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Comments to FDA on Proposed Rule “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products"

03 January 2014

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane – Room 1061
Rockville, MD 20852

Re: Docket No. FDA-2011-N-0898, Proposed Rule, “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products”, 04 November 2013

Dear Dockets Manager:

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. Members are located in more than 80 countries.

Thank you for the opportunity to comment on the proposed regulations titled “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products.” AABB agrees with the concerns expressed in the proposed rule and that the Food and Drug Administration (FDA) should look at meaningful processes to mitigate the effects of drug or biological product shortages on affected patient populations.  However, AABB recommends that whole blood and blood components and cellular and gene therapy products be exempt from the proposed regulations.  Despite being listed as products that would be subject to the new regulation, whole blood and blood components and cellular and gene therapy products do not have a history of shortages as described for other drugs and biologicals affected by the requirements of the proposed rule. 

Whole blood and blood components
As noted in the introductory language to the proposed rule, there are redundant processes in place to monitor, coordinate, and report on the status of blood component inventories. Blood needs in times of disaster are monitored under the leadership of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism; routine non-disaster activities are tracked through a variety of networks including America’s Blood Centers stoplight system and the government’s Blood Availability and Safety Information System (BASIS). As noted in the introductory discussion section of the proposed rule, blood components have not been listed as being in a shortage situation. AABB believes the additional regulatory requirements are not necessary. Biologics License Applications (BLA) holders should be reporting to FDA at least annually what products are being manufactured under the license. When or if a license holder is experiencing difficulty with a manufacturing line, a conversation with an FDA Consumer Safety Officer occurs.

A particular concern of AABB is that the proposed regulation does not provide a definitive way for a blood establishment to know if it is an affected BLA holder that must report. This is especially important because of the punitive noncompliance letter that will be issued by the FDA to affected non-reporting BLA holders. Page 65908 reads:

“FDA intends to consider an applicant that holds a BLA for blood or blood components to be a manufacturer of a significant percentage of the US blood supply if the applicant manufactures 10 percent or more of the US blood supply (e.g., greater than 1.5 million units of whole blood annually or approximately 125,000 units per month).”

In the United States, the National Blood Collection and Utilization Survey (NBCUS) provides a tremendous amount of data that is used widely throughout government and the private sector. The NBCUS is the best data available nationally on collection and utilization of blood in the US; however, the survey is voluntary and does not occur on an annual basis. Currently, it is not possible for a BLA holder to know what percentage of the US blood supply it is collecting.  If blood and blood components are included in the final rule, AABB recommends that the FDA identify an annual whole blood collection number to be used as the threshold for reporting. This is more straightforward than asking a BLA holder to estimate whether its annual collection numbers are a percentage of a US annual collection number that currently is not available.

A second concern is that monthly reporting of a decrease in any blood component produced by an affected BLA holder (see page 65913) is overly burdensome and will result in reports that are meaningless. AABB recommends that if blood and blood components are included in the final rule that the FDA provide information and recommendations in a draft guidance to more fully explain the goals of this particular data collection. 

Cellular and gene therapy products
Cellular and gene therapy products are relatively new products in the drug and biological products listing and the regulations propose that all manufacturers of the identified products would be affected applicants. AABB believes the new regulations are not necessary. BLA holders should be reporting to the FDA at least annually what products are being manufactured under the license. When or if a license holder is experiencing difficulty manufacturing a product using approved standard operating procedures, a conversation with an FDA Consumer Safety Officer should occur. It is difficult to understand the “meaningful” process FDA would initiate if a report is received from a cellular or gene therapy manufacturer. Although a brief mention is made in the introductory language of the Federal Register Notice that cellular and gene therapy products will be included in the biological products covered by the regulations, there is no additional information. AABB recommends that a specific guidance document is appropriate if these products are included in the final regulations.

Thank you for the opportunity to offer these comments. AABB looks forward to continuing to work with the FDA on patient safety initiatives. Questions concerning these comments may be directed to acarrgreer@aabb.org.

Sincerely,

M. Allene Carr-Greer
Director
Regulatory Affairs    

Rafael K. Cassata 
Deputy Director, Cellular Therapy 
Regulatory Affairs