- Generic Drug Shortage Solutions on the Horizon (drugtopics.com)
Shortages of vital generic drugs—particularly since the start of the coronavirus disease 2019 pandemic in the US—are well known by pharmacy teams in both health systems and community settings...although pharmacy associations appreciate the Trump administration’s efforts to move more pharmaceutical and active pharmaceutical ingredient manufacturing to the United States...they say government initiatives must include an overall plan for drug pricing, payment model, and supply chain transparency...READ MORE
- FDA puts India’s Wintac on blast for lackadaisical probe into bacterial contamination (fiercepharma.com)
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
- McKesson signs up with Warp Speed to distribute COVID-19 shots in U.S. (fiercepharma.com)
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
- Scientists uneasy as Russia approves 1st coronavirus vaccine (apnews.com)
Russia..became the first country to approve a coronavirus vaccine, a move that was met with international skepticism and unease because the shots have only been studied in dozens of people...President Vladimir Putin announced the Health Ministry’s approval and said one of his two adult daughters already was inoculated. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness...READ MORE
- FDA scolds Mylan for ‘repeated’ manufacturing problems (biopharmadive.com)
The Food and Drug Administration is concerned that generics giant Mylan has deep-rooted problems in its global manufacturing network, with the latest evidence coming from a site in India...The agency posted this week a warning letter about Mylan's Unit 7 facility, which makes dozens of active pharmaceutical ingredients, or APIs, used in blood pressure drugs, antifungals and central nervous system treatments. During a February inspection, regulators found the site did not have adequate procedures in place to prevent contamination. They noted that similar issues were seen last year at Unit 8..."These repeated failures at multiple sites manufacturing API demonstrate that your company's oversight and control over the manufacture of drugs is inadequate. You should immediately and comprehensively assess your company’s global manufacturing operations,"...READ MORE
- What is Gilead’s role in the war on Hydroxychloroquine? (americanthinker.com)
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
- GoodRx: These are the most expensive drugs in the U.S. (fiercehealthcare.com)
GoodRx has released its latest list of the most expensive drugs in America, with orphan drugs and therapies for rare conditions continuing to top the ranking...The most expensive drug as of July is Myalept, an orphan drug that treats leptin deficiency in patients who have generalized lipodystrophy, which is a genetic disorder where a patient has an almost total lack of body fat...Myalept's list price is $5,093 per vial, and patients typically use 14 vials in a year, GoodRx said. The drug's price most recently went up January...READ MORE
Ravicti
Mavenclad
Actimmune
Oxervate
- NCPA Urges Investigation of Mail Order Prescription Plans After USPS Delays (drugtopics.com)
Soon after the House Energy and Commerce Committee launched an investigation into potential US Postal Service delivery delays for mail order medications, NCPA said in a letter that the committee should broaden its investigation to probe long-term problems with mail order prescription plans...“Policymakers should investigate the cost and safety of mail order prescriptions as well as the impacts of any delivery delays on drug safety and efficacy,” said Karry La Violette, NCPA senior vice president of government affairs, in a news release. “We’re confident they will find that in many cases there are better, more reliable options—namely, patients’ neighborhood pharmacies—to help improve outcomes, protect patient choice, and control costs.”...“NCPA questions the integrity of a drug distribution system that relies exclusively on the mail and in which drugs are dispensed in excessive volume, over long distances, often exposed to extreme temperatures or humidity, delayed, and otherwise compromised.,” La Violette said in the letter...READ MORE
- Sutter Health posts $857M loss in first half of 2020 due to COVID-19 (fiercehealthcare.com)
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
- Government Creates the High Drug Costs It Then Seeks to Fix (breitbart.com)
As President Trump wrestles with trying to rein in the high cost of medicine in the United States, he is contemplating an executive order and a proposed rule from the Center for Medicare & Medicaid Services that would set Medicare Part B prescription drug costs based on an International Pricing Index (IPI). The problem is that the IPI includes countries that utilize socialized medicine and artificial price controls. Here, President Trump is mistakenly focused upon the symptom rather than the cause of the problem. The symptom is the cost, the cause is the incredible barriers to approval and pernicious middle-men known as Pharmacy Benefit Managers which make medicines more expensive...READ MORE