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Renewed Legislation Improves Safety of FDA-Regulated Products
Frequently Asked Questions

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The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the Food and Drug Administration authority to regulate food, drugs, and medical devices, among other products. New provisions are added from time to time—or existing ones enhanced or expanded—to enable the agency to better do its job.

Sometimes existing provisions of the law are scheduled to expire on certain dates and must be reauthorized by Congress. One such provision is the agency's user fee program—fees paid to FDA by companies submitting new product applications. New provisions are known as amendments to the FD&C Act.

On Sept. 27, 2007, the President signed into law the most recent amendments and reauthorized some existing provisions in what is called the Food and Drug Administration Amendments Act (FDAAA) of 2007. The information below answers some of the more common questions concerning what this critical measure means both to FDA and to the public.

1. What is FDAAA?

FDAAA is the name for legislation that adds many new provisions to the FD&C Act. Certain existing laws were set to expire on September 30, 2007. Various changes to those laws were made, and new amendments added, to provide important resources and strength to the agency's ability and commitment to safeguard and advance public health.

2. What are some of the new provisions enacted under FDAAA and what do they mean?

Four of the provisions (or "Titles") included in FDAAA reauthorize existing laws:

Prescription Drug User Fee Act (PDUFA) - allows FDA to collect fees from drug companies to help fund reviews of new drugs. The act enables shorter review times and a more predictable review process, while still maintaining high-quality reviews.
Medical Device User Fee and Modernization Act (MDUFMA) - allows for user fees, and will allow FDA to make significant improvements in the medical device review program.
Best Pharmaceuticals for Children Act (BPCA) - encourages more studies in children and promotes the development of treatments for children.
Pediatric Research Equity Act (PREA) – continues FDA's authority to require studies in children concerning certain medical products and under other specific circumstances.

Among other things, the law also provides for:

additional encouragement of specialized pediatric medical device development
the creation of a foundation (Reagan-Udall) to modernize product development, accelerate innovation, and enhance product safety
food safety provisions
advisory committee provisions
clinical trial registries
provisions intended to enhance drug safety

The amendments also authorize a new program for the collection of user fees to support FDA review of television advertisements directed at consumers.

3. How will FDAAA affect consumers?

Among other things, the passage of this legislation reauthorizes user fees for the agency's drug and device programs, which is a critical part of FDA's operating budget. With these user fees, FDA will improve its review of drugs and devices coming into the marketplace. The agency also will be able to better monitor those drugs and devices after they are on the market.

FDAAA also contains important provisions that will affect the nation's children. The reauthorized provisions on studies of children will help ensure that drugs prescribed for children are safe for them. In addition, they will further encourage the development of important new safety, effectiveness, and dosing information for drugs used in children.

4. Where can I get more information on FDAAA?

FDA has dedicated a Web site, http://www.fda.gov/oc/initiatives/advance/fdaaa.html to answer further questions about the renewed legislation intended to improve the safety of FDA-regulated products.

Date Posted: September 27, 2007