The U.S. House of Representatives Energy and Commerce Committee recently launched an initiative called 21st Century Cures aimed at finding the best reform for regulations governing the drug approval process, as well as how best to move forward toward cures. The group has held several hearings and forums on topics ranging from modernizing clinical trials to personalized medicine.
During a comment period, AACI submitted remarks to the committee, thanking members for their commitment to ensuring quality care for cancer patients, as well as for providing researchers with the resources that they need to develop better cancer treatments and, ultimately, to find cures.
AACI reminded Congress that the partnership between the federal government and our nation’s cancer centers is mutually beneficial, and cancer centers continue to make strides in biomedical research thanks to federal funding. Without such support, research projects with the potential to deliver breakthrough therapies would not be possible. The committee asked what Congress can do to improve the digital health care landscape. AACI noted that while progress can be made to help the U.S. maintain its standing as the leader in biomedical research, the negative impact of flat or decreased funding to the NIH and NCI is a far greater concern.
AACI informed the committee that its cancer centers are collaborating through AACI’s Molecular Diagnostics Initiative (MDI), which addresses clinical oncology’s transition from a treatment model based on the anatomic site of tumor origin to a model in which the molecular characteristics of the tumor guide treatment. Targeted cancer therapies are on the rise, requiring the development and implementation of companion diagnostic approaches and identifying patients who may respond to particular therapies. Gene mutations and other predictors allow oncologists to foresee patient sensitivity or response to specific therapies.
MDI participants are considering formulation of a white paper that would include recommendations regarding regulatory and commercial issues surrounding molecular diagnostics and clinical trials. Of particular interest are two challenges: 1) acquisition of medications for patients on trials, and 2) inconsistencies in guidelines for determining when an investigational device exemption is required before a trial can proceed. AACI hopes to share the recommendations with the 21st Century Cures Initiative when available.
— Jennifer W. Pegher, AACI Government Relations Manager