- UK pharma trade group on Brexit: ‘There’s a potentially negative story here’ (statnews.com)“UK must send strong signal it is open for business”, ABPI responds to Britain voting to leave the European Union (abpi.org.uk)
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...
- Astellas suspended from UK pharma trade group for ‘deception on a grand scale’ (statnews.com)
In an unusual step, the pharmaceutical industry trade group in the United Kingdom has suspended Astellas for a year after discovering the drug maker disguised the true purpose of a meeting held for doctors, and then senior executives compounded the infraction by withholding crucial information when asked to explain the arrangements..."There was an institutional failure," an oversight panel for the Association of British Pharmaceutical Industries (Prescription Medicines Code of Practice Authority) concluded in a harshly worded...report. "This was one of the worst cases (the panel) ever had to consider…Very senior staff at Astellas Europe had lied and there was deception on a grand scale which was appalling and shocking."...The suspension had its roots in a meeting that the Astellas division in the UK held in...February 2014 for more than 100 physicians. The company billed the gathering as an educational event to obtain advice about prostate cancer when, in fact, it was more of a promotional stunt designed to woo doctors who were targeted to become high prescribers for Xtandi (enzalutamide)...it is rare...for the ABPI to suspend a company from its membership...
- Pharmacy Week in Review: June 24, 2016 (pharmacytimes.com)
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.
- Medicare Part D spending on compounded drugs is skyrocketing (statnews.com)
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...
- Drug industry overstates impact of patent reviews on innovation (statnews.com)
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...
- Sandoval opens summit, calls drug abuse one of deadliest epidemics (reviewjournal.com)
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,"...
- Brexit spells upheaval for EU and UK drug regulation (reuters.com)
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...
- Indonesian lawmakers seek seizure of unapproved vaccines amid fake drug scare (reuters.com)
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...
- This Week in Managed Care: June 25, 2016 (ajmc.com)
Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Drug Stocks Surge After U.S. Says Cost Panel Will Wait Until 2017 (bloomberg.com)The Facts About the Independent Payment Advisory Board (whitehouse.gov)
Drug and biotechnology stocks surged...after the U.S. government said a cost-cutting mechanism created under Obamacare, known as the Independent Payment Advisory Board, or IPAB, will likely be triggered in 2017, not this year as some investors had feared...The 2017 projection is in line with estimates from last year by Medicare’s Board of Trustees, which...released its annual report on the U.S. health-care program’s long-term finances. The trustees also said that Medicare’s hospital insurance trust fund, which finances some care under the program, will be unable to meet all of its obligations in 2028, two years earlier than projected...Investors had been watching nervously for news of the determination, concerned that it could trigger this year and set in motion reductions in Medicare payments to biotech and pharmaceutical companies, as well as other health-care firms. The Nasdaq Biotechnology Index of 189 stocks had fallen for 11 of the past 12 trading days as of Tuesday’s close...The IPAB is a 15-member panel that would be appointed by the president and has broad authority to propose cuts to payments made through Medicare. Its proposals could affect drugmakers, biotechnology companies, hospitals and insurers, with some restrictions. Congress, which has typically controlled many aspects of Medicare’s payments through legislation, has limited oversight of the IPAB, which was set up specifically to make reductions to U.S. health spending, at a distance from lawmakers and lobbyists...