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GPhA Statement on Nomination of Dr. Margaret Hamburg as Commissioner and Dr. Joshua Sharfstein as Deputy Commissioner of FDA
Date:3/14/2009

ARLINGTON, Va., March 14 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the nomination of Dr. Margaret Hamburg as Commissioner and Dr. Joshua Sharfstein as Deputy Commissioner of the U.S. Food and Drug Administration (FDA).

"GPhA stands ready to work with Dr. Margaret Hamburg on the critical issues facing the Agency as it carries out its mission to protect the public health. Dr. Hamburg's outstanding experience both in government and the health care arena make her an excellent choice to lead the FDA. Now more than ever, FDA needs a strong, smart manager and Dr. Hamburg answers that call.

"As Deputy Commissioner, Dr. Joshua Sharfstein brings exceptional knowledge of what it takes to ensure the safety and efficacy of the medicines that Americans rely on to improve their health. His commitment to protecting the public health is stellar. As Commissioner and Deputy Commissioner, Drs. Hamburg and Sharfstein will work to give FDA scientists the resources they desperately need to uphold the Agency's gold standard of quality and safety.

"With Americans growing increasingly concerned about paying for needed medicines as the economy continues to struggle, it is critical that consumers have access to safe and affordable generic and biogeneric medicines. FDA scientists and reviewers are working hard every day to bring generic medicines to market, but the FDA's resources are simply stretched too thin and long-existing barriers to access must be eliminated. With generics saving government and consumers billions of dollars annually, we look forward to working with Dr. Hamburg to increase investments in the Agency and remove barriers that are keeping affordable medicines from getting to patients.

"The time has also come for Congress to give FDA the authority and flexibility to create a workable biogenerics approval pathway. President Obama stated in his budget proposal his desire to move the process forward and his action was followed by the bipartisan consensus bill introduced by Chairman Waxman, and Representatives Deal, Pallone and Emerson earlier this week. Dr. Hamburg's leadership will be instrumental in this effort.

"We also look forward to working with Drs. Hamburg and Sharfstein on a host of other important Agency issues including strengthening the foreign inspection system and addressing the proliferation of carve-out legislation being introduced in state capitols across the country. As we celebrate the 25th anniversary of the passage of the landmark Hatch-Waxman Act, the generic industry is rolling up its sleeves to work with the new FDA leadership, the Obama Administration and Congress in creating history again through passage of biogenerics legislation and strengthening our health care system."

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 69% of the total prescriptions dispensed in the United States, but only 16% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.


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SOURCE Generic Pharmaceutical Association (GPhA)
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