Medical Device Link.

Originally Published PMPN June 2004

NEWS

FDA’s “DailyMed” program and PhRMA’s paperless labeling initiative should provide drug manufacturers enough incentive to move labeling to an electronic format. But a lot of logistical hurdles remain in the meantime, according to a labeling expert.

The FDA program would allow consumers to access labeling via the World Wide Web. The PhRMA program would allow pharmacists to receive electronically a current version of all drug labeling each day. One would think that there would be a way for firms to coordinate both efforts efficiently, said Steven W. Bass, PhD, director of global labeling and promotion compliance for Bristol-Myers Squibb (New York City).

But that probably won’t happen, he told the audience at a recent meeting of the New York/New Jersey chapter of the Regulatory Affairs Professionals Society (Baltimore).

Part of the problem, he said, is that FDA wants to implement the “DailyMed” idea quickly but some technical issues have yet to be sorted out.

The agency established the DailyMed program in a final rule dated December 11, 2003. It would make labeling information archived at the National Library of Medicine available to the public in hopes of preventing medication errors. It is supposed to go into effect June 8, 2004. 

Soon, FDA will expect firms to submit an electronic version of the “Content of Labeling” for each product in its annual report and at other times. The December 11 final rule requires it to be in PDF format. Firms hope that this could also be used for DailyMed purposes, Bass said.

But a draft guidance on electronic submission of content of labeling, published February 5, 2004, stated that PDF is not sufficient to support electronic prescribing and electronic health record initiatives. Therefore, FDA is proposing that firms use a new technology, called Clinical Document Architecture (CDA). CDA allows information to be exchanged in extensible markup language (XML), and is being strongly considered as the standard for the format of electronic health records.

However, Bass said, that standard has not yet been finalized. Health Level Seven (HL7), a group tied to the American National Standards Institute, is still working on a CDA-for-labeling standard called Structured Product Labeling (SPL). Yet FDA intends to require SPL for labeling submissions by the end of 2004.

“The timing is way off. This is not going to work,” Bass said. “PhRMA has asked for a major push-back on the time frame. Most (drug) companies couldn’t have cared less about SPL two months ago. Now, we are acutely aware. Some of us have become part of HL7.” 

PhRMA and some of its member companies have responded to FDA with concerns about the short implementation period and about how certain issues have still not been clarified, he noted.

Electronic labeling submissions to FDA and their use in DailyMed could help firms prepare for PhRMA’s paperless labeling initiative in pharmacies, he added. But it’s not clear how the DailyMed program or FDA’s sudden preference for SPL will impact it, he noted. Current versions of both systems being tested use PDF files, as that was what FDA was thought to prefer. 

Proof-of-concept testing was completed at 10 pharmacies in the Washington, DC, area. Now a large-scale field trial at 265 pharmacies across the nation is being prepared. At this pace, commercial rollout would come in 2005 at the earliest, Bass said.

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