Regulating Donation Options - AFA Raises Concern over New FDA Guidelines

Main Category: Fertility
Article Date: 10 Feb 2005 - 15:00 PDT


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 (AFA), 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

The new FDA guidelines require donor testing for a number of diseases the FDA identifies as communicable - ranging from HIV to hepatitis -- 7 days prior to oocyte (egg) retrieval. This 7-day window seems arbitrary and has serious ramifications for gamete and embryo donors and recipients.

"The 7-day requirement is not based on clinical evidence," said Dr. Owen Davis, M.D., Medical Director for The American Fertility Association and Associate Director of the Center for Reproductive Medicine and Infertility at Cornell University Weill Medical College.

"The AFA would like to see this testing window extended to at least 14 days prior to oocyte retrieval to ensure that the results are available prior to the donor undergoing the retrieval process. This would allow timely cancellation of the donor's cycle, should she be deemed ineligible, thus avoiding the invasive retrieval process if it is not necessary," added Dr. Davis.

"It is impossible to predict the exact date when eggs are ready for retrieval, because there is no set biological timetable. Each case is unique," said Madsen. "We urge the FDA to create guidelines that help rather than hinder those trying to build families."

For example, New York State's 30-day testing requirement, the most stringent in the country, has proven efficacious in detecting disease and preventing transmission while accommodating responsible reproductive medical practices.

"The implications that these new FDA regulations hold for the future of oocyte and embryo donation cannot be ignored. We will continue to raise awareness among physicians and our patients and continue an active dialogue with the FDA to ensure that recipients of donated reproductive tissue are protected in a scientifically valid and ethically sound fashion," said Dr. Eric Surrey, M.D., President of the Society for Assisted Reproductive Technology (SART).

Future of Embryo Donation

Donor eggs or embryos were used in over 13,000 Assisted Reproductive Technology (ART) cycles carried out in 2002, slightly more than 11% of the total number, according to the Centers for Disease Control (CDC).

Beginning in May, new donors will be tested according to the FDA guidelines. However, frozen embryos will not be screened for the infectious diseases identified by the expanded FDA guidelines. Patients will be notified about their options.

The couple wishing to donate their additional embryos to other infertile couples would have to be tested during the 7-day window prior to oocytes retrieval. This adds additional costs to a cycle for those who only want to help others. Those who are not tested during the 7-day window are disqualified from donating their embryos. Their remaining options may be unacceptable -- destruction of the embryos or donating them to someone they know.

Laboratory Requirements for Labeling Specimens

Implementation of labeling requirements, which were not developed with the special needs of Assisted Reproductive Technologies in mind, may actually lead to the destruction of embryos if these particular guidelines are enforced in the future.

THE AMERICAN FERTILITY ASSOCIATION (AFA) is a national organization dedicated to educating, supporting and advocating for men and women concerned with reproductive health, fertility preservation, infertility and all forms of family building. Visit http://www.TheAFA.org or call 888-917-3777 for more information and support.

The American Fertility Association
http://www.TheAFA.org

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