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...Walgreens Boots Alliance and Prime Therapeutics rolled out a highly innovative partnership. It could have wide-ranging implications...This novel union aligns a pharmacy benefit manager, retail pharmacy chain, and health plans via joint ownership of a new mail and specialty pharmacy company. If executed properly, it will be a best-of-breed business model that could reshape the PBM and pharmacy industries. For manufacturers, organized customer management just got even more complicated...The new business could also pose a serious challenge to pure-play PBMs that lack a health insurer partner or an economically-aligned retail dispensing channel…

Celator Pharmaceuticals proudly displayed a large poster touting its experimental Vyxeos (CPX-351) medication as an effective salve for treating acute myeloid leukemia. The poster was, in fact, one of countless placards featured prominently on the exhibit floor at the American Society of Clinical Oncology meeting…the Celator poster managed to stick out...Vyxeos has not yet been approved to treat AML...Celator reported positive clinical trial results for the drug...But that’s not the same thing as having clearance to market a product. Unfortunately, that’s the impression regulators had after looking at the poster…As far as the Food and Drug Administration is concerned, Celator was, effectively, promoting a drug that was misbranded. And so the FDA sent the company (now Jazz Pharmaceuticals)...a letter to complain about its promotional behavior...From a public health perspective, these claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA...

Many patients haven’t heard of "biosimilars," generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests...To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease or Crohn’s disease, chronic intestinal problems that are increasingly treated with biosimilars...just 38 percent (383) of the survey respondents had heard of biosimilars...researchers asked...more questions to see what they knew about these medicines, 47 percent said they worried about whether the copies were safe and 40 percent said they had concerns about whether the generics were effective…The study by Dr. Laurent Peyrin-Biroulet...found most patients were more concerned about the safety and effectiveness of biosimilars than whether they were a lower-priced alternative to brand name biotech drugs...the findings highlight the need for more patient education about biosimilars...

You can add Suffolk County, N.Y., to the list of local and state governments that are filing lawsuits against the drug makers that market opioid painkillers...The Long Island county...accused several companies — Purdue Pharma, Johnson & Johnson, and Endo International, among others — of using deceptive marketing to downplay the risks of their painkillers, and of improperly encouraging physicians to prescribe the medicines in a way that caused some patients to become addicts…The allegations are...identical to lawsuits filed by the city of Chicago; Orange and Santa Clara counties in California; and the state of Mississippi. In each case, the governments have charged the drug makers with illegally widening markets for their opioid painkillers and, as a result, forcing taxpayers to pay for medicines that were often prescribed unnecessarily...The companies "sought to create a false perception of the safety and efficacy of opioids in the minds of medical professionals and members of the public that would encourage the use of opioids for longer periods of time and to treat a wider range of problems, including such common aches and pains as lower back pain, arthritis, and headaches…

... cells generally like having company, forming communities with other cell types to make complete tissues. However, quite often, researchers isolate cells from their 3-D environments, creating 2-D models that don’t always replicate complex biology...But now, an entire industry is emerging to recapitulate various tissues more realistically. 3-D bioprinting has the capacity to layer different cell types, creating more biologically accurate liver, kidney, skin and even tumor tissues. The hope is that more lifelike tissues will produce better scientific results...Organovo is the leader in 3-D bioprinting...The...company has been selling 3-D liver tissue to pharma companies for about 18 months and is about to expand into kidney tissue. The goal is to support drug development by using these 3-D models to gauge toxicity...Kidney and liver toxicology studies are required for every product before it goes into humans....The high costs of clinical trials could eventually make this a go-to technology for pharma and biotech, providing better data to spot toxicity early and avoid costly mistakes…

Physicians expect pharmaceutical companies to provide more beyond-the-pill services, as they face increasing pressure from empowered patients as well as accountable care organizations and integrated delivery networks...The report...found that 46% of the physicians it surveyed expect drugmakers to provide beyond-the-pill services, and 34% have used a beyond-the-pill service from a pharma company...Here are three key insights for pharma marketers to take note of:

1. Drugmakers should provide more than just product information on their websites.
2. Physicians are more likely to prescribe a product if it comes with beyond-the-pill services.
3. Sales reps should be leveraged to engage physicians.

Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country’s exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year...Yet even as China’s drug industry has grown in global stature, so have questions about the safety of its products...about 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials...Among those were some medicines that were separately approved for sale in the U.S. by the Food and Drug Administration. Some of the companies say their data in China were flawed because of faulty information by local research firms...

There is a real need for patients to have information about out-of-pocket costs and clinical tools being used when it comes to their coverage. A new prescription drug search tool that includes information about cost sharing, prior authorization and step therapy will be available to residents of Washington, D.C., shopping for coverage during the upcoming open enrollment period. These types of tools are important for patients, enabling them to find the best health care plan to meet their needs...DC Health Link’s new offering will allow patients in D.C. purchasing private health insurance to input up to 10 prescriptions and see which plans cover their drugs and the cost sharing that goes with them...The new DC Health Link tool also improves transparency and information about deductibles. One feature allows people to clearly see plan details, including whether available plans have a separate drug deductible, whether a medication is subject to a copayment or coinsurance and copayment amounts and coinsurance percentages...While progress continues to make marketplace websites more consumer friendly, additional improvements are still necessary to ensure consumers have a clear understanding of the choices in front of them when picking a health plan...

A top pharmaceutical lobbying group is launching an ad campaign to defend drugmakers that have been under fire for their pricing practices..."We’re under pressure and scrutiny like never before," said Jim Greenwood, chief executive officer of the Biotechnology Innovation Organization. The campaign, called "Innovation Saves," says new drugs can save both lives and costs to the health-care system...BIO is trying to reshape perceptions after a year of finger-pointing among insurers, drugmakers and health-care providers about why the medical system is so expensive..."This campaign is about defending the indefensible: astronomical price increases, drug pricing gimmicks, and massive cost increases," Clare Krusing, a spokeswoman for America’s Health Insurance Plans, said in a statement. "The way that the pharmaceutical industry can show real innovation is by embracing solutions that make treatments and cures affordable to every patient."...

In every loaf of bread we buy, the total cost of direct selling is buried in its price tag...We accept this because we know that organization within these markets utilize coordinated public relations, marketing and direct sales efforts to grow their revenues...In health care, we tend to see things differently...But somehow, we’re prone to think those involved in the delivery of care are immune to such promotional tactics. We like to think that we’re giving our patients what’s needed based on therapeutic value and hope our decisions aren’t influenced by factors other than safety and efficacy concerns...Today, the role of direct selling in health care is experiencing unwelcome attention and unprecedented pressure. The pharmaceutical industry is a case in point, but lessons are clear across the entire health system...The health care industry needs to adopt stricter codes of ethics and business practices upon which relationships with sales representatives engage in our organizations...management...must take fresh looks at how selling in our organizations is conducted, and how the companies with whom we do business manage their sales processes and personnel...

1. Are confidentiality agreements kept?
2. How are confidentiality agreements monitored?
3. Are consultant, lawyer and accountant credentials verified?
4. Are affirmations in proposals about client satisfaction and relevant engagements independently validated or taken at face value?
5. And is the organization’s posture toward its selling—its culture, compensation and performance evaluation procedures — conducive to principled growth or is selling anything at any cost the unwritten policy that rules the realm?

The selling game in health care is out of the closet.