Firms Applaud Guidance; Express Concerns About Part 11

January 4, 2006

Pharmaceutical firms have generally lauded the FDA’s efforts to advance electronic dissemination of data, according to recent industry comments posted to the agency’s “Draft Guidance for Industry on Using Electronic Means to Distribute Certain Product Information.”

But some commentators also expressed concerns the September 2005 guidance is vague regarding Part 11’s scope, and that there is a lack of adequate edata safeguards during recalls.

Drugmakers Abbott and Merck, for example, commented that fraudulent information can be spread much more quickly electronically, and current regulation does not adequately discourage it in the same way laws address fraudulent activity using traditional mail service.

“Abbott is concerned that such protections do not discourage the dissemination of fraudulent information electronically, such that nefarious parties could disseminate false information that could potentially harm the public,” wrote John Wolfinger, vice president of Abbott’s Quality Center of Excellence.

For example, a person could type “URGENT RECALL” in a subject line and collect recipients’ information or provide false information, Wolfinger said. He called on the FDA to encourage firms to build in safeguards to assure customers can verify the legitimacy of the firm’s own electronic communication. Abbott also called for the FDA to address this issue in the final guidance.

In its comment, Merck noted that “one of the highest risks associated with electronic deliver is…‘spoofing’…[which] includes illegitimately claiming to be an entity or authority, e.g. illegitimately claiming to be the originator of a medical product-related action.” These fake recall notices can be tough to trace and stop, noted Brian Mayhew, with Merck’s U.S. Regulatory Policy division.

Merck called on the agency to take appropriate steps to provide a validated secure ecommunication process for product recall communications. One of its suggestions was for the agency to leverage its website that allows healthcare professionals and providers to register for and receive recall communications via an elist. “By using this website, the originator of a product recall message is validated by the FDA prior to posting, which minimizes the risk of falsification of the originator,” Merck said in its comment letter.

Part 11 Concerns Raised

Wyeth devoted the bulk of its comments to issues regarding the scope of Part 11. “This draft document lists in detail FDA’s current thinking on electronic communication but, unfortunately, is somewhat vague regarding applicability of the Part 11 electronic record requirements,” wrote Roy Baranello, Wyeth’s assistant vice president of regulatory policy and operations.

Asking the FDA to provide more guidance in this area, Wyeth suggested that the agency limit Part 11 applicability to only those specific circumstances “where records are explicitly required by predicate rules and those circumstances should be clearly identified in the guidance.”

In its letter, Pfizer asked the agency to consider including metrics and a pilot period to assess the effectiveness of ecommunications, and do so under actual usage conditions.

A copy of the FDA guidance is at http://www.fda.gov/ohrms/dockets/98fr/05-19731.pdf.

Abbott’s letter is at http://www.fda.gov/ohrms/dockets/dockets/05d0385/05d-0385-c000001-01-vol1.pdf.

Wyeth’s letter is at http://www.fda.gov/ohrms/dockets/dockets/05d0385/05d-0385-c000003-01-vol1.pdf.

Pfizer’s letter is at http://www.fda.gov/ohrms/dockets/dockets/05d0385/05d-0385_emc0002-02.pdf.

Merck’s letter is at http://www.fda.gov/ohrms/dockets/dockets/05d0385/05d-0385_emc0001-02.pdf.