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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

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

The good news: The United States has a window of opportunity to beat back Covid-19 before things get much, much worse...The bad news: That window is rapidly closing. And the country seems unwilling or unable to seize the moment...Winter is coming. Winter means cold and flu season, which is all but sure to complicate the task of figuring out who is sick with Covid-19 and who is suffering from a less threatening respiratory tract infection. It also means that cherished outdoor freedoms that link us to pre-Covid life — pop-up restaurant patios, picnics in parks, trips to the beach — will soon be out of reach, at least in northern parts of the country...Unless Americans use the dwindling weeks between now and the onset of “indoor weather” to tamp down transmission in the country, this winter could be Dickensianly bleak, public health experts warn...READ MORE

Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week...New rules issued last week in the wake of a federal court ruling in February instructed clinical trial sponsors to submit missing data for trials conducted between 2007 and 2017 “as soon as possible.” For years, many trials conducted during that span have largely been exempted from reporting their data to ClinicalTrials.gov, a public database, meaning a decade of data about approved drugs and medical devices has never been made public...The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data...READ MORE

Hospitals and health systems are building a major presence in the specialty pharmacy industry...nine out of ten large hospitals now operate a specialty pharmacy. Hospitals and other healthcare providers account for one-third of all U.S. accredited specialty pharmacies...Clinical and general financial motivations are driving hospitals’ DIY specialty pharmacy growth. The enormous profit opportunities from the 340B Drug Pricing Program offer further encouragement for hospitals. In-house specialty pharmacies are also a valuable hedge against the potential loss of contract pharmacies...READ MORE

...the...Department of Health and Human Services awarded more than $101 million to 116 organizations in order to address substance use disorders (SUD) and opioid use disorders (OUD)...The awards...will go to organizations in 42 states, particularly in highly afflicted rural communities. HRSA’s Federal Office of Rural Health Policy supported 89 rural organizations in 38 states with $89 million as part of the Rural Communities Opioid Response Program-Implementation..."President Trump has focused on expanding access to treatment for Americans with substance use disorders, including opioid use disorder, and that commitment continues during the COVID-19 pandemic," said Alex Azar, MD, secretary of HHS. "The pandemic has created particular stresses for many Americans struggling with substance use disorders, and these HRSA awards will help strengthen prevention, treatment, and recovery services, especially in rural America, at this difficult time."...READ MORE

Johnson & Johnson has agreed to supply the U.S. government with 100 million doses of its experimental coronavirus vaccine, a stockpile that could be used either in clinical trials or, if cleared by the Food and Drug Administration, a widespread inoculation campaign...If necessary, the U.S. government can negotiate to buy up to 200 million additional doses of the shot, which would be available at no cost in any U.S. vaccination program, excepting charges from doctors for administration...READ MORE

This past week Minnesota became the second state to reject regulations that effectively ban the controversial drug hydroxychloroquine for use by COVID-19 patients...The decision, which comes two weeks after the Ohio Board of Pharmacy reversed an effective ban of its own, was rightfully praised by local health care advocates...The reversal by (Gov Tim Walz) Walz, a first-term Democrat, clears the way for doctors to prescribe hydroxychloroquine, a drug commonly used to treat malaria and other conditions but one the FDA has declined to recommend for COVID-19 treatment...The politics of hydroxychloroquine are unlikely to cool before November’s presidential election. Yet, if Walz’s decision is any indication, at least some leaders are starting to recognize the ethical dilemma of using the long arm of government to stand between suffering patients and a drug that may have the potential to save them...READ MORE

The world’s biggest drug makers and their trade groups have cut checks to 356 lawmakers ahead of this year’s election — more than two-thirds of the sitting members of Congress…It’s a barrage of contributions that accounts for roughly $11 million in campaign giving, distributed via roughly 4,500 checks from the political action committees affiliated with the companies…The spending follows a long tradition of generous political giving. Major manufacturers typically make hundreds of modest donations to incumbent members of Congress but avoid donating to presidential candidates… pharma’s giving underscores the breadth of its influence and its efforts to curry favor through lobbying and donations to the lawmakers who regulate health care…READ MORE

Washington, Oregon, Nevada and Colorado will share best practices for telehealth and remote patient monitoring, and follow their own state policies while also adhering to seven key principles, their governors say...Given their states' "significant individual and collective experience with telehealth," the governors say they'll work together to help "ensure that the nation benefits from our knowledge as changes to federal regulations are contemplated, to support continued application and availability of telehealth in our states, and to ensure that we address the inequities faced in particular by tribal communities and communities of color."...READ MORE
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