Ga., struggled to maintain that record in 2015. In response, Petit and Taylor falsely recognized revenue upon the shipment of Mimedx products to four stocking distributors and then reported roughly $8.2 million in inflated revenue to investors to show that the company had met its guidance and that its growth was continuing.
Australia’s Therapeutic Goods Administration (TGA) released version 5.0 of a guidance outlining the approach the agency uses in identifying and managing the risks associated with drugs and devices. The guidance, which provides an overview of the TGA’s monitoring, compliance and enforcement efforts, was first issued in 2004, with updates released three times in 2011. The latest version – the first in nearly 10 years – is both a rewrite and an update, according to the agency.
The U.S. FDA extended the recommended timeframe for completing risk assessments of nitrosamines in active pharmaceutical ingredients and finished drugs to March 31. Manufacturers don’t need to submit the risk assessments to the agency, but they should retain them so they’ll be available upon request, according to a Feb. 24 revision of the agency’s September guidance on controlling nitrosamine impurities in drugs.
Citing concerns about the complexities related to the active pharmaceutical ingredient (API) remdesivir and the formulation of drugs containing the API, the FDA said compounding remdesivir would be “particularly challenging.” In a statement released Feb. 24, the agency said it is concerned that patients could receive substandard compounded remdesivir drugs that could harm them. The FDA approved Gilead Sciences Inc.’s Veklury (remdesivir) in October, making it the first drug fully approved to treat COVID-19. It had received emergency use authorization five months earlier.