What are the concerns over new FDA guidelines?
NEW YORK, Feb. 10 — On May 25, 2005, new FDA guidelines for the donation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), will go into effect. Reproductive tissue — sperm, eggs and embryos — falls under these testing guidelines. The potential impact for men and women seeking to build families through such donations will be significant. “The American Fertility Association, always a staunch advocate of patient safety, recognizes the FDA’s new guidelines as an important step forward in disease prevention. But we are concerned that the FDA does not acknowledge that reproductive tissue is distinct from all other tissues that fall under these regulations,” said Pamela Madsen, Executive Director of The American Fertility Association. As they stand, the expanded guidelines will have tremendous logistical and cost implications for patients, who often carry the burden for paying for fertility treatments in full. Key areas of concern include: 7-Day Testing Requirement
