GPhA responds to possibility of more stringent FDA regulations
NEW YORK — A ghost from 2008 soon could come back to haunt 2010.
According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.
FDA Center for Drug Evaluation and Research director Janet Woodcock reportedly told one media outlet that the agency was considering strengthening regulations on some generic drugs on the basis of statements by some patients and employees of generic drug companies that the generics didn’t work as well as the branded drugs. Woodcock’s statement followed a speech given at a technical conference organized by the FDA and the Generic Pharmaceutical Association, though she was reported as not elaborating further.
In 2008, controversy arose amid anecdotal reports that patients taking generic drugs for epilepsy had experienced breakthrough seizures—seizures that occur even when patients are using drugs—which they had not experienced while taking branded versions of the drugs. As a result, legislatures in 35 states considered generic “carve-out” bills that would have placed restrictions on when a generic drug can be used for certain diseases, though only three of them passed.
Following Woodcock’s remarks, the GPhA sought to allay concerns that may have arisen. “As evident from the GPhA/FDA Fall Technical Conference this week, generic industry companies and the FDA share a unique partnership and commitment to assuring consumers and patients that all drugs—brand and generic—are safe and effective,” the organization’s statement read. “In fact, forums such as this conference provide opportunities for all constituents in our industry to seek ways to partner with the FDA to ensure the generic drug approval process is the most stringent in the world. The FDA has the ultimate authority to ensure the safety of the pharmaceuticals in America’s medicine cabinets and to preserve the confidence that consumers place in our products.”
NACDS, NCPA claim pharmacy victory after withdrawal of Medicaid program provisions
ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association heralded the withdrawal of two provisions from the Medicaid program that would have had retail pharmacies selling generic drugs at a loss.
The Centers for Medicare and Medicaid Services cut provisions that defined average manufacturer price and determined calculation of federal upper limits. The NACDS and NCPA sued CMS in the U.S. District Court for the District of Columbia in November 2007 to obtain an injunction against the provisions, which the court granted. In response, CMS revised its definition of multiple source drugs in October 2008, though the pharmacy lobby groups amended their lawsuit to block that as well, saying it was still against the law. CMS’ new rule removes that provision as well.
In a joint statement, NACDS president and CEO Steve Anderson and NCPA EVP and CEO Kathleen Jaeger heralded the decision, saying the rule would have reduced patients’ access to pharmacies by cutting reimbursements, thus forcing retail pharmacies to sell generic drugs at a loss.
“We insisted that this policy was not appropriate,” the statement read. “Separately, we also have urged that policy-makers should recognize the ability of pharmacies and pharmacists to help improve health and reduce healthcare costs. We are gratified that this sense is reflected in the pharmacy provisions of the new healthcare-reform law. The new law contains provisions ranging from dramatically reducing the [accelerated manufacturing of pharmaceutical] cuts to advancing medication therapy management, through which pharmacists can help patients take their medications correctly, which is referred to as ‘medication adherence.’”
Roadside announces partnership to further ‘drive’ wellness programs
BOSTON Two companies have formed a partnership to provide services for long-haul truck drivers.
Sleep HealthCenters and Roadside Medical Clinic + Lab announced a partnership Wednesday to provide sleep medicine services as part of Roadside’s driver-wellness programs.
Roadside provides medical services, such as Department of Transportation-compliant physicals, drug testing, driver-wellness programs and sleep services for professional drivers on the highway and at company terminals. Sleep HealthCenters will support Roadside’s programs by providing education, professional diagnosis and treatment support, which will be incorporated into the driver-wellness program.
“You cannot effectively screen, test and treat sleep apnea without addressing and improving drivers’ overall health condition, such as weight, [body-mass index], stress and cardiac strength,” Roadside COO Rob Scheschareg said. “By providing continuous care for drivers for sleep, fitness, health and [Department of Transportation] compliance from the terminal to the highways, Roadside Medical is able to move the needle toward better driver health.”