Update October 3, 2007
Requirements for Contract Manufacturers and Contract Sterilizers –
Registration and Listing and the new User Fees
December 3, 2007
FDA Update - FDAAA 2007
On September 27, 2007, President Bush signed the Food and Drug
Administration Amendment Act of 2007 or FDAAA. The act contained
numerous issues that relates to
- The expansion of the Clinical Trials Databases
- The pre-review of television advertisements
- Incentives for development of drugs and medical devices for
- Pediatric use
- Treatment of tropical diseases
- Orphan antibiotics
- Guidance for antibiotics
- Drug User Fees
- Pediatric Research
- Clinical Trial Databank
- Post-marketing Safety
It is considered the most significant revision to the Federal Food, Drug
and Cosmetic Act (FDCA) in decades.
Drug User Fees
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.
New restrictions can be imposed on advertising.
The Agency may require companies to submit DTC television advertisements
not later than 45 days prior to dissemination. The "major statement" of
safety information in television and radio advertisements must be
presented in a "clear, conspicuous, and neutral manner," and FDA must
issue regulations defining this standard. Finally, the FDAAA
authorizes--for the first time--hefty civil money penalties (CMPs) for
DTC advertisements (including print ads) that are "false or misleading."
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 and devices.
New enforcement tools include substantial civil money penalties (CMP).
In addition to the new penalties available for violative DTC
advertisements, the FDAAA authorizes CMPs for violations of the new REMS
provisions, post-market study requirements, and for labeling violations.
Source: “What you should know about FDAAA 2007!” December 1, 2007 in
Health, investments by KHOI; “The Food and Drug Administration
Amendments Act of 2007:” by Scott M. Lassman
For further detailed information on FDAAA 2007 please visit FDA website:
http://www.fda.gov/oc/initiatives/advance/fdaaa.html
or contact mdi at
info@mdiconsultants.com
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