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Comments to FDA, Pertinent to Cellular Therapies, on Proposed Rule “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products”

May 18, 2015

Division of Dockets Management (HFA–305)
Food and Drug Administration
10903 New Hampshire Ave, Bldg 71, Rm 3128
Silver Spring, MD 20993-0002

Re: Docket No FDA-2007-N-0363: Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products, Proposed Rule

Dear Dockets Manager:

AABB appreciates the opportunity to provide comments on the proposed rule titled “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products.” In a separate letter, AABB has submitted comments to this docket pertinent to blood and blood components.

The AABB Center for Cellular Therapies believes the requirement to have prescribing information be distributed electronically and, with few exceptions, not in paper form, would be a burden when applied to certain biological products. Cellular therapy products, including licensed umbilical cord blood products, are provided on a regular basis to and from international facilities for administration. Individual lots or batches of 351 products are unique to each patient due to HLA matching requirements, where only one lot of product is manufactured for a specific patient. As these products are unique and may in the future be manufactured specifically for a patient, the labeling and administration requirements are specific to that product. These products may be shipped cryopreserved and have extremely limited expiration times (usually a matter of hours after thawing). The labeling and associated administration requirements must accompany each product or be provided in advance of the product. Because of the short expiration times, the time required to access a web site or contact an information hub or an individual may not be practical in all situations.

For the reasons stated above, AABB and its membership believe that a dual system for 351 products would be the most efficient way to distribute updated prescribing information. The dual system should allow paper information to be shipped with the product and also include a reference to an electronic site.

Section II: Discussion.

“In cases where the immediate container label does not have adequate space for the statement, the statement would be required to be affixed to the immediate container by other means such as a peel-back label” (pg 75511).

Request: We request that the final rule not suggest a peel-back label when containers are too small to bear the information about the labeling repository web site and toll-free telephone number.

Rationale: Peel-back labels would not be practical for cryopreserved products. They probably are also not practical for refrigerated products in pliable plastic bags since such labels may peel-off during handling and storage.

Section II: Discussion.

B. Why is electronic distribution of prescribing information better?
2. Time for Updated Electronic Prescribing Information to Reach the Marketplace.

“Since FDA’s labeling repository Web site will link prescribing information to specific National Drug Code (NDC) numbers, the prescribing information will be product-specific and will correspond to the NDC that may appear on a product’s label. The Agency expects that the repository will also be searchable by, among other things, active ingredient and proprietary name” (pg 75512).

Recommendation: AABB recommends that FDA include the option to search products by ISBT 128 class name (e.g., HPC, Cord Blood).

Rationale: Not all cellular therapy products contain NDC numbers. In addition to using NDC numbers to search the FDA labeling repository, searching by ISBT 128 product nomenclature would be a user-friendly option.

Section II: Discussion.

B. Why is electronic distribution of prescribing information better?
2. Time for Updated Electronic Prescribing Information to Reach the Marketplace

“FDA will be able to provide the public with a complete source for the most current prescribing information for products approved under NDAs, ANDAs, and BLAs, and those marketed and not approved” (pg 75512).

Request for clarification: We request that the final rule provide clarification on the scope of the rule. The language above is confusing because it sounds like it is potentially applicable to INDs and other unlicensed products. Moving forward, it will not be feasible for IND products to be subject to these rules as prescribing information in a structured product labeling format will not yet be available. The final rule needs to be clear that it relates only to licensed products for which FDA has approved the prescribing information in the package insert.

Section IV: Description of the Proposed Rule

B. Label Statement

“FDA also invites comment on what would be considered a reasonable amount of time to respond to a request for current prescribing information. The proposed requirement is to ‘promptly’ respond” (pg 75515).

Recommendation: AABB requests that 72 hours be considered a reasonable time for a manufacturer to respond to requests for faxes, emails, or mailed copies of the prescribing information. We also ask that timeliness of response for prescribing information be clearly differentiated from contacting the manufacturer for an unexpected event during administration.

Rationale: Manufacturers of licensed 351 umbilical cord blood products are often small facilities without 24-hour staffing available to respond to requests. As a result, requests received on weekends may require more time to respond. Also, under a dual system, the information accompanying the cell therapy product would provide an alternate method to obtain current information. This would remove the need to have 24-hour staffing available to provide information when internet is unavailable.

Additionally, mail sent to international clients may take an unknown amount of time for delivery, so we request that “response time” measure time for manufacturer to mail information and not time for a client to receive the information.

Time differences, response time and time for mail to be delivered all pose a potential impact on clinical facilities using these products outside of the U.S. According to the World Marrow Donor Association, in 2014, donor registries shipped about 20,200 HPC products and 49 percent of these crossed international borders. This is a tremendous number of products crossing international borders, and we ask the agency to consider international challenges when formulating requirements. Additionally, as the field is rapidly evolving, flexibility of this rule regarding cellular therapy products would assist with compliance.

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

The Center for Cellular Therapies appreciates the opportunity to comment on the proposed rule. If you have any additional questions, please contact me at


Naynesh Kamani, MD
Vice President, Center for Cellular Therapies & Research