- Martin Shkreli says securities fraud charges are ‘baseless’ (reuters.com)
Martin Shkreli, the pharmaceuticals entrepreneur vilified for jacking up the price of a life-saving AIDS drug, said on Saturday that unrelated securities fraud allegations that resulted in his arrest this week were "baseless and without merit."…Federal prosecutors have alleged that Shkreli was running a Ponzi-like scheme at his former hedge fund and a company he headed before he took the helm of Turing Pharmaceuticals Inc, where he created an uproar in September when the company raised the price of the drug Daraprim from $13.50 to $750 a tablet…"I am confident I will prevail," Shkreli wrote on Twitter on Saturday… The allegations have amplified the public outrage over the brash, boyish-looking Shkreli, who has become the poster child for the issue of soaring prices for prescription medications.
- Martin Shkreli out as Turing CEO. Ron Tilles named interim replacement (statnews.com)
Martin Shkreli, the pharmaceutical executive who became the public face of greed in the industry and who was arrested this week on securities fraud charges, has been replaced...Turing Pharmaceuticals, announced Friday that Shkreli will resign as chief executive and be replaced by Ron Tilles, the chairman of the board, who will serve as interim CEO..."We wish to thank Martin for helping us build Turing Pharmaceuticals into the dynamic research-focused company it is today, and wish him the best in his future endeavors," Tilles said in the statement...The announcement marks a swift and stunning fall for the 32-year-old Shkreli...Meanwhile, Turing is scrambling to reassure the medical community that Daraprim...will remain available. The company is sending letters to doctors to reiterate that patient assistance programs are intact and "distribution partnerships" with hospitals and clinics are being expanded.
- Isis Pharma changes ‘unfortunate’ name to avoid confusion (reuters.com)
After deliberating for most of the year, Isis Pharmaceuticals Inc said on Friday it would change its name to avoid being confused with the Islamist militant group known as ISIS...The biotechnology company said it would be called Ionis Pharmaceuticals Inc from Dec. 22 and also changed its stock exchange ticker symbol to "IONS" from "ISIS"...When you talk about the company you want people to immediately think about the incredible work you're doing to deliver transformational drugs to patients ... not as an unfortunate namesake...The...company's stock dropped about 4 percent on the first trading day after the Paris attacks, for which ISIS claimed responsibility.
- China watchdog to strengthen drug trial inspections (reuters.com)
China's drug regulator said on Thursday it will strengthen oversight of clinical trials of new drugs, where it said regulation was falling short despite a recent push to improve the quality of local drugs and compete better with international rivals...China Food and Drug Administration has rejected dozens of drug applications over the past few months due to false or incomplete trial data. A further 82 firms withdrew applications earlier this month...The drug regulator said in a statement...that while some regions had made progress in cracking down on poor drug trial data, many regions were still falling behind...The inspection work in some regions is not being taken seriously enough and the quality of inspection is too low...Global drugmakers in China are facing a tough challenge as local firms get increasingly competitive and as the central government looks to rein in drug prices to help curtail a wider medical bill expected to hit $1.3 trillion by around 2020...
- Prices for many generic drugs rising faster than inflation (modernhealthcare.com)
Prices rose faster than inflation for 22% of top generic drugs reviewed between 2005 and 2014, according to a report released Thursday by HHS' Office of Inspector General....Had those generic drugs been subject to the same requirement that branded drugs face—where manufacturers pay additional rebates to Medicaid when the price of a drug increases faster than inflation—Medicaid would have pulled in $1.4 billion in rebates for the top 200 generic drugs, according to the report...The OIG produced the report in response to a request from Congress to examine recent increases in generic drug prices and the effects of those prices on Medicaid and Medicare drug spending...the OIG didn't make any recommendations, noting that that the two-year budget deal recently passed by Congress would extend the rebates to generics starting in 2017. In a previous, similar report, OIG had recommended CMS consider seeking legislative authority to broaden the rebate program.
- FIP publishes guide to help pharmacists establish tobacco-free communities (fip.org)
In time for the quit smoking New Year resolutions that are anticipated at the end of this month, the International Pharmaceutical Federation has outlined the wide variety of different ways in which pharmacists can reduce the use of tobacco through a new publication. The briefing document, "Establishing tobacco-free communities: A practical guide for pharmacists", gives a number of examples from around the world, showcasing pharmacists’ value in performing health promotion, triage and referral as well as other interventions.
- EHR use a ‘frustrating’ time suck, physicians tell American Medical Association (healthcareitnews.com)Providers press for delay, flexibility in EHR rule (modernhealthcare.com)
...more physician groups are making the case that stringent regulations and suboptimal technology have left physicians spending too much time grappling with their electronic health records...It's not that physicians are against health IT. In fact, most have adopted technology "at a blistering pace,"...But unrealistic and uncoordinated requirements are overburdening physicians' time and affecting the quality of patient care...AMA published a list titled "How EHRs tied up physician time in 2015."...EHR technology continues to underwhelm...Meaningful use is outliving its usefulness...Physicians are talking back -- and being heard...the Association of American Physicians and Surgeons also put out a strongly worded complaint this week, charging that EHRs could "crash" the U.S. healthcare system..."EHRs are supposed to be a cure-all for inefficiency and medical errors,"..."But the costly, clunky systems the government demands are worsening the problems and even driving some software experts back to paper."..."It's a major distraction from face-to-face patient care and interaction, thereby increasing the chance of missing important information, and in the end, increasing the probability of clinical and treatment errors,"..."The federal government should have no role in telling how physicians how to keep their records,"...
- Push Is On for Medical Records Transparency (realclearhealth.com)Foundations Unite to Support Access to Clinical Notes for 50 Million Patients Nationwide (opennotes.org)
Perched on an exam table at the doctor’s office watching the clinician type details about their medical problems into their file, what patient hasn’t wondered exactly what the doctor is writing? As many as 50 million patients may have a chance to find out in the next few years, following the announcement this week of $10 million in new grants to expand the OpenNotes project, which works with medical providers to expand patient access to clinician notes...OpenNotes started in 2010 as a research project to examine what would happen if patients had easy access to their doctor’s visit notes, which may include a summary of their conversation, the symptoms patients describe and their doctor’s findings from a physical exam. Although patients have a legal right to their medical records, getting those documents is often difficult and expensive...Our goal is basically to make fully transparent medical records the standard of care across the country...The project works with providers, patient groups and electronic health record vendors, among others, to encourage the use of OpenNotes, and evaluates the impact of OpenNotes on health outcomes and costs...In addition to improving communication between patients and their providers, some research suggests OpenNotes may improve patients’ ability to stick with their medication regimens...
- Pharmacy Week in Review: December 18, 2015 (pharmacytimes.com)
Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)
- Will Independent Specialty Pharmacies Disappear in the Future? (specialtypharmacytimes.com)
National Association of Specialty Pharmacy Executive Director James E. Smeeding, RPh, MBA, discusses the trend of larger entities absorbing independent specialty pharmacies.










