The US Food and Drug Administration (FDA) is, first and foremost, a regulatory agency charged with overseeing the safety, efficacy and quality of healthcare and other consumer products. But it is also an agency that frequently finds itself at the nexus of political battles, such as this week when its appropriations were put to a vote in the US House of Representatives, leading to a bizarre political debate.
The US government has been "shut down" since 1 October 2013 after the US House and Senate were unable to come to terms over a budget. Democrats have generally favored a "clean" budget resolution, while Republicans have pressed for a resolution that includes a one-year delay of the Patient Protection and Affordable Care Act's (PPACA) insurance provisions, among other demands.
As a result, FDA has been forced to furlough (that is, suspend without pay) 45% of its staff, leaving the remaining staff to either work under left-over industry-provided user fee funding from the previous fiscal year (known as "carryover" funds) or without pay.
Some divisions have been hit harder than others. The Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), for example, obtain much of their funding from user fees, and have thus been at least temporarily shielded from some of the cuts. Conversely, FDA's Center for Food Safety and Applied Nutrition (CFSAN), which regulates foods, supplements and cosmetics-and receives comparatively little user fee funding-has been almost entirely shut down.
The situation with respect to food safety has been especially concerning to some legislators, and Republicans last week proposed authorizing funding for some agencies on a piecemeal basis, including FDA.
Traditional Legislative Dynamic
The agency, though it enjoys general support throughout the Congress, has traditionally been viewed by two lenses within the legislative community. To Democrats, the agency is a well-intentioned and historically under-funded regulator whose actions are critical to the American people, but often doesn't go far enough when it comes to ensuring patient safety through regulation. Republicans, meanwhile, generally agree that the agency is critical, but have often lambasted the agency for fostering an unfriendly environment for businesses to operate in, the time it takes to approve drugs, and for being too risk-averse in its decision making.
But to hear legislators on the House floor this week debating the terms of the Food and Drug Safety Act (H.J. Res 77), you would think legislators had temporarily switched parties. That's because in recent months, Republicans in the House have been relatively hostile (compared to their Democratic counterparts, at least) to FDA, lambasting its handling of the pharmaceutical compounding crisis, approval times for medical devices, its approach to mobile medical device regulation, its removal of over-the-counter inhalers from the market, and drug shortages, to name but a few.
The Republican Viewpoints: FDA's Great!
But on 7 October, Republican legislators had little aside from warm words for the agency. A selection of some of those remarks is as follows:
- "As I noted in my opening remarks a few minutes ago, I would speculate that many of our colleagues don't realize how the FDA impacts every single one of our constituents in one way or the other. From formula fed to babies, to blood transfusions needed during emergencies and routine surgeries, to drugs that extend the lives of the sick, to the domestic or imported foods we feed to our families, on every occasion, the FDA is there." - Rep. Robert Aderholt (R-AL)
- "We have the most dynamic and productive medical research firms in the world. American companies and universities are paving the way to incredible new cures. In fact, three American scientists were just honored with this year's Nobel Prize in medicine for their research into how our cells function. Americans can continue leading the world in this field, but we have to make sure that the FDA conducts reviews promptly. Let's get the FDA back open and performing their important work. Patients, young and old, are counting on it." - Rep Joe Pitts (R-PA)
- "One of the most important missions of the government, one of the premier agencies of the Federal Government is the Food and Drug Administration. Its job is to ensure that medical drugs and medical devices are safe and effective. The FDA is also a gateway for patients who are suffering disease and disability with the hope of one day getting past that disease and disability. The FDA is the gateway for those patients. We've taken legislative steps to fix some of the issues with the FDA. They aren't always functioning in a perfect manner, but I know one thing for sure: keeping FDA employees away from their jobs is not the way to accomplish those goals." - Rep. Michael Burgess (R-TX)
- "From food inspections to approvals of breakthrough new drugs and devices, members on both sides of the aisle indeed understand and appreciate the important role of the FDA. This essential work should continue as we wait at the negotiating table for the President to join in a conversation to resolve our differences." - Rep. Fred Upton (R-MI)
- "This bill makes sure that, even during this shutdown, the Food and Drug Administration's critical safeguards remain in place to protect our food and drug supply. The health of our people should not be jeopardized. This legislation provides funding for the FDA at the current post-sequestration annual rate of $2.3 billion. This will provide funding to maintain protections for food, drugs, and medical devices, and allow the FDA to collect and spend user fees." - Rep. Hal Rogers (R-KY)
- "I think everyone here in the House agrees that funding for the FDA is necessary to this critical operation in order to support our Nation's public health and the millions of jobs associated with FDA activities. Most Members of this body may not realize it, but FDA-regulated industries account for almost 25 percent of the consumer spending in the United States of America." - Rep. Rob Aderholt (R-AL)
Democratic Viewpoint: No Funding through this Mechanism
Democrats, meanwhile, saw themselves on the opposite side of the bill, arguing against funding for the agency--at the levels set by the legislation, anyways--saying the Congress should not consider bills piecemeal but should instead look to take up a bill to fund all agencies. Again, some selections:
- "For years, we've been trying to get the Republican majority to be serious about the FDA and food safety funding. Food illnesses account for 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year, and particularly affect children, pregnant women, and older adults. … This bill does not protect our families from contaminated food. It doesn't adequately fund the FDA. It's another in a series of purely political bills put forward by the Republican majority." - Rep. Rosa DeLauro (D-CT)
- "Now, I support the FDA. Who doesn't support the FDA? It's very important that they do their job. But you know what's also important? What's also important is the Centers for Disease Control and Prevention, which responds to disease outbreaks and works to prevent the spread of seasonal flu. They're not going to be reopened. There's no funding for the Substance Abuse and Mental Health Services Administration, which limits its ability to improve mental health across the country. … And you should understand something else, Mr. Speaker, they're not giving FDA the full funding. What they're doing is still continuing the draconian sequestration cut which took over $200 million out of FDA's budget. If they love FDA so much, fund it where it should be funded, not with $200 million less." - Rep. Henry Waxman (D-CA)
- "My colleague and chair, Mr. Aderholt, just said that this bill is necessary because funding for the FDA is necessary. He's absolutely right, but this bill doesn't do all that. You cannot just fund one component of government and not have the rest of government. FDA is the Food and Drug Administration. It relies heavily on the Centers for Disease Control. You do nothing to fund the Centers for Disease Control. So as just one critical component of the Federal Government, it isn't the Federal Government, and that's what has been shut down, and so I adamantly oppose this legislation." - Rep. Sam Farr (D-CA)
The bill ultimately passed the House in a fiercely divided vote (235-162), but stands little chance of passage in the Democrat-controlled Senate.
But for FDA, the entire vote offers an illuminating view into the viewpoint of their sometimes-adversaries in the legislature, offering some choice soundbites that might be worth filing away for a rainy-or scandal-ridden-day in the future when those same legislators aren't feeling quite so charitable with their praise.