Category:

With HHS Secretary Alex Azar by his side, President Trump...promised that “we are going to see prices go down, and it will be a beautiful thing.” Based upon the actual blueprint, which remains a work in progress, that may well be the case. But if it proves to be so, it will not be because the administration is wielding the metaphorical meat cleaver to cut prices by government edict and risk gutting our biomedical innovation engine...Instead...he appears to...endorse a series of incremental policy and market-based reforms that will eliminate many of the existing incentives that compel drug manufacturers to push list prices ever higher...These relatively modest proposals will not satisfy Democrats who remain fixated on adopting a single payer system where the Federal government can set prices, as is the case in western Europe. But then, it might be good to remember that risk capital and large drug companies are necessary to develop the compounds that are discovered in government and university research laboratories. If we wish to realize the promise of new medicines in treating rare diseases and in harnessing our immune systems to fight cancer, a thoughtful, cautious incrementalism is preferable to the harshness of the meat cleaver.

The U.S. Food and Drug Administration...listed a number of drugmakers it said could be improperly blocking access to their medicines in order to delay generic competition...But many of the companies immediately pushed back, saying the FDA list of drugmakers may be out of date and that some of the drugs included on it already have generic competitors...The FDA said the list contained all of the inquiries about drugs it had received from generic drugmakers since 2005. It said companies generally do not inform it if they have made samples available after a generic developer has reached out to the agency...The agency said companies on the list may be using FDA safety regulations and other tactics to deny access to their medicines from generic drugmakers hoping to copy them...The FDA is notifying the Federal Trade Commission, which can investigate anti-competitive acts, of cases where drugmakers may be blocking access to their products if there is no safety reason...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The Centers for Medicare & Medicaid Services launched its first "Rural Health Strategy"...an effort, officials said, to better consider the rural impact as part of the of the agency's work...The strategy, which highlights tactics such as improving access to telemedicine, is meant to avoid unintended consequences of policy and program implementation in rural health settings...“Through its implementation and our continued stakeholder engagement, this strategy will enhance the positive impacts CMS policies have on beneficiaries who live in rural areas," said CMS Administrator Seema Verma in a statement...CMS said it is changing access to telehealth services, particularly in rural areas, by paying for additional services and making it easier for providers to bill Medicare..."Something that our organization has been promoting and pushing for quite a while is we just want CMS internally, before they promulgate any rules, to take a look at the impact on rural providers and communities," said Alan Morgan, CEO of the National Rural Health Association...

Inefficient pharmaceutical supply chains are partly to blame for a substantial proportion of the world still being without access to basic live-saving medicines, the International Pharmaceutical Federation says in a new report...The report, “Pharmacists in the supply chain: The role of the medicines expert in ensuring quality and availability”, is released in a landscape of challenges such as substandard and falsified medicines, and a shortage of human resources in the health supply chain. “The need to ensure effective and safe medicines supply prompted FIP to take a close look at the actual role of pharmacists in pharmaceutical supply chains. This report -

• aims to provide a foundation from which improvement can develop
• gives a global overview of the role of pharmacists in different supply chains in low-, middle- and high-income countries, and describes the evolution of supply chains
• points out that investment in training and education are needed to strengthen pharmacists’ roles in supply chains.

The U.S. Department of Justice has joined whistleblower litigation accusing Insys Therapeutics Inc of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications...The government’s involvement...adds firepower to the civil litigation as Insys tries to resolve a federal probe into its marketing of Subsys, a spray form of fentanyl...Six U.S. states - California, Colorado, Indiana, New York, North Carolina and Virginia - also joined whistleblower litigation against Insys, according to the filing in U.S. District Court in Los Angeles...The litigation comes amid a wave of related criminal cases against medical practitioners, and former executives and sales representatives employed by Insys, including its billionaire founder John Kapoor.

The heads of five major drug distribution companies downplayed their contribution to the opioid crisis...while testifying before a Congressional subcommittee tasked with investigating the epidemic spurred by abuse of opioids. Their testimony drew bipartisan wrath and one Republican suggested prison terms for some company officials...Miami-Luken CEO Joseph Mastandrea told the House panel that his company played a role in the opioid crisis, but executives from the other four drug distributors demurred saying the responsibility lied with prescribers and pharmacists more than it did with distributors...While distributors have been responsible for reporting suspicious orders for more than 40 years, some told members of Congress their screening systems had failed...AmerisourceBergen, Cardinal Health, and McKesson -- often known as the big three drug distributors, shipping 80 percent of prescription drugs in the United States, say their current systems for detecting suspicious orders has been greatly improved in recent years, relying more on algorithms to automatically detect issues...

Allergan Inc was sued...by four large U.S. retailers that accused the drugmaker of antitrust violations for trying to stop rivals from selling generic versions of Restasis, its medication to treat dry-eye disease...Walgreen Co, Kroger Co, Albertsons Cos and HEB Grocery Co accused Allergan of illegally preserving its monopoly by obtaining illegal patents, suing rivals that challenged those patents and transferring the patents to a sovereign Native American tribe, New York’s Saint Regis Mohawk Tribe, to escape scrutiny by U.S. courts...The retailers said generic Restasis would have been on the U.S. market by May 2014 but for Allergan’s activities, and that the...company should pay triple and other damages for its anticompetitive conduct...The company holds patents covering various elements of Restasis that expire in 2024...

• Lower drug prices for older people
• Persuade other countries to pay more
• Require drug ads to include the price
• Ban ‘gag clauses’ for pharmacists
• End the patent games
• On the horizon

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.