Author: Peter

While the world continues to navigate the impacts of the COVID-19 pandemic, our other epidemic hasn’t gone away: The rate of opioid overdoses, already a national nightmare, has accelerated since the onset of COVID-19...It’s time to end this continuing tragedy. One of the ways to do this is by making naloxone...a safe, effective and use-specific antidote to opioid overdose — as common among bystanders as CPR...Narcan can be purchased in its generic or branded forms by anyone, without a prescription, at any participating pharmacy...In order to stem our national overdose epidemic, Narcan must be omnipresent in our public places, in our workplaces and schools, and in our homes...Years ago, CPR became a public health imperative. CPR became common after the American Red Cross, the American Heart Association and other major national organizations assumed the task of training. In today’s world, Narcan needs to have similar importance...As we observe International Overdose Awareness Day, it’s time to establish a new public health priority. Surgeon General Jerome Adams, in the first Surgeon General advisory of its kind in the past 15 years, is urging every American to carry Narcan, and be trained to administer it...READ MORE

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

Joining a recent spate of digital health companies hitting the public market, GoodRx filed its initial public offering...The startup, which helps consumers find deals on their prescription medications, is looking to raise up to $100 million in an IPO...Unlike many other digital health companies that have gone public, GoodRx has been profitable since 2016...The majority of the company's revenue, or 97%, comes from its prescription offering in which if collects fees from pharmacy benefit managers when consumers use a GoodRx code to fill a prescription...With the acquisition of telemedicine company HeyDoctor...GoodRx...now competes with other startups that combine virtual care and pharmacy services such as Hims, Hers, Ro and Nurx...GoodRx doesn’t sell medications; it instead directs consumers to the drugstore with the best prices and offers coupons...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

The medical school at the University of Nevada-Reno will team with the state’s largest non-profit health care organization to boost education and research in northern Nevada, the new partners announced...The planned long-term agreement between UNR’s School of Medicine and Reno-based Renown Health is expected to be formalized later this year...Medical School Dean Dr. Thomas L. Schwenk said the partnership will increase access to care for the public and expand teaching and research opportunities...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