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Statement of Senator Tom Harkin (D-IA) At the HELP Committee Hearing: “Protecting the Public Health: Examining FDA’s Initiatives and Priorities”

“We have convened this hearing to examine FDA’s implementation of key public health initiatives being undertaken by the agency, including several significant reforms passed out of this Committee over the last few years.

“Our nation faces a variety of public health challenges in this early part of the 21st century.  There have been rapid changes in where our products are made and where our food comes from.  There have been major innovations, including treatments that save lives, and a better and more diversified food supply.  But these new dynamics also present new risks and greater challenges for regulatory oversight.

“The HELP Committee has been able to address many of these challenges in recent years through legislation, proving that things can still get done in Washington.  I thank Ranking Member Alexander for being my partner in these endeavors, and before him, Senator Enzi.  This Committee’s ability to work in a collaborative, bipartisan manner has allowed us to address these public health issues head on, and has made a difference in people’s lives. I want to briefly summarize the legislation I’m talking about as it relates to FDA’s oversight responsibilities:

“Last fall, a year after the meningitis outbreak from compounded sterile drugs that killed 64 patients and sickened 751 patients across 20 states, we joined with the House to pass the Drug Quality and Security Act, which clarifies and strengthens oversight of compounded drugs.  The DQSA also mandates development of an unprecedented electronic, interoperable system for tracing prescription drugs throughout the supply chain to help protect patients from adulterated and counterfeited drugs‎.  

“In 2012, we passed the Food and Drug Administration Safety and Innovation Act, which along with authorizing several FDA user fee programs, sped up patients’ access to generic drugs, modernized FDA’s ability to regulate the global drug supply chain, established tools to prevent and mitigate shortages of prescription drugs, and implemented reforms to help bring critical drugs and medical devices to market faster.

“In 2011, we enacted the Food Safety Modernization Act, a landmark law that brings America’s food safety system into the 21st century to better protect Americans from contaminated food and food-borne illness.

“Finally, in 2009, the Family Smoking Prevention and Tobacco Control Act, which this Committee spearheaded, became law.  It gives the FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.  

“I also want to take this opportunity to thank you and to commend the FDA for the recent proposal to update the Nutrition Facts Panel we see on packaged food. The last update to these labels, in 2006, prompted manufacturers to reduce trans-fat in many of their products, and I’m hopeful that this new proposal will further support Americans in their efforts to make healthy decisions for themselves and their families.

“Today’s hearing will focus on FDA’s implementation of these reforms, as well as other key public health initiatives being undertaken by the agency, and other public health issues of concern to the Committee.  We are pleased to have Commissioner Hamburg of the FDA here to talk about FDA’s recent efforts and answer our questions.”