ACRO Update: ACRO Requests Additional funds for FDA’s OIP

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March 10, 2010

ACRO Update: ACRO Requests Additional funds for FDA’s OIP

March 10, 2010

Statement of: The Association of Clinical Research Organizations Submitted for the Record United States House of Representatives Committee on Appropriations – Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

Chairwoman DeLauro, Ranking Member Kingston, and members of the Subcommittee: The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations (CROs). Our member companies provide a wide range of specialized services across the entire spectrum of development for new drugs, biologics and medical devices, from pre-clinical, proof of concept and first-in-man studies through post-approval and pharmacovigilance research. With more than 70,000 employees engaged in research activities in more than 115 countries around the world, ACRO advances clinical outsourcing to improve the quality, efficiency and safety of biomedical research. Last year, member companies were involved in conducting more than 9,000 clinical trials that included nearly two million research participants.

From approving new drugs and biologics to ensuring the safety of the food supply, the U.S. Food and Drug Administration faces many challenges across a diverse portfolio. And, whether the issue is assessing the safety of marketed drugs or monitoring the conduct of clinical trials, that portfolio is increasingly global in scope. Thus, we applaud Commissioner Hamburg’s commitment to international cooperation and engagement. In fact, under Section 903 of the Food Drug & Cosmetic Act, it is part of the FDA’s mission to “(b)(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.”

Today, FDA-regulated products are part of an international marketplace in which consumers shop, and borders are no longer barriers. In 2007, the United States imported more than $2 trillion worth of FDA-regulated products from roughly 200 countries or territories. Both the number of drugs manufactured at foreign sites and the number of foreign sites making FDA regulated drugs have more than doubled since 2001. Given these realities of the 21st century, international activities at FDA are no longer “discretionary”; rather, they are an integral part of our nation’s public health apparatus.

Like many other important economic activities, the conduct of clinical research has become increasingly globalized in recent years. For example, in 2004 clinical trial activity in India totaled $30 million; the estimate for 2010 is $1.5 billion, a figure that will constitute 5% of all clinical trials worldwide. According to clinicaltrials.gov, today 53% of clinical studies are performed in the U.S., 24% are performed in Europe, and 23% are performed in the rest of the world.

The expansion of clinical research to foreign countries results in benefits to U.S. patients. As The Case for Globalization, (a white paper ACRO commissioned in 2009,) suggested, a cancer trial that would take 5.8 years using only U.S. patients would be completed in only 1.9 years when global research sites are used. While this globalization is a positive trend for many reasons, it presents challenges as well, especially in terms of the FDA’s capacity to oversee non- U.S. drug development and manufacturing. Globalization of the biomedical research industry has greatly increased the demand on the FDA’s resources. Between 2004 and 2007, the number of FDA-regulated investigators increased by 15.9% in Central and Eastern Europe (CEE), by 12.1% in Latin America and by 10.2% in the Asia-Pacific region. (Meanwhile, the number of North American and Western European investigators declined by 5.2% and 6.1%, respectively.) Yet, despite the tremendous growth of clinical research abroad, 83% of FDA clinical investigator inspections between 2000 and 2008 were conducted in the U.S. and only 10% outside the U.S. and Western Europe. As part of the Alliance for a Stronger FDA, ACRO supports an FDA budget that provides adequate resources to fulfill the agency’s far-flung obligations. Beyond the agency-wide budget, ACRO is especially interested in funding for the FDA’s Office of International Programs (OIP).

The President’s proposed budget for FY 2011 requests only $16.9 million for OIP.

ACRO recommends funding OIP at $35 million in FY 2011. Such an increase would not only improve the FDA’s capacity to perform audits and inspections around the world, but facilitate capacity-building in, and in cooperation with, the non-U.S. regulatory authorities whose competence and strength will ultimately impact the safety and efficacy of the drugs and biologics used by patients in the United States. Simply, the FDA remains the gold standard among drug regulators worldwide. As such, it is imperative for the FDA to increase its oversight capabilities in countries where many of the drugs it will approve in the future are being tested and to actively partner with its foreign counterparts. A budget of $35 in FY 2011 would allow the Office of International Programs to accelerate the necessary globalization of the FDA’s presence.

Thank you for allowing ACRO to submit this statement. Please feel free to have your staff contact us with any questions.

Douglas Peddicord, Ph.D.
Executive Director
March 17, 2010