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Some major U.S. drug companies have hired their own auditors to perform compliance reviews mandated in government settlements over alleged civil violations, such as paying kickbacks or off-label drug promotion, according to federal records...Third-party compliance reviews are playing an increasingly large role in helping the government ensure companies fulfill their obligations in federal settlements...Some lawmakers and legal experts say that practice creates conflicts of interest and could impair outside reviewers' independence...Susan Gillin, an attorney in the inspector general's office, said she agreed that "theoretically, a potential conflict of interest exists."...But she said her agency has not observed any problems with weak oversight by auditors serving in dual roles. Such arrangements are allowed, she said, as long as the firm is not involved in corporate management or advising on policies it will also review...Senate Judiciary Chairman Charles Grassley...said such arrangements could weaken enforcement..."If the firms enforcing the agreements aren't independent,"...that "defeats the purpose of the agreements."

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,"...

The U.S Attorney prosecuting the case against Richie West and Dr. Robert Rand and seven other defendants accused of operating an illegal Oxycodone distribution and street-buying operation says he has records from the Nevada Pharmacy Board. Those records identify when and where the defendants had their prescriptions filled. The system is part of the board's Prescription Monitoring Program...It’s not a perfect system, and there are some loopholes. But it’s helped keep track and monitor those who doctor-shop looking to feed their opioid habits...“So we know who wrote the prescription, what it is, the quantity. Who the patient is that got it, and all of that including who filled it. First thing we do is send an unsolicited report to every one of those physicians, all 10 of those guys, and ladies, and every one of those pharmacies. So now all of a sudden all of those people know the patient that is sitting in that office right now has been to nine other physicians in that same week and then, game over. We don't tell them what to do. We just tell them, doc, you need to know this,” says Executive Director (Executive Secretary) for the Nevada Board of Pharmacy Larry Pinson Pharm. D...Pinson says the information in the database is sensitive. A court order is needed if law enforcement wants access to it...Pinson says the system is designed to get the patient help rather than punish him. And he admits the system is geared toward the patient.

Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses...The review comes as regulators disclosed that the number of doctors who completed voluntary training programs is less than half that targeted by the agency...Under the current risk-management programs, drugmakers fund voluntary training for physicians on how to safely prescribe their medications...many experts - including a previous panel of FDA advisers - said those measures don't go far enough and that physician training should be mandatory...The FDA's initial ideas to improve safety included mandatory certification for doctors and a national registry to track patients taking the drugs. But industry pushed back. Drugmakers and the pain specialty groups they fund argued that certification would be too burdensome for doctors, leaving many patients undertreated. And patient groups said that registries would unfairly stigmatize those who rely on painkillers to deal with long-term pain....

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.

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...

About 10 months after the only hospital in a 100-mile radius closed, Tonopah will welcome a new medical center, according to Northern Nevada health care group Renown Health...will open June 1 at the site of the former Nye Regional Medical Center in a partnership between Renown and the Nye County Board of Commissioners, it was announced Tuesday at a meeting of the board...The site...will use secure telehealth videoconferencing technology to connect patients with doctors, said Rich Conley, director of Renown Regional Medical Center...The technology will “help patients access primary care providers as well as more than 30 specialties...“This partnership with Nye County allowed us to create an innovative and sustainable solution for the residents of Tonopah and the surrounding communities in central Nevada,”...Renown said it is working to expand the number of services that the facility will offer by looking for an on-site advanced practitioner, hiring more support staff and expanding lab and imaging services...“It was important to us to restart health care services, and we are glad Renown stepped in to help find a solution for this community,” Nye County Commissioner Lorinda Wichman said...

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 U.S. drug repackager is in hot water with the FDA, earning itself a warning letter by taking liberties with the expiration dates on the drugs it repackages and a having quality unit that pretty much shirked its responsibilities, even though the problems had been noted during inspections 5 years earlier...The warning letter to Apotheca Supply, which does business as Apothecares, was posted this week...the FDA said the company had extended the expiration dates...by as much as two years beyond those listed by the manufacturers without any scientific justification to do it and no stability testing that would insure the APIs would still be effective...In addition, the agency was concerned about potential for cross contamination because of its procedures...On top of that the inspector found expired cleaning products and there had been no testing to ensure that surfaces were cleaned of one product before work began on another...

The Colombian health ministry plans to override a patent that Novartis holds on its widely used Gleevec cancer treatment, the latest clash between the pharmaceutical industry and some governments over intellectual property and access to medicines...The move...could prompt the government patent office to grant a so-called compulsory license to allow a generic company to make a lower-cost version of the drug...Compulsory licenses allow generic drug makers to make low-cost versions of brand-name medicines without the consent of the company holding a patent...a Colombian government committee explained that issuing licenses to other companies would be in the public interest by widening access and saving health care dollars. Issuing a license would "restore competition for this product in the Colombian market,"..."A Declaration of Public Interest leading to a compulsory license should never be used as a mechanism to force price negotiations,"..."This runs counter to the spirit and intent of a compulsory license and its legal framework, and would create a damaging precedent that could apply to all patent-covered innovations — pharmaceutical or otherwise."