Author: Peter

The federal government already has several tools for reducing the prices of drugs it buys...The VA and DOD pay drug prices that are roughly half as much as those paid by retail pharmacies...Drug pricing is having its moment. Proposed treatments for the drug pricing epidemic are varied, but some call for government to do more...While others resist the idea of government involvement, the federal government, in fact, already employs a number of effective tools for reducing the prices of drug purchased by certain public programs. These fall into two broad categories:

1. Price controls, usually in the form of required discounts off of the average price paid by other purchasers.
2. Negotiated pricing, in which the government wields its market power to bargain for favorable rates from pharmaceutical suppliers.

These strategies do not exhaust the available approaches, nor are they necessarily the most desirable...The Programs:

• Medicaid
• Veterans Health Administration and the Department of Defense (DOD)
• 340B Program

The bottom line is that the government can and does get better deals on drugs than private purchasers. The effects of these policies on quality and innovation need to be better understood—but were the government to expand them, it would be more of an evolution than a revolution.

Drug regulation has failed to keep up with a globalized world and governments should harmonize oversight to improve patients' access to new and innovative medicines...That is the view of the former leader of the U.S. Food and Drug Administration, the world's top drug regulator, and the research head of French drugmaker Sanofi, who made a joint plea to governments for action...Margaret Hamburg, who led the FDA until 2015, and Elias Zerhouni said there was an urgent need to harmonize a "mosaic of regulations" in different countries, and they called for the issue to be taken up at the G8 or G20 groups of nations..."Essentially, it is a hidden bureaucratic inefficiency tax on the whole effort of finding new and valuable therapies," he said in a telephone interview...Drug development is global and we need to have safety and efficacy data globally, so we should have a global system, just like with airplanes...Sanofi was spending around 20 percent of its research and development budget on ensuring convergence between different systems, often involving duplication of efforts.

New medical schools are launching across the country to address a projected physician shortage. They’re promising innovative curriculums that let aspiring doctors spend time doing research, working in community health settings, and following the same patients for months...But they face big obstacles, starting with the challenge of recruiting students and faculty when they’re not yet accredited — and won’t be, even in the best-case scenario, for several years...An equally big challenge: raising the tens of millions it takes to build and then run a top-tier medical school...all in an effort to create a new breed of American doctor...What we’re doing is certainly a little bit risky…At the University of Nevada, Las Vegas, which is on track to launch its med school in the fall of 2017, student training will involve getting out of the hospital to work at a hospice, a home for developmentally delayed patients, or some other community organization. Plus, students will spend a year at an outpatient clinic where they can follow the same individuals over time, rather than jumping among different specialized clinics each month, as is often the case..."The students will actually get to know their own patients," said founding dean Dr. Barbara Atkinson...Massive fundraising campaigns and acceptance from the local community are needed...The financial urgency is even more pronounced at UNLV. Last year, Nevada legislators approved $27 million in startup funds — but that’s just a drop in the bucket of the full amount the university needs to get up and running..."We’re working hard to cultivate donors," said Atkinson...We’re very fortunate to be starting from scratch when we are...It would be virtually impossible to do what we’re doing at a school that’s already set in its ways...

While many groups are criticizing the FDA's backlog of generic drug approvals, the agency said the situation has improved...In December 2015 alone, OGD (Office of Generic Drugs) issued 99 approvals and tentative approvals...the most approvals and tentative approvals granted in a single month since the start of the generic drug program...FDA’s Office of Generic Drugs awarded 580 generic drug approvals and 146 tentative approvals in 2015...the Campaign for Sustainable Rx Pricing...is pressing legislators to grant FDA more resources, to allow quicker processing of generic drug applications. The group's members include AARP, ASHP, numerous health plans, providers, and Walmart...The FDA faces a backlog of nearly 4,000 generic drug applications, yet approval times can be three or more years...The FDA should be provided necessary resources to clear this backlog and prioritize generic drug approval applications...

Oncologists and other doctors are urging the Medicare agency to rescind a proposed demonstration that would test six different approaches for paying for Part B drugs that are administered in physician offices and outpatient departments...The American Society of Clinical Oncology said...that the CMS should "withdraw an experiment of this magnitude without first understanding its potential impact on patient care."...The proposed regulation, published in the March 11 Federal Register, "is particularly ill-suited to the delivery and treatment of cancer care, which is complex and highly personalized to each patient," ASCO President Julie M. Vose said in a statement...The Federation of American Hospitals said the CMS needs to go back to the drawing board to develop policy proposals that more directly and effectively address the problem of unsustainable increases in drug costs.

A majority of Americans opposes federal regulatory changes to speed up the development and approval of new medical treatments, a new STAT-Harvard poll finds — suggesting the public has serious doubts about legislation now moving through Congress...both parties are pushing to change government regulatory standards that they blame for slowing the approval process to get new products to patients...nearly 6 out of 10 Americans said they oppose changing government safety and effectiveness standards to allow for faster approvals of new prescription drugs by the Food and Drug Administration, while 38 percent said they’re in favor of speedier FDA action...The poll sheds new light on how Americans balance their priorities between speed and safety in the approval of new medical treatments.

A Boise jury...returned guilty verdicts against Michael Minas, 50...on charges that he unlawfully distributed controlled substances outside the usual course of professional practice and not for a legitimate medical purpose…Minas illegally distributed was primarily oxycodone 30 mg, but the jury also found Minas guilty of distributing fentanyl and hydromorphone. The jury heard evidence that Minas wrote prescriptions for extraordinary dosages, such as 240, 300, and even 420 oxycodone 30 mg. They also heard evidence that he often wrote prescriptions at intervals of two or three weeks, but wrote dosage instructions on the prescriptions indicating that it was a month’s supply…Minas faces a maximum prison sentence of up to 20 years in prison, a maximum fine of $1,000,00 ($1,000,000) and at least three years of supervised release on each count of conviction.

Gilead Sciences has received Indian Patent Office approval for Sovaldi (sofosbuvir), with the U.S. drugmaker saying that the nod for a patent on the blockbuster hepatitis C medicine does not hinder access--even as civic groups such as Médecins Sans Frontières decried the ruling...Gilead has worked with several Indian drug manufacturers to produce licensed versions of the drug for defined emerging markets at a significantly lower cost for the therapy (than) in major reimbursed developed markets in the U.S., Europe and Japan...But the access program has not ended complaints from MSF, and other groups, that the particular decision sends a poor signal on access to a wide variety of generics made by Indian firms--some of which were approved under compulsory licenses in the country. At the same time, Indian officials have denied reports that patent policies are changing in favor of stronger intellectual property rules sought by multinational drug firms...according the Hindu, the drug may not be out of the woods yet in India, with a separate application before the Kolkata patent office with civic groups geared up to offer opposing views.

The U.S. Attorney's Office...is investigating contracts between drugmakers and companies that manage prescription benefits...Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co and Endo International Plc, demanding information about their contracts with pharmacy benefit managers...Pharmacy benefit managers...which administer drug benefits for employers and health plans and also run large mail-order pharmacies, have been challenging the rising cost of new medications...When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.

Walgreens’ posting of a seemingly sympathetic blog about the use of medical marijuana has created quite a buzz, with some online observers speculating the retail chain has its sight on that lucrative industry...But a Walgreens spokesperson insists the chain has not taken a stance on the use of medical marijuana and cautions people against reading too much into the blog posting. Pharmacies cannot legally dispense medical marijuana...The blog, entitled "What is Medical Marijuana? Clarifying Clinical Cannabis," was written by Dahlia Sultan, who is a resident pharmacist at Walgreens and associated with the University of Illinois at Chicago...Sultan...suggests "marijuana provides pain relief in ways traditional medicines don’t" and "medical marijuana can improve appetite and relieve nausea in those who have cancer and may help relieve symptoms such as muscle stiffness in people who have multiple sclerosis."...Not surprisingly, the blog has attracted the attention of medical marijuana advocates. Some believe that pressure from giant retailers such as Walgreens could eventually convince the federal government to reclassify marijuana so that it could be dispensed by pharmacies...Jim Cohn, spokesperson for Walgreens, said that people shouldn’t read too much into the blog. "The content [of the blog] is strictly informative, and nowhere do we take any stance on the issue,"...