An infertility patient advocacy group is criticizing government regulations that go into effect soon, claiming the rules will place "cumbersome new restrictions" on infertility clinic donor programs. RESOLVE: The National Infertility Association argues the regulations will have a negative impact on infertility treatment.

FDA: Rules Aimed at Patient Protections
Beginning May 25, the regulations will require pre-screening of donated umbilical cord blood, semen, eggs and embryos no more than 1 week before or after the donation is made. The new rule is one of three proposed regulations by the Food and Drug Administration that it says is aimed at preventing the transmission of contagious diseases when these cells and tissues are transplanted. "The requirements are comprehensive, yet adequately flexible, and they provide needed protections for patients without imposing unnecessary regulation," said the FDA, in a news release.

But RESOLVE argues that the tight screening period may not give labs enough time to obtain results and this will be "extremely inconvenient" for patients.

"While RESOLVE supports the FDA's efforts to safeguard the health of all consumers and prevent the unnecessary spread of diseases, we join the American Society for Reproductive Medicine and others in the medical community in calling for an expanded screening period of at least 14 days to allow necessary testing without negatively impacting infertility treatment," said Joseph Isaacs, RESOLVE's president and CEO.

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. "For those patients who are going through cycles, the 7 day requirement would be very difficult because if [a positive test result] comes back, they may have already started a cycle and they might have to end a cycle right there," she said.

Additionally, there are questions over whether the approximately 400,000 frozen embryos created through sperm or egg donation could be used relative to the new regulations, Greenstein pointed out. "They might have to be discarded," she told Priority Healthcare.

Expanded Screening Requirements
Since 1993, the government has required tissue donors to be screened and tested for HIV, and hepatitis B and C. Now, donors of semen, eggs, embryos, umbilical cord stem cells used in transplant procedures, peripheral blood sources (as opposed to bone marrow), cellular therapies, and other innovative products will fall into this group. And these new donors will additionally be screened for such diseases as human transmissible spongiform encephalopathies, including Creutzfeldt-Jakob disease (CJD) and syphilis, as well as the bacteria that cause gonorrhea and chlamydia. Semen and cord blood stem cell donors will be screened for human T-lymphotropic virus (HTLV) under the new rules.

The FDA also established a new framework to identify emerging diseases that may pose a risk to recipients of reproductive tissues.

Yet Isaacs argues there is no known scientific proof that communicable diseases can be transmitted through the transfer of donated eggs or embryos, he said. "Therefore, RESOLVE believes that the FDA should not implement new regulations without a firm scientific basis."

Rule Exceptions
The only reproductive tissues exempt from the new rules will include those "from a sexually intimate partner", the FDA stipulated. In other certain cases, if a donor is found to be ineligible, his or her donated tissue or cells could still be used if the recipient is a first or second-degree relative or if the transplant meets "a documented urgent medical need," the agency stated.

"This new rule was developed with input from many concerned consumers, associations, and tissue establishments," said Acting FDA Commissioner Lester Crawford, MD., in a statement. "In all cases, we carefully considered the comments we received in the proposed rule and made changes in the final rule when the science supported the change."

But Isaacs claims that the new regulations will not only likely increase the number of cancelled cycles or discarded embryos, but will force couples to abandon their plans to donate embryos due to the increased cost and testing requirements.

Both RESOLVE and the American Society for Reproductive Medicine (ASRM) are hoping the government agency will stay the regulations so it can review these petitions. "We're hoping in the next couple of days, we'll hear from them," Greenstein said.

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.