New regulations requiring the screening of egg, embryo or sperm donors have been eased on the heels of criticism from a patient advocacy group and others. The FDA regulations, which took effect May 25, mandate pre-screening of donated umbilical cord blood, semen, eggs and embryos. The new rules are aimed at preventing contagious disease transmission when the cells and tissues are transplanted into patients.

But when the government initially required that the screening process take place no later than 1 week prior to or following the donation, RESOLVE: The National Infertility Association and the American Society for Reproductive Medicine (ASRM) cried foul. Their objection centered on the strict deadline and patient inconvenience, and pushed the FDA to ease the restrictions.

The regulations could negatively influence the critical timing of treatment cycles and, as a result, lower the odds of success in procedures that use donated eggs or embryos, explained Julie Greenstein, RESOLVE's Director of Government Relations.

But after lobbying efforts, the FDA announced that the regulations had been revised, now requiring the screening process to be completed up to 30 days prior to the use of the donated tissue. "We are very pleased with the changes and believe that these final regulations will allow for the continued and appropriate use of donated eggs and embryos for family building purposes," said Joseph Isaacs, CAE, President and CEO of RESOLVE, in a statement. "We applaud FDA for implementing regulations that ensure patient safety while respecting the treatment protocols and the overall process of infertility treatment."

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.