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A Mississippi owner of pharmacies and pharmacy distributors has been sentenced to 18 years in prison and ordered to repay the government nearly $287.7 million for his part in what prosecutors described as a $510 million health care fraud involving high-priced pain cream...Wade Ashley Walters...of Hattiesburg, also was ordered...to forfeit nearly $56.6 million that he gained personally from the scheme...Walters had been charged in a 37-count indictment. He pleaded guilty in July to one count each of conspiracy to commit health care fraud and conspiracy to commit money laundering...Between 2012 and 2016, Walters orchestrated a scheme to defraud Tricare, the insurance program for U.S. military, veterans, and their families, and private health insurers by distributing compounded medications that were not needed...READ MORE

Several pharma companies and the two leading industry trade groups are pausing political donations in the wake of the U.S. Capitol riots. They join a broad and growing coalition of businesses reevaluating donations and refusing to fund politicians who denied the presidential election results...Eli Lilly, Johnson & Johnson and Sanofi are among the pharma companies who have either canceled donations to some elected officials or are pausing to reconsider funding. They join dozens of companies across the business spectrum—including Amazon, AT&T, Google, Microsoft, Coca-Cola and J.P. Morgan—who have paused donations completely or cut ties to specific candidates for their false claims of election fraud...READ MORE

President Donald Trump's Operation Warp Speed promised 20 million COVID-19 vaccines administered to Americans by the end of 2020. Halfway into January, the rollout is still lagging behind those expectations...But President-elect Joe Biden's team is planning to shake up how doses are delivered after he takes office next week. Rather than holding back supply to ensure people can get their second doses, the Biden administration plans to release all available doses...It’s a departure from the Trump team’s approach at a time when the coronavirus vaccine rollout is failing to meet the pace needed to stem the pandemic...READ MORE

Pharma companies have inked a series of federal settlements over payments to charity organizations, which the federal government argues are a “conduit” to boosting drug sales. Now, after an opioid investigation, two Senators want all those charity payments disclosed publicly...And they have just the mechanism for it. Sens. Chuck Grassley and Ron Wyden have called for an expansion of the Centers for Medicare and Medicaid Services Open Payments database. That database now includes payments from pharma companies to doctors and other medical providers, but the senators propose adding payments to tax-exempt groups, too...READ MORE

Yvelice Villaman Bencosme of Miami, Florida, has entered a guilty plea in US District Court for the Southern District of Florida, in response to one count of conspiracy to commit wire fraud...Bencosme (who served as primary investigator for clinical purportedly conducted at the medical clinic Unlimited Medical Research in Miami) admitted that from approximately 2013 to 2016, she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at UM Research...READ MORE

The Trump administration finalized a rule...that will grant faster Medicare coverage decisions on new breakthrough medical devices...The rule will tackle the lag time between when a new device is approved or cleared by the Food and Drug Administration and when it gets covered by Medicare, a time the administration refers to as the “valley of death” for innovative products, officials have said. The rule creates an accelerated Medicare coverage pathway for "breakthrough" devices, or those which the FDA approves on an expedited basis...READ MORE

FDA officials have released an alert for clinical laboratory staff and health care providers regarding information on viral mutations of coronavirus disease 2019...Amid reports of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant from the United Kingdom, known as B117, the FDA announced that it is acting to ensure the accuracy of molecular diagnostic tests authorized by the agency...the FDA has identified 3 authorized molecular tests that may be negatively affected by genetic variants: MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit. However, “the impact does not appear to be significant,”...READ MORE

After AstraZeneca pledged not to profit off its COVID-19 shot during the pandemic, a report emerged that the drugmaker might be ready to declare the pandemic over as soon as July. But according to EVP and biopharma president Ruud Dobber, it’s still “too speculative” to predict when the vaccine may start earning money...The company is building a capacity of 3 billion doses for countries around the world, and it won’t be until after AZ delivers on its government supply deals that it might “feel open" to selling the vaccine commercially...READ MORE

The lawsuits, filed...in different federal courts, seek to get rid of an advisory opinion filed by the Department of Health and Human Services’ general counsel that says drug companies must offer 340B drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of hospitals participating in the program...The drug companies argue that the advisory opinion contracts (contradics) the statute for the 340B program, which requires manufacturers to offer discounted products to safety net hospitals and other providers in exchange for participation in Medicare and Medicaid...“The statute, on its face, does not require manufacturers to recognize any contract pharmacies, much less unlimited contract pharmacies,” the legal filing from AstraZeneca said...READ MORE

In order to deliver COVID-19 vaccine to more people more quickly, the Trump administration intends to expedite rollout of its immunization partnership with pharmacies. The logic behind the concept is that getting vaccinated at a local pharmacy will be more accessible and efficient for many Americans than going to a hospital...READ MORE