The biologics industry may be eager to speak to FDA reviewers over the telephone, but agency guidelines make such contacts difficult for agency officials.

"It's just debilitating to have to wait for these 30-day ping-pong games with letters when it's obvious to most people that scientist-to-scientist they can get a response over the telephone to everyone's satisfaction and to no one's detriment and save a whole lot of time," Biotechnology Industry Organization CEO James Greenwood said in an interview.

"It's just debilitating to have to wait for these 30-day ping-pong games with letters," BIO CEO James Greenwood said.

"Our members have reported difficulty in having formal meetings with FDA," Andrew Emmett, BIO's director for science and regulatory affairs, said, noting the agency has felt resource constraints as it implements the new drug safety responsibilities it was given by Congress in 2007. "Those meetings aren't granted on a consistent basis so it's certainly something that we'd like to discuss in greater depth with FDA to identify and minimize those barriers."

Ensuring smoother reviews is one of industry's key goals as negotiations on the renewal of the user fee program get under way (Also see "PDUFA Negotiations Focus On Review Delays; Firms, FDA See Different Causes" - Pink Sheet, 6 September, 2010.).

BIO "would also like to engage FDA in a discussion around what types of discussions – scientific, technical discussions – are not appropriate for the formal meetings process and can be resolved in a more timely manner outside of the formal meetings process," Emmett said.

"When there's an instance of a simple clarifying question that may not rise to the level of a formal meeting, we would like to look at more efficient processes for resolving those types of clarifying questions outside of the formal meetings process, [perhaps] by giving reviewers the opportunity to pick up the phone and talk to the sponsor," Emmett added.

SOPPing Up The Review

The problem is that the Center for Biologics Evaluation and Research has standard operating policies and procedures in place which, while not prohibiting telephone contacts with industry, require its officials to verify the identity and authorization of the person they are speaking to and document the call in detail if it deals with anything substantive.

Moreover, the SOPP says, some topics, such as major deficiencies in an application, may not be discussed over the phone and have to be communicated in writing to the applicant. SOPP 8104 has been in place since 1994, with revisions in 2001 and 2007 in addition to the latest version, which took effect Aug. 3.

The Center for Drug Evaluation and Research, which calls its formal advice to employees MAPPs (Manual of Policies and Procedures) rather than SOPPs, does not have a document that addresses the types of issues raised in the CBER phone SOPP. MAPP 5020.1 (Responding to Telephone Inquiries in the Office of Generic Drugs) is similar, although it is more geared to encouraging rapid responses and does not contain the same documentation advice that CBER offers.

CBER's Caller ID Program

One possible reason for the CBER's emphasis on documentation lies in a section of the SOPP that urges caution when talking to strangers.

"In the past, unauthorized individuals representing themselves as members of a sponsor/applicant firm or as agents for the firm have attempted to obtain information from various centers within the FDA for their own advantage or personal financial gain," the SOPP says. "Additionally, some callers have made inquiries of CBER staff during ongoing inspections without full disclosure of their identity or purpose."

While not saying how often this has happened, the SOPP requires the CBER official answering the phone to tell the caller in cases of doubt "that a designated contact at the sponsor's/applicant's organization should initiate the call, or the CBER contact should attempt to return the call utilizing recognized contacts and phone numbers."

"A written authorization from the sponsor/applicant to the file designating a representative agent must be obtained prior to communication," the policy says.

Documentation Required

"All substantive teleconferences with non-FDA persons are to be documented in writing, signed, recorded in the appropriate CBER regulatory database and imported into the Electronic Document Room," the policy says. "Substantive teleconferences are those which add new information or change old information in a submission. These communications include discussions involving clarification or resolution of an issue or one that was the basis of a decision."

Examples include any discussion that changes the status of an application, for example by imposing or removing a clinical hold, and any discussion of protocols. "Examples of non-substantive teleconferences are confirmation of meeting time and location with no discussion of meeting topics [and] confirmation of receipt of submission/data with no discussion of contents of the submission/data," the policy says.

Additional procedures in the SOPP also seem likely to discourage extensive phone calls between CBER staff and industry. For example, whenever possible and especially when sensitive information is being discussed, more than one CBER staff person should take part, and if the sponsor mentions another product or calls back on the same day, the CBER staff people have to create separate documentation.

By Martin Berman-Gorvine

CBER Restricts Telephone Contacts With Firms As BIO Presses For Flexibility

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