MEMORANDUM
September 9, 2015
To: Subcommittee on Oversight and Investigations Democratic Members and Staff
Fr: Committee on Energy and Commerce Democratic Staff
Re: Update on the Committee’s Ongoing Investigation of Planned Parenthood
Federation of America
I. INTRODUCTION
This memorandum serves as an update on the Committee’s ongoing investigation into
claims regarding the alleged sale of fetal tissue by affiliates of Planned Parenthood Federation of
America (PPFA) to tissue procurement organizations (TPOs). The review has included
bipartisan briefings by Planned Parenthood officials as well as representatives from
StemExpress, Novogenix Laboratories, and Advanced Bioscience Resources - three TPOs that
partner with Planned Parenthood affiliates and other healthcare providers to collect specimens to
supply to researchers working with fetal tissue.
In addition to these briefings, the Committee has received documents and written
responses to a series of questions it posed in writing to PPFA regarding its “practices relating to
fetal tissue collection and sale or donation.”
1
To date, the Committee has received no evidence
to substantiate the allegations that Planned Parenthood has engaged in the sale of fetal tissue for
profit. Furthermore, the Committee has received no evidence to support the allegations that fetal
tissue was procured without consent, that Planned Parenthood physicians altered the timing,
method, or procedure of an abortion solely for the purposes of obtaining fetal tissue, or that
Planned Parenthood physicians performed intact dilation and evacuation in order to preserve
fetal tissue for research. Thus far, the investigation has revealed that PPFA requires all affiliates
to ensure compliance with all state and federal laws and that specific PPFA guidance requires
affiliates to ensure that reimbursement for fetal tissue is limited to actual costs.
1
Letter from Chairman Fred Upton, House Committee on Energy and Commerce, to
Cecile Richards, President, Planned Parenthood Federation of America (July 17, 2015).
FRED UPTON, MICHIGAN
FRANK PALLONE, NEW JERSEY
CHAIRMAN RANKING MEMBER
ONE HUNDRED FOURTEENTH CONGRESS
Congress of the United States
House of Representatives
COMMITTEE ON ENERGY AND COMMERCE
2125 RAYBURN HOUSE OFFICE BUILDING
WASHINGTON, DC 20515-6115
Majority (202) 225-2927
Minority (202) 225-3641
2
The Committee received evidence that the individuals making these unsubstantiated
claims misrepresented themselves in order to gain access to Planned Parenthood personnel and
facilities, and that the videos released by the Center for Medical Progress (CMP) are incomplete,
selectively edited, and intentionally misleading.
II. THERE IS NO EVIDENCE THAT PLANNED PARENTHOOD OR ITS
AFFILIATES HAVE VIOLATED ANY FEDERAL OR STATE LAWS
A. PPFA Requires All Affiliates to Comply With All State and Federal Laws, Including
Laws Pertaining to the Donation of Fetal Tissue for Research
i. PPFA Guidance to Affiliates Regarding Human Fetal Tissue Donation
Specifically Advises That It Is Illegal to Receive “Valuable Consideration” for
Fetal Tissue, and Requires Affiliates to Ensure that Reimbursement Represents
Actual Costs
The NIH Revitalization Act of 1993 established the legal standards governing fetal tissue
donation.
2
The law states, “It shall be unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human fetal tissue for valuable consideration if the transfer affects
interstate commerce.”
3
The law further provides: “The term ‘valuable consideration’ does not
include reasonable payments associated with the transportation, implantation, processing,
preservation, quality control, or storage of human fetal tissue.”
4
Current PPFA guidance on fetal tissue donation tracks federal law, and it clearly and
explicitly prohibits affiliates from receiving valuable consideration for fetal tissue. The guidance
also requires affiliates to ensure that reimbursement represents actual costs incurred by the
affiliate. The current PPFA guidance, revised in May 2015, provides as follows:
Federal law prohibits the payment or receipt of money or any other form of valuable
consideration for fetal tissue, regardless of whether the program to which the tissue is
being provided is federally funded or not.
There are limited exceptions that allow reimbursement for actual expenses (e.g. storage,
processing, transportation, etc.) of the tissue. If an affiliate chooses to accept
reimbursement for allowable expenses, it must be able to demonstrate the reimbursement
represents its actual costs. PPFA recommends that an affiliate consult with CAPS
[Consortium of Abortion Providers] about steps to take to document and demonstrate
actual cost. [emphasis in the original]
5
2
National Institutes of Health Revitalization Act of 1993, P.L. No. 103-43.
3
42 U.S.C. § 289g–2(a).
4
42 U.S.C. § 289g-2(d)(3).
5
Planned Parenthood Federation of America, Programs for Donation of Blood And/Or
Aborted Pregnancy Tissue for Medical Research (May 2015).
3
The guidance also advises affiliates that “there are federal, and frequently, state laws that
govern these activities, as well as ethical considerations. Great care must be taken to assure that
these programs are above reproach in all respects.”
6
In a briefing with Committee staff, Dr. Raegan McDonald-Mosley, the Chief Medical
Officer of PPFA, explained that PPFA accredits its affiliates. Affiliates are autonomous legal
entities, with their own separate boards, executive personnel, and legal counsel.
7
Dr. McDonald-Mosley further described how PPFA oversees its affiliates and verifies
their compliance with its fetal tissue donation guidance. Each affiliate is independently
responsible for ensuring compliance with the guidance, as well as with all applicable state and
federal laws.
PPFA oversees its affiliates through an accreditation process, whereby each affiliate is
reviewed at least once every three years. Affiliates are evaluated on a range of hundreds of
possible elements of performance, including, as of 2013, compliance with PPFA’s fetal tissue
donation guidance. Accreditation involves both offsite reviews of affiliate documentation as
well as onsite reviews that include interviews with staff and direct observation of patient care.
8
Non-compliance with PPFA required standards may affect an affiliate’s accreditation status and
result in actions that jeopardize that affiliate’s ability to continue to use the Planned Parenthood
trademark.
9
Although the precise language of PPFA’s fetal tissue guidance has been revised over the
years, affiliates have always been required to ensure that their tissue donation programs are in
compliance with all state and federal laws, including the prohibition on receiving valuable
consideration. For example, an earlier version of the guidance from 2001 provided to the
Committee instructs affiliates that federal laws “forbid the payment or receipt of valuable
consideration for fetal tissue. However, they permit ‘reasonable payments associated with the
transportation, implantation, processing, preservation, quality control, or storage’ of fetal
tissue.”
10
This guidance was reissued to affiliates in 2011.
11
6
Id.
7
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned Parenthood
Federation of America, to House Energy and Commerce Committee Staff (Aug. 14, 2015).
8
Id.
9
Planned Parenthood Federation of America, U.S. House of Representatives Committee
on Energy & Commerce, Subcommittee on Oversight & Investigations, Follow-Up Questions
Dated August 20, 2015.
10
Planned Parenthood Federation of America, Memorandum to Affiliate Chief
Executives, Affiliate Medical Directors, Patient Services Directors Re: Federal Regulations for
Aborted Pregnancy Tissue Donation Programs (Apr. 4, 2001).
11
Planned Parenthood Federation of America, Memorandum to Affiliate CEOs, Medical
Directors, Patient Services Directors Re: Aborted Pregnancy Tissue Donation Programs (Jan. 26,
2011).
4
Several years ago, PPFA undertook an effort to revise their Manual of Medical Standards
and Guidelines (the Manual) by removing those sections not directly related to clinical care.
12
According to Dr. McDonald-Mosley, the Manual is a desk reference for clinicians for directing
medical care.
13
It is intended to assist practitioners in providing regular care for a patient and is
revised on a two-year cycle. As a result of this revision effort, the fetal tissue guidance was
separated from the Manual and is now a standalone document.
14
It is distributed to affiliates
through the PPFA intranet. Dr. Deborah Nucatola, who is PPFA’s Senior Director for Medical
Services and has had primary responsibility for the Manual since July 2009, explained to
Committee staff that guidance on fetal tissue donation was removed from the Manual as part of
this process to streamline and remove non-clinical information.
15
As of November 6, 2013, affiliates are now permitted to facilitate fetal tissue donation
without prior approval from PPFA.
16
PPFA distinguishes between “core services,” which all
affiliates are required to provide, such as well-women visits and education and prescribing for all
FDA-approved methods of contraception, and services which are voluntary or optional for
affiliates to offer.
17
Earlier versions of the fetal tissue guidance instructed affiliates to “submit a
written request to initiate an aborted tissue and/or blood donation program to PPFA for review
and approval.”
18
According to PPFA, it “implemented this policy change as part of a broader
effort to reduce the administrative burden on affiliates and support affiliate service expansion.
12
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
13
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
14
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
15
Id.
16
Planned Parenthood Federation of America, U.S. House of Representatives Committee
on Energy & Commerce, Subcommittee on Oversight & Investigations Follow-Up Questions
Dated August 20, 2015.
17
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
18
Planned Parenthood Federation of America, Manual of Medical Standards and
Guidelines: Programs for Donation of Blood And/Or Aborted Pregnancy Tissue for Medical
Research, Education, or Treatment (June 2011).
5
This overhaul affected other services besides facilitation of tissue donation; PPFA no longer
requires prior approval for an affiliate to offer certain other non-core services.”
19
ii. PPFA Guidance to Affiliates Includes Additional Requirements Pertaining to
Fetal Tissue Transplantation Research, Although This is Not Required by Law
Federal law imposes additional requirements on providers and on researchers when the
donated tissue is used in federally funded research involving the transplantation of human fetal
tissue for therapeutic purposes.
20
Under the statute, human fetal tissue may be used in federally
funded research on the transplantation of fetal tissue if the attending physician declares in writing
1) that the woman’s consent for abortion was obtained prior to requesting or obtaining consent to
donate the fetal tissue for research; 2) that the timing, method, or procedure used to terminate the
pregnancy were not altered in order to obtain the tissue; 3) that the abortion was performed in
accordance with applicable state law; and 4) the woman has been fully informed of the
physician’s interest, if any, in the research, and of any medical or privacy risks associated with
the tissue donation.
21
According to the National Institutes of Health (NIH), the federal government has not
funded any fetal tissue transplantation research since 2007.
22
The federal rules relating to the
timing and method of abortion are therefore not applicable to any recent fetal tissue donations in
the United States. However, PPFA’s fetal tissue donation guidance nonetheless incorporates
these requirements as recommended practices for affiliates. The 2015 PPFA guidance provides:
Federal law establishes additional requirements applicable whenever the research
involving fetal tissue is conducted or supported by the federal government. PPFA
recommends that these requirements be adhered to without regard to whether the tissue
donation program is federally supported or not. These requirements are:
1. That the client’s consent to donate not be sought until after she has decided to have an
abortion and has signed the consent form for the abortion.
19
Planned Parenthood Federation of America, U.S. House of Representatives Committee
on Energy & Commerce, Subcommittee on Oversight & Investigations Follow-Up Questions
Dated August 20, 2015.
20
Congressional Research Service, Fetal Tissue Research: Frequently Asked Questions
(July 21, 2015).
21
42 U.S.C. § 289g-1(b)(2). The statute also requires that the patient sign a statement
that 1) the donation is made without any restriction regarding the identity of individuals who
may be recipients of transplantations of the tissue; and 2) the woman has not been informed of
the identity of any such individuals. 42 U.S.C. § 289g-1(b)(1). The statute imposes additional
requirements on researchers, which are not discussed here. 42 U.S.C. § 289g-1(c).
22
Letter from Jim R. Esquea, Assistant Secretary for Legislation, Department of Health
& Human Services, to The Honorable Fred Upton, Chairman, House Committee on Energy and
Commerce (July 14, 2015) (“Fiscal year 2007 was the most recent year NIH provided funding
for this purpose.”).
6
2. That the client acknowledge that the blood or tissue is being donated as a gift and that
she will not be paid.
3. That the client acknowledge that she has not been told and that she has no control over
who will get the donated blood and/or tissue or what it will be used for.
4. That there will be no changes to how or when the abortion is done in order to obtain
the blood or tissue.
23
The guidance further instructs affiliates that “It must be documented that no substantive
alteration in the timing of terminating the pregnancy or of the method used was made for the
purpose of obtaining the blood and/or tissue.”
24
Similarly, earlier versions of the PPFA guidance required the clinician to make a notation
that: “[a]borted tissue was donated,” “[c]onsent for the abortion was obtained prior to requesting
or obtaining consent for the tissue donation,” and “[n]o substantive alteration in the timing of
terminating the pregnancy or of the method used was made for the purpose of obtaining the
tissue.”
25
Previous versions of the guidance also required specific language in consent forms
used for tissue donation. These versions were issued under the previous system, in which
affiliates were required to seek service approval from PPFA for tissue donation programs.
26
Appended to PPFA’s May 2015 guidance is a recommended sample consent form, which
prompts the patient who is donating tissue to affirm the following statements:
Before I was shown this consent, I had already decided to have an abortion and signed a
consent form for it.
I agree to give my blood and/or the tissue from the abortion as a gift to be used for
education, research, or treatment.
I understand I have no control over who will get the donated blood and/or tissue or what
it will be used for.
23
Planned Parenthood Federation of America, Programs for Donation of Blood And/Or
Aborted Pregnancy Tissue for Medical Research (May 2015).
24
Id.
25
See, e.g., Planned Parenthood Federation of America, Manual of Medical Standards
and Guidelines: Programs for Donation of Blood And/Or Aborted Pregnancy Tissue for Medical
Research, Education, or Treatment (May 2005).
26
Planned Parenthood Federation of America, Manual of Medical Standards and
Guidelines: Programs for Donation of Blood And/Or Aborted Pregnancy Tissue for Medical
Research, Education, or Treatment (June 2011); Planned Parenthood Federation of America,
Manual of Medical Standards and Guidelines: Aborted Pregnancy Tissue Donation Programs
(March 2001).
7
I have not been told the name of any person who might get my donation.
I understand there will be no changes to how or when my abortion is done in order to get
my blood or the tissue.
I understand I will not be paid.
I understand that I don’t have to give my blood or pregnancy tissue, and this will not
affect my current or future care at (affiliate name).
27
Earlier versions of the guidance included a substantially similar consent form, although use of
the consent form was required rather than recommended under the previous system of service
approvals by PPFA, and substantive deviations from the consent form required approval from
PPFA Medical Services.
28
B. There Is No Evidence that Planned Parenthood Affiliates Knowingly Received
Valuable Consideration in Exchange for Fetal Tissue
The Committee has received no evidence that any Planned Parenthood affiliate or
employee ever received any “valuable consideration” for donated fetal tissue. The information
and the documentary evidence received by the Committee support Planned Parenthood’s
assertions that the few affiliates that have participated in fetal tissue donation comply with the
requirement to limit reimbursement to reasonable payments associated with facilitating tissue
donation.
In an August 27, 2015, letter to congressional leaders, PPFA President Cecile Richards
listed the reimbursement rates at affiliates that are currently or were recently participating in fetal
tissue donation.
29
At present, only two out of PPFA’s 59 affiliates are participating in fetal tissue
donation, and only one affiliate is receiving any reimbursement for costs. An additional four
affiliates facilitated fetal tissue donation for research in the past five years.
30
The California
affiliate that is currently participating receives a reimbursement of $60 per tissue specimen from
a TPO. The other four affiliates, which had participated in fetal tissue donation programs in the
past five years, either sought no reimbursement or had reimbursement rates ranging from $45 to
27
Planned Parenthood Federation of America, Programs for Donation of Blood And/Or
Aborted Pregnancy Tissue for Medical Research (May 2015).
28
See, e.g., Planned Parenthood Federation of America, PPFA Manual of Medical
Standards and Guidelines: Programs for Donation of Blood and/or Aborted Pregnancy Tissue
for Medical Research, Education, or Treatment (June 2011).
29
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
30
Planned Parenthood Federation of America, U.S. House of Representatives Committee
on Energy & Commerce, Subcommittee on Oversight & Investigations Follow-Up Questions
Dated August 20, 2015.
8
$55 per tissue specimen.
31
The letter states, “[i]n every case, the affiliates report that these
amounts were intended to recover only their costs, as allowed under the federal law and our
guidance.”
32
The evidence received by the Committee during the course of this investigation
supports this assertion.
The May 2015 tissue donation guidance notes that affiliates “must be able to demonstrate
the reimbursement represents its actual costs.” Dr. McDonald-Mosley explained that the way
that each affiliate determines cost is fact-specific to that affiliate.
33
Dr. Nucatola stated that fetal
tissue donation is not a revenue stream for affiliates, and that reimbursement should generally be
reasonable for the impact it has on the clinic.
34
Both the statute governing fetal tissue donation and Planned Parenthood’s May 2015
guidance on pregnancy tissue donation outline the exceptions for reimbursement. The types of
costs that may arise for clinics facilitating tissue donation include staff time to identify patients
who are interested in donating fetal tissue, staff time spent explaining fetal tissue donation and
securing consent, staff time spent drawing maternal blood samples, space in the pathology lab,
storage of supplies, sterilization of equipment, and other related costs.
In a briefing with the Committee, Cate Dyer, the Chief Executive Officer of
StemExpress, stated that it is her understanding that the valuable consideration requirement
applies to all fetal tissue her company obtains.
35
The contracts between StemExpress and two
Planned Parenthood affiliates state, “The reasonable costs associated with the services specified
in this Agreement shall be fifty-five dollars ($55.00) per POC [product of conception]
determined in the clinic to be usable.”
36
According to Dyer, the reimbursement covers the space
and storage at the Planned Parenthood facility, particularly within the lab and pathology
departments, sterilization of equipment, and staff participation in consent and facilitating
involvement in the clinic. Additionally, clinic staff is also involved in obtaining maternal blood
samples for StemExpress, so that the company can screen for infectious diseases. Dyer stated
31
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
32
Id.
33
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
34
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
35
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015).
36
Services Agreement between Stem-Ex, LLC and Planned Parenthood affiliate (Apr. 1,
2010), and Services Agreement between Stem-Ex, LLC and Planned Parenthood affiliate (May
15, 2012).
9
that she believed Planned Parenthood is losing money on fetal tissue donation, given the amount
of staff time involved and space StemExpress takes up at the clinics.
37
In a briefing with Committee staff, Dr. Ben Van Handel, the Executive Director of
Novogenix Laboratories, confirmed that at the affiliate where Novogenix has a contract, Planned
Parenthood set the price of $45 for services rendered on a per specimen basis.
38
The contract
between Novogenix and the Planned Parenthood affiliate states, “Novogenix will reimburse [the
Planned Parenthood affiliate] for reasonable administrative costs associated with the
identification of potential donors, as well as the obtaining of informed consent.”
39
Similarly, in a briefing with Committee staff, Advanced Bioscience Resources (ABR)
confirmed that the reimbursement rate at the Planned Parenthood affiliate with which they
partner is $60 per patient product of conception.
40
The contract between ABR and the Planned
Parenthood affiliate states:
[Affiliate] will provide, and ABR will pay the reasonable costs for, services and facilities …
associated with obtaining consents and with the removal of fetal organs and tissues from
POCs [products of conception], and their processing, preservation, quality control,
transportation, and storage; including appropriate space in which ABR employees can work,
disposal services for non-used portions of cadaveric materials, and for seeking consent for
donation of tissues and organs from appropriate donors, and maintaining records of such
consents so that verification of consent can be supported.
41
C. There Is No Evidence That Planned Parenthood Physicians Conducted Intact
Dilation and Evacuation To Preserve Fetal Tissue
To date, the Committee has received no evidence that any physician employed by
Planned Parenthood affiliates has performed an “intact” dilation and evacuation (D&E) to
preserve fetal tissue for research. CMP claims suggesting that Planned Parenthood physicians
are violating the Partial Birth Abortion Act in order to preserve fetal tissue for research appear to
have no basis in fact.
37
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015).
38
Briefing by Dr. Ben Van Handel, Executive Director, Novogenix Laboratories, LLC, to
House Energy and Commerce Committee Staff (Sept. 3, 2015).
39
Specimen Donation Agreement Between Novogenix Laboratories, LLC and Planned
Parenthood affiliate (Mar. 1, 2010).
40
Briefing by Linda Tracy, President, Advanced Bioscience Resources, Inc., to House
Energy and Commerce Committee Staff (Sept. 3, 2015).
41
Agreement between Advanced Bioscience Resources, Inc., and Planned Parenthood
affiliate (Oct. 1, 2010).
10
There are three primary methods of surgical abortion: D&E, induction of labor, and
hysterotomy. D&E is the only method available at Planned Parenthood facilities.
42
In a briefing
with Committee staff, Dr. McDonald-Mosley stated to the Committee that the confusion over
“intact” fetuses is the result of deceptive video editing by CMP, and that she believes that the
“intactness” that Planned Parenthood staff are referring to is the intactness of the tissue and
specific organs. She noted that during most procedures, such as a D&E, the fetus is not delivered
intact.
43
She stated there is no evidence that Planned Parenthood staff are removing the fetus in
an intact manner.
44
Similarly, Dr. Nucatola explained that it would be rare for a patient to be sufficiently
dilated to deliver an intact fetus.
45
When questioned whether it was possible to do a D&E
resulting in an intact fetus, she stated that while possible, no Planned Parenthood physician
would intentionally perform such a procedure because to do so would be illegal.
46
Representatives of all three TPOs also stated to the Committee that the donated fetal
tissue specimens they receive do not include intact fetuses.
47
D. There Is No Evidence That Planned Parenthood Physicians Altered the Timing,
Method, Or Procedure Solely for the Purpose of Obtaining Fetal Tissue for
Research
To date, the Committee has not obtained any evidence that Planned Parenthood
physicians altered the timing, method, or procedure of an abortion solely for the purpose of
obtaining fetal tissue for research. The law requires physicians to certify that “no alteration of
the timing, method, or procedures used to terminate the pregnancy was made solely for the
purposes of obtaining the tissue.”
48
Although this section of the law applies only to federally
funded research involving transplantation of human fetal tissue for therapeutic purposes, Planned
42
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
43
Id.
44
Id.
45
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
46
Id.
47
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015); Briefing by Linda Tracy, President, Advanced
Bioscience Resources, Inc. to House Energy and Commerce Committee Staff (Sept. 3, 2015);
Briefing by Dr. Ben Van Handel, Executive Director, Novogenix Laboratories, LLC, to House
Energy and Commerce Committee Staff (Sept. 3, 2015).
48
42 U.S.C. § 289g-1(b)(2)(A)(ii).
11
Parenthood has voluntarily incorporated the principles of the law into its tissue donation
guidance.
49
The PPFA May 2015 guidance instructs affiliates that “[i]t must be documented that
no substantive alteration in the timing of terminating the pregnancy or of the method used was
made for the purpose of obtaining the blood and/or tissue.”
50
There are limited methods of abortion. At Planned Parenthood affiliates, there are two
methods of an early abortion: (1) a medication abortion, and (2) surgical abortion involving
mechanical or manual aspiration.
51
For abortions after approximately 13 weeks gestation, the
only surgical abortion method available at a Planned Parenthood facility is D&E. A physician’s
decision about which method to use is made in consultation with the patient.
52
PPFA has not identified any cases in which changes in methods for abortions were made
for the purposes of fetal tissue donation.
53
It is reasonable for providers to make small
adjustments in technique for clinical reasons, and such small adjustments would not constitute a
change in method or procedure. As is common across the medical profession, techniques are
different for each physician, and physicians commonly make clinical judgments to adjust their
approach in the course of a surgery.
54
Dr. Nucatola confirmed that changing the position of the fetus is not a change in the
method or procedure; instead, it often needs to be done for patient safety. Although she does not
personally change the position of the fetus in her practice, she believes that some physicians may
need to convert the fetus to breech position in order to perform the abortion procedure safely; it
is a matter of skill and experience.
55
49
42 U.S.C. § 289g-1(b)(2)(A)(ii); Letter from Cecile Richards, President, Planned
Parenthood Federation of America, to Speaker John A. Boehner, et al (Aug. 27, 2015).
50
Planned Parenthood, Programs for Donation of Blood and/or Aborted Pregnancy
Tissue for Medical Research (May 2015).
51
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
52
Id.
53
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
54
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015); Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
55
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015)
12
All Planned Parenthood staff emphasized that patient safety is their top priority. Dr.
McDonald-Mosley stated, “The ultimate goal is the safety of the patient.”
56
Dr. Nucatola said,
“Patient safety comes first.”
57
PPFA’s August 27, 2015, letter reiterated the same message:
“Our patient’s health is our paramount concern.”
58
E. There Is No Evidence That Fetal Tissue Was Ever Obtained Without Appropriate
Consent
To date, the Committee has not received evidence that Planned Parenthood affiliates or
employees have been involved in obtaining fetal tissue without appropriate consent. For donated
fetal tissue that will ultimately be used in federally funded fetal tissue transplantation research,
the law requires that informed consent of the patient be obtained prior to donation of fetal tissue,
after a separate consent for the abortion procedure has been obtained.
59
Planned Parenthood has voluntarily incorporated the informed consent requirements into
its guidance, and provides affiliates with a sample consent form that specifically tracks the
requirements of the statute.
60
The consent form prompts the patient to affirm the following
statement: “Before I was shown this consent, I had already decided to have an abortion and
signed a consent form for it.”
61
Dr. Nucatola explained the process, as she understands it, for obtaining informed consent
for tissue donation at the Planned Parenthood health center where she works.
62
First, a medical
assistant counsels the patient in the counseling room and obtains informed consent for the
abortion. The patient signs consent for the abortion before she knows the gestational age of the
fetus. It is only after an exam to determine gestational age that a patient is given the option for
tissue donation.
63
56
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
57
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
58
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
59
42 U.S.C. § 289g-1(b)(2)(A)(i).
60
Planned Parenthood, Programs for Donation of Blood and/or Aborted Pregnancy
Tissue for Medical Research (May 2015).
61
Id.
62
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
63
Id.
13
At Planned Parenthood affiliates participating in fetal tissue donation, either Planned
Parenthood staff or the tissue procurement organization are responsible for obtaining consent.
Both StemExpress and ABR stated that there have been instances where their employees have
obtained informed consent for the tissue donation, depending on timing and clinic staff
availability.
64
According to officials from these companies, their staffs are trained in the process
of obtaining patient consent.
Dyer explained that sometimes StemExpress employees obtain consent for tissue
donation.
65
After the patient has consented to the abortion procedure, StemExpress can meet
with those patients to review the donation consent and answer questions about the process.
Regardless of whether the Planned Parenthood staff or the StemExpress staff obtain consent, the
Planned Parenthood tissue donation consent form is used at the affiliate partnered with
StemExpress.
66
ABR stated that for the most part, Planned Parenthood staff obtains consents.
67
Occasionally, ABR staff obtains consent for the fetal tissue donation in Planned Parenthood
affiliates, always using the Planned Parenthood consent form.
Dr. Van Handel stated that Novogenix ensures that informed consent has been obtained
for all tissue they procure.
68
However, Novogenix employees have no involvement in the
consent process because they do not interact with patients.
StemExpress and ABR stated unequivocally that they have never procured fetal tissue
from a medical waste bin, as was suggested by one of the CMP videos. Dyer, CEO of
StemExpress, confirmed that everything is done with consent.
69
Linda Tracy, President of ABR,
confirmed that tissue has never been obtained from the waste bin at ABR or a facility where
ABR works.
70
64
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015), and briefing by Linda Tracy, President, Advanced
Bioscience Resources, Inc., to House Energy and Commerce Committee Staff (Sept. 3, 2015).
65
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015).
66
Id.
67
Briefing by Linda Tracy, President, Advanced Bioscience Resources, Inc., to House
Energy and Commerce Committee Staff (Sept. 3, 2015).
68
Briefing by Dr. Ben Van Handel, Executive Director, Novogenix Laboratories, LLC, to
House Energy and Commerce Committee Staff (Sept. 3, 2015).
69
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015).
70
Briefing by Linda Tracy, President, Advanced Bioscience Resources, Inc., to House
Energy and Commerce Committee Staff (Sept. 3, 2015).
14
III. EVIDENCE INDICATES THAT THE CENTER FOR MEDICAL PROGRESS
MISREPRESENTED ITSELF TO GAIN ACCESS TO PLANNED
PARENTHOOD FACILITIES AND PERSONNEL
According to Planned Parenthood officials, CMP made a number of misrepresentations
and may have broken several federal and state laws by accessing Planned Parenthood personnel
and facilities in the course of creating the videos.
David Daleiden, an anti-abortion activist and the CMP Project Lead, created a fake tissue
procurement company called BioMax Procurement Services (“BioMax”).
71
According to
Planned Parenthood officials, using BioMax as a front company, CMP was able to gain access to
medical conferences, Planned Parenthood staff, Planned Parenthood facilities, and staff from
legitimate tissue procurement companies in an attempt to discredit Planned Parenthood and its
affiliates.
72
As explained in an August 27, 2015, letter sent from Cecile Richards to Speaker Boehner,
in the course of their campaign, CMP officials may have violated state and federal laws by:
• violating federal tax laws by misrepresenting the Center for Medical Progress as a
biomedicine or bioengineering organization in its application for nonprofit status;
• violating California criminal laws that prohibit forgery, fraud, and perjury by creating
fake drivers licenses or obtaining official licenses fraudulently;
• violating California’s Invasion of Privacy Act by recording individuals without consent;
and
• violating California’s penal code by making false charitable solicitations.
73
CMP may have also committed identity theft and/or credit card fraud.
74
Daleiden’s
attorneys have advised a federal district court that he intends to invoke his Fifth Amendment
right to refrain from self-incrimination in response to a lawsuit by the National Abortion
Federation alleging that Daleiden and his associates violated federal and state laws.
75
71
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
72
Letter from Roger K. Evans, Senior Counsel, Law & Policy, Planned Parenthood
Federation of America, to Chairman Fred Upton, House Committee on Energy & Commerce
(July 20, 2015).
73
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015).
74
Id.
75
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015); Civil Minutes, National Abortion Federation v.
Center for Medical Progress (case no. 15-cv-03522-WHO) (Aug. 21, 2015).
15
In a briefing with Committee staff, Dr. Nucatola stated that she first met the individuals
posing as BioMax in April 2014 at a booth at the annual meeting of the National Abortion
Federation, and they exchanged business cards.
76
These individuals claiming to represent
BioMax then contacted Dr. Nucatola to request a meeting to discuss fetal tissue donation.
According to Dr. Nucatola’s briefing to Committee staff, she agreed to meet with them not to
establish a business relationship, but simply to help this new “company” understand more about
Planned Parenthood and fetal tissue donation. Dr. Nucatola explained to Committee staff that
she accepted the meeting because her patients often want the option to donate and she supports
that option, as well as the research that the donations support. Dr. Nucatola also informed
Committee staff that she has never been in a role to contract with a TPO and played no role with
respect to the contract for fetal tissue donation at the affiliate where she was a provider.
77
BioMax also approached StemExpress under false pretenses, claiming to be a third party
that could help source fetal tissue for research.
78
According to StemExpress, BioMax
represented themselves as a company in the fetal tissue research business and signed a non-
disclosure agreement with StemExpress. They subsequently violated the non-disclosure
agreement, and StemExpress asserts that CMP or “BioMax” conducted themselves in a way that
violated California law.
79
IV. EVIDENCE INDICATES THAT THE CENTER FOR MEDICAL PROGRESS IS
RELEASING INCOMPLETE AND DECEPTIVELY MANIPULATED TAPES TO
THE PUBLIC
On July 14, 2015, CMP began regularly releasing videos purporting to capture Planned
Parenthood and TPO staff discussing violations of the federal law that governs fetal tissue
donation. Thus far, CMP has released nine videos, six of which depict undercover videos with
Planned Parenthood and TPO staff. The three remaining videos feature interviews with a former
StemExpress employee.
CMP has released the “full footage” for the six undercover videos and seven transcripts
purportedly capturing the entirety of the videos.
On August 27, 2015, PPFA released a forensic analysis conducted by Fusion GPS of the
first four videos and accompanying transcripts (both the long and short versions) released by
76
Briefing by Dr. Deborah Nucatola, Senior Director of Medical Services, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 27,
2015).
77
Id.
78
Briefing by Cate Dyer, Chief Executive Officer, StemExpress, to House Energy and
Commerce Committee Staff (Aug. 25, 2015).
79
Briefing by StemExpress to House Energy and Commerce Committee Staff (Sept. 2,
2015).
16
CMP between July 14, 2015 and August 4, 2015.
80
According to its website, Fusion GPS is a
Washington D.C. based firm that “provides premium research, strategic intelligence, and due
diligence services to corporations, law firms, and investors worldwide.”
81
In conducting their
analysis, Fusion GPS additionally commissioned the services of several qualified experts to
review both the videos and the accompanying transcripts.
82
A. Fusion GPS Found That The CMP Videos Lack Credibility and Have “No
Evidentiary Value”
Fusion GPS reviewed four “full footage” videos, which collectively totaled
approximately 12 hours of video footage.
83
The Fusion GPS analysis found that, “A thorough
review of these videos in consultation with qualified experts found that they do not present a
complete or accurate record of the events they purport to depict.” They concluded that, “CMP
edited content out of the alleged ‘full footage’ videos, and heavily edited the short videos so as to
misrepresent statements made by Planned Parenthood representatives.”
The Fusion GPS analysis concluded that the videos have questionable “evidentiary
value.”
84
The analysis states, “the manipulation of the videos does mean they have no
evidentiary value in a legal context and cannot be relied upon for any official inquiries unless
supplemented by CMP’s original material and forensic authentication that this material is
supplied in unaltered form. The videos also lack credibility as journalistic products.”
Fusion GPS also hired an independent transcription agency to examine and transcribe the
four short and “full footage” videos released by CMP between the dates of July 14, 2015, and
August 4, 2015.
85
Fusion GPS found all four transcripts by CMP “contain substantive
omissions,” and one transcript “appears to be grossly edited.” Fusion GPS therefore concluded
that the transcripts released by CMP “cannot be relied upon in official inquiries as a credible text
record of what is said in the videos.”
86
B. The CMP Videos Repeatedly Omitted Representations by Planned Parenthood Staff
About Compliance with the Law
80
Letter from Cecile Richards, President, Planned Parenthood Federation of America, to
Speaker John A. Boehner, et al (Aug. 27, 2015). CMP Analysis, Fusion GPS (Aug. 25, 2015).
81
Fusion GPS, CMP Analysis (Aug. 25, 2015).
82
See, Fusion GPS (online at www.fusiongps.com/) (accessed Sept. 4. 2015).
83
Id.
84
Id.
85
See TranscriptionWing (online at www.transcriptionwing.com) (accessed Sept. 4,
2015).
86
Fusion GPS, CMP Analysis (Aug. 25, 2015).
17
Similar to the findings by Fusion GPS, Planned Parenthood also found that CMP
deceptively edited the videos to suggest deliberate violations of the law.
87
According to
briefings with Committee staff, the short videos deliberately omitted most mentions of efforts to
comply with the law, discussions of fetal tissue donation as a not-for-profit activity, and
conversations about the consent process. In a briefing, PPFA told Committee staff that without
the master tapes, key questions could not be answered about them.
88
PPFA also reported that Dr. Nucatola emphasized that Planned Parenthood is not profit
seeking at least 10 times, but nine of those statements were omitted from the short-form video.
89
A discussion of affiliates seeking to “break even” was also omitted. Additionally, Dr. Nucatola
raised consent requirements 37 times, but none of those are in the short version of the video.
PPFA also stated that Melissa Farrell, the Director of Research at Planned Parenthood
Gulf Coast, an affiliate captured in the undercover videos, referenced compliance with federal
and state laws, but that is not included in the short video. Moreover, according to PPFA,
Planned Parenthood Gulf Coast does not even have a fetal tissue donation program. Although
the CMP video does not make this clear, the Gulf Coast affiliate had only a placental and decidua
donation program in place.
90
V. IMPORTANCE OF FETAL TISSUE RESEARCH
The Committee has received evidence regarding the continuing importance of fetal tissue
in basic scientific research. Although NIH has not funded human fetal tissue transplantation
research since 2007, it continues to fund other research using fetal tissue.
91
In fiscal year 2014,
NIH funded $76 million in research involving fetal tissue.
92
Since the 1930’s, fetal tissue has been used in a broad range of research that has led to
lifesaving discoveries. In the past, human fetal tissue research has been critical in establishing
permanent cell lines for use in vaccine research for diseases such as polio, hepatitis A, measles,
mumps, rubella, chickenpox, and rabies. These established cell lines are currently being used to
establish an Ebola vaccine.
According to information provided by the NIH, fetal tissue continues to be an important
resource for biomedical research. Fetal tissue is used when scientists need a cellular system that
87
Briefing by Dr. Raegan McDonald-Mosley, Chief Medical Officer, Planned
Parenthood Federation of America, to House Energy and Commerce Committee Staff (Aug. 14,
2015).
88
Id.
89
Id.
90
Id.
91
Briefing by the National Institutes of Health to House Energy and Commerce
Committee Staff (Sept. 1, 2015).
92
Id.
18
is less differentiated than adult cells.
93
According to the Department of Health and Human
Services, “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.”
94
Some commentators have argued that technological advances have obviated the need for
research using fetal tissue. When questioned about whether there are alternatives to fetal tissue
for stem cell research, such as induced pluripotent stem cells derived from adult tissue, NIH
acknowledged that such technology bears promise. However, according to NIH, the technology
is not yet mature, and for the immediate future, fetal stem cells continue to play an important role
in scientific research. Indeed, during the period while the new technologies are being developed
NIH said that it is important to continue to have access to fetal tissue to validate these new
methods.
95
NIH also explained the value of fetal tissue studies of diseases and conditions that affect
fetal health and development, organ development, and neural development.
96
NIH noted that for
the study of fetal growth and human development fetal tissue could not currently be replaced.
VI. CONCLUSION
The Committee’s ongoing investigation into Planned Parenthood’s fetal tissue donation
program to date has uncovered no evidence that Planned Parenthood and its affiliates have
violated the law. The Committee has received letters and documents and has conducted
bipartisan briefings with individuals familiar with Planned Parenthood’s fetal tissue donation
program. The information the Committee has gathered revealed that (1) there is no evidence that
Planned Parenthood affiliates knowingly received valuable consideration in exchange for fetal
tissue; (2) there is no evidence that Planned Parenthood physicians conducted intact dilation and
evacuation to preserve fetal tissue for research; (3) there is no evidence that Planned Parenthood
physicians altered the timing, method, or procedure solely for the purpose of obtaining fetal
tissue for research; and (4) there is no evidence that fetal tissue was ever obtained without
appropriate consent. Furthermore, the investigation has found that Planned Parenthood requires
its affiliates to meet stricter standards than are required by federal law.
93
Id.
94
Letter from Jim Esquea, Assistant Secretary for Legislation, Department of Health and
Human Services, to Senators Joni Ernst and Roy Blunt (Aug. 14, 2015).
95
Briefing by the National Institutes of Health to House Energy and Commerce
Committee Staff (Sept. 1, 2015).
96
Briefing by the National Institutes of Health to House Energy and Commerce
Committee Staff (Sept. 1, 2015).
