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Obama administration responds to Sen. Ernst: 'No known violation' of fetal tissue law

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WASHINGTON, D.C. (KWWL) -

The Obama administration tells Iowa Senator Joni Ernst that government researchers and companies they work with are following the law when it comes to fetal tissue.

On Friday, the Department of Health & Human Services sent Sen. Ernst a letter (posted below) that says it knows of no known violations regarding fetal tissue medical research.

Sen. Ernst is among a group of lawmakers asking questions after videos surfaced showing Planned Parenthood officials describing how they provide fetal tissue to researchers. Some claim those videos catch Planned Parenthood illegally selling the organs for profit. Planned Parenthood disagrees, saying they've followed the laws.

The Department of Health & Human Services says it knows of "no violation of these laws in connection with the research done at our agencies." The letter to Sen. Ernst then says, "...we have confirmed that HHS researchers working with fetal tissue obtained the tissue from non-profit organizations that provided assurances to us that they are in compliance with all applicable legal requirements."

A spokesperson for Sen. Ernst told KWWL, "Senator Ernst is still reviewing the letter and there are several state and congressional investigations into Planned Parenthood's selling of baby body parts. As she has stated, Senator Ernst does not believe that taxpayers should be forced to foot the bill for roughly a half a billion dollars annually for an organization exhibiting such disrespect for human life."

Planned Parenthood receives more than $500 million in taxpayer money every year. By law, federal money cannot be used for abortions except for cases of incest, rape or when a woman's life is in danger.

Recently, the Senate voted to end federal funding for Planned Parenthood. That vote fell seven short of the 60 needed to keep the bill moving forward.

Iowa Senator Chuck Grassley is investigating how the agency obtains fetal tissue. He has requested information from the companies involved in the process.

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TEXT OF LETTER

TO:  The Honorable Joni Emst

The Honorable Roy Blunt

United States Senate

Dear Senator Ernst and Senator Blunt,

Thank you for your recent letter regarding medical research using human fetal tissue. The use of fetal tissue in medical research has been an instrumental component of our attempts to understand, treat, and cure a number of conditions and diseases that affect millions of Americans. Scientists have been working with fetal tissue since the 1930s. For example, fetal tissue is an important resource for researchers studying retinal degeneration, pregnancy loss, human development disorders, and early brain development, with relevance to autism and schizophrenia . Research conducted with fetal tissue continues to be a critical resource for important efforts such as research on degenerative eye disease, human development disorders such as Down syndrome, and infectious diseases, among a host of other diseases.

Within the Department of Health and Human Services (HHS), the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) currently fund or conduct research involving fetal tissue samples. This research constitutes only a tiny fraction of the total research budgets of these institutions.

The majority of this research is conducted by third-party institutions using NIH funding. In FY 2014, research involving fetal tissue samples accounted for less than 0.3 % of NIH's total research budget. Like all HHS funding recipients, NIH employees, grantees, and contractors are required to comply with applicable legal requirements, including relevant provisions relating to research involving fetal tissue. When submitting an application and accepting an award, the designated representative of the organization receiving the funding certifies that researchers using these samples are in compliance with applicable legal requirements such as the Public Health Service Act, 42 U.S.C. 289g-2, which governs the use of human fetal tissue. In addition, by accepting an award, funding recipients agree that they will follow all applicable legal requirements and the applicable agency's grants policy statement, and must be able to demonstrate their compliance with applicable legal requirements. HHS also requires funding recipients to certify no less than annually that they are in compliance with applicable legal requirements.

NIH has confirmed that third-party institutions receiving NIH funding for research involving fetal tissue samples have confirmed that their activities are in accordance with applicable legal requirements. That assurance includes a specific reference to relevant provisions relating to research involving fetal tissue. As a reminder to all NIH funding recipients, as well as researchers who may apply for funding in the future, NIH has released a guide notice reminding researchers of their obligations to follow applicable legal requirements pertaining to research involving fetal tissue. This guide notice has been published in the NIH Guide to Grants and Contracts, which is the official publication for NIH medical and behavioral research grant policies, guidelines and funding opportunities, and is an effective way to communicate with the entire research community.

In addition, a small amount of research involving fetal tissue samples is conducted by researchers at NIH and FDA. This research involving fetal tissue conducted by NIH researchers accounts for less than 0.01 % of its total research budget and is principally related to the study of eye disease, infectious diseases, and human development. The amount of funding involving fetal tissue samples accounts for a tiny fraction of FDA's total research budget and is principally conducted in connection with testing potential new drugs and biologics.

NIH and FDA researchers obtain tissue from non-profit organizations that have provided assurances to us that they are in compliance with applicable legal requirements. In addition, NIH and FDA have obtained assurances verifying that the research they support is in compliance with applicable legal requirements, including relevant provisions relating to research involving fetal tissue. NIH and FDA have also sent a reminder notice to their intramural research communities that all research must be in compliance with all applicable legal requirements.

The Public Health Service Act (42 U.S.C. 289g-2), prohibits knowingly acquiring, receiving, or otherwise transferring any human fetal tissue for valuable consideration if the transfer affects interstate commerce. Violation of this statute carries criminal penalties that apply to both those who supply and those who acquire human fetal tissue. 42 U.S.C. 289g-1 sets forth additional requirements for HHS-conducted or HHS-supported research on the transplantation of human fetal tissue for therapeutic purposes. However, HHS has not funded or conducted this specific type of research involving fetal tissue in recent years. Currently, we know of no violation of these laws in connection with the research done at our agencies. Furthermore, as noted above, we have confirmed that HHS researchers working with fetal tissue obtained the tissue from non-profit organizations that provided assurances to us that they are in compliance with all applicable legal requirements.

While HHS provides funding to Planned Parenthood Federation of America through competitively-awarded grants and contracts, the funding does not support research involving fetal tissue. Instead, the funds are used to provide critical health services, including annual wellness exams, cancer screenings, contraception, and to further the study of sexually-transmitted diseases. Further, no federal funds can be used to cover abortions or health benefits coverage that includes abortions, except in the case of rape, incest, or when the life of the woman is endangered. This has been federal law, enacted in annual appropriations legislation, since the 1980s.

We hope you find this information helpful. Please let us know if we can be of further assistance. We will also provide this response to the other signatories to your letter.

cc:

Sincerely,

Jim R. Esquea Assistant Secretary for Legislation

Department of Health & Human Services

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