[Congressional Record Volume 163, Number 57 (Monday, April 3, 2017)]
[Extensions of Remarks]
[Pages E425-E426]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 IN RECOGNITION OF DR. STEPHEN OSTROFF

                                  _____
                                 

                           HON. PETE SESSIONS

                                of texas

                    in the house of representatives

                         Monday, April 3, 2017

  Mr. SESSIONS. Mr. Speaker, together with Congressman Eric Swalwell, 
we rise today to thank Acting Commissioner of the Food and Drug 
Administration (FDA), Dr. Stephen M. Ostroff, and his team for their 
efforts to assist Congress and the Administration in improving patient 
enrollment, retention, minority participation and equitable access in 
cancer clinical trials, especially among underserved and 
underrepresented populations.
  Patient participation is the single most critical ingredient to 
successful cancer trials being completed on time and on budget as well 
as bringing life-saving cancer drugs to market.
  Unfortunately, most cancer clinical trials only provide for the cost 
of the trial drug and require the patient to cover all other costs 
affiliated with participation including but not limited to travel, 
lodging, and ancillary medical costs.
  The result of this has been abysmally low cancer participation rates. 
Overall, only 6 percent of eligible cancer patients participate in 
clinical trials and a mere 5 percent of those participants represent 
the Black, Hispanic, Asian, Native American and Pacific Islander 
populations combined. According to Tufts Research, 38 percent of all 
clinical trials fail to finish on time or within budget due to lack of 
enrollment, and an astonishing 11 percent of trials fail to ever enroll 
a single patient, primarily due to the financial burden on patients to 
participate.

[[Page E426]]

  Joined by over a dozen of our colleagues from both sides of the 
aisle, we sent a letter to the FDA regarding possible misperceptions 
surrounding the regulatory meaning of inducement and coercion and asked 
for its assistance in providing clarity.
  The FDA's letter in response we include in the Record today, helps 
provide this needed clarity, explaining that reimbursement is neither 
inducement, coercion, nor even a so-called ``benefit'' but rather fair 
compensation creating parity and equality in cancer trial access. The 
letter also states the FDA's commitment to further addressing our 
concerns when it finalizes guidance on this issue.
  Accordingly, we, along with our colleagues, will continue our 
dialogue with national stakeholders, patient advocacy organizations, 
the pharmaceutical industry, and the Administration to continue to 
improve patient enrollment, retention, minority participation and 
equitable access in cancer clinical trials, especially among 
underserved and underrepresented patients.

                              U.S. Food & Drug Administration,

                                Silver Spring, MD, March 22, 2017.
     Hon. Pete Sessions,
     House of Representatives,
     Washington, DC.
       Dear Mr. Sessions: Thank you for the discussion on 
     September 21, 2016, with Dr. Robert Califf, the former 
     Commissioner of the U.S. Food and Drug Administration (FDA or 
     the Agency) and Dr. Richard Pazdur, regarding the improvement 
     of patient participation, enrollment, retention, and 
     equitable access to oncology clinical trials. In a follow-up 
     letter dated October 6, 2016, you asked the Agency to confirm 
     that it views reimbursement for travel expenses to and from 
     clinical trial sites, including reimbursement for travel 
     costs such as parking and lodging, as permissible and 
     suggested that such reimbursement should not be construed as 
     coercion or inducement.
       As discussed with you on September 21, 2016, FDA generally 
     would not consider reimbursement for such expenses to be 
     undue influence or coercion intended to induce participation 
     in a clinical trial. FDA has stated in the past that it is 
     not uncommon for subjects to be paid for their participation 
     in research, and has provided guidance on how those payments 
     should be addressed during Institutional Review Board (IRB) 
     review of a proposed clinical tria1. When appropriate, the 
     informed consent would identify any additional costs to the 
     participant that may result from participation in the 
     research and whether such expenses would be reimbursed.
       In July 2014, FDA issued a draft guidance entitled, 
     ``Informed Consent Information Sheet Guidance for IRBs, 
     Clinical Investigators, and Sponsors,'' which provides 
     recommendations on informed consent content and the informed 
     consent process. In this draft guidance, the issue of 
     additional cost and payment to research participants is 
     briefly addressed. For example, we recommend that, beyond the 
     costs directly related to participation in the research, it 
     may be appropriate to identify additional costs that the 
     subject may incur. Additional costs may include the loss of 
     income when the subject takes time off from work to 
     participate in the clinical investigation and transportation 
     costs. The consent form would also make clear whether and, if 
     so, how funds for reimbursement will be made available to 
     subjects, or the form would provide direction to subjects 
     regarding how to obtain further information. The draft 
     guidance also states that FDA considers payment to subjects 
     for participation in clinical investigations to be 
     compensation for expenses and inconveniences, not a benefit 
     of participation in research and that if payments are 
     provided, the consent process should not identify them as 
     benefits. Further guidance on when payments to research 
     participants may be considered coercive or an exercise of 
     undue influence is available on FDA's webpage ``Payment to 
     Research Subjects--Information Sheet.''
       As we finalize the draft guidance, we will look for ways to 
     address your concerns about reimbursement of these types of 
     expenses so that the final guidance will be more useful to 
     patients and our stakeholders. We will also take advantage of 
     our educational outreach activities to clarify this issue 
     with the research community.
       Thank you again for bringing this important issue to our 
     attention. Please let us know if you have any further 
     questions.
           Sincerely,
                                         Stephen M. Ostroff, M.D.,
     Acting Commissioner of Food and Drugs.

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