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Sara Belanger with The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network...

...the US Food and Drug Administration filed an annual report to Congress about citizen's petitions that can be used to ask the agency to refrain from approving a generic drug or a biosimilar...FDA officials reiterated complaints that many petitions generally do not raise valid scientific concerns and appear to have been filed to delay approval of competing medicines...Congress...requires the FDA to respond to most petitions within 150 days. And as far as the FDA is concerned, this creates an unnecessary problem...agency officials are concerned that most petitions are merely a competitive ruse, and they wrote Congress that they are forced to redirect efforts at the expense of completing the other work of the agency...The concerns expressed by FDA officials largely mirror a forthcoming analysis...The analysis found that brand-name drug makers filed 92 percent of such citizen petitions between 2011 and 2015...Citizen petitions represent a hidden tool in (the brand-name drug maker's) toolkit of entry-delaying activity, all to the detriment of consumers forced to pay high drug prices...the analysis concludes.

The notorious virus is running rampant through global phishing campaigns to a wide range of industries, but U.S. healthcare is ground zero...Locky ransomware is back in the spotlight...the virus has evolved and is targeting hospitals with a massive campaign...The ransomware strain – first observed by security researchers in February this year – began as a straight-forward virus sent in an email attachment disguised at a Microsoft Word invoice...This latest campaign, however, uses DOCM files (macro-enable files used in Microsoft Word) to deliver the ransomware payload...Further, these are global attacks, but the U.S. tops the list…Each email campaign has distinct ‘one-off’ codes, used to download Locky from the malware server and the malicious URL is embedded within macro code, using the same encoding function...The volume of Locky ransomware downloaders is increasing and the tools and techniques being used in campaigns are constantly changing...

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

Illinois' attorney general...sued Insys Therapeutics Inc, accusing it of deceptively marketing and selling an addictive fentanyl-based medication, intended to treat cancer pain, to doctors for off-label uses...The lawsuit...comes as Insys faces a number of state and investigations involving its drug Subsys (fentanyl sublingual) as U.S. authorities seek to combat a national opioid abuse epidemic...This drug company's desire for increased profits led it to disregard patients' health and push addictive opioids for non-FDA approved purposes…the lawsuit seeks to bar Insys from selling its products in Illinois and impose financial penalties on the company...

Physicians typically rely on treatment guidelines issued by medical associations, but a new study finds that many experts involved in assembling these guidelines in Canada have financial ties to drug makers. And the study authors recommend that medical societies implement tougher disclosure rules to avoid undermining clinical decisions...researchers...examined 400 financial conflicts of interest statements in connection with the guidelines published in 2012 and 2013...found that relationships with drug makers varied...75 percent of the disclosures, at least one guideline author revealed such a relationship (conflicts of interest) and in 21 percent of the guidelines, all of the authors disclosed a conflict with drug companies...These guidelines...provide specific drug treatment recommendations that are considered to be authoritative regarding doctors・ treatment decisions for their patients...Clinical practice guidelines are also widely distributed by medical associations. Therefore, the financial relationships held by the physician-authors of these guidelines is an important step towards analyzing their choices of drug recommendations...

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network.

Mylan Pharmaceuticals took steps...to make its EpiPen device more affordable. Specifically, the company is increasing the amount of money on a copay assistance card from $100 to $300, and is also widening eligibility for patients to receive the device through that assistance program..."We recognize the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter. Patients deserve increased price transparency and affordable care, particularly as the system shifts significant costs to them," Mylan Chief Executive officer Heather Bresch...These moves do not actually involve lowering the $600 list price, which has been rising steadily in recent years and caused consternation among parents across the country...By expanding programs that can help patients pay for its device, Mylan is trying to say that it is addressing the issue of affordability...Mylan hopes to blunt further damage to its reputation, which has taken a beating this week as one lawmaker after another publicly demanded the company lower the price, provide data to justify its pricing, and prepare for congressional hearings...The rebukes appeared to reach a crescendo Wednesday when Hillary Clinton called the EpiPen price hikes "outrageous," triggering yet another slide in biopharma stocks as investors braced for a new round of finger-pointing and negative news streaming from Washington...Mylan...is...trying to shift the conversation to insurance coverage...price is only one part of the problem that we are addressing with today’s actions...Bresch said that she is ready to work with Congress to fix the system, and that other key players, like pharmacy benefit managers, retail pharmacies, and doctors, also need to be part of the conversation.

The Medivation hunt may be all but over. Pfizer is close to striking an agreement to buy the...biotech in a deal worth about $14 billion...If Pfizer and Medivation do finalize a deal, it would wrap up a months-long buyout race that pulled in much of Big Pharma and Big Biotech along the way. With its blockbuster oncology med Xtandi (enzalutamide) ready to add to a buyer’s sales, plus a much-anticipated late-stage cancer candidate and a pipeline of other prospects, Medivation has been a sought-after prize in an otherwise slow summer for biopharma M&A....

There’s some bad news in our latest exclusive annual analysis of pharmacist salaries, based on the Bureau of Labor Statistics’ recently released Occupational Employment Statistics...In 2015, the average gross base salary for a pharmacist at a retail, mail, and specialty pharmacy was $119,517—up a paltry 0.1% from 2014. Retail employment grew slowly, with slightly fewer pharmacists working at drugstores and mass merchants...Meanwhile, employment at mail pharmacies and hospitals grew. Pharmacists who work at hospitals also got some good paycheck news: Their salaries rose by 1.6%. The share of pharmacists who work at hospitals grew, too...The pharmacy industry’s ongoing shift from traditional to specialty drugs is altering long-standing pharmacist employment patterns…

Here are my observations about 2015 trends:

• Mass merchants still ahead.
• Mail employment rose sharply.
• Hospital employment keeps growing.
• Pharmacist salaries exceeded those of other healthcare workers, but growth lagged in 2015.