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A federal judge has dismissed a lawsuit filed by several hospital groups seeking to get the Department of Health and Human Services to clamp down on drugmakers restricting access to products...Federal Judge Yvonne Gonzalez Rogers issued a ruling...that hospitals had to use a new dispute resolution process to settle the feud with the drugmakers, which the hospitals cannot sue individually under federal law for 340B violations...READ MORE

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device...Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan paid bribes and kickbacks to a group of pharmacy benefit managers —referred to collectively as CVS Caremark, Express Scripts, and OptumRx — to ensure that Mylan could raise the price of its EpiPen auto-injector with impunity while also keeping a monopoly share of the market...Mylan and the PBM defendants filed separate motions to dismiss for failure to state a claim...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

A federal appeals court...upheld a White House-backed rule to require hospitals to disclose the prices they negotiate with insurers for an array of common tests and procedures...The...decision...is a victory for President Donald Trump’s effort to make health care pricing more transparent so patients can be better informed when deciding on treatment...The American Hospital Association and other hospital groups had challenged the rule...They said it would require them to divert scarce resources, including to fight COVID-19, to the “herculean” and costly task of compiling health care costs, while reducing competition and causing confusion about patients’ out-of-pocket expenses...READ MORE

Fresenius Kabi Oncology fell afoul of the FDA in 2013 when the agency discovered employees had hidden records before a manufacturing inspection. Now, the drug ingredients manufacturer is admitting fault—and has reached a deal with the U.S. Department of Justice to put the investigation to bed...The Fresenius Kabi unit agreed to pay a $30 million fine, forfeit another $20 million and plead guilty to concealing and destroying records ahead of a 2013 FDA inspection in Kalyani, India...READ MORE

A Nevada man has been charged with fraudulently obtaining about $2 million in federal coronavirus relief aid, meant for small businesses, to buy luxury vehicles and condominiums in Las Vegas...The U.S. attorney’s office in Nevada accused Jorge Abramovs with bank fraud after he allegedly applied for funding to at least seven banks between April and June 2020...The complaint said Abramovs used a variety of company names — National Investment Group Corporation, National Legal Advisors In Care Of and National Investment Group — that “misrepresented the number of employees and the amount of revenue and payroll his companies had” to the banks...READ MORE

With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow...With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said...All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview...READ MORE

McKinsey & Company, the consultant to blue-chip corporations and governments around the world, has agreed to pay nearly $600 million to settle investigations into its role in helping “turbocharge” opioid sales, a rare instance of it being held publicly accountable for its work with clients...The firm has reached a $573 million agreement with attorneys general in 47 states, the District of Columbia and five territories, according to a court filing in Massachusetts on Thursday. Separate deals were announced in Washington State, for $13 million, and in West Virginia, for $10 million...The settlements come after lawsuits unearthed a trove of documents showing how McKinsey worked to drive sales of Purdue Pharma’s OxyContin painkiller...READ MORE

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

On the drug pricing front, a major effort by the Trump administration to cut Medicare prices has been temporarily blocked by a federal judge...The president's "most favored nation" clause, which aims to tie drug prices in Medicare to lower prices abroad, has hit an early setback as a federal judge in Maryland ruled the administration didn't give the public a chance to weigh in...Judge Catherine Blake ruled the executive order was rushed unlawfully...After Trump moved to implement the measure in November, industry trade groups PhRMA and BIO sued to stop it. Blake's ruling is temporary and the Trump administration could still win the lawsuit...READ MORE