| Comment Record|
Dr. Celso Bianco ||
2002-07-30 15:54:56 |
America's Blood Centers |
| Comments for FDA General |
1. General Comments
America's Blood Centers
725 15th St NW, Suite 700
Washington, DC 20005
July 30, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Docket No. 00N-1652. Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, Proposed Rule, Food and Drug Administration
Dear Docket Officer:
America’s Blood Centers (ABC) appreciates the opportunity to comment on the proposed rule spelling out requirements for submitting labels for human prescription drugs and biologics in electronic format. For your information, ABC is a national network of locally-controlled, non-profit community blood centers that collect almost half of the US blood supply from volunteer donors. Collectively, we operate in 45 states and serve patients at more than half of the nation’s 6,000 hospitals. ABC’s total blood collections exceeded 7 million pints in 2001.
ABC endorses FDA’s stated goals of simplifying the drug and biologics labeling review process and speeding up the approval of labeling changes. We have the following specific comments on the proposed rule.
Section I: Background. This section specifies the license applicants that would be affected by the new proposed rule. They include those applicants governed by 21 CFR 601.2, which includes all licensed blood banks.
Section I notes that the “labeling” that would be required under CFR 201.100(d) is commonly known as the “package insert.” For blood establishments, this would be the Circular of Information for the Use of Human Blood and Blood Components. Part B of this section states that the proposal would require the Circular of Information to be submitted in electronic format but gives the option of submitting container labels in electronic or paper format. We believe that this option is appropriate for blood component container labels, which are very simple and straight-forward. Since they contain only the blood type, product name and code, expiration date, nature of the anticoagulant, and name and address of the licensed establishment, we question whether the review period would be shortened or the overall process improved by electronic submission.
We have been informed by the Center for Biologics Evaluation and Research (CBER) that the division that reviews all blood license applications (BLAs), annual reports and label submissions from licensed blood banks currently does not have the capability to review labels in electronic format.
We ask FDA to confirm that blood banks are exempt from a requirement for submitting blood product container labels electronically.
If it was not FDA’s intention to exempt blood product container labels, we ask FDA to delay implementation of the requirement until such time as CBER has the capability to accept electronic label submissions, and then provide a time period of 6 months prior to implementation of the rule.
Section II: Rationale for Requiring Electronic Submission of the Content of Labeling, Part A: Why is it Important for the Content of Labeling to be Submitted Electronically? Our interpretation of this proposed rule is that it does apply to the Circular of Information. In this regard, however, we would like to point out that this document is prepared once in approximately every two years by a committee on which all blood organizations are represented, and a single submission is made to FDA. The same approved version of the Circular is used by the vast majority of licensed blood establishments.
We recommend that FDA exempt the Circular of Information for the Use of Human Blood and Blood Components from the requirement for electronic submission.
Section II, Part B: Why Should the Content of the Labeling be Submitted in PDF? ABC agrees that currently, PDF formatting software is relatively low-cost and easily available. We are concerned, however, about the provision in this rule giving FDA the ultimate flexibility in determining the type of format of label it will accept. As new technology becomes available, we would request the FDA expand the types of electronic formats it accepts and not limit it to the most current version.
Requiring blood banks to continuously upgrade their software and other technology for label submissions (even if only the Circular of Information) would create an unnecessary burden, without adding value to the review process.
Section IX: Analysis of Economic Impact. Finally, we believe that FDA has underestimated the economic impact on blood centers of requiring electronic submission of labeling. We estimate that only about 25 percent of the blood establishments that would be affected by this regulation currently have the scanning technology and software required to scan a pre-printed label as a portable document format (PDF), before formatting it to meet FDA requirements and sending it electronically to the FDA for review.
We recommend that the requirement for purchasing scanners and software, as well as conducting the required process validation, be included in the analysis of costs.
We appreciate the opportunity to comment on this proposed rule. I would be glad to answer any questions you might have.
Celso Bianco, M.D.
Executive Vice President