Paid donors typically receive between $15 and $20 for the 2 hours of time required to remove whole blood, separate the plasma from the cells and serum, and reinfuse the latter back into the donor. Risk of Infectious Units Entering Plasma Pools Is Somewhat Higher for Donations From Paid Plasma Donors Than for Donations From Volunteers

The risk of incorporating a potentially infectious plasma unit into a plasma pool for HIV, HBV, or HCV is somewhat higher for donations from paid donors than for donations from volunteer donors. These rates include donors who pass the initial screening tests and donate but who subsequently seroconvert and whom a screening test later detects during another donation as being positive. included in that pool if it were made exclusively from donations from paid donors. Manufacturers have recently taken steps to reduce the size of the plasma pools they use for producing plasma derivatives. further manufactured by Baxter Healthcare. Thus, these modeling data suggest that smaller plasma pool sizes will reduce the likelihood of transmission of viral agents to infrequent users of plasma products but will have only a minor impact on frequent recipients of such products. In addition, risk of exposure does not always equate with risk of infection. For example, the recent transmission of HCV by a plasma derivative that had not undergone viral inactivation procedures showed that the risk of seroconversion for recipients of this product increased with the number of positive HCV lots infused and the quantity of HCV viral material infused. Not all recipients experience seroconversions because of two factors: (1) each recipient’s dose and (2) the reduction of infectiousness due to steps in the manufacturing process in addition to viral removal and inactivation. These techniques virtually eliminate enveloped viruses such as HIV, HBV, and HCV. All types of plasma derivatives undergo viral inactivation or removal. Assessing the amount of viral clearance obtained through a particular inactivation or removal process determines the effectiveness of these different procedures. This assessment is based on the amount of virus that is killed or removed and therefore the extent to which these processes eliminate viruses through manufacturing. cause infection, research has shown that infection is much more likely to occur with higher concentrations of virus. Recent Noncompliance With Current Good Manufacturing Practices Could Jeopardize Plasma Products’ Safety

Although viral inactivation and removal techniques have proven to be highly effective, they are only useful if the steps in the manufacturing process are carried out properly. The lack of strict adherence to these practices could compromise the safety of plasma products. In May 1997, FDA authorized the distribution of Centeon’s products from the facility, but, in a subsequent inspection completed in July 1998, FDA found that Centeon had failed to fully comply with the consent decree, and the company was notified to immediately cease manufacturing, processing, packing, holding, and distributing all biological and drug products manufactured at that facility. The company may, however, manufacture products deemed medically necessary. If properly implemented, these actions by plasma manufacturers and FDA should help alleviate the problems related to adherence to current good manufacturing practices and quality assurance. A recorded menu will provide information on how to obtain these lists.
Why GAO Did This Study

GAO provided information on blood plasma safety, focusing on: (1) comparing the risks of incorporating infected plasma from donations from volunteer donors with those from paid donors into the manufacturing process; (2) the impact on frequent and infrequent plasma users when pooling large numbers of plasma donations into manufactured plasma products; (3) the safety of end products from plasma after they have undergone further manufacturing and inactivation steps to kill or remove viruses; and (4) the recent regulatory compliance history of plasma manufacturers.

What GAO Found

GAO noted that: (1) viral clearance techniques have made the risks of receiving an infected plasma product extremely low when manufacturers follow all the procedures in place to ensure safety; (2) although paid plasma donors are over one and a half times more likely to donate potentially infectious units, several initiatives by the paid plasma industry have greatly reduced the chances of these units being included in the plasma production pool; (3) these initiatives include using only repeat donors and a 60-day inventory hold on all units to allow manufacturers to retrieve units from donors who subsequently test positive for disease or are otherwise disqualified; (4) even with those initiatives in place, plasma donated by paid donors poses a higher risk of infection; (5) limiting the number of donors whose plasma is pooled for production into plasma products helps to reduce the risks of viral transmission for recipients of these products; (6) a more significant step in reducing risk of infection takes place in manufacturing, during which all plasma products undergo viral removal or inactivation procedures, which virtually eliminate enveloped viruses; (7) epidemiological and laboratory data on the transmission of viruses through plasma products since the introduction of viral removal and inactivation procedures support the value of these procedures; (8) the effectiveness of these processes is limited, however, in reducing transmission of nonlipid enveloped viruses; (9) voluntary initiatives by the commercial plasma industry, technological advances from increasingly sophisticated screening tests, and viral removal and inactivation procedures are only effective if manufacturers of finished plasma products adhere to current good manufacturing practices; (10) not all of the major manufacturing companies producing plasma products adhere to these practices; (11) recent Food and Drug Administration (FDA) inspection reports highlight many instances of noncompliance with current good manufacturing practices; (12) this has led to consent decrees between FDA and two companies, temporary suspensions of production at one company's facility, and shortages of some plasma products; (13) a lack of strict adherence to these practices related to viral removal and inactivation procedures could compromise the safety of plasma products; and (14) actions being taken by FDA and the plasma manufacturers since these problems were identified should help to alleviate some of these problems.