September was a busy month for Congress as well as the generic pharmaceutical sector. Congressional action was anticipated on several bills that could significantly increase the costs of prescription drugs, delay affordable medicines from coming to market, and make the health care system unsustainable. Specifically, Congress was considering changes to the biodefense arena and the patent system, and the generic industry will be keeping a close eye on these developments.
By the end of September, US senators were expected to introduce new legislation meant to encourage pharmaceutical companies to become involved in efforts to produce countermeasures that can be used in the event of a bioterrorist attack. In previous proposals, some senators have suggested that generous patent extensions, extended product monopolies, a broad definition of what products qualify as countermeasures, and other provisions would jump-start research and development in the biodefense area. Those provisions, however, would not encourage innovation but would impose a larger cost burden on America's sick and elderly, who would continue to pay higher prices for their prescription medicines.
Instead, Congress should consider bolstering the biodefense pharmaceutical sector by providing funding throughout the full development cycle of countermeasures, as well as additional tax credits and grants, product liability reforms, guaranteed purchasing, and fast-track FDA review, among other measures. These tools would help to stimulate the production of countermeasures and ensure that the cost burden of this initiative would be spread among all US citizens, not rest solely on the most vulnerable ones.
Three Congressional hearings on patent reform were held in September, focusing on legislation that would change the way questionable patents are filed and challenged, as well as how disputes are resolved. Unfortunately, the legislation would have the effect of indefinitely extending product monopolies on branded medicines, thus delaying patient access to affordable generic medicines. The Generic Pharmaceutical Association (GPhA) will be actively involved in the debate on this legislation and has encouraged Congress to give thorough consideration to the ramifications of making these changes to the patent system.
GPhA will continue to monitor these issues, while focusing efforts on those initiatives that will help boost generic utilization and lower prescription drug costs to the federal and state governments and to employers, insurers, and all patients. Already, generic pharmaceuticals are helping Americans save tens of billions of dollars each year in prescription drug costs, and we are working with Congress to ensure that those savings will be even greater in the future.
Kathleen Jaeger, RPh, President and CEO, Generic Pharmaceutical Association
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