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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

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

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

The U.S. Department of Justice has been hot on the heels of some of pharma's biggest players in a yearslong probe into an alleged industrywide co-pay kickback scheme...Federal prosecutors accused Teva in a new lawsuit of paying kickbacks to two patient copay assistance charities as part of a scheme to pump up prescriptions of multiple sclerosis med Copaxone...The filing in a Boston district courthouse alleged the company paid more than $300 million to those third-party organizations and defrauded Medicare of "hundreds of millions" in reimbursements...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

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

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

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

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. government has placed a series of multibillion-dollar bets on potential COVID-19 vaccines. But actually getting those vaccines to patients is another story, and now the government has picked a distributor to aid that effort...The Trump administration has tapped Dallas-based distribution giant McKesson to partner with the Centers for Disease Control and Prevention as a national distributor for COVID-19 vaccines...Under a 2016 childhood vaccine deal, the CDC had an option to draft McKesson to distribute vaccines in case of a pandemic, according to a Department of Defense...McKesson's Warp Speed pact comes as the Trump administration looks to flesh out a production and distribution framework for one or more approved vaccines by the end of the year...READ MORE