When UCS started looking at the use of science at the FDA several years ago, I sat down and read The Jungle, which has been credited with prompting President Theodore Roosevelt to establish the first iteration of the Food and Drug Administration more than a century ago. The grisly descriptions of the Chicago meat-packing industry still conjure up vivid images in my mind.
We’ve made great strides over the past century in protecting the public from unsafe food products. But it’s an entirely different part of the FDA’s wheelhouse that will be taking center stage over the next two months: the regulation of prescription drugs and medical devices.
The FDA: A Big Job
While the FDA is no longer responsible for the safety of meat products or poultry—that now falls under the purview of the USDA—the agency’s responsibilities have grown to encompass the oversight of more than $2 trillion in food, drugs, medical products and other consumer goods, from cosmetics to veterinary supplies. The FDA’s mission is to advance public health and “protect the public health by ensuring the safety, efficacy and security” of products that account for 25 cents of every dollar spent by consumers, according to the agency.
Photo: Flickr user hitthatswitch
Drugs and medical devices can improve your health if they work, or seriously injure you if unsafe. In recent years, FDA scientists raised concerns about the whether the painkiller Vioxx, the antibiotic Ketek, and the knee implant Menaflex met the threshold of safety and effectiveness, yet the products were approved, with disastrous consequences.
Evaluating Drugs and Medical Devices
This year, two laws governing the FDA are up for Congressional reauthorization: the “Prescription Drug User Fee Act” (PDUFA) and the “Medical Device User Fee Act “(MDUFA). Both the names and the acronyms are a mouthful and may sound more like Grecian deities than anything else.
But the laws are critical: they ensure that the FDA can continue to collect fees from the drug and device industries, giving the agency much needed funds for drug and device reviews and monitoring. The First PDUFA, which passed in 1992, authorized FDA to collect “user fees” from pharmaceutical companies to review the safety and efficacy of drugs and medical devices more quickly.
Competing Interests
The FDA’s position at the intersection between the public and pharmaceutical companies has created unique challenges for the agency. There are four variables: safety, efficacy, speed of approvals, and cost.
The formula for achieving all four of these goals isn’t simple. Various interests prioritize these variables in vastly different ways. The competing interests create an interesting tension as the FDA attempts to do what is best for public health.
What’s Next
Congress is under heavy pressure from drug and device companies to change PDUFA and MDUFA in ways that would increase their influence over how FDA operates. Public interest advocates are pushing for more transparency and independence for FDA scientists, and more emphasis on drug safety and effectiveness.
But one thing is clear: Congress must act by this summer. If Congress fails to reauthorize the legislation within the next few months, FDA scientists will get pink slips and the approval and monitoring processes will come to a screeching halt.
Over the next several weeks, we will explore in detail how the FDA approves drugs and medical devices, and examine various influences on the system. Because there is a lot at stake—both lives and profits—both PDUFA and MDUFA should and will receive a good deal of scrutiny. Our goal is to help you understand what’s going on and advocate for reforms that will allow FDA to do its job free from inappropriate commercial interference.
Corporate Pressure Persists
UCS recently released a survey of scientists at FDA showing that political and corporate pressure on the agency persists.
We already see that industry lobbyists are making headway. Several legislative proposals now pending before lawmakers would relax conflict of interest standards and make science at the agency significantly more vulnerable to special-interest pressures. One legislative proposal would actually change the FDA’s mission to include job creation, diluting its core obligation to protect American families from unsafe drugs, food, and medical devices.
A recent UCS survey found that despite improvements in scientific integrity at the FDA, agency scientists still experience significant political and corporate pressure. The FDA’s mission is to protect public safety, not increase corporate profits at the public’s expense.
When asked about The Jungle, its author Upton Sinclair said, “I aimed at the public’s heart, and by accident I hit it in the stomach.” While the FDA has come a long way since its inception in 1906, a more complex world has presented the agency with new challenges. The agency needs protection and strengthening to deflect blows to its stomach. That will require pressure on Congress from all of us.