FDA cracking down on non-compliant IVF programs

April 2, 2013Carole 8 Comments »

The FDA appears to be getting more serious about IVF program compliance with their regulations, specifically regarding whether a person is medically eligible to donate gametes. Used to be, you never or rarely found a warning letter to an IVF clinic but fairly recently, there were two issued, for a clinic in Florida  and one in New York . Click on the link to see the actual warning letter. Warning letters and Cease Operation letters are issued only after violations have been identified by the FDA and program attempts to explain or correct the deficiencies are deemed insufficient by the FDA.

Below is an explanation about what the FDA regulates, copied from the FDA website. Although written with sperm donors in mind, egg donors are also included though some aspects of the regulations are modified (eg. testing interval before egg retrieval):

“What You Should Know – Reproductive Tissue Donation


Did you know that FDA regulates human reproductive tissue, which include donated eggs (oocytes) and sperm (semen)?  Below is information that you may want to know before becoming a recipient of donated sperm.

1) Is the establishment registered with the Food and Drug Administration (FDA)?

Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).  Any establishment that performs one or more manufacturing steps for HCT/Ps (recovery, processing, storage, labeling, packaging or distribution of products) must register with FDA and list their HCT/Ps in accordance with Title 21 Code of Federal Regulations (CFR) Part 1271.

You can access information on registered HCT/P establishments by visiting our website.  The site includes the names of registered establishments, the products that they manufacture, and the manufacturing steps they perform. 

2) Are reproductive HCT/P donors required to be screened for risk factors that may increase the chances of transmitting a communicable disease?

Yes.  Donor screening consists of reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.  These records include a current donor medical history interview to determine medical history and relevant social behavior, a current physical examination, and treatments related to medical conditions that may suggest the donor is at increased risk for a relevant communicable disease.

3) Are reproductive HCT/P donors required to be tested for infectious diseases?

Specimens from reproductive tissue donors must be tested for the following infectious diseases (referred to as “relevant communicable disease agents and diseases” in the regulations):

  1. Human Immunodeficiency Virus (HIV), types 1 and 2 
  2. Hepatitis B Virus (HBV) 
  3. Hepatitis C Virus (HCV) 
  4. Treponema pallidum (i.e. syphilis)
  5. Chlamydia trachomatis
  6. Neisseria gonorrhea

In addition to those listed above, sperm donors must also be tested for:

  1. Human T-lymphotropic virus (HTLV), types I and II
  2. Cytomegalovirus (CMV)

4) Are reproductive HCT/P establishments inspected by FDA?

Yes.  Various factors can determine the frequency of inspection, including any objectionable conditions found on a prior inspection and/or if FDA received Information regarding an establishment indicating there is a potential violation of FDA regulations. 

5) Where can I get more information?

Related information about the regulation HCT/Ps can be found on FDA’s website at:

Your IVF program, if they do IVF with donated gametes, must be able to prove that a donor was properly vetted and is eligible to donate.  It makes no difference if the program does one egg donor cycle a year or hundreds. They have to produce proof that they followed FDA regulations. Commercial sperm banks do the same for sperm they sell. It’s good for patients to know what the FDA expects and these public warning letters are useful for patients to recognize non-compliant clinics.

© 2013, Carole. All rights reserved.

8 Responses to this entry

  • Marna Gatlin Says:

    Thank you for all you do. I for one appreciate you.

  • Carole Says:

    Thanks Marna! 🙂

  • Catherine Tucker Says:

    Thank you Carole for this great post. I wonder if the clinics actually were not conducting the required tests, or if they just were poor about their record-keeping?

    So what happens to the patients who have stored embryos that were affected by this failure to test? Can those embryos still be used in some way?

    I also see the FDA warning letters request that the clinics provide the names of the impacted patients. Wouldn’t that be fun to get a letter from the FDA stating “your donor was not tested for HIV”?

  • Carole Says:

    Hi Catherine,
    In answer to your questions:
    1)Based on the letters themselves– click on the links in the post to read the dirty details for yourself— it looks like there were failures of both types: to perform any test and ignoring positive test results when the tests were performed, and still proceeding to use the eggs. The record keeping was dreadful as well.
    2) Based on past open forums with FDA reps, patients–at least in the past– have lost the right to use their embryos for procreation. You could probably donate them to stem cell research but you couldn’t put them in a person for implantation. This caused at uproar at an FDA seminar for embryologists that I attended. I wrote a blog post about that FDA Q&A session which you can read here. There is an appeal process for patients whose donated gametes or embryos are in limbo due to testing irregularities but the appeal process is is slow and often unsatisfactory in outcome.

    FDA is inconsistent regarding known vs. unknown donors. If you know your donor personally or are related to them, there appears to be a loophole–not for testing- you still need to do the testing and labeling–but the patients are permitted to use ineligible donor gametes from their known donors. Meaning that if your brother in law tests positive for hep-c and you still want to use his sperm, the FDA won’t stop it as long as the clinic shows that the physician was duly informed that all the proper testing and labeling steps were performed. Surprisingly, it is not the patient per se who must be informed -but presumably the doctor would share the info-=informed consent) I wrote about that in a previous post

    3) Nope, not a fun letter at all!! but I am sure it’s happened.

    The FDA donor eligibility rules were initially developed for donor tissues like cadaver tissues (bone, cartilage), blood bank etc and then reproductive tissues were made to fit into the regs as an after thought. The afterthought nature of inclusion of reproductive tissues is obvious in some parts of the regs and whole parts could not be applied at all. It’s an interesting legal area!! Thanks for your comments.

  • nikki Says:

    Hello I wanted to know what can be done if a doctor says he wants to do the fda testing and social worker review after you already did all the work and made embryos and you working on round two after a positive pregnancy that later failed due to misarriage?????

  • nikki Says:

    He says this during an appointment that we was suppose to be only discussing the next implantation dates for round two. We told them on our initial consultation that we were not together and were friends that both want to have a baby. We already paid over 25k out of pocket because we were not married etc. All of the sudden we get asked after the loss of our first baby due to miscarriage and I now feel like something is not right. Why didn’t they do this prior to everything we been through.

  • nikki Says:

    keep in mind we never had sex and we have been friends for 22 years

  • Carole Says:

    Hi Nikki,
    I am sorry about your miscarriage. I think you could ask and possibly expect the doctor to pay for tests he was supposed to do the first time around- since he failed to order them ahead of time. If you are not intimate, FDA would expect you both to be tested as a safeguard- you would be considered “donors”. If you are intimate, then the assumption is that you have already had the exposures so no extra STD risk from insemination/IVF. If you feel you have lost your confidence in this doctor, you might consider transferring your care. Good Luck.Carole

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