Public Comments

03/20/2013

Margaret Anderson's written testimony to House Appropriations Subcommittee regarding FDA

Chairman Aderholt, Ranking Member Farr, and members of the subcommittee, thank you for the opportunity to present my testimony on the critical importance of increased federal investment in the Food and Drug Administration (FDA). I respectfully request the committee prioritize FDA funding as this agency cannot take additional cuts while continuing to fulfill Congressional mandates. Further investments in the agency are vital if it is to fulfill its mission of ensuring that the products it regulates are safe, effective, and properly made.

I am Margaret Anderson, executive director of FasterCures, the Milken Institute’s Center for Accelerating Medical Solutions. FasterCures is a nonprofit and nonpartisan organization focused on improving the medical research and development (R&D) system – so that we can speed up the time it takes to get important new medicines from discovery to patients. We work across diseases, disciplines, and sectors – academic institutions, government agencies, biotechnology and pharmaceutical companies, investors, medical research foundations, and patient advocacy groups – to catalyze transformative action that's focused on improving the medical research system to meet patients' needs.

I would like to express my gratitude to this Committee for increasing FDA appropriations over the last few years. As you are aware, the FDA is responsible for the safety of the foods we eat, the effectiveness of the drugs we use, and the oversight of countless other products that are used in the United States on a daily basis. The agency oversees 100 percent of drugs, vaccines, medical devices, and personal care products and 80 percent of our nation’s food supply. The FDA oversees aspects of several industries that are key to our nation’s growth and prosperity and is responsible for ensuring the safety of products that comprise almost 25 percent of all national consumer spending.

Each year the FDA’s responsibilities continue to grow as a result of not only new legislative requirements but also due to the agency’s increasing international workload. Food imports and medical device imports are growing at a rate of 10 percent annually, and drug imports are growing at an even quicker pace of 13 percent annually. Currently, about 50 percent of all medical devices used in the United States are imported, and approximately 80 percent of active pharmaceutical ingredients are manufactured abroad, as are 40 percent of finished drugs. Additional funding is necessary to make sure that the agency can remain accountable for ensuring product safety and providing the therapies that millions of Americans need.

No agency with a critical role like FDA’s should be asked to do more, with less. If we are to advance medical progress and improve patients’ lives—which will significantly bolster the U.S. economy—we need to start making the FDA a national priority. To address the increased agency responsibility, I request that the committee prioritize FDA and increase FDA funding for FY 2014 to help the agency fulfill its public health mission. Increased funding at the FDA will allow the agency to bolster its scientific infrastructure and expertise and be able to more effectively take the baton of medical innovation from the medical research community and bring it into the marketplace, where scores of patients impatiently await access to potentially life-saving therapies and life-enhancing scientific advances.

The FDA is charged with protecting and promoting the public’s health, ensuring safe and effective products, and delivering lifesaving drugs to patients as quickly as possible. However, sequestration and subsequent cuts in funding will hinder the agency’s ability to meet these expectations. With the sequester reducing FDA spending in FY 13 by about 5 percent, or $209 million, the agency will struggle to fulfill its goal of evaluating new, innovative technologies. The FDA is essential to the process of bringing to market promising breakthroughs that can help improve patients’ quality of life, and even save lives. Americans who are desperately waiting for new disease therapies will be adversely impacted by cuts due to increases in approval times for new drugs and devices. As a result of decreased funding, the FDA will have to shift its focus from pre-investigational new drugs (IND) and Phase 2 drug submissions, and spend less time studying and providing feedback to new drug applicants. Orphan drugs for rare diseases will face significantly increased waiting times for approval, affecting patients, researchers, and drug companies. Development of other drugs could be put on hold entirely.

Agency-wide cuts will also hinder the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) at the expense of patients and the economy. As part of the legislation passed last year, FSASIA authorizes the FDA to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. However, as much as $1.6 billion in user fees is subject to sequestration, even though industry continues to pay the fees as if they were not being sequestered. These cuts will impact the review and approval of biologics, a complex class of medications used to treat overwhelmingly prevalent conditions like arthritis, multiple sclerosis, and other major diseases. The FDA’s capacity to continue regulatory science initiatives, address drug shortages, advance medical countermeasures, and maintain efforts for biosimilars will be devastated if significant funds are not appropriated to make up for the cuts that will follow sequestration.

The FDA will feel the impact of lost funding more than any other agency. More than 80 percent of FDA funding is spent on administrative and personnel-related costs. With all of the responsibilities FDA is held accountable for, the agency cannot afford to lose any staff members to funding cuts. To avoid furloughs and personnel cutbacks, it is likely the agency will delay filling vacancies. Failing to adequately staff the agency has the potential to slow drug development and approval and leave many medical needs unmet. Increased funding would allow the agency to meet the growing demands of globalization. The United States imports products from hundreds of thousands of facilities located in 200 countries across the globe. FDA needs improved appropriations to effectively guarantee that our imports are safe and that we do not suffer from a potential decrease in foreign food and device safety.

Increased funding for the FDA must be a national priority. Federal investment in the FDA has a real impact on the economic and fiscal health of the nation, and the potential for science to provide great returns to our nation and patients is better than ever. Increased funding for FY14 supports industries that are essential to our nation’s growth and prosperity and is essential for safeguarding a strong and robust FDA, which is critical to ensuring the agency will be able to deliver on its mission of getting safe food and safe and effective medical therapies into the hands of consumers and patients, and ensuring the safety of those products. At FasterCures, our mission is to speed up the process of turning medical discoveries into effective and accessible therapies. We need an FDA that's fully resourced if we are to accelerate the therapeutic development process and deliver the safe and effective drugs and devices patients need.

Thank you again, Mr. Chairman, for the opportunity to submit this testimony to you and the Subcommittee today. I would be happy to provide additional information and answer any questions you have.

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