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As generic drug manufacturers are gearing up to argue that a deal Allergan Plc made with a Native American tribe to shield patents from administrative review is a sham, some experts say the generic companies are in uncharted legal territory...Last week, Allergan announced it would transfer the patent rights to its Restasis dry-eye treatment to the Saint Regis Mohawk Tribe, which will license them back to the company in exchange for ongoing payments...Richard Torczon, a lawyer for generic drug company Mylan NV, said the tribe is abusing the defense of sovereign immunity, which he said is intended to shield tribes that get dragged into court without their consent...“The tribe here has not been dragged into this proceeding against its will,” Torczon said during a hearing...before three judges from the patent board. “It has deliberately by its own admission targeted these proceedings for exactly this kind of revenue-generating opportunity,”

The state of Nevada is preparing a public information campaign to address the increasing use of marijuana by pregnant women and highlight the potential harm the drug can do to a fetus...The public service TV and radio ads, which will begin airing in December, come as research shows that more pregnant women are using pot. A federal study last year found that marijuana use by pregnant women in the U.S. increased from 2.4 percent in 2002 to 3.9 percent in 2014, a 62 percent jump...Studies in states that have legalized recreational pot suggest the rate of use is far higher...In Colorado, where marijuana was legalized in 2014, one Pueblo hospital reported that the number of babies born with the chemical effects of marijuana in their systems doubled in two years. Dr. Larry Wolk, executive director and chief medical officer of the Colorado Department of Public Health and Environment, called the report anecdotal but noted that the state’s most recent official survey found that 6 percent of pregnant women were using marijuana.

Quest Analysis of 3.4 million tests shows evidence of dangerous drug combinations...A majority of test results from patients taking prescription medications show signs of drug misuse—including potentially dangerous drug combinations...The Quest Diagnostics Health Trends study is based on analysis of the company's de-identified laboratory data, believed to be one of the largest nationally representative datasets of objective laboratory information of patients prescribed opioids and other commonly abused medications. Physicians order laboratory services to aid their ability to monitor patients for signs of prescription or illicit drug misuse or abuse...(The report, "Prescription Drug Misuse in America: Diagnostic Insights in the Growing Drug Epidemic")

• evidence of misuse has declined in recent years, 52% of test results showed evidence of potential misuse in 2016, suggesting a majority of patients took their prescribed drugs in ways that were inconsistent with their physician's instruction...
• disturbing patterns of concurrent drug use. Among more than 33,000 specimens tested for opioids, benzodiazepines, and alcohol in 2016, more than 20% were positive for both opioids and benzodiazepines, more than 10% were positive for both opioids and alcohol, and 3% were positive for all three...
• 19% of specimens positive for heroin in 2016 were also positive for nonprescribed fentanyl...
• drug misuse rates were high among most age groups and both genders. However, adolescents (10 to 17 years of age) showed a striking improvement, with the rate dropping from 70% to 29% between 2011 and 2016...
• Misuse rates were higher for men and women of reproductive age (58%) than in the general study population (52%)

In a word: patents...The Biologics Price Competition and Innovation Act (2010) was...part of the Affordable Care Act. Its essential goal was to infuse competition and lower the prices of drugs that were made from living cells -- so-called biologics...Until the 2010 law, biologics had no fear of competition -- there was no legal way to introduce generic versions into the market -- so they were able to maintain their monopoly price even after their patents expired. The BPCIA was intended to establish mechanisms within the Food and Drug Administration, the Patent and Trademark Office, and the courts that would allow the introduction of "biosimilars." These drugs weren't exact replicas of biologics, but were similar enough, and safe enough, to be used instead of the brand-name drugs...Here we are seven years later. Guess how many biosimilars have made it to market?..Two...companies are forced to fight through thickets of patents to get a biosimilar to market, a law that was supposed to save the U.S. billions will continue to do just the opposite: make it easy for biologic makers to maintain unwarranted monopolies...

Federal regulators...approved the first mobile app to help treat substance use disorders...The app, developed by a start-up called Pear Therapeutics, is designed to be prescribed by clinician and used alongside counseling...Pear's technology digitizes a form of talk therapy called cognitive behavioral therapy, or CBT, which focuses on "examining the relationships between thoughts, feelings and behaviors...Pear Therapeutics is part of a burgeoning category of health start-ups known as digital therapeutics. The idea is that software can improve a person's health, without the same cost and side effects of medical treatment...Pear's app has not been approved to treat opioid dependence, but...the company has developed a version of the software that is currently under submission. It's designed to be used alongside opioid replacement therapies.

The drugmaker Allergan announced...that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug from a patent dispute...Under the deal, which involves the dry-eye drug Restasis, Allergan will pay the tribe $13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive $15 million in annual royalties as long as the patents remain valid...The surprising legal move rippled quickly through the pharmaceutical world...setting off speculation about whether other drug companies would soon follow suit in order to protect their patents from challenges through a patent-review process that the industry despises...If Allergan succeeds in holding onto its patents, “we will probably see multiple branded companies housing their patents with Indian tribes...

The Food and Drug Administration...accused the drugmaker Pfizer of failing to properly investigate reports of malfunctioning EpiPens, including incidents when patients died or became severely ill after the device failed to work. Pfizer manufactures the EpiPen, which treats allergic reactions, for the drugmaker Mylan...In a warning letter...the agency said Meridian Medical Technologies, which is a unit of Pfizer, did not adequately look into problems with a crucial component of the EpiPen — the mechanism on the device that insures that it fires and delivers the proper dose of epinephrine, which stops an allergic reaction... the company failed to conduct a proper investigation even though it received numerous complaints about problems with activating the device. "Our own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died...

Shkreli is expected to be locked up...for four months...Martin Shkreli's new home in a Brooklyn, New York, federal jail is definitely not the kind of place "where you want to be,"…Metropolitan Detention Center Brooklyn...Shkreli...was thrown into the MDC...after a Brooklyn federal court judge revoked his $5 million release bond...Judge Kiyo Matsumoto ruled that Shkreli represented a danger to the community because of a bizarre $5,000 bounty he offered to Facebook followers who grabbed samples of Hillary Clinton's hair for him...Shkreli, who previously ran two pharmaceutical companies and several hedge funds...A jury convicted him in August of three securities fraud charges...

FDA commissioner Scott Gottlieb has sounded a crystal clear warning over the high — and growing — cost of drug development. And in a speech to regulatory execs...Gottlieb committed the FDA to backing up more efficient drug development programs with new measures to clear the regulatory path for developers barreling ahead to relatively swift pivotal data in search of an accelerated OK...Gottlieb started by outlining a bleak picture in drug R&D, noting that the economic model for drug development is broken. It costs too much to develop a drug so it can be approved for marketing. And costs are swelling fast at the discovery end of the business, which will help swamp a system that already doesn’t work particularly well...Gottlieb held up some of the rapid-fire clinical trials we’ve been seeing in the cancer field as a model for what can work, paving the way to the accelerated approval pathway at the FDA. And he believes...that moving drug development into the fast lane can reduce R&D costs and thereby allow biopharma companies to pass on savings to patients through lower costs.

Many Obamacare customers who take specialty drugs had to personally pay anywhere from $262 to $1,762 more each month in 2017 than they did last year for those medications,,,The report, from the insurance comparison site HealthPocket.com, found that the average specialty drug coinsurance fee for the most popular type of Obamacare plans rose by five percentage points from 2016...That increase reflects a trend of insurance plans shifting the burden of directly paying for often-high priced specialty medication onto consumers..,And that burden can be heavy...The report underscored the relatively large change in cost burden on customers of so-called silver individual health plans who use specialty drugs...About 70 percent of all customers who purchase individual coverage through a government-run Obamacare marketplace are enrolled in silver plans. Those plans pay, on average, 70 percent of all of their customers' health costs, with enrollees being personally responsible for the remaining 30 percent...