Mylan seeks approval for generic fibromyalgia drug
PITTSBURGH — Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug’s manufacturers.
Mylan said Wednesday that Forest Labs and Royalty Pharma had sued it in the U.S. District Court for the District of Delaware in connection with its filing of a regulatory approval application with the Food and Drug Administration for milnacipran hydrochloride tablets in the 12.5-mg, 25-mg, 50-mg and 100-mg strengths. The drug is a generic version of Savella.
If Mylan is the first company to successfully file an approval application with the FDA for a generic version of Savella, it will receive 180 days of market exclusivity in which to compete directly with Forest following FDA approval.
Savella had sales of about $123 million during the 12-month period ended in June, according to IMS Health.
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It’s all about patient engagement
The healthcare industry has always had its fair share of buzz words and the pharmacy sector is no exception. Medication synchronization, outcomes, clinical services, medication therapy management, accountable care organizations… our conferences and publications are full of experts discussing how pharmacies can successfully participate in these new opportunities. What I find to be so interesting in this new crop of go-to phrases is they all really boil down to one common element and that is patient care.
Across healthcare right now, a common theme is how to better engage the patient. How do we empower them to make better healthcare choices? How can patients be encouraged to stay healthy? While driving in to work this morning, I saw a bench at a bus stop with a health plan ad encouraging children to brush their teeth. Similar wellness ads are covering billboards, websites and even office break rooms across the country. The focus on patient health and wellness has never been so prominent. The mass migration to electronic medical records is paving the way for robust analytics to actually measure and even predict the impact of health and wellness initiatives on patient outcomes. For decades we have tried to find a way to compensate healthcare providers for keeping patients well. Today it’s quickly becoming reality.
Generally speaking, within the mix of providers, the person patients typically interact with most often just happens to be their local pharmacist. For generations pharmacists have guided their customers on which over the counter cold medicine to use and more importantly guarded against adverse drug reactions and aided them in finding the most effective drug therapies. They have built a trust in their communities that can serve not only as a foundation but a springboard to the future.
I’m sure our organization isn’t the only one thoughtfully developing strategic plans for 2014. Congruently we’re keeping a watchful eye on both state and federal regulations opening the doors for additional clinical services in the pharmacy. Although the pace may not be as quick as we would like, in my opinion we have begun an important evolution that will continue to gain momentum. Our legislators and healthcare communities have discovered what the community has always known: That pharmacists are indeed healthcare providers with an ability to help keep patients healthy while reducing overall healthcare costs.
Emdeon EVP of pharmacy services
As EVP of pharmacy services at Emdeon, Kevin Mahoney oversees the company’s entire pharmacy services division including strategic initiatives, industry partnerships and pharmacy product development for all pharmacy products. Mahoney has spent more than 25 years in the healthcare industry with a predominant focus in pharmacy. Mahoney received a Bachelor of Arts in accounting from Belmont Abbey College and an Master of Business Administration from Pace University.
Our solution to how to engage and empower patients to make better healthcare choices is to make sure that patients understand their prescription and medication information. Often limited English proficiency (LEP) patients do not understand their prescription directions for use and supplemental medical information forms that are given to them in English only. RxTran (www.RxTran.com) works to overcome the language barriers between pharmacies and LEP patients by providing affordable, high quality interpreting and translation services, including translated SIGs (directions for use) and AWLs (auxiliary warning labels) that can be printed directly on prescription labels. Pharmacies being aware of and in tune to the needs of their LEP patients makes for healthier patients. As an added bonus to the pharmacies enjoy increased customer loyalty and revenue that comes from the relationship built with pharmacists able to communicate and meet LEP patients needs.
SPAARx heralds revised regulations to HIPAA HITECH Act
FLORHAM PARK, N.J. — A decision by the Department of Health and Human Services to resolve conflicts that arose when it issued regulations under a law that establishes privacy rules for health information technology has drawn applause from a specialty pharmacy organization.
The Specialty Pharmacy Association of America said that it received a "positive response" from HHS to concerns it expressed to the department about 2013 regulations under the HIPAA HITECH Act. According to SPAARx, a number of questions related to patient adherence and refill reminders under the regulations were left unresolved, resulting in conflict with healthcare practices for compliance and persistency programs developed by specialty pharmacies.
In response to lobbying by SPAARx and other industry groups, HHS provided revised guidance on remuneration for refill reminders and other similar communications. The previous guidelines allowed covered entities to be compensated for direct costs like labor, materials and supplies, while the new ones also include indirect costs like capital and overhead. In addition, business associates will be compensated based on the fair market value for patient adherence and refill reminder services.
"We are encouraged that the Department of Health and Human Services has responded to many of the clarifications that SPAARx and our specialty pharmacy members requested over the past several months," SPAARx CEO Kevin Alder said. "The clarifications they made are improvements to the rules governing the ability of specialty pharmacies to continue to advance the necessary patient-care to achieve positive patient health outcomes."
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