Category:

A Native American tribe holding patents for drugmaker Allergan Plc...moved to dismiss a case brought by generic drug company Mylan NV challenging the patents...In a filing to the U.S. Patent Trial and Appeal Board, the Saint Regis Mohawk Tribe asked that Mylan’s case seeking to invalidate Allergan’s patents on dry-eye medicine Restasis be thrown out on the grounds that the board has no jurisdiction over the tribe...The move was expected after Allergan announced on Sept. 8 that it had transferred Restasis patents to the tribe in order to protect them from administrative challenges...the tribe said it is sovereign government that cannot face litigation in an administrative court unless it expressly waives its immunity or the U.S. Congress abrogates immunity...(Allergan) has said the transfer is only intended to shield the patents from review at the patent board, which it has called a flawed forum for patent disputes. Allergan has said it will not invoke tribal immunity in federal courts

The head of the U.S. Food and Drug Administration said...the agency is working on a new policy that would encourage more compounding pharmacies to register under...the Drug Quality and Security Act, which aimed to bring more compounding pharmacies...under the authority of the FDA rather than state pharmacy boards...The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients...In exchange, those compounders would have to follow federal manufacturing standards and subject themselves to routine inspections...around 70 firms have registered as outsourcing facilities...compounders that did not register with the FDA would remain under state oversight, and...could only compound drugs based on prescriptions for specific patients...Gottlieb said that in order to encourage more compounders to register, the FDA would release draft guidance in the next two months reflecting its intention to adjust its enforcement priorities based on the size of registered compounders and the riskiness of their products...We’re looking at ways we can provide more of a gradation in our regulatory architecture so we don’t have a one-size-fits-all approach...

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...

Canada is set to begin deploying a national electronic prescribing platform, called PrescribeIT...Canada Health Infoway, a federally funded, nonprofit digital health organization, said...that it has reached agreements to enable PrescribeIT in six provinces: Alberta, Ontario, Manitoba, Nova Scotia, New Brunswick and Newfoundland/Labrador. Those provinces represent 61% of the Canadian population...PrescribeIT will allow prescribers to securely transmit an prescription from an electronic medical record to the pharmacy management system at a patient’s pharmacy of choice...PrescribeIT’s features will include the ability to securely send e-scripts for all medications, including controlled substances; deliver a prescription to a patient’s pharmacy; send prescription renewal requests from a pharmacist to a prescriber; and cancel a transaction by the prescriber or pharmacist...PrescribeIT is expected to decrease patient wait times for their prescriptions, enhance patient safety by reducing the possibility of medication errors, improve medication management and patient health outcomes, reduce fraud and abuse by eliminating handwritten prescriptions, ensure data integrity for monitoring of controlled substances, and create a commercial-free prescribing and dispensing environment...

Allergan Plc’s decision to pay a Native American tribe $15 million a year rather than let one of its blockbuster drugs be scrutinized by the U.S. Patent & Trademark Office is part of a backlash against an agency review panel that has been dubbed a “death squad.”...The drugmaker earlier this month transferred ownership of patents protecting a medicine with $1.49 billion in sales last year to the Saint Regis Mohawk Tribe of upstate New York. The tribe, which will receive royalties every year, says that as a sovereign entity it is immune from such civil patent challenges....The creative -- and untested -- maneuver is designed to circumvent the Patent Trial and Appeal Board...critics say the board has made it too easy for rivals to attack patents and they’re pressing Congress, the courts and the patent office for changes...companies such as Google or Apple Inc., which are among the biggest users of the review board to fend off what they consider nuisance lawsuits from companies looking for a quick payday...the Supreme Court agreed to take a case to determine if the reviews are constitutional -- critics of the reviews say a patent is a property right that only federal courts can revoke. But even those who want to see the system dismantled say that case is a long shot...The patent office has been considering changes to its procedures...

...state authorities and patient advocates in Maryland are preparing to enforce the nation’s first law designed to punish drugmaker price-gouging...The state Attorney General’s office said it will field complaints and investigate “unconscionable increases” in essential generic medicines when the closely watched law takes effect Oct. 1...Drugmakers fear the Maryland law will embolden other states and are seeking a court injunction. Both sides made their arguments...before a U.S. District Court judge in Baltimore, who could decide on an injunction in the coming days...But states, struggling to cover rising healthcare costs, are taking up the fight. At least 176 bills on pharmaceutical pricing and payment have been introduced this year in 36 states, according to the National Conference of State Legislatures...Maryland’s law is the most aggressive legislation to be passed so far, and allows the state to levy fines and order a reversal of price increases...

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...

In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market...A new analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done...among the 614 studies mandated in 2009 and 2010, 20 percent were never started and 9 percent have been delayed...When drugs are approved, the trials are usually small and short-term, and some side effects may not emerge until the post-marketing phase...The problem is, the faster you get them on the market, the more open questions there are about their safety or the best dose...In some cases, the FDA has simply dropped a requirement for a postapproval study without giving a reason...

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.

The Pharmaceutical Research and Manufacturers of America the Biotechnology Innovation Organization today initiated litigation in the United States District Court for the District of Nevada challenging provisions of SB 539, a Nevada law that would violate patent rights and negate trade secret protection for designated diabetes medicines in a way that would harm patients and chill future biomedical innovation...PhRMA and BIO seek a declaration from the Court that the challenged provisions of SB 539 are preempted by federal law and violate several provisions of the United States Constitution...also seek an injunction prohibiting the implementation or enforcement of these challenged provisions...The Complaint alleges that provisions of SB 539 violate the Constitution in at least four ways:

1. by interfering with federal patent law;
2. by interfering with federal trade secret law;
3. by violating the Takings Clause of the Fifth Amendment of the United States Constitution which prohibits government from taking property without just compensation; and
4. by violating the dormant Commerce Clause of the United States Constitution, which prohibits Nevada from impeding commerce in other states.