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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 U.S. Food & Drug Administration...said it authorized the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the disease...The FDA...said early evidence suggests blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization..."It appeared that the product is safe and we're comfortable with that and we continue to see no concerning safety signals," said Peter Marks, director of the Food and Drug Administration's Center for Biologics Evaluation and Research...The agency also said it determined this was a safe approach in an analysis of 20,000 patients who received this treatment...Patients who benefited the most from this treatment are those under 80 years old and who were not on a respirator, the agency said. Such patients had a 35 percent better survival rate a month after receiving the treatment...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

Yet, while we’re hyper-focused fighting COVID-19, our country’s opioid epidemic is growing worse...A report released...suggests that overdose deaths have increased due to COVID-19. The Washington Post reported that suspected overdoses jumped 18% in March, 29% in April and 42% in May. The figures are based on data from ambulance teams, hospitals and police...What’s not being reported is the potential threat of drug diversion within healthcare settings, which is often undetected and underreported...Given the social, economic and healthcare implications of COVID-19, it’s not hard to see how drug diversion might escalate...data suggest a rise in depression and mental health disorders with the coronavirus stemming from isolation, "shelter at home" guidelines and the economic fallout of the pandemic. Healthcare providers, who are more likely to treat patients with COVID-19, may be more susceptible to mental health issues such as depression and burnout...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

The U.S. Environmental Protection Agency said...it has granted emergency approval for American Airlines to use a disinfectant against the coronavirus on certain surfaces that lasts for up to seven days, and is studying whether it could be effective in places like schools...EPA Administrator Andrew Wheeler said at a news briefing that SurfaceWise2, made by Allied BioScience Inc, is the first long-lasting product approved by the agency to help fight the spread of the novel coronavirus...American Airlines will begin spraying its airplane cabins with the disinfectant in its home base of Texas after the state filed the request for emergency approval. The carrier hopes to eventually use it across its entire fleet, including its American Eagle regional partners...READ MORE