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GPhA Urges Congress and the FDA to Strengthen Foreign Inspection Resources, Create a Uniform System for Inspection

Arlington, VA, March 10, 2010...The Generic Pharmaceutical Association (GPhA) today issued the following statement from Kathleen Jaeger, President and CEO of GPhA, on the testimony of FDA Principal Deputy Commissioner Joshua Sharfstein, M.D., before the House Energy & Commerce Health Subcommittee:

“Our foreign inspection program is only as strong as its weakest link. Recognizing this, it is critical that Congress provide FDA with the resources it needs to ensure the safety of the nation’s drug supply. Equally important is for Congress and the agency to enact reforms that strengthen the foreign inspection system.

“Americans have the right to expect that their medicines are safe and effective. The U.S. brand and generic drug industries are the most regulated industries in the world, and rightfully so. We should, and must expect the same high quality product standards for all drug products marketed in the United States regardless of where they are manufactured. To achieve this goal, it is imperative that Congress:

• Strengthen FDA funding. In addition to maintaining adequate funding to ensure the safety and integrity of the domestic inspection program, GPhA also supports annual registration or inspection fees to fund inspections of foreign facilities.
• Establish one uniform, high-quality inspection system for both domestic and foreign facilities. Such a system would guarantee that inspections are conducted with the same frequency and same extent, whether the facility is domestic or based overseas.
• Implement a "risk-based" approach. To help maximize resources and ensure that facilities at greatest risk receive the greatest attention, the generic industry supports a "risk-based" model for the foreign inspection program. This model would prioritize inspection resources according to a company's safety and compliance track record.

“The generic pharmaceutical industry goes the extra mile in ensuring safety and quality by investing tens of millions of dollars annually into making sure that manufacturing plants are producing safe and effective medicines. We applaud Principal Deputy Commissioner Sharfstein and Congressional leaders for working to protect the U.S. drug supply. We must all work together to guarantee that all drugs used by Americans meet the U.S. gold standard for quality and effectiveness.”

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.gpahonline.org.

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