Regulatory Beat: FDA Proposes New Systems and Procedures for E-filing Labeling and Other Data - New document format will allow quicker updating and dissemination of information but presents some roll-

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Regulatory Beat: FDA Proposes New Systems and Procedures for E-filing Labeling and Other Data
New document format will allow quicker updating and dissemination of information but presents some roll-out challenges.


BioPharm International



Jill Wechsler
Everyone in Washington is jumping on the national electronic health information bandwagon. The Medicare Modernization Act (MMA) requires the government to establish technical standards for an electronic prescribing system, and federal officials are taking action to comply. As a result, FDA is stepping up efforts to set standards and policies for a broad range of electronic filing and reporting activities.

In April, President Bush set a 10-year goal for developing an e-medical records system. Health and Human Services Secretary Tommy Thompson appointed a national health information technology coordinator and announced HHS support for the work of Health Level 7 (HL7), a voluntary health standards development organization. In addition, the National Committee on Vital and Health Statistics (NCVHS) is working on technical standards for e-health billing and e-prescribing. The Medicare bill calls for HHS to establish initial e-prescribing standards by September 1, 2005 in order to conduct a pilot project during 2006.

FDA AT THE TABLE One main component of an e-prescribing system is access to accurate, up-to-date information on prescription drugs and biologics based on FDA-approved labeling. The agency is establishing a new system to provide this information in a form that will be accessible to all computer systems. This builds on FDA's efforts over the past decade to develop policies and systems for electronic submission of data and documents to the agency. FDA has supported efforts at the International Conference on Harmonisation (ICH) to establish common standards and formats for e-filing of market applications for new drugs and biologics and for collecting data on adverse events.

The federal e-health program is accelerating a number of FDA initiatives and giving IT activities a higher profile in the agency. In April, FDA Acting Commissioner Lester Crawford named Randy Levin director for health and regulatory data standards in the Office of the Commissioner. Levin's responsibilities include representing FDA in government-wide e-health activities and overseeing agency initiatives as chair of the FDA Data Council. Levin comes to the commissioner's office from CDER, where he headed the organization's Office of Information Management (OIM). He will continue to serve as CDER's associate director for medical informatics and will function as scientific advisor and consultant to CDER management on medical informatics and information management.

CHANGE FOR E-LABELING A current priority for FDA is establishing an electronic labeling system for drugs and biologics. The aim is to speed up FDA review of initial labeling and post-approval changes and to be able to communicate such changes quickly to pharmacists, physicians, and patients. To move forward in this area, FDA issued a new rule in December requiring manufacturers to submit product labeling data electronically when filing a new drug application, supplement, or annual report.

Initially, this change appeared fairly straightforward because FDA and manufacturers have been sending and receiving labeling content electronically in PDF since 1999. But in February, FDA published a draft guidance calling for a switch from PDF to the XML-based Structured Product Labeling (SPL) system by the end of 2004 (see "Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Content of Labeling," http://www.fda.gov/cder/guidance/6028dft.pdf).

Manufacturers generally supported the new system but requested more time to carry out such a major change. According to BIO, small biotech companies in particular anticipated difficulty adopting SPL quickly. Astra Zeneca estimated that, in a best-case scenario, it would take a manufacturer six to nine months to set up, configure, validate, and test an SPL system once it became available.

At a meeting with manufacturers in June, Levin addressed these concerns and offered a more flexible implementation timetable. Seven software vendors attended this meeting to demonstrate their interest and capability for providing SPL software to industry. Even though the December e-labeling rule became effective in June, Levin emphasized that until FDA establishes a system for receiving and storing manufacturer data in SPL, the agency will accept e-labeling data in either PDF or SPL formats. FDA hopes that the first phase of this project, which involves completing regulations, standards, and systems needed to switch labeling content from PDF to SPL, will be completed for prescription drugs by next July and for all drugs by 2006.


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