PhRMA Testifies Before House Subcommittee on Health
Stresses Importance of Risk-Based Approach for Foreign Inspections

Washington, D.C. (May 1, 2008) — Pharmaceutical Research and Manufacturers of America Vice President for Policy & Research Lori Reilly testified today before the House Energy and Commerce Committee’s Subcommittee on Health about the Food and Drug Administration (FDA) Globalization Act.

While PhRMA is currently taking a closer look at the discussion draft offered by Chairman John Dingell – including the scope of the language and how it could help improve the current inspections process – we generally support some of the concepts that could enhance FDA’s inspection regime for foreign facilities. We also support several anti-counterfeiting concepts recently offered by Congressman Buyer and Congressman Matheson – in the Safeguarding America’s Pharmaceuticals Act of 2008 – that could help America’s supply chain become even more secure.

In response to some of the general provisions in the Food and Drug AdministrationGlobalization Act, Lori Reilly publicly stated at the hearing that, “PhRMA agrees with the Committee that the rate of FDA foreign inspections should be increased and recommends that FDA utilize a risk-based approach to prioritize such inspections. We also support the establishment of FDA regional offices around the world. This would allow FDA officials to educate and train foreign government personnel about the importance of the FDA’s quality system and good manufacturing standards to help ensure product quality, safety and efficacy.”

At the hearing, PhRMA also stressed the importance of Congress increasing appropriated funds to help the FDA fulfill its mission of protecting patient health and safety; the significant steps that America’s pharmaceutical research companies already take to help assure the quality, safety and integrity of prescription medicines; and the importance of maintaining a secure drug supply system in the U.S.

The alarming rate of counterfeit products being manufactured and sold around the world poses great challenges to federal agencies such as FDA and Customs and Border Protection under the Department of Homeland Security. “It also poses significant challenges to America’s pharmaceutical research companies, whose lifeblood is the safety and integrity of the products they develop,” Reilly said. “This is why we commend the Committee for considering additional safeguards that could help better protect patient health and safety and prevent the proliferation of counterfeit medicines in the U.S.”

Stressing the importance of maintaining a relatively closed drug supply system in the U.S., Reilly said, “In order for America’s drug supply system to remain, for the most part, protected from the worldwide counterfeit epidemic, it is critical that this system remain closed and not put in a position where it could be made more vulnerable to the counterfeit threat. The challenges we face today would increase significantly and our current system would become weaker – not stronger – if prescription drug importation proposals move forward.”

“PhRMA will continue to work with Congress on ways to help strengthen our robust regulatory system so that the FDA has the tools it needs to develop a strong and comprehensive inspections regime and most importantly, help protect patient health and safety,” Reilly concluded.

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.

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