PhRMA, BIO, GPhA weigh in on healthcare-reform bill passage
WASHINGTON While calling it “not perfect,” an organization representing the country’s drug manufacturers called the healthcare-reform bill that the House passed Sunday “a step in the right direction.”
The Pharmaceutical Research and Manufacturers of America expressed the view Monday that healthcare reform would benefit patients and the country’s future.
The House sent the bill to Barack Obama’s desk after a vote of 219-212, with all the Republicans and 34 Democrats voting against the bill. The Senate had passed the bill on Dec. 24.
“The existing barriers to quality health care simply are not acceptable,” an organization statement read. “Today’s important and historic vote in the House will help to expand healthcare coverage and services to tens of millions of Americans who are uninsured and often forced to forego needed medical treatments.”
Meanwhile, the Biotechnology Industry Organization touted the bill’s provision for an abbreviated approval pathway for knock-off versions of biotech drugs variously known as biosimilars, biogenerics and follow-on biologics.
“The healthcare-reform bill passed by the House of Representatives last night includes key provisions that provide real solutions for our nation’s healthcare challenges and real hope for patients living with debilitating diseases such as cancer, multiple sclerosis, Parkinson’s, HIV/AIDS and many rare diseases,” BIO president and CEO Jim Greenwood said.
The bill provides for a 12-year data exclusivity period for biotech drugs, meaning that the Food and Drug Administration would have to wait until a biotech drug had been on the market for 12 years before it approved a biosimilar version. By contrast, the Generic Drug Association has pushed for a five-year exclusivity model, similar to the one that exists for generic pharmaceutical drugs. BIO argues that the 12-year model is necessary because it would prevent a biosimilar manufacturer from circumventing a biotech patent by making a drug that is functionally identical to the original but can be claimed to be different because it comes from a different cell line or has been modified in some way, while GPhA says that the 12-year model would deprive patients of access to cheaper alternatives to branded biotech drugs. The Obama administration has in the past pushed for a seven-year model.
For that reason, the bill’s passage got a less enthusiastic response from GPhA, which praised the bill’s closure of a gap in Medicare benefits called the “doughnut hole” and its expansion of healthcare access to uninsured Americans, but decried the provision for biosimilars.
“The bad news is that the bill provides a biogeneric pathway in name only, giving false hope to patients who desperately need access to life-saving biogeneric medicines,” GPhA president and CEO Kathleen Jaeger said. “Simply put, the bill fails to infuse competition and choice into the healthcare system due to the excessive and unprecedented market exclusivity protections for the brand industry.”
Retail Clinician special report focuses on patient-centered care
NEW YORK Drug Store News’ sister publication, Retail Clinician, has issued a special report on an exclusive study conducted by Take Care Health Systems in conjunction with Gallup Consulting that measured patient engagement levels among Take Care Clinic visitors, with an eye toward elevating the patient experience.
The report, which is anchored by the original white paper — written by Sharon Glave Frazee, Ph.D., VP corporate healthcare analytics and research team for Walgreens, along with John H. Fleming, Ph.D., principal, chief scientist customer engagement and humansigma®, Gallup, and Margaret Ozan Rafferty, R.N., M.H.A., M.B.A., healthcare global practice leader for Gallup — and also includes an interview with Take Care CEO Peter Miller discussing the significance of the findings and what it means both for Walgreens and Take Care, and the impact Take Care’s unusually high levels of patient engagement is having on clinic traffic.
A copy of the report can be downloaded here.
High doses of cholesterol drug may raise muscle injury risk, FDA warns
SILVER SPRING, Md. Patients taking a common drug for treating high cholesterol may be at increased risk of muscle injury, the Food and Drug Administration warned Friday.
The FDA warned patients and healthcare professionals of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.
Merck originally marketed simvastatin under the brand name Zocor, and it is now available as a generic from several suppliers. It’s also an active ingredient in several other cholesterol-lowering drugs, including the Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. All formulations of Simcor contain only 20 mg of simvastatin, though Vytorin is available with 80 mg, according to an FDA database.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”