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Statement from GPhA President and CEO Kathleen Jaeger in Response to Remarks by FDA Commissioner Margaret Hamburg at the GPhA Annual Meeting

“We welcome Commissioner Hamburg’s call for regulated industries, like the generic pharmaceutical industry, to partner with FDA on upholding the Agency’s mission to protect the public health. The safety, effectiveness and quality of our products is the generic industry’s number one priority, and we look forward to working with the FDA to increase access to generic medicines that improve lives for less.

As Commissioner Hamburg emphasized, the key to increasing access to affordable generic medicines is providing the FDA with the resources it needs to do its job. We agree with the Commissioner that the FDA Office of Generic Drugs (OGD) is stretched too thin and that it is unacceptable to have nearly 2,000 pending new generic drug applications. We remain committed to working with the Agency to ensure that FDA gets the resources it so desperately needs. We were pleased that the President’s budget included an increase of 10 million dollars in FDA funding.

The Commissioner commented that the President’s budget also included a provision for generic drug user fees. As we stated to the Commissioner this morning, GPhA welcomes reengaging in user fee negotiations. Our shared goal must be to create a meaningful user fee program with measurable results. To this end, we were pleased to hear the Commissioner state this morning that significant performance metrics must be part of any generic user fee program.

Commissioner Hamburg also noted that the generic pharmaceutical industry saved the federal government and the entire health care system about $750 billion over the past decade. An investment in increasing access to generic medicines is clearly an investment that reaps significant dividends. We must ensure that such an investment actually results in getting affordable generics to consumers in a timely fashion and we look forward to joining Commissioner Hamburg and the FDA to achieve this goal.

Similarly, we look forward to working with FDA in its efforts to move forward on a biogenerics approval pathway. We were pleased to hear Commissioner Hamburg state that the Agency is committed to developing a robust biogenerics approval pathway driven by science. We couldn’t agree more that there is not a “one-size fits all” approach to approving biogenerics, and that science must drive the process.

Finally, GPhA appreciates the opportunity to work with the FDA on continuing to ensure the public that generic medicines are just as safe and effective as their brand counterparts. We applaud the Agency for working to dispel the myths around generics and look forward to partnering with FDA on promoting the message that FDA-approved generic medicines are safe, effective and affordable for consumers.”

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 74 percent of the total prescriptions dispensed in the United States, but only 22 percent of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.

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