Alliance for a Stronger FDA Explains Why Sufficient Funding for FDA is Critical

Resources Must Keep Pace with FDA’s Increasing Responsibilities to Patients and Consumers

05.28.13 | By Sascha Haverfield, Ph.D.

For more than 50 years, biopharmaceutical companies have partnered with the Food and Drug Administration (FDA) to help ensure the safety and efficacy of medicines. Due to the vital nature of the FDA’s public health oversight, PhRMA supports an empowered agency that is adequately resourced through Congressional appropriations which are supplemented by user fees.

A variety of organizations that work closely with the FDA to support its consumer protection mission joined together to form the Alliance for a Stronger FDA. PhRMA was a founding member and continues to be active in the Alliance, which represents diverse industries ranging from patient and medical specialty groups to trade associations for medicines, medical devices, groceries and pet foods to individual biopharmaceutical companies. We are united in advocating for robust appropriated federal funding to ensure that the FDA has the resources it needs to fulfill its ever-expanding, critical responsibilities.

I invited Ladd Wiley, Executive Director of the Alliance for a Stronger FDA to share more about the Alliance’s work and the urgent need to sufficiently fund the FDA.

The FDA regulates approximately twenty-five percent of products that consumers spend their money on in America.  The FDA is responsible for food safety and the review of the safety and efficacy of medical products.  The Agency protects the American people, their pets, and their farm animals from poorly made, counterfeit, and illegal food, drugs, and cosmetics.

In addition to its public health role, the FDA and the industries it regulates have a significant, positive role in our nation’s economy and in stimulating economic growth and job creation. The industries that FDA regulates are generally net exporting industries, and are among the few industries in America that contribute towards a positive balance of trade.  Furthermore, the jobs created by these industries generally are high-paying jobs, particularly in the pharmaceutical and medical device areas.  You can learn more about FDA’s impact on the economy in a white paper titled, “The US Food and Drug Administration: A Cornerstone of America’s Economic Future.”

The amount of FDA’s federal funding does not fully reflect the agency’s importance. The amount of federal funding through appropriated dollars is roughly equivalent to the budget of the school superintendent of Montgomery County, Maryland, the county in which the FDA is headquartered.  The federal government gives the FDA about $8 per year for each American. 

Nowhere else in the federal budget does so little money need to go so far.

The demands on the agency are significant and growing.  The FDA regulates industries that have globalized manufacturing and supply chains, the scientific complexity of regulated products is increasing, and Congress continues to ask the FDA to do more.

In the face of these challenges, the Alliance for a Stronger FDA has worked to improve the appropriated budget of the agency.  The Alliance is comprised of almost 200 patient, industry, and consumer organizations. 

While industry, patients, and consumer groups have a variety of perspectives on how well the FDA is functioning, all stakeholders recognize that for FDA to make science-based decisions, it must have resources to keep up with the demands placed on the agency. 

Since the inception of the Alliance for a Stronger FDA almost seven years ago, we have successfully advocated for more funding to allow FDA to hire its first employees based in China and India, invest in regulatory science, advance medical countermeasures and work to improve the clinical trial process. 

However, groundbreaking initiatives like these are threatened unless sequestration is lifted and Congress stops adding responsibilities without adequate funding.  In the recent across-the-board Federal budget cuts from sequestration, the agency lost $209 million, of which $124 million came from appropriations and $85 million from industry user fees.

In response to these budget challenges, the Alliance is working to:

  • Make sure policymakers understand the importance of the agency –from both the  public health and economic perspectives.
  • Shine a light on the consequences of removing funding from the agency, including both appropriated dollars and industry user fees.
  • Explain the concern that user fees should not replace appropriated funding, but instead should augment appropriated funding.
  • Advocate for sufficient resources in the appropriations process.

The Alliance’s focus is to make sure that policymakers recognize the critical importance of the FDA to America’s patients and consumers as they face increasingly difficult decisions in course of the federal budget process.

For more information, please visit the Alliance’s website and follow us on Twitter (@StrengthenFDA).

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