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Drugmakers are getting bolder in their bid to restrict access to drugs discounted under the 340B program as legal experts say a lack of enforcement has created a regulatory void...Hospitals are imploring the Department of Health and Human Services to clamp down on several moves by drug companies, including Novartis and AstraZeneca, to limit distribution of certain 340B drugs. But experts say an administration-wide change in what agencies can enforce is likely behind drugmakers’ aggressive moves...“It is an outrage that these actions are being taken at a time when hospitals are in the midst of their response to the COVID-19 public health emergency, which has further demonstrated the fractured, inadequate state of the prescription drug supply chain,” the American Hospital Association said in a release last week..It is the most aggressive move in a fight sparked last month between drug companies against contract pharmacies, which are a popular tool among 340B hospitals...READ MORE

When FDA investigators identify potentially grave issues at a drug manufacturer's facility, the general assumption is that the company will do its best to remedy the problem. But few things rile up the agency more than a lazy investigation—a reality Indian CMO Wintac is finding out the hard way...The FDA blasted Wintac, the CMO arm of New Jersey-based Somerset Therapeutics, after the company performed a cursory investigation into bacterial contamination on an aseptic fill line at its Bangalore, India facility, according to a warning letter posted Tuesday...During an inspection in November, Wintac found its operations were contaminated with ralstonia pickettii, a gram-negative bacteria. Instead of performing a wide-ranging investigation into the source of that contamination, Wintac highlighted only one possible source and ignored others, the FDA said...READ MORE

California-based Sutter Health suffered an $857 million loss in the first half of the year thanks to major declines in revenue due to the COVID-19 pandemic...“The need for Sutter to adjust its entire integrated network to respond to COVID-19 has been, and continues to be, a costly and difficult endeavor,”...Sutter experienced rapid declines in patient revenue in the first half of the year as states required the cancellation of elective procedures and patients were hesitant to come back to the hospital...Patient revenue from commercial plans suffered the most, generating $2.7 billion in revenue, a $543 million drop compared with the first half of 2019...Medicare revenue also declined by $179 million in the first half...Like other health systems, Sutter Health got $400 million from a $175 billion provider relief fund passed by Congress as part of the CARES Act...The system also got $1 billion from the Medicare Advance and Accelerated Payment program, which gave out advance Medicare payments to hospitals...Facilities have to start repaying the loans as soon as this month...READ MORE

An Alabama doctor was sentenced to 30 years in prison for his involvement in running a "pill mill" out of a Birmingham medical clinic, the U.S. Department of Justice said...U.S. District Court Judge R. David Proctor sentenced...Patrick Emeka Ifediba...for his involvement with Care Complete Medical Clinic...Ifediba was a doctor of internal medicine who owned and operated CCMC. Prosecutors alleged he and others, including his wife, operated CCMC as a "pill mill" and "illegally, repeatedly prescribed opioids there, often in combination with other controlled substances to form potent and deadly drug cocktails."...READ MORE

The Trump administration is now going to require all hospitals to submit daily critical information on COVID-19, including bed capacity and the availability of essential supplies...The Centers for Medicare & Medicare Services released an emergency regulation...calling for the mandatory reporting. The agency also posted new requirements for lab reporting and revised a policy for physician and pharmacist orders for COVID-19 tests...“While many hospitals are voluntarily reporting this information now, not all are,” CMS said in a release. “The new rules make reporting a requirement of participation in the Medicare & Medicaid programs.”...READ MORE

Is Gilead, the maker of Remdesivir, waging war on HCQ (hydroxychloroquine)? Attacks on the drug have been continuous ever since Dr. Didier Raoult used this quinine derivative to save the lives of COVID-19 patients last March. The first attempt to discredit HCQ was a hastily compiled Veterans Administration hospital system study last April. Notably, one of the study’s authors had in the past received numerous grants from Gilead...After deep flaws in the VA study were exposed, Surgisphere came to the rescue in May with a “15,000 patient” megastudy allegedly compiled from hospitals all over the world. This strategy succeeded: Following its publication in the Lancet and the NEJM, all outpatient use of HCQ was severely restricted...When the Surgisphere scam was exposed, both articles were quietly retracted and the editor-in-chief of the Lancet tried to wash his hands of this embarrassing incident by denouncing Surgisphere’s “monumental fraud.”...READ MORE

A friendly animated syringe is in the FDA ad police crosshairs. The Office of Prescription Drug Promotion sent Xeris Pharmaceuticals an untitled letter last week over "false or misleading claims" in a TV ad for its new Gvoke pre-filled syringe...OPDP takes issue with several statements the animated glucagon syringe says in the 60-second ad. The commercial begins: “If you have diabetes and take insulin, you know low blood sugar can be scary. You might start to sweat, panic, worry you might pass out. You may even feel like you’re falling.”...That's a no-no, OPDP says. Its letter to Xeris points those “claims are misleading and minimize the seriousness of the condition because they include some of the early, mild symptoms of hypoglycemia, but fail to present the symptoms of severe hypoglycemia for which Gvoke is indicated."...READ MORE

With the walls closing in around it on a yearslong generics price-fixing probe, Israeli drugmaker Teva faced two options: Reach a deal with prosecutors or gamble. Teva chose to roll the dice, and now it finds itself facing conspiracy charges—and a potentially bigger penalty on the horizon...Federal prosecutors have charged Teva with conspiring to fix prices for a range of generic medicines between 2013 and 2015 as part of an industrywide scheme to overcharge consumers by more than $350 million, the U.S. Department of Justice said...The DOJ indicted Teva on three counts of criminal conspiracy and acting as a ringleader for a group of drugmakers that have previously pleaded guilty to their own price-fixing charges and are now cooperating with prosecutors...READ MORE

Humana has filed suit against Florida-based telehealth company QuivvyTech, saying it was defrauded out of millions of dollars...filed in Southern Florida district court, QuivvyTech telemarketers would cold-call Humana members and ask them questions about common ailments. They would then wire that information to physicians who were in the scheme to secure prescriptions for pricey, unneeded creams...The physicians would prescribe these creams without ever speaking to the patient directly, according to the lawsuit. The prescriptions would then be wired to pharmacies that were also active participants in the scheme to be dispensed to members...One doctor, for instance, submitted 1,600 claims through the scheme to which Humana paid out more than $1.1 million, the insurer alleges in the suit...A New York pharmacy submitted 2,100 claims for one type of cream, for which Humana paid more than $2.5 million, the insurer alleges...READ MORE

The COVID-19 pandemic cost Florida’s hospitals an estimated $3.8 billion in financial losses through the end of June, a new report from the Florida Hospital Association found...The report...also accounted for federal relief funds that were intended to help providers weather the financial crisis caused by COVID-19. The association said more funding is needed to help ensure the state’s hospitals are ready for a second surge of COVID-19.,,She said hospitals have faced increased staffing costs, lost revenue from delayed elective procedures and higher costs for personal protective equipment (PPE), testing supplies and vital drugs such as remdesivir...READ MORE