10 Things You Need to Know About the FDA

April 11, 2014

by Shawn Sullivan, Associate, Executive Administrator & Policy Analyst

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Chances are, by the time you’re into the first hour of your morning, you will have touched an average of 10 products that are regulated by the U.S. Food and Drug Administration. Coffee, bagels, toothpaste, soaps, makeup and daily medications are just a sampling of the products that the FDA is responsible for.

It is one of the oldest agencies of the federal government and can trace its roots back to before the American Civil War. Its modern role in American life started when President Teddy Roosevelt championed the Pure Food and Drug Act at the infancy of the 20th century. You might remember this, because you probably read Upton Sinclair’s famous novel The Jungle in high school and strongly considered becoming a vegetarian (I know I did).  Still, over one hundred years later, the FDA remains an essential agency – protecting and promoting your health.

Here are 10 things you need to know about the FDA:

1)   The FDA oversees a huge portion of our economy

Nearly 25 cents out of every consumer dollar spent in the U.S. is spent on a product that is regulated by the FDA.  That accounts for over $1 trillion of consumer spending per year.  There are very few organizations – either public or private – that are more engrained in our daily lives than the FDA.

2)   And, it’s not just food and drugs

Along with most of our food supply and all prescription and non-prescription drugs, the FDA regulates medical devices, cosmetics, vaccines and blood products, infant formula, microwaves and x-ray equipment, dietary supplements, pet food/animal feed and veterinary products, and tobacco products.

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3)   It drives the economy

In addition to its public health role, the agency and the industries it regulates have a significant, positive role in our nation’s economy and in stimulating economic growth and job creation. Consider that the biomedical sector employs over 1.3 million people and another 5.8 million in related industry sectors. Safe and effective medical products create jobs and save and improve lives. For this industry to thrive, it needs an FDA that can continue to help drive innovation.

4)   The FDA does more with less money than any other government agency….or just about anyone period

The FDA currently costs American taxpayers roughly 2 cents per day.  For the amount you can find in the “give a penny take a penny” tray at a convenience store, Americans enjoy an extraordinary number of public health benefits including life-saving and life improving medicines approved as fast or faster than anywhere in the world, unrivaled confidence in the medical products they rely on daily, and a food supply that is among the safest in the world. 

We must invest in strengthening our FDA. To put the FDA budget into context:

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5)   We all want the FDA to do more

Since 2007, the responsibilities of the FDA have kept increasing because Congress has passed numerous laws that have led to an increase its scope without providing the agency adequate resources. These new mandates push the FDA to be responsible for the quality of generic drugs, addressing drug shortages, drug tracking and tracing, food safety modernization, and medical product quality and safety. Each one of these laws requires new scientific knowledge, new talent acquisition, and new training. But without the resources necessary to fill these gaps, the additional responsibility in one area requires a subtraction somewhere else, stretching already thin resources even further.  

6)   The FDA is creating innovative new ways to get treatments to patients faster

FasterCures is excited by the FDA’s continued efforts to accelerate drug development by implementing innovative mechanisms to potentially life-saving products. The FDA’s new “Breakthrough Therapy,” designation passed as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) - which allows for the expedited approval of a drug that treats a serious condition when there is evidence that the drug may provide patients with a substantial improvement in their condition when compared to available therapies  - The Breakthrough Therapy designation has already proven to be very popular, and the FDA has received ten times as many applications for the designation as it originally expected, further highlighting the need for more resources to process these time-intensive and scientifically complex applications. 

7)   Patients perspectives will now be part of the regulatory process

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Another feature of FDASIA is a more structured and formal framework for assessing the benefits and risks of products under review, and a Patient-Focused Drug Development Initiative (PFDDI) that provides patients a conduit for communicating to regulators on the particulars of their conditions and current treatment options. Simply, when a regulator is deciding whether the benefits of a particular treatment outweigh the risks, shouldn’t the patient who will ultimately have to consume the treatment have a huge say in that decision? For more information, FasterCures recently held a webinar on Benefit-Risk and Patient Preference, and our director of Strategic Initiatives, Kimberly McCleary offers a deeper dive on this topic as well.

 8)   At FDA, your tax dollars go to human capital

More than 80% of the FDA’s budget goes directly to staff costs. It is not used on outside grants or private contracting. When the FDA is provided with adequate financial resources, it uses that money to hire more regulators and inspectors. This allows them to do their job faster, which leads to the certainty and confidence that industry is looking for.  Conversely, when resources are cut, FDA staff is cut. This leads to food being less safe, putting everyone who eats – AKA everyone - at risk, and drug and device reviews being slower, conflicting with the expectations of companies and costing patients time they cannot afford to waste.  

9)   The FDA is a global agency, with global responsibilities

As the world economic supply chain has become more globalized and interconnected, the FDA has been forced to adjust to that new reality.  Because of this, the FDA has established a permanent, physical, in-country presence in China, India, Europe, Latin America, and Sub-Saharan Africa.  The reasons for this are clear when you look at the trends. Drug imports are growing at about 13% per year and in 2012, 80% of the manufacturers of active drug ingredients were located outside the U.S., and more than half of medical devices were imported. The U.S food chain is also facing similar pressures from the growth of imported food. For example, almost 80% of the seafood consumed in the U.S is imported.

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10)   The FDA works closely with other agencies and industries

It is mission-critical for the FDA to collaborate with other agencies.

The NIH and FDA have formed a Joint – Leadership Council, whose charter states that “The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) share a common goal of advancing public health by promoting the translation of basic and clinical research findings into medical products and therapies. The agencies are complementary in their roles and functions—NIH supports and conducts biomedical and behavioral research and FDA ensures the safety and effectiveness of medical and other products…” The FDA is also a partner in the NIH’s new Accelerated Medicines Partnership (AMP), an exciting new venture between the NIH and other government agencies, 10 biopharmaceutical companies and several non-profit organizations to transform the current model for developing new diagnostics and treatments.

The FDA is collaborating with the Centers for Disease Control on numerous public health issues tied to possible biological, chemical or radiological contamination of food. The FDA is also working on improving collaborative efforts with the Center for Medicare and Medicaid Services (CMS) to help make sure that FDA approved treatments can actually be paid for and delivered to patients.  Notably, the pharmaceutical industry consistently notes that their relationship with the FDA is a constructive partnership which makes their industry stronger and that a robust, well-funded FDA is a key element to the industry, not a hindrance.

FasterCures has made it a policy priority to advocate for appropriate resources at the FDA because it is a critical component to bringing safe and effective medical solutions to patients. Spotlighting the FDA’s critical role -  whether testifying before Congress or during panels held at our annual Partnering for Cures conference - is an important part of this advocacy.  We are a founding member of the Alliance for a Stronger FDA, a coalition made up of the vast array of industries and interests that interact with the FDA.  We will continue to be champions for a stronger, well-funded Food and Drug Administration because the agency is a crucial factor in getting safe, effective treatments to patients faster. Our mantra at FasterCures is Time = Lives, and we can’t expedite the drug development process if our FDA does not have the human or financial capital to be able to do its job.

Photo Sources: Alliance for a Stronger FDA, FDA.gov

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