Blood Safety

Plasma, a liquid portion of blood containing, among other things, nutrients, electrolytes, albumin, and hormones, is used in various medical procedures--from surgery and burn treatments to the replacement of clotting factor in hemophiliacs. An estimated half million people each year receive products manufactured from human plasma, including more than 20,000 who receive intravenous immune globulins. During the past six months, there have been reported shortages in some plasma products, particularly the immune globulins. Several factors have been cited as possible causes of the current shortage, including recalls and withdrawals of plasma products. Recalls are used to remove products from the market that violate the laws or are defective, while withdrawals are used to remove products that present only minor or unknown risks or that are removed completely at the manufacturer's discretion. This testimony examines the amount of plasma products and, in particular, the amount of intravenous immune globulin being lost because of the removal of products from the market. GAO discusses the number of recent product recalls and withdrawals, the reasons for these actions, the different types of plasma products affected, and the amount of product that has been returned as a result of these actions. GAO also examines the impact on the current shortage of intravenous immune globulin of reducing the number of donors for each plasma product.

GAO noted that: (1) the data showed that only a small proportion of distributed IVIG--about 1.1 percent--has been removed from the market as a result of recalls or withdrawals; (2) however, only 5 percent of the vials of plasma products that were recalled or withdrawn has been retrieved to date; (3) while additional quantities might still be retrieved, some portion of these products has already been transfused or is otherwise unretrievable; (4) further, changes to reduce the number of donors in each product appear unrelated to the current shortages; (5) during the period GAO reviewed, 11 manufacturers reported to the Food and Drug Administration (FDA) that they undertook a total of 12 recalls (affecting 33 lots of 7 types of plasma products) and 38 withdrawals (affecting 1,001 lots of 10 types of products); (6) the reasons for the product recalls varied, but generally they related to specific manufacturing errors resulting in problems in product potency, sterility assurance, or incorrect labeling; (7) the product withdrawals were all related to donors who were diagnosed with Creutzfeldt-Jakob disease (CJD) or were considered to be at increased risk for CJD; (8) as reported to FDA, the proportion of IVIG vials retrieved following a recall was 15 percent, which amounted to less than 1 percent of total IVIG distributed in 1997; (9) in total, about one-third, or 38 percent, of the number of vials of all plasma products recalled has actually been retrieved from distribution or known to be destroyed; (10) the proportion of distributed products retrieved following a withdrawal has been much lower; (11) data from the plasma product manufacturers showed 6 percent of the vials of IVIG that were withdrawn to actually have been recovered, representing 1 percent of the total product distributed in 1997; (12) for other plasma products, the proportion of distributed vials retrieved following a withdrawal was 2 percent; and (13) manufacturers also claim that their production of IVIG was reduced by 5 to 10 percent in 1997 because they had to quarantine or destroy plasma because of CJD risk, but these amounts cannot be verified.