PHARMACY

FDA generic user fees moving closer to reality

BY Jim Frederick

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

Call it pay to play. FDA commissioner Margaret Hamburg has told the generic industry, in no uncertain terms, that the massive logjam at the agency’s Office of Generic Drugs in the review and approval of abbreviated new drug applications for new me-too medicines has grown steadily worse as budget cuts have taken their toll and applications from generic manufacturers continue to pile up. The situation isn’t likely to get better, she warned, without the additional funds that user fees would bring to the agency.

Such a user-fee model could mimic the pattern established by the Prescription Drug User Fee Act established by Congress for the branded drug industry. “An effective user fee program negotiated between FDA and industry—a model that has seen major successes with other FDA-regulated items, including innovator prescription drugs, medical devices, animal drugs and generic animal drugs, to name a few—would reduce review times and make funding more flexible,” Hamburg asserted at a mid-September hearing by the agency to gather stakeholder input on the development of a generic drug user-fee program. “The fact is that no one benefits from a pending application queue of 2,000-plus products.”

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, ticked off the potential benefits a generic drug user-fee program would bring both to the industry and to public health during a recent meeting with generic industry representatives. Noting that me-too medicines now account for 75% of all prescription drugs dispensed in the United States—and they saved Americans $824 billion in the last decade—Woodcock said that “user fees with performance goals” could help transform the FDA approval process.

Among those benefits, she said, would be “faster access to products,” as well as “greater predictability of the review process” and a higher level of quality assurance. For the agency, the additional money would mean “increased and more stable funding” and “better staffing and management of the review process,” Woodcock told industry leaders.

Generic drug manufacturers generally agree with the FDA, at least in spirit. Summing up the industry’s position, the Generic Pharmaceutical Association noted, “the generic industry has stated its willingness to work with the FDA to create an effective and meaningful user-fee program to provide more resources and more certainty in getting affordable generics to consumers.”

However, said the GPhA, “to make the user-fee program work, [the] FDA must address core fundamental issues that are blocking timely access to generic medicines. These core issues have been around for more than a decade—the citizen petition process, scientific consults, enhanced communication, more inspection resources and the accountability and structure of the Office of Generic Drugs.”

Thus, the GPhA has put itself on record as endorsing the establishment of user fees, with some very big conditions. Gordon Johnston, the group’s VP regulatory science, laid out those conditions during the FDA’s public hearing on Sept. 17. “[The] GPhA is supportive of user fees based on predetermined performance goals and metrics,” Johnston told the agency. However, he said, the generic industry wants some things in return.

Among them: a “substantial” increase in resources for the FDA’s Office of Generic Drugs in order to speed up the lengthy review process. “Generic drug manufacturers are acutely aware of the need to get much-needed additional resources to the FDA and the [OGD] to help handle the work associated with the review and approval of generic applications,” Johnston said.

The trade group also wants “certainty in review and action timelines,” Johnston asserted, as well as “increased opportunities for communications between industry and OGD” and “phased-in performance goals over the first five years of the [user-fee] program.”

On a more basic level, the GPhA wants user fees to serve as “a supplementary source” for OGD funding, “above and beyond congressional appropriations.” Those annual budget outlays from Congress, Johnston told the agency, “remain critical to the base funding for OGD.”

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NACDS, NCPA claim pharmacy victory after withdrawal of Medicaid program provisions

BY Alaric DeArment

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.’”

 

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Roadside announces partnership to further ‘drive’ wellness programs

BY Alaric DeArment

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.”

 

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