On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 or FDAAA. Along with continuing FDA user fees, the act contained numerous other issues and is considered the most significant revision to the Federal Food, Drug and Cosmetic Act (FDCA) in decades. We’ll cover the overview of it here.

  • Drug User Fees
  • Pediatric Research
  • Clinical Trial Databank
  • Post-marketing Safety

Drug User Fees

Currently the FDA charges companies to submit their application for New Drug Application (NDA), this was to expire September 30 of this year. This expiration prompted the quick passage of FDAAA – Title I, the Prescription Drug User Fee Amendment (PDUFA). This amendment authorizes the FDA to continue to collect these fees until 2012, increasing total fees by $90 million a year to $393 million annually. Additionally, it allows the FDA to collect an additional $225 million to enhance drug safety. One of these fees will come from direct-to-consumer television advertisements. The fee is for reviewing such ads.

Pediatric Research

Title IV – Pediatric Research Equity Act (PREA). This act requires manufacturers of new ingredients, indications, dosage forms, regimens and route of administrations to submit a pediatric assessment. Manufacturers may request a waiver if pediatric formulations are not possible. PREA is active through 2012.

Clinical Trial Databank

Title V – Requires that all drug/device/biologics clinical trials (except Phase I) be registered in an FDA controlled database. This is significant to what was previously required of “serious or life-threatening” diseases. The information from the database will include demographics, primary and secondary outcomes. The intent of this section is to enhance patient access to and understanding of clinical trial results. A penalty of $10,000 per day will be accessed for those companies who do not follow these guidelines.

Post-marketing Safety

Title IX – strengthens the FDA’s powers of asking companies for post-marketing studies on their drugs. One of the biggest problems that I have with the previous FDA system is the lack of post-marketing data from drugs. In the current structure, the FDA uses primarily Phase 3 clinical trials (large pre-marketing clinical trials conducted on thousands of participants) to decide passage of a New Drug Application (NDA) and rarely asked for Phase 4 clinical trials (post-marketing) data.

While at the FDA, I brought up the issue of Phase 4 trials on numerous occasions but quickly became aware that changes could only be done from the top (Congress). Title IX still does not go far enough in regards to post-marketing data. In my perspective all manufacturers need to conduct Phase 4 trials. While Phase 3 trials are large (thousands), Phase 4 trials can contain millions of participants and a much broader patient demographic.

With the recent string of debacles at the FDA, the public does not understand that the FDA is drastically under-funded to look after the prescription drug/device/biologic market. I am really glad that FDAAA allows the bureau to obtain more money and consequently more man power to regulate this system.