The FDA Amendments Act of 2007 (FDAAA) extends the regulatory scope of the Food and Drug Administration (FDA) and increases the fees that the FDA collects from pharmaceutical companies for reviewing new drug applications. Under the legislation, the FDA can require companies to study the risks associated with drugs even after they have been approved for sale when new safety information may have emerged. The agency can then demand changes in product labeling, such as restrictions on use and distribution. The bill also authorizes the FDA to collect fees for reviews of direct-to-consumer advertisements and establishes punitive fines for ads that the agency determines are false or misleading. FDA oversight of pediatric pharmaceuticals and medical devices is strengthened and drug companies are encouraged to investigate pediatric applications of medical products. Finally, the FDAAA creates a registry of contaminated food and a searchable public database of clinical trial data, strengthens limitations on the conflicts of interest that are permitted in the advisory committees responsible for drug application approval, and establishes a non-profit institute to encourage investigation of improved methods of product safety evaluation.
The Middle-Class Position:
The Middle Class Supports. Middle-class Americans depend on over-the-counter and prescription drugs for everything from relieving aches and pains to sustaining life. Because these medications are so important, and because every drug has risks associated with it, the power this legislation provides the FDA to more closely regulate the pharmaceutical industry is vital. Middle-class Americans, inundated with advertisements extolling the benefits of innumerable and at times indistinguishable medications, need the FDA to ensure that the drugs they rely upon are safe and appropriate for the individuals to whom they are marketed.
For more than five years, 20 million Americans took the arthritis pain medication Vioxx before studies demonstrating an increased risk of heart attacks associated with the drug forced Merck to withdraw it. The new authority that this legislation grants the FDA to demand post-approval studies of medications is a regulatory tool that could have exposed the risks associated with Vioxx much sooner, saving many Americans from heart attack and death. Fines to punish false advertisements will do much to ensure that Americans are not misled about the purposes, risks, and benefits of the medications they are taking. Finally, the concealment and obfuscation of safety information that puts consumers at risk of taking dangerous drugs – a charge that Merck has faced in the products liability litigation involving Vioxx – will be made difficult by the FDAAA’s expansion of public access to safety data. A public database of clinical trial data with mandatory disclosure requirements will allow consumer advocacy groups, concerned academics, and products liability litigators, along with jealous industry competitors, to expose misinformation, ultimately protecting middle-class consumers.
From the Experts:
“This law signals a new era of openness and accountability when it comes to prescription drug safety…The Food and Drug Administration will begin to have the tools and resources to protect the public from unsafe medications. And the drug industry has been put on notice that it no longer can keep vital safety information from consumers…We can’t have a fair, just and safe marketplace if industry keeps vital safety information from the public…Making clinical drug trial results public is one of the biggest consumer victories in this legislation, because it will more clearly show the benefits, as well as the risks, of a drug…This legislation shows how Congress can and should be working, and the impact real people can have on reforming consumer protection laws.”- Jim Guest, President, Consumers Union (September, 27, 2007)
“The new law improves the FDA's ability to ensure drug safety by enhancing post-marketing surveillance, and by giving the FDA the authority to require necessary post-marketing safety studies. It calls for greater transparency in clinical research by requiring that all clinical trials be cataloged in a clinical trials registry, and that information about the results of these trials be made public…The new law continues to ensure patient access to medically indicated drugs, and it does not unduly limit the discretion and professional judgment of physicians to make determinations about the needs of their individual patients…” -Ronald M. Davis, President, the American Medical Association (October 4, 2007)
Beyond this Bill:
The FDAAA appropriately prioritizes the financial health of the FDA. However, the FDA’s reliance on fees paid by the very industry it regulates at least creates the appearance of impropriety and at worst influences regulators’ decision-making. Future legislation must finance this vital agency with appropriations from general revenues to ensure complete regulatory independence. Further, as the Institute of Medicine, chartered by the National Academy of Sciences, points out, the FDA should have specific authority to prohibit direct-to-consumer advertising for newly introduced medications and to set conditions for drug distribution based on safety concerns and potential benefits. Finally, FDAAA’s creation of an adulterated food registry falls far short of what is necessary to protect consumers from unsafe food. Congress should empower the FDA to order mandatory food recalls and provide the agency with more money to inspect food imports, two issues addressed in the Food and Drug Import Safety Act of 2007 that is currently in committee.
Number of letters sent by the FDA to pharmaceutical manufacturers warning them that they had violated regulations for prescription-drug advertising in 1997: 142
Percentage of the warning letters regarding direct-to-consumer advertisements between 1997 and 2006 that admonished drug companies for minimizing drug risk or exaggerating drug effectiveness: 84
Pounds of imported foods the average American eats in a year: 260
Percentage of food imports currently inspected by the FDA: 1
Estimated number of Americans who become sick each year due to food-borne illness: 76 million
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