This transfer of inspectional responsibilities to ORA has advanced FDA's goals of regulatory consistency and efficiency across all regulated products by making the inspection process for fractionators comparable to that for other regulated products. The new approach to inspections of plasma fractionators has resulted in more in-depth inspections and, we believe, in production on a higher quality of product. More warning letters have been issued, and two companies are presently under consent decree to ensure that the plasma products are manufactured under quality conditions. As a result of these changes, plasma fractionators have been under increased enforcement scrutiny in the past year. We believe that such scrutiny is necessary to assure the purity and potency of plasma products.
Quality is particularly important with blood and blood products.
FDA can assist in speeding up the process, but we will not lower safety standards, or minimize or abolish compliance programs. FDA can sometimes help to avert a crisis or minimize the harm to patients if a shortage does occur. FDA is sensitive to shortage issues when the Agency takes regulatory action against a company and will work with a company to avoid a shortage situation if at all possible. For example, if shutting down a plant while the manufacturer corrects problems could lead to a shortage of a medically necessary drug, the Agency might exempt a single production line from the shutdown to keep that drug available. Plasma, as the underlying source materials used in the manufacturer of derivative products has inherent risks because many diseases are characterized by the presence of an infectious agent in the bloodstream which can be transmitted through blood and blood products.