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The aftermath from the Brexit vote in the United Kingdom is only first being digested the world over. As with so many other sectors, there are implications for the pharmaceutical industry. Some 70,000 people in the UK work for drug makers, including AstraZeneca and GlaxoSmithKline, which are based there. Will companies want to shift substantial portions of their operations elsewhere? The European Medicines Agency, which oversees product approvals, is also headquartered in London, raising questions about the ability of the UK’s own regulator, the Medicines and Healthcare products Regulatory Agency, to fill that role. Then there is concern about government support for basic research. We spoke with Michael Thompson, who heads the Association of the British Pharmaceutical Industry, the large trade group, about these unknowns...

Prescription drug addiction, the downward spiral of lives ruined, loved ones lost, and the cost to society were the focus of a daylong meeting convened...by Gov. Brian Sandoval, who called the problem a crisis...Without question this is one of the most important health challenges we currently face...calling prescription drug abuse "one of the deadliest epidemics" in the United States...Statistics are sobering. While overdose deaths related to opiates in Nevada have declined from 517 in 2010 to 382 last year, at least one Nevadan dies every day from an opiate overdose...From 2010 to 2014, hospital inpatient admissions related to opioids jumped to 3,783 from 2,993...Sandoval said he wants the panel to focus on duties and responsibilities of health care licensing boards; coordination among law enforcement; substance abuse treatment; and sale and availability of pharmaceuticals..."We seek answers, not excuses,"...

Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based European Medicines Agency, which approves treatments for all EU countries, expected to have to relocate...The association of Germany's pharmaceuticals industry said on Friday that Europe's equivalent of the U.S. Food and Drug Administration would need to move to a city within the EU...EMA...said it was premature to comment on its future...It is too early to foresee the implications of this decision and at this stage we are waiting for further guidance from the European Commission...Drug companies and healthcare officials in Sweden, Denmark, Italy and Germany have all expressed interest in hosting the EMA instead of London, since firms in these countries are keen to be located close to the region's...The pharmaceuticals industry employs more than 70,000 people in the UK and accounts for 25 percent of all business research and development spending in the country...Many scientists are concerned that funding for academic research, which has been well supported by the EU in recent decades, will now be jeopardized, along with important UK-European research collaborations...

For the third time...congressional lawmakers have introduced a bill designed to end a practice that generic drug makers say is used by brand-name rivals to thwart competition...Known as the Creating and Restoring Equal Access to Equivalent Samples Act, the bipartisan legislation comes amid ongoing complaints that brand-name drug makers sometimes refuse to provide samples to generic companies. They need samples to prove their copycat versions are equivalent to the brand-name drugs in order to pass regulatory muster...The legislation would allow the secretary of Health and Human Services to vet the request for samples and create a "cause of action," presumably making it easier for a generic company to go to court in hopes of forcing a brand-name rival to make samples available...Whether the legislation will gain any traction is unclear...

Drug makers complained bitterly...after the Supreme Court left intact a controversial procedure for reviewing patent disputes, arguing that the decision threatens valuable research efforts and that patients will eventually suffer. But the truth of those claims is debatable...The ruling upheld a process Congress created...for challenging patents outside the courts. It allows the Patent and Trademark Office to issue the "broadest reasonable interpretation" of patents. The case at hand had nothing to do with pharmaceuticals, but drug makers believe it will make their patents more easily challenged, and more likely to be overturned...The companies believe the procedure, known as inter partes review, is riskier than patent disputes decided in federal courts... Without the promise of effective patent rights, investments [in new medicines] would be far more difficult — if not impossible — to undertake...

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

As federal regulators try to crack down on compounding pharmacies over safety concerns, a new report finds that spending by the Medicare Part D program for these medicines rose more than 600 percent over the past decade. And federal auditors say the trend raises questions about whether the drugs, which are customized for specific patient needs, were medically necessary or dispensed appropriately...Between 2006 and 2015...spending for compounded drugs went from $70 million to $508 million, a 625 percent increase...By comparison, spending for all prescription drugs covered by the program rose 167 percent during the same period...Center for Medicare and Medicaid Services...will review the data brief OIG (Office of the Inspector General) released as it continues to monitor drug spending and trends in Part D...the International Academy of Compounding Pharmacists...does not condone marketing or billing practices involving fraud, waste or abuse…Clearly, proper controls around the billing of compounded medications are needed to ensure patients can still access these important medications. It is apparent from the OIG report those proper controls are not in place...

Indonesian lawmakers...urged authorities to seize from hospitals and health clinics all vaccines made by unapproved manufacturers, after police exposed a syndicate selling fake child vaccines for more than a decade...In a country where counterfeit drugs are widespread, the case deals a blow to government health regulators whom many believed to have kept a tight leash on the distribution of vaccines...Authorities have shut some private health facilities after police smashed a drug-making ring last week that sold fake and potentially harmful booster vaccines for measles, hepatitis B and other viruses in Jakarta and the island of Java...Police uncovered the syndicate after a pharmacist in Bekasi...was arrested in May for selling medicine without a license. The drugs turned out to be fake and led to the arrest of 14 distributors and makers of the fake vaccines, whose ingredients included the antibiotic gentamicin and saline...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

A former Food and Drug Administration official was accused of insider trading...by the Securities and Exchange Commission, which said he was paid hundreds of thousands of dollars for his efforts...The charges came...after Gordon Johnston...pleaded guilty to securities fraud and three other crimes as part of a scheme to provide information to a high-profile hedge fund about upcoming agency approvals of generic drugs...Between 2005 and 2011, Johnston...provided information about generic drug applications to Visium Asset Management by tapping FDA contacts...Insider trading appears to be a growing problem in the pharmaceutical industry as several cases have emerged. The issue has raised concerns in connection with clinical trial work, as well as deal-making and the FDA approval process, which some fear can be distorted by such activities...