Author: Peter

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

The Trump administration released $1.4 billion to almost 80 children’s hospitals that have been impacted by the COVID-19 pandemic...The money comes out of a $175 billion fund Congress passed a few months ago to help providers that have been slammed by a financial crisis caused by the COVID-19 pandemic...“Children’s hospitals have seen decreasing patient visits and increased costs,” the Department of Health and Human Services said...“This distribution will help to ensure children’s hospitals receive relief funding proportional to other hospitals across the nation and providers caring for children are able to continue operating safely in some of our most vulnerable communities.”...HHS already gave out nearly $15 billion to safety hospitals and $11 billion to rural healthcare providers. The agency is also allocating funding to hospitals that have seen a high number of COVID-19 cases...READ MORE

Trevena notched its first drug approval...with intravenous opioid Olinvyk. Now comes the tricky part—navigating the politics of marketing a new opioid product...To do that, Trevena plans to take a narrowly focused approach, targeting healthcare professionals in acute care settings with a focus on complex patient types including elderly, obese and renally impaired people...Sales rep training, compliance and monitoring programs are also in place to ensure marketing sticks to FDA guidelines. Trevena will look to use a range of digital, virtual, on-demand and in-person channels to reach HCPs...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

Papua New Guinea blocked the arrival of a flight carrying workers from China after a Chinese mine operator said its employees were given a coronavirus vaccine in a possible unauthorized trial…The Pacific nation’s pandemic response controller, David Manning, banned COVID-19 vaccine trials after Ramu NiCo Management Ltd. said it vaccinated Chinese employees… Manning said he ordered a flight carrying 180 Chinese workers turned back…as a precaution. He said he acted “in the best interests of our people” because of “possible risks or threat that it might cause.”… Manning said the National Department of Health had not approved any trials. He said any vaccines required approval by the World Health Organization and had to undergo “vigorous vaccine trials, protocols and procedures.”…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

Hospitals say revenue from the 340B program is essential, while others contend the original law is being abused...an federal appeals court ruled that 340B hospitals will now be subject to Medicare cuts in outpatient drug payments by nearly 30%... gives...the Department of Health and Human Services the legal authority to reduce payment for Medicare Part B drugs to 340B hospitals...the action means patients – particularly those who live in vulnerable areas – will pay less out-of-pocket for drugs in the Medicare Part B program...providers...said the 340B decision will hurt hospitals and patients in these vulnerable areas...Hospitals that serve large numbers of Medicaid, Medicare and uninsured patients were getting the drugs for a discounted price, but, getting reimbursed at the higher price...The hospitals...are in the red or operating on thin margins, were using the pay gap in the price difference to cover operational expenses. HHS deemed it inappropriate that these facilities would use Medicare to subsidize other activities and initiatives...READ MORE