FDA approves test to monitor levels of Zortress in the bloodstream
SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).
Zortress is a drug used to prevent rejection of transplanted kidneys.
“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.
FDA approves Quixin generic
AMITYVILLE, N.Y. — The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.
Hi-Tech announced the approval of levofloxacin ophthalmic solution in the 0.5% strength, a treatment for bacterial conjunctivitis. The company plans to launch next month.
The drug is a generic version of Vistakon’s Quixin, which had sales of $2 million in 2010, according to IMS Health.
Congress nixing FSA rule changes is no surprise
WHAT IT MEANS AND WHY IT’S IMPORTANT — It never made much sense to make health care less affordable under the Affordable Care Act — neither did the requirement of a prescription for a nonprescription remedy jive with proponents of flexible spending accounts. So it’s little wonder that the FSA rule changes were the first piece of ObamaCare to face a congressional axe, as was widely speculated just last week.
(THE NEWS: FSA restrictions first piece of ObamaCare to be challenged. For the full story, click here)
But the unifying thread throughout this whole debate, the underlying factor that’s going to end up tying everything together across multiple disciplines, is this: Retail pharmacy saves money. Period. End of story.
It’s the inherent value within over-the-counter medicines and self-care that will be trumpeted as Congress debates the cons around this FSA rule-changing. And part of that value lies within the healthcare professionals on hand to help guide those self-care decisions — the pharmacist, the nurse practitioner and, in some states, a licensed pharmacy technician.
Of course, while nonprescription aisles won’t be the only touch points between retail healthcare practitioners and the general public, they very well may serve as an entrée to the remaining value that pharmacy affords health care — increased participation in compliance programs and medication therapy management initiatives that help keep patients out of the emergency rooms, for example; or greater and more convenient access to vaccinations thanks to immunizing pharmacists now practicing in every state. It all can start in the pharmacy, and more likely in the OTC aisle, as a patient asks for recommendations.
According to a Nielsen Group poll conducted in December 2010, more than half of all participants in an FSA used their accounts to buy an OTC in the preceding 12 months. And of those approximate 9.8 million consumers, 46% suggested they would make that extra visit to their doctor’s office and request prescriptions for their OTC medications. Many impact models not only account for those increased doctor bills, but also the fact that many doctors more familiar with the latest prescription-only remedies may steer patients to those more expensive therapies.
According to the Foundation for HealthSmart Consumers, if only 10% of consumers opted to see their doctors for an OTC prescription, overall heathcare costs would increase $4.5 billion in one year. If 50% of consumers opted to see their doctors, the projected additional costs skyrocket to more than $27.7 billion.