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Cancer Policy Monitor: August 2, 2016          

House Appropriations Committee Approves $1.25 billion Increase for NIH in Labor-HHS BillAACR Partners with FDA on a Workshop to Discuss How Liquid Biopsies can Transform Cancer Patient Care
AACR and Patient and Medical Research Organizations Discuss the Common Rule with OHRP
Still Time to Register for the Rally for Medical Research Hill Day 2016

House Appropriations Committee Approves $1.25 billion Increase for NIH in Labor-HHS Bill         

On July 15, Congress adjourned for a seven-week congressional recess. Just before they left town, the House Appropriations Committee approved its fiscal year (FY) 2017 Labor-HHS appropriations bill. The bill, typically one of the committee’s most contentious, provides a $1.25 billion (3.9 percent) increase for the National Institutes of Health (NIH), which would bring the agency's budget to $33.3 billion. The action on the House Labor-HHS-Education Appropriations Subcommittee bill follows work in the Senate Appropriations Committee, which in June approved a $2 billion funding increase for the NIH.

The actions by the House and Senate Appropriations Committees are an important achievement in prioritizing the important research efforts of our nation’s researchers and physician-scientists who work tirelessly to provide hope to the millions of families battling devastating diseases such as cancer.

These noteworthy steps build upon the momentum that began in December 2015 when Congress passed the FY 2016 omnibus appropriations bill that provided a $2 billion increase for the NIH and a corresponding $264 million increase for the National Cancer Institute (NCI). Despite the lower mark in the House, Subcommittee Chairman Tom Cole (R-Okla.), noted his commitment to increasing NIH funding as the appropriations process moves forward in that chamber. Cole acknowledged the “importance of building on what we accomplished [for NIH] last year and even what [the committee has] proposed this year so far.” Cole added that he believes the committee will be able to “raise the number that’s already in the base bill substantially, working together across the aisle, because our friends in the Senate have the same goal.”

The AACR issued a press release commending Chairman Cole for proposing a $1.25 billion increase for the NIH in the subcommittee's FY 2017 bill.

Congress’ waning legislative calendar suggests the likelihood of a temporary spending bill, or continuing resolution (CR), to fund the government through at least the November elections.

In addition to pushing for a $2 billion increase for the NIH (consistent with the Senate mark) in FY 2017, the AACR will continue to urge Congress to complete its work on the FY 2017 spending bills before the end of the calendar year. A long-term CR would be the worst case scenario for NIH funding, particularly because there is overwhelming bipartisan support for medical research this year, and next year brings added uncertainty because of the impending changes in the administration and on Capitol Hill.

The AACR also encourages its members and other advocates to TAKE ACTION and contact their legislators to complete their work on a FY 2017 spending bill that provides predictable, robust and sustained funding for cancer research and medical science.

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AACR Partners with FDA on a Workshop to Discuss How Liquid Biopsies can Transform Cancer Patient Care            

In an effort to address the challenges and identify next steps to move the field of liquid biopsies forward, the FDA and AACR jointly held a public workshop on “Liquid Biopsies in Oncology Drug and Device Development,” in Washington, D.C., July 19. More than 900 people registered for this workshop, which provided a forum for the discussion of relevant scientific advances in the field and of the regulatory environment that will support the translation of this technology into improved patient care.

The public workshop was co-chaired by Gideon Blumenthal, MD, from the Office of Hematology and Oncology (OHOP) and Center for Drug Evaluation and Research (CDER) at the FDA; Pasi Jänne, MD, PhD, from Dana-Farber Cancer Institute and Harvard Medical School, and a member of the AACR Regulatory Science and Policy Subcommittee; and Reena Philip, PhD, from the Division of Molecular Genetics and Pathology (DMGP), Office of In Vitro Diagnostics and Radiological Health (OIR), and Center for Devices and Radiological Health (CDRH) at the FDA.

Liquid biopsies, noninvasive tests performed on biofluids to detect genetic alterations in tumors, are a recent revolution in the oncology field. When successfully integrated into clinics, liquid biopsies have the potential to improve cancer diagnosis, monitoring, drug development, and, ultimately, patient outcomes. This technology is rapidly advancing – last month, the U.S. Food and Drug Administration (FDA) approved the first liquid biopsy test, a companion diagnostic called cobas® EGFR Mutation Test v2, to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with the EGFR-targeted therapeutic erlotinib (Tarceva).

Scientists from Roche Molecular Systems Inc., and the FDA, who were involved in the development and approval of the cobas® EGFR Mutation Test v2 for use in analyzing cfDNA from lung cancer patients, took the audience through the major steps in the process, including, the development, testing, validation, generating data that fetched the FDA approval, other premarketing studies, regulatory considerations, and clinical reproducibility studies and nonclinical performance studies following FDA approval.

While liquid biopsies offer manifold possibilities for improving cancer care, like with any emerging technology, there are many practical and logistical challenges in taking this technology to the next level and making it a standard of care for cancer patients.

Experts from various sectors of cancer care, including cancer centers and research institutes, pharmaceutical industries, federal agencies, patient advocacy groups, and payers discussed the state of the science, the possibilities and challenges of developing liquid biopsy-based tests, and mechanisms to accelerate the applications of such tests in improving patient care.

At the end of the day, what matters to a cancer patient is whether the test is “reliable, accurate, and leads to safe and effective therapy,” Blumenthal noted. Efforts by the AACR and the FDA to bring together thought leaders and stakeholders in the field offers immense hope that such technologies will soon be translated into improved cancer patient outcomes.

See details on the topics discussed at the workshop and a list of speakers.

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AACR and Patient and Medical Research Organizations Discuss the Common Rule with OHRP            

The AACR and eight patient and medical research organizations met with, Jerry A. Menikoff, MD, JD, director, and staff of the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on July 25 to discuss the 2015 Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).

The meeting built upon the April roundtable discussion hosted by the AACR, which convened both patient and medical research organizations to discuss the impact of the Common Rule on not only the research enterprise but the patient community as well. The Common Rule is not a patient versus research issue and not a cancer-centric issue but one that impacts all of health research and care.

The diverse group of patient and medical research organizations representing both cancer and non-cancer communities met with Dr. Menikoff and the OHRP staff to advocate for the areas within the proposed rule that have some consensus on being common sense productive changes to the Common Rule – areas including: implementing single Institutional Review Board (IRB) for multisite studies, the streamlining of the informed consent process, the additional exemption categories with modified informed consent, and the harmonization of guidance among the Common Rule agencies. Additionally, each of the organizations presented their perspectives on the most controversial proposed change to the Common Rule –the expansion of the definition of “human subject” to include all biospecimens regardless of identifiability. The OHRP staff heard the importance and value of biospecimens for medical research and the need for patients to get the right treatments at the right time.

OHRP and 19 other federal departments and agencies retain the final decision on whether to move forward with the finalization and implementation of this version of the proposed Common Rule before the end of the current administration. The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised their existing human subjects regulations. The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 federal departments and agencies.

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Still Time to Register for the Rally for Medical Research Hill Day 2016           

The fourth annual Rally for Medical Research Hill Day will be held Sept. 21-22, 2016, in Washington, D.C. Held every September, this Capitol Hill Day event continues the momentum established in 2013, and includes more than 300 national organizations coming together in support of the Rally for Medical Research. The purpose of the rally is to call on our nation's policymakers to increase funding for National Institutes of Health (NIH) and raise awareness about the importance of continued investment in medical research that leads to more progress, more hope, and more lives saved.

To register for the Rally Hill Day and view the highlight video from last year's rally please visit: Rallyformedicalresearch.org.

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