End of pilot program nears as FDA prepares to require electronic submissions only.(Electronic Submission)

BALTIMORE, MD -- FDA is gearing up for going live with its requirements for electronic submission of drug establishment and listing information, still slated to go into effect June 1.

The agency has been gearing up for the launch date since July 2008, when it first announced a new draft guidance "Providing Regulatory Submissions in Electronic Format--Drug Establishment and Drug Listing. and voluntary pilot program.

In the months preceding the law's enactment, the pilot program has helped transition firms from paper-based submission processes to electronic, serving also as a trial period for FDA. All participants have had an opportunity to ensure the program's functional operation.

At a meeting of the American Assn. of Pharmaceutical Scientists in Baltimore last month, CDER's Deputy Director of the Office of Business Process Support, Gary M. Gensinger, MBA, told conference attendees FDA "intends to only accept electronic drug establishment registration and drug listing information beginning June 1, 2009." Gensinger said the agency has already received "dozens of official electronic drug establishment registration and drug listing submissions," ranging in quality from good to excellent.

Information required and recommended by FDA is outlined in the guidance, as well as how to prepare and submit the information electronically. According to the document, companies must submit the name and address of each drug establishment, trade names, ownership type and owner or operator's name. The agency has also established "recommended data," or supplemental information, that includes:

* Name of establishment(s) manufacturing or processing the listed drug and the type of operation(s) performed

* Drug Enforcement Agency schedule

* Route(s) of administration

* Inactive ingredients and strength or amount

* Package size and type

* Web address and telephone number for voluntary reporting of adverse reactions, if such information appears on the drug labeling

* Reference drug, if the strength of the drug being listed is based on a reference drug

FDA has remained flexible on submission format and method, but on June 1, the new policy will be enforced in full. Unless a waiver approved by the HHS Secretary is granted, all companies must abide by the new terms.

Sponsors will submit the content of their product labeling using Structured Product Labeling (SPL), an extensible markup language (XML) mechanism for exchanging medication information. XML puts more control in the hands of companies and reviewers, allowing them to define mark-up elements and support information sharing.

The SPL standard also loosens the restraints on content, at the same time improving efficiency by allowing companies and reviewers to pinpoint specific parts of a submission. In addition, SPL facilitates label information exchange. PDF, a format previously accepted by the agency, locks the information contained within in a way that is difficult to reuse and expand.

The newly formatted information will be more cleanly structured, consistent and reliable. Documents will essentially contain text and images from an approved prescription package insert for machine processing of label content. According to the industry guidance, "Providing Regulatory Submissions in Electronic Format--Content of Labeling," one of the potential advantages of electronic formatting is its benefit to patients:

"Electronically formatted content of labeling will be used to support health information management technologies such as electronic prescribing; the electronic health record (EHR), which will provide health care providers, patients and other authorized users access to patient information in electronic format; and the DailyMed, a new way to distribute up-to-date and comprehensive medication information in a computerized format for use in health care information systems."

The guidance and pilot program are two important efforts that support elements of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 510 of the Federal Food, Drug, and Cosmetic Act, "Registration of producers of drugs and devices," states: "Registrations and listings under this section (including the submission of updated information) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver."

FDA has scheduled web-based and live educational sessions to cover SPL basics in addition to the guidance and pilot program. Companies could benefit enormously from the pilot program--an opportunity for all participants to iron out any kinks and address areas of confusion prior to June 1.

By Carrie Nathans

Managing Editor

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