New law will remove barriers and expand opportunities for cancer researchers
Standing before a room of exuberant Democratic lawmakers and other key supporters, President Obama signed a comprehensive health care overhaul into law last month. The bill passed narrowly in the Senate on Christmas Eve and after months of strategizing, the House managed to narrowly approve the bill on March 20 by a vote of 220-215 with no support from Republicans.
In addition to expanding access and improving health care for millions, the bill addresses some specific priorities for the cancer research community and opens the door to new opportunities.
The new law includes a provision that will create a new office within the National Institutes of Health (NIH), under the director's leadership, charged with speeding translation of basic scientific discoveries into treatments for patients. The Cures Acceleration Network (CAN) will provide grants of up to $15 million per year, per project, to both industry and academic research to speed translational research.
The CAN will be advised by a 24-member board of diverse membership, including leaders in medicine, research and venture capitalism. Rather than creating an unfunded mandate for the NIH, the establishment of the CAN would be dependent on appropriation, requiring Congress to direct funding to it each year through the annual appropriations process.
COMPARATIVE EFFECTIVENESS RESEARCH
Referred to as "patient-centered outcomes research," the new law will establish an independent nonprofit center to conduct and oversee this emerging area of research, which seeks to learn what works in health care by comparing different health care and treatment options. The center will be overseen by a Board of Governors and assisted by expert advisory panels.
There is a clause forbidding the research findings from being construed as guidance for payment, coverage or treatment. The federal government is also forbidden from using the data solely to deny coverage.
CLINICAL TRIALS COVERAGE
The law will address a major barrier to clinical trial participation by requiring that health plans cover routine costs for patients on clinical trials. The language covers all clinical trial stages for cancer and other life-threatening diseases.
The National Center on Minority Health and Health Disparities will be elevated to "Institute" status within the NIH, which would give it additional authority to better coordinate and manage minority health and health disparities research.
GENERIC BIOLOGIC DRUGS
The new law helps to establish a pathway by which generic biologic drugs, or "biosimilars," can be safely and accurately developed and advanced to patients. Under the new law, biologics manufacturers will be granted 12 years of exclusivity before lower-cost generic versions can be developed.
Pharmaceutical companies maintain that the industry needs at least a 12-year period to recoup the billions it spends on developing new therapies.
BREAST CANCER RESEARCH AND PREVENTION
The new law includes a provision sponsored by Rep. Debbie Wasserman-Schultz (D-Penn.) The new law directs the Centers for Disease Control to develop and implement a national education campaign about the threat breast cancer poses to young women. The campaign will be intended to help educate young women and better enable health care professionals to identify the specific threats and warning signs of breast cancer. Grants will be provided to organizations that support young women diagnosed with breast cancer in order to receive the assistance they need including social and psychological support, fertility preservation counseling and recurrence prevention training.
The NIH will be directed to conduct research to develop and validate new screening tests and methods for prevention and early detection of breast cancer in young women. Grants will also be awarded for the provision of health information to young women diagnosed with breast cancer and pre-neoplastic breast diseases.
QUALIFYING THERAPEUTIC DISCOVERY PROJECT CREDIT
The new law allows emerging innovative companies with fewer than 250 employees the ability to apply for a reimbursement of up to 50 percent of the eligible costs associated with the development of new therapies designed to treat or prevent diseases. This credit would fund activities such as hiring researchers and scientists and conducting clinical studies.
Read more from the April 2010 Edition of the AACR Cancer Policy Monitor: