- Novartis agrees to $25m settlement over bribery charges in China (statnews.com)
Novartis...agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act by making illegal payments to health care providers in China. In doing so, the company becomes the latest drug maker to get punished for paying bribes in order to boost sales in a foreign country...The settlement also comes just one month after South Korean authorities raided Novartis offices in search of evidence the company bribed local doctors...In China, Novartis employees at two different Chinese subsidiaries gave money, gifts, vacations, and entertainment, among other things, to health care professionals between 2009 and 2011, according to an administrative order filed by the US Securities and Exchange Commission...At the same time, the SEC said that Novartis failed to devise and maintain a sufficient system of internal accounting controls and lacked an effective anticorruption compliance program to detect and prevent these schemes. As a result, the improper payments were not accurately reflected in Novartis’s books and records...Novartis spokesman...the issues raised by the SEC largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years. We believe these measures...address the issues raised by the SEC and reflect a broader initiative by Novartis to align and enhance our compliance standards globally...
- U.S. spends $3 billion a year on unused cancer drugs (reuters.com)
U.S. doctors and hospitals throw out almost $3 billion in unused cancer drugs each year because the medicines come in supersized single-use packages and excess medicine must be discarded for safety reasons, a recent paper suggests...Researchers focused on 20 expensive medicines that are given by injection or intravenous drip and require doses adjusted based on the patient’s body size. Often, the packages contain much more medicine than patients need, and the leftovers wind up in the trash...The waste is driving up the cost of their care and it is money that they are spending that provides them no benefit...It also drives up the cost for their insurance, which leads to higher premiums, which costs them more money too...Patients and insurers pay drug manufacturers about $1.8 billion a year for medicines that are thrown away...Biologic medicines often lack preservatives and have a higher risk of contamination than other drugs, and leftovers from single-use vials are thrown out because using them could give patients infections...One of the clearest solutions to this waste is to have more dosing options available...That would require drug makers to sell the medicines in a variety of package sizes.
- FDA proposes guidelines for generic abuse-deterrent opioids (statnews.com)General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (fda.gov)
In the latest attempt to curb the spiraling opioid epidemic, generic companies will face new drug development requirements before they can sell copycat versions of abuse-deterrent opioids, according to a draft guidance released today by the Food and Drug Administration...the agency is recommending that generic drug makers run a variety of studies and provide data analyses to demonstrate that their medicines are no less abuse-deterrent than the brand-name products on which they base their own medications...We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse...encouraging generic alternatives can achieve that goal, especially since these are generally lower-cost alternatives to brand-name medicines...The draft guidance, however, won’t be finalized until after a 60-day comment period and the agency digests the reactions...The greater concern is whether the tamper resistance and abuse deterrence of the original formulation is sufficient. Many people abuse and misuse opioids orally, in which case tamper resistance will be essentially ineffective...
- Aprecia announces availability of 3D-printed drug Spritam (drugstorenews.com)
Aprecia Pharmaceuticals announced the U.S. availability of its Spritam (levetiracetam) tablets...The epilepsy medication is the first tablet made using the company’s ZipDose 3D printing technology to be approved by the Food and Drug Administration. It is designed to dissolve with a sip of liquid, easing the process of taking medication for patients with difficulty swallowing...
- Sprout investors say Valeant prices ‘female Viagra’ too high: Bloomberg (reuters.com)
Investors in Sprout Pharmaceuticals, which makes the first drug to treat low sexual desire in women and was bought by Valeant Pharmaceuticals International Inc last year, say the drug has been priced too high...By overcharging for the drug and neglecting to market it, Valeant has undercut the commercial success of the drug...Valeant priced Addyi (flibanserin)... at $800 a month even though Sprout had established a price point of about $400 a month based on market research...Due to the higher price point, insurance companies refused to cover the drug, helping to make it unaffordable for millions of women...Valeant said it was continuing to work closely with pharmacists, healthcare providers, and patients to educate them about the drug...Valeant intends to comply with all of its obligations under our agreement with the former shareholders of Sprout, including, as they relate to marketing spend, number of sales reps, and post-marketing studies...
- Pharmacy Week in Review: March 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.
- Poland to ban prescription-free emergency contraception (reuters.com)
Poland's ruling conservatives plan to reinstate a prescription requirement for "morning after" emergency contraceptive pills, a move critics say reflects Catholic Church pressure and may lead to unwanted pregnancies...the...Law and Justice party has taken steps to redesign Poland's young democracy to reflect the country's traditional Catholic values...The party has already said it will end state funding for in-vitro fertilization, saying it is too expensive. The powerful Polish Catholic Church strongly opposes IVF, as well as morning after pills...There is now just one morning after pill available in Poland without a prescription to women 15 and over. It became available over the counter early last year, following a decision of the European Commission to authorize its prescription-free sale...Polish health ministry wants to reinstate the prescription requirement...
- BMA plans full-scale walkout by junior doctors (pharmatimes.com)
British Medical Association is stepping up industrial action by junior doctors over the government’s imposition of a new working contract...including a full-scale walkout next month as relations between the two sides continue to deteriorate...It claims that the government continues to ignore the union’s concerns about the impact of imposition on morale and the already worsening recruitment and retention crisis in the ranks of junior doctors...We deeply regret the disruption to patients and our message to patients is clear; this action is wholly avoidable but the government must choose talks over imposition...Department of Health said in a statement: This escalation of industrial action by the BMA is both desperate and irresponsible - and will inevitably put patients in harm’s way...
- Canadian Stocks Fall Third Day as Concordia Weighs on Drugmakers (bloomberg.com)
Canadian stocks retreated for a third day, as disappointing earnings from Concordia Healthcare Corp. dragged drugmakers lower and financial shares slumped...The Standard & Poor’s/TSX Composite Index fell 0.2 percent to 13,358.11 at 4 p.m. in Toronto. The benchmark gauge has lost 1 percent in the holiday-shortened week, capping the longest streak of losses since Feb. 11. The index remains one of the top performers among developed markets this year with a gain of 2.7 percent...Health-care stocks faltered. Concordia plunged as much as 13 percent, the most since October, after the company posted earnings that missed analysts’ estimates. Valeant Pharmaceuticals International Inc. slipped 6.7 percent to halt a three-day rally that added 26 percent to shares in the embattled drugmaker...
- Drug Disposal Kiosks Help Hospitals Serve Their Community (ashp.org)
Patients who need to dispose of unwanted controlled substances and other medications are embracing the convenience of drug disposal kiosks managed by their local health-system pharmacies..."We've collected a little over two tons, in the last year, of unwanted medications," said Buck Stanford, community pharmacy operations director for Intermountain Healthcare...all 25 of Intermountain Healthcare's community pharmacies have a way for patients to dispose of their medicines...Kristina McGill...at Beth Israel Deaconess Hospital...fall became the second in Massachusetts to set up a drug disposal kiosk and the first to install one outside of the pharmacy...Both health systems obtained their kiosks, known as MedSafe units, from Sharps Compliance Inc....The steel kiosks are double padlocked and contain an inner receptacle consisting of sturdy inner and outer cardboard boxes plus plastic liners and absorbent pads. The inner boxes double as a shipping container for sending the medications away for incineration...The Drug Enforcement Administration in...2014 implemented a regulation that allows pharmacies and other healthcare entities to register as collection sites for controlled substances and other unwanted medications...as of February 29, a total of 882 DEA registrants had been designated as collectors...ASHP policy 0614, Safe Disposal of Patients' Home Medications, encourages pharmacists to develop patient-oriented medication disposal options that minimize the risk of accidental poisoning, drug diversion, and adverse effects on the environment...