Four organizations – the National Hemophilia Foundation (NHF), the Hemophilia Federation of America (HFA), the Committee of Ten Thousand (COTT) and the World Federation of Hemophilia (WFH) – have jointly published an open letter to clotting factor manufacturers and government agencies on the need for ongoing vigilance concerning blood and product safety (click here to view the letter). The letter stated that it was issued because of community concerns regarding “recent issues that have potential implications for the safety of plasma derived clotting factor concentrates.” These issues included a media story about plasma collection centers near the US-Mexico border who accept donations from residents of Mexico. They also included an FDA warning letter that was sent to a collection center in Ohio and its parent company, which manufactures clotting factor. The letter mentioned a number of deviations from required procedures that were highlighted in an inspection report, and cited the company for failing to respond to the issues in a timely and adequate manner. As our joint letter pointed out, these issues “did not result in tainted product or any other immediate danger to consumers.”
Grifols, the parent company cited, has since addressed the issues and is taking the necessary steps to correct the problems. However, many in the community felt that these events constituted “red flags” that, if not addressed, could lead to a lax attitude about blood safety issues. In addition, there was a strong feeling that the community needed more proactive communication with regard to issues like the warning letter. Representatives of the four organizations, after discussing these issues and their implications, decided that a joint open letter would be the best way to express the community’s concerns.
NHF will continue to work with the other community organizations, with the manufacturers of clotting factor products, and with the FDA and other relevant government agencies to ensure that vigilance on these issues remains strong and that consumers have uninterrupted access to safe, effective factor products. For more information on this issue, please contact Glenn Mones, NHF Vice President for Public Policy, at firstname.lastname@example.org.
Click here to read the FDA warning letter regarding the Ohio Collection Center
Click here to read Grifol’s response to community concerns.
Click here to read the FDA acknowledgment of the company's revised response and corrective action plan.