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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.

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...

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...

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...

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...

Pharmacists are weighed down with the strain of coping with their workload, the stress of the job and numerous other concerns, according to...new research...Workload and stress are the main challenges facing pharmacists today in their day-to-day practice. Three-quarters are "extremely" or "very" concerned about coping, according to a survey of pharmacists’ attitudes by CIG Research...We can...reveal that pharmacists working in multiples are more worried about stress and overwork than their counterparts in independent outlets. Pharmacists in multiples are also equally as concerned about meeting targets – something that is much less of an issue for independents, who rank funding, stock shortages, regulatory demands, and GPhC inspections as greater challenges...

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 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...

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...