FDA Citizen’s Petition

The United States Department of Health and Human Services’ Food and Drug Administration is currently reviewing a reconsideration of the citizen’s petition filed by donor-conceived individual Nicholas Isel. While the comment period initially closed March 18th, 2019, it has now been reopened for an undetermined amount of time, until the FDA reaches their final conclusion.

What is a Citizen’s Petition?

An FDA citizen petition is a process provided by the FDA for individuals and community organizations to make requests to the FDA for changes to health policy. (Source: Wikipedia)

Why petition the FDA?

Currently, one of the only regulations regarding donor conception in the U.S. is through the FDA, which requires that records of Donated Human Cells and Tissues must only be retained for 10 years (Source: FDA). The citizen petition requests that this be extended to 50 years, to ensure that vital medical information of donor-conceived individuals is not lost. This Petition to Reconsider has been filed because in August 2018, the FDA denied the original petition on the grounds that genetic medical history does not contain “communicable diseases.”

The Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products ruling by the FDA outlines the requirements for screening donors, however as long as they refuse to acknowledge the impact that genetic medical history has on health, donor-conceived individuals will continue to suffer. Please let the FDA know how not knowing your medical history (or finding out that you inherited serious genetic health risks from your donor) has impacted your life. You can comment anonymously, so don’t feel like you have to put yourself at risk in order to contribute!

What has happened so far?

September 2016 – Original citizen’s petition filed

10 years of record retention is an insufficient amount of time to satisfy the stated mission and authority of Section 361 of the Public Health Service, or PHS act, which addresses prevention of the introduction, transmission, or spread of communicable disease. No less than 50 years of record retention and availability is sufficient to stop the potential proliferation of genetic ailments which can result in severely debilitating physical and/or mental disability that can leave the sufferer incapable of functioning self-sufficiently and contributing as a productive member of society. Certain physical/mental illnesses do not present themselves until later in life and introduction, transmission and/or spread of these diseases are currently not monitored.

In addition to self-maintained records by the establishment for no less than 50 years, instead of 10; the FDA CBER division should themselves store duplicate copies of all relevant personal and medical records collected by sperm and/or egg donation ART industries for a period of no less than 50 years to provide “document redundancy” in case of catastrophic natural disaster, accidental loss/destruction of data, or breakdown in lines of communication between the establishment and donors/recipients.

All personal information from an intended donor should be collected prior to donation and made non-confidential to potential recipients for the purposes of individual/public health and well-being. The current practice of “Donor Anonymity” can have several unintentional negative after-effects, including but not limited to: increased risk of consanguinity, donors of many offspring can potentially transmit disease/disability (which is not self-reported during the personal and family medical history either due to neglect/misrepresentation or because the donor has yet to be afflicted with symptoms from still unknown or genetically recessive conditions) to scores of children, and misleading sense of security instilled in the potential donor prior to donation through the establishment imparting a false sense of protection and “guaranteed donor anonymity”; when confronted with technological realities of the day that prove this belief to be an outright fallacy: Increased availability and prominence of commercial DNA testing through commercial DNA websites (23andme, Family Tree DNA, etc.) show that any declaration of “Guaranteed Donor Anonymity” made on the part of any establishment is an unfulfillable promise.

Citizen Petition from Nicholas Isel

December 2016 – Nicholas interviewed by We Are Donor Conceived

March 2017 – FDA submits an interim response indicating they need more time to review the petition

September 2018 – FDA denies the original petition

As mentioned, section 361 of the PHS Act authorizes FDA to make and enforce regulations to “prevent the introduction, transmission, or spread of communicable diseases.” Some of the requests in the Petition are for regulations to control the risk of transmission of genetic diseases or conditions (referred to, collectively, as “genetic diseases” for purpose of this response). Based on our current scientific understanding, we do not consider genetic diseases, including mental illness, to be “communicable diseases” within the meaning of section 361 of the PHS Act because genetic diseases do not arise as a result of an infectious agent or its toxic products.

Instead, genetic diseases occur as a result of a genetic defect or gene mutation that is due to a change in the sequence of DNA. Some genetic diseases are caused by gene mutations that can be inherited, whereas other genetic diseases can be due to acquired gene mutations that result from either a spontaneous new mutation of a gene or environmental exposure. There are also genetic disorders that are “multifactorial inheritance disorders,” meaning they are caused by a combination of inherited mutations in multiple genes and exposure to certain environmental factors. Since we do not consider genetic diseases to be “communicable diseases” within the meaning of section 361 of the PHS Act, we decline to issue regulations for the purpose of preventing the introduction, transmission, or spread of genetic diseases.

The Petition does not adequately explain why expanding the required record retention period beyond 10 years is necessary for preventing the introduction, transmission, or spread of communicable diseases. When determining that a 10-year record retention requirement would be appropriate, FDA took into account, among other considerations, that certain communicable diseases appear to have long latency periods (see 69 FR 29786 at 29787 (May 25, 2004)). Additionally, a requirement for retaining records for 50 or more years may create a significant burden on and be impractical for some tissue establishments. Accordingly, although we may, in the future, determine that extending the required record retention period is necessary to prevent the introduction, transmission, or spread of communicable diseases, we decline to expand the requirement at this time.

You also contend that anonymous donation can result in disease transmission when diseases are not self-reported by donors due to neglect, misrepresentation, or lack of knowledge regarding existing diseases. However, we are unaware at this time of any causal relationship between donor anonymity and transmission of communicable diseases within the meaning of the PHS Act, and you fail to provide any information to demonstrate such a relationship. Moreover, existing regulations regarding donor testing help to reduce the risk of communicable disease transmission in the circumstances you describe (see 21 CFR 1271.80 and 1271.85). Accordingly, we decline at this time to require that all personal information from an intended donor be collected before donation and provided to potential recipients.

Response from FDA CBER to Nicholas Isel

September 2018 – Petition to reconsider (appeal) is filed

Petitioner does not merely disagree with the Agency’s conclusions and is not simply attempting to engage in a scientific dispute. However, the failure of the FDA to amend regulations as set forth in the Citizens Petition has the inevitable result of sacrificing the interests of the Petitioner and those born in a similar position to him, simultaneously ignoring the real-life 21st century medical requirements of an entire generation of children born from late 20th century technology.

The FDA failed to examine the issues within the scope of the genetic disease transmission, relying on definitions of sections which were not germane to the Citizens Petition. Refusing to revisit the issues set forth in the Citizens Petition because the rules as originally promulgated did not contemplate the present-day mental health or genetic health of the offspring of sperm or egg donors is a failure to meet the mandate provided by Congress to comprehensively regulate this industry. The failure of the existing regulations to contemplate the difficulties of progeny such as Isel is precisely why new regulations must be promulgated, particularly when the old regulations divest this new group of their Constitutional Rights to receive and maintain their own personal, health, and genetic information. Isel and those like him had no ability to opt-in or opt-out of the destruction of their personal, health and genetic information. Reconsideration of the Petition would, therefore, be “in the public interest and in the interest of justice” 21 CFR §10.33(d).

In this Petition for Reconsideration, Isel requests that the FDA correct is errors in statutory and regulatory interpretation and to amend Part 1271.270( d) in regards to establishments involved in sperm and/or egg donation Assisted Reproductive Technology (“ART”) industries to require collection, upkeep, communication with donors/recipients of updates, and retention of all relevant personal and medical information from donors and recipients for a period of no less than 50 years, instead of the currently required 10 year time span. This is necessary in order to stop the proliferation of genetic ailments which can result in severely debilitating physical and/or mental disability that can leave the sufferer incapable of functioning self-sufficiently and contributing as a productive member of society. Certain physical/mental illnesses do not present themselves until later in life and introduction, transmission and/or spread of these diseases are currently not monitored. The FDA did not include proper and well-reasoned reasons for its denial of this petition, and was therefore an unlawful denial of the Citizen Petition which was arbitrary and capricious and otherwise not in accordance with law. Administrative Procedure Act, 5 U.S. C. §706(2)(A).

The FDA simply did not contemplate Isel’s existence in 2004. Nor did they contemplate that someone like Isel could desire the genetic information from his sperm donor, in order to better his own life, the life of his family, and his own children. Now that we have called their attention to the Agency’s oversight, it is error for the FDA not to act to amend the regulations. Despite the fact that the sole purpose of a sperm or egg donor is to create a human life, it is clear that the current version of the FDA regulations in Part 1271 never contemplated the actual existence of someone like Petitioner, or that such a person may wish to exercise his rights to obtain information about his genetic makeup.

Petition to Reconsider from Rozovics Law Firm LLC on behalf of Nicholas Isel

February 26, 2019 – FDA submits an interim response indicating they need more time to review the petition reconsideration

How can you help?

Any U.S. citizen who believes in this important step toward effective regulation is invited to comment on the petition and have their voice heard by government officials.

To read the petition, visit this page, scroll down to “Attachments” and click the PDF icon to download and review the document. At the top right of the petition page you will see a button that says “Comment Now!” Enter your comment in the text box (if you are composing a long comment, it’s best to do so in a word document and then copy/paste, so you don’t risk losing your work), enter your name if you would like to be identified, select “Individual Consumer” in the Category drop-down, and click Continue. Review your comment on the next page, check the “I read and understand” box, and hit “Submit Comment.” Here is a helpful document with advice for writing an effective comment.

We urge all donor-conceived people and allies to speak their truth to the importance of these very basic regulations on the fertility industry.