Muted Enthusiasm Greets FDA's Electronic Labeling Guidance
The FDA’s new guidance offering questions and answers on the structured product labeling (SPL) standard for labeling provides general help but lacks specifics such as templates to better assist regulated firms working to implement the new standard, experts tell PIR.
“I think it’s a fairly high level set of Q&A,” said Laura Ramos, vice president at Forrester Research. “It focuses on the basic ‘what,’ not on the ‘how,’” she told PIR Dec. 12. The guidance lacks specific examples of how different types of labels can and should be submitted, she noted.
Templates Would Help
Acknowledging that the guidance is just a Q&A and not designed to be a broader document, Ofni President Ty Mew said he and other experts who recently gathered in his Raleigh, N.C., region were disappointed that it didn’t include templates and clear examples of SPL documents. “Very few people actually know how to do this, and specific templates would really help,” he told PIR Dec. 17.
Ramos agreed. “This is the main complaint that I have heard so far — that the companies and the FDA must learn together how to implement SPL for electronic submission and that the FDA — due to legal constraints — can’t dictate how the company creates the document … [the agency] can only offer guidance,” she said.
The guidance, released Dec. 11, is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) using SPL in extensible markup language (XML). The guidance is also designed to provide information to CDER staff who review and manage that product information using the Electronic Labeling Information Processing System (ELIPS) at the electronic Common Technical Document (eCTD). The agency said it anticipates issuing additional guidances as new questions arise about the use of SLP and/or ELIPS.
Mew and his colleagues hope future guidances will include templates and programs to test SPL as part of the eCTD submissions program, he said. Officials with the Clinical Data Interchange Standards Consortium told Mew’s PEERS industry consultant and life sciences professionals group in October that they were working on such test programs.
The Dec. 11 guidance contains 45 Q&As, including:
Should the sponsor submit SPL to FDA before labeling discussions are complete? Yes. SPL should be included with the initial submission. Before an approval action, FDA may ask a sponsor to submit SPL updated to include the changes that occurred as a result of labeling discussions with the Agency.
Should companies resubmit labels submitted before October 31, 2005, in SPL that are currently under review? No, but sponsors should work with the individual review division or divisions to ensure that SPL is available for new products within a reasonable time frame.
What software do I use to create SPL? An SPL document can be created using a variety of possible tools, ranging from a general-purpose word processor or XML editor to an SPL-specific editing tool. The type of tool suitable for a specific organization will vary depending upon a wide variety of business and technical factors. Whatever tool is used, the final SPL document will be independent of the tool used for creation; all tools should be valid against the SPL schema and should conform to FDA guidance documents.
The questions and responses are generally straightforward, experts told PIR. But a few of them raised eyebrows. For example, several experts said they were surprised by Question 13, in which the FDA said the content of labeling that had been in PDF, but now must be in SPL, is in “addition to the 12 copies of paper labeling.”
“If they are pushing esubmissions, what’s with the dozen paper copies?” said one consultant, who asked not to be identified. Others have speculated that the agency is trying to help make the transition from paper to electronic smoother — especially for relatively reluctant “old guard” types at the agency — by giving them a “hybrid” option that emphasized electronic but allows for paper.
“That’s an approach we take with many clients,” another consultant told PIR. “You give people the paper option to make it all go down more smoothly … even if they never actually use the paper it helps them to be less nervous about the transition.”
FDA officials have acknowledged some reluctance in industry and within the walls of the FDA regarding esubmissions. Acting CIO Fred Farmer recently told an industry gathering that companies should help push the agency to adopt standards to advance esubmission.
To view the guidance, go to http://www.fda.gov/cder/guidance/7074fnl.pdf. — Michael Causey