- 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.
- 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.
- Drugmaker Settles Free Speech Dispute as FDA Agrees on Label (bloomberg.com)
U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing...After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel (bupivacaine), rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries...The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use...FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses...Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request…
- 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...
- 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.
- PhRMA launches biologics and biosimilars online resources (catalyst.phrma.org)
Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available. A biosimilar product is exactly what its name implies — it is a biologic that is "similar" to another biologic drug already approved by the FDA. To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, PhRMA is excited to launch a new section of our website today that provides educational resources on these topics.
- How biologics and biosimilars work;
- What data protection measures are in place to promote research and development of these medicines; and,
- How science-based regulatory policies protect patient safety and facilitate health care provider and patient choice.
Our goal is to create a comprehensive source of information on biologics and biosimilars, so that we can help improve awareness, science and evidence-based decision-making and patient choice. To access the new biologics and biosimilars web page, go to: Biologics and Biosimilars
- 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.
- 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,"...
- Lack of cyber security draws hackers to hospital devices (ft.com)
Imagine if simply typing “password123” into a computer did not open your email account, but an internet-connected medical device responsible for feeding you drugs or monitoring your blood oxygen or insulin levels...It may sound like the nightmare stuff of fiction, but the lack of basic cyber security on hospital equipment is attracting hackers who want to use them as a way to enter medical networks...Experts say that while they have not yet seen someone die as a result of hacking, the risks are growing...Motives for attacks could range from wanting to harvest patient information or stealing intellectual property from medical trials to simply wanting to create chaos...Devices with default passwords that are left unchanged, and outdated operating systems that are connected to the network, such as medical databases, are all too common in healthcare...Each provider needs to carefully examine for themselves what types of risk are being brought in by new devices. They will have to give careful consideration to making sure they are kept up to date, behind firewalls and in networks segmented off from key medical and personnel data…