CFSAN Adverse Event Strategy: Will Notifying Industry Create A 2-Way Road?

CFSAN will begin sending letters to companies notifying them when an adverse event report involving one of their products has been received on or after Sept. 16.

Each letter will contain any information about the AER not deemed confidential by the agency. The initiative is part of the Center for Food Safety & Applied Nutrition's larger effort to launch a comprehensive CFSAN Adverse Events Reporting System (CAERS) (¹ (Also see "FDA Dietary Supplement Claims Oversight Will Be “More Aggressive” – Troy" - Pink Sheet, 22 Apr, 2002.), p. 17).

The primary goal of each letter will be "informational," CFSAN Office of Scientific Analysis & Support Director Ken Falci said during an Aug. 29 conference call.

"We believe that the company should be aware that the FDA has received this type of report," Falci said. "It's a way for us to be up front with the industry as far as adverse reports that we have received."

The letters also could lead supplement firms to submit more of the AER data they collect. Falci noted each letter "encourages the company to share with the FDA any information that it might have that it's willing to voluntarily share with the agency about a particular adverse event."

A sample letter provided by the agency adds that FDA "may receive additional information about this adverse event in the future...You can receive copies of the publicly available information...by filing a Freedom of Information Act request."

The initiative will likely be received positively; the supplement industry has frequently voiced its displeasure over the lack of transparency and timeliness regarding CFSAN's collection of AERs.

Falci admitted the center's current AER system has not been user-friendly and noted the new system will be significantly better. To allow CFSAN to focus its resources on getting CAERS up and running, the Web site for CFSAN's current Special Nutritionals Adverse Event Monitoring System was taken down Aug. 29.

Under SN/AEMS, people did not get "a clear and accurate record [of] information from that site because unfortunately, we haven't had the resources to update the site," Falci said.

FDA plans to "create a new user-friendly Web site for all adverse events" under CAERS, he noted, adding the site probably will not be available until at least 2004.

CFSAN has yet to determine what information will be disclosed on the CAERS site. The center is looking to avoid the confusion that was caused by the SN/AEMS Web site due to the limited information it provided.

The new system will be easier for CFSAN staffers to use as well, Falci stated. He noted FDA field personnel will be able to download adverse event information onto CAERS on a daily basis using linked computer systems.

"What we'll have in CAERS is a direct down-link from the field computers into the CAERS computers, so we'll know at the end of the day what information they're putting down as far as an adverse report is concerned," he said.

Information on CAERS will also be more accessible to CFSAN's safety reviewers, who analyze and assess the AERs for levels of risk.

According to Falci, CAERS will "get very real-time information and get that information to the safety reviewers here in CFSAN." Previously, the AERs were hand-delivered to the safety reviewers.

Another advantage of CAERS will be its ability to conduct trend analysis. "I think that it's important to try to develop systems that will take a look at the database and see if there's anything unusual that should be brought to safety reviewers' attention," Falci said.

The system is currently in the pilot-testing stage. Falci pointed out "there's a lot of basic background user-acceptance testing that has to be done on a system of this size."

The process is focused on "software design and requirements that we need to have in the system in order to process, and process quickly, an adverse report." Falci noted software code is being written and tested "to make sure that a link actually goes to where it says it's supposed to go for the safety reviewers."

"The system is big enough to be able to pilot certain sections of it at a time [to] get user acceptance and then move on to other sections of it for testing, and that's what's going on currently and probably will be going on until May," he said.

Other areas being addressed include migrating data from the old AER systems into CAERS and improving the system's search capabilities.

"Searching capabilities and artificial intelligence are being built into the system, so that we should be able to answer many, many different kinds of questions, not only from the press, but also from Congress and anyone else who has a question about adverse reports that come in from FDA" Falci said.

The system was designed by Booz Allen Hamilton (McLean, Va.). CAERS currently has 15 FDAers assigned to it, along with 35 contractors.

CFSAN expects to have the system fully operational by May 2003. CAERS will replace the center's three existing AER systems for food and color additives, cosmetics and dietary supplements. The old systems probably will continue to operate for a little while after CAERS launches to ensure it is functioning properly.

CFSAN estimated it receives about 7,000 AERs annually. After years without funding to upgrade its AER systems, the center received $1.5 mil. from Congress in FY 2001, $2.5 mil. in FY 2002 and an additional $1 mil. from bioterrorism measures.

Every AER CFSAN receives is sent in voluntarily; as a result, estimates often vary regarding the actual number of adverse events caused by certain products.

Falci said CFSAN hopes to get a better sense of what is occurring in the market by improving its data sharing with the American Association of Poison Control Centers. The HHS Office of Inspector General suggested CFSAN contract with AAPCC to obtain their supplement AERs in a report issued last year (² (Also see "CFSAN/Poison Control Center Supplement AER Contract Recommended By OIG" - Pink Sheet, 23 Apr, 2001.), p. 4).

Coordinating their collection systems could prove difficult. Falci noted "the information that comes into poison control centers isn't exactly in the format as an adverse event report." While CFSAN has "an AE questionnaire," AAPCC data frequently do not list individuals who could be contacted for further information, he stated.

"The best thing that could be done...is to try and talk to the poison control center[s] about how they collect data and that would involve a series of meetings that would establish a change in their procedures, which...would take a considerable amount of time," Falci said.

However, CFSAN has "scheduled talks with the people at poison control...to try to figure out how that might be done better," he added.