Fast-breaking News from AABB PulsePoints The following has been reproduced from the November 9, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

November 9, 2006
No. 758

FDA Delays PDMA Compliance Date to 2008 for Blood Establishments that Qualify as Health Care Entities

AABB PulsePoints

The Food and Drug Administration (FDA) has announced an additional delay in the date that registered blood establishments must comply with provisions in the Prescription Drug Marketing Act (PDMA) that involve wholesale distribution of blood derivatives by health care entities. According to the advance announcement published Nov. 9 in the Federal Register, registered blood establishments will now have until Dec. 1, 2008, to meet the new requirements, allowing FDA additional time to address comments received in response to the proposed rule issued in February as part of the PDMA implementation process.

Blood establishments have long maintained that Congress did not intend to prohibit them from distributing drug products used in transfusion medicine and cellular and related biological therapies that are not blood derivatives. The blood community addressed this issue at the May meeting of the Advisory Committee on Blood Safety and Availability in comments submitted to the docket:

“AABB, America’s Blood Centers [ABC], the American Red Cross [ARC], and Blood Centers of America [BCA] believe that the Proposed Rule only partially addresses a problem with FDA’s original regulations implementing the Prescription Drug Marketing Act. We applaud FDA’s decision in the Proposed Rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. However, to be faithful to Congress’s intent in enacting PDMA, and to avoid disrupting the current ability of FDA-licensed blood establishments to perform their core blood-related mission, the exclusion in 21 C.F.R. § 203.22 should be broadened to read as follows: ‘The sale, purchase, or trade of, or the offer to sell, purchase, or trade any transfusion medicine and cellular and related biological therapy product by a registered blood establishment that qualifies as a health care entity, so long as any health care services that it provides are predominantly related to its activities as a registered blood establishment.’”

To view the February 2006 proposed rule, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1225.pdf.

To view comments submitted on behalf of AABB, ABC, ARC and BCA, visit the AABB Web site at www.aabb.org under “Members Area > Regulatory > Miscellaneous.”