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FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

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Current Actions

Law to Exempt Employee Wellness Plans from GINA Protections

The Genetic Information Nondiscrimination Act (GINA) was passed in 2008. The law prohibits insurance companies and employers from using a family history of disease or genetic test results to discriminate against people. A new law introduced into congress could weaken GINA and allow employers to require employees to provide genetic information in order to participate in company-sponsored wellness programs. Read our letter on this important issue.

FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests

Next generation sequencing (NGS) describes new technologies that allow rapid sequencing of large segments of an individual’s DNA. NGS technology has the potential to accelerate “personalized” or “precision” medicine, the tailoring of medical treatment to the individual characteristics of each patient. Unlike other laboratory tests that typically detect a single or a defined number of substances to diagnose a limited set of conditions, a single NGS test can identify thousands -- even millions -- of genetic variants and the results of that test could be used to diagnose or predict an individual’s risk of developing many different conditions or diseases. The FDA is drafting plans for regulatory oversight of NGS. FORCE submitted this testimony at a public hearing on recommendations for their regulatory plan.

Recommendations for Population-Wide BRCA Testing

New research and public comments have recently raised the subject of expanding BRCA genetic testing to all women of Ashkenazi Jewish ancestry, or offering testing to every woman in the U.S. as part of routine medical care.  FORCE is working with its scientific advisory board and other experts to evaluate these proposed changes in health care practice. Download a copy of our brief statement on this issue. We plan to convene a forum of experts at our 2015 Joining FORCEs Conference to discuss the many aspects of the topic and will publish a white paper based on conclusions from this session.

FDA Approval of Lynparza (Olaparib)

On December 19, 2014, the FDA announced approval of Lynparza (also known as olaparib) for women with BRCA mutations who have ovarian, fallopian tube or primary peritoneal cancer, and who responded favorably to their initial treatment. FORCE has been a strong advocate for PARP inhibitor research for nearly a decade. This is the first FDA-approved PARP inhibitor, and it is a great win for the HBOC and BRCA community. Read more...

Participation in Amicus Regarding SCOTUS Oral Contraception Cases

In March 2014, the Supreme Court heard two cases, the Hobby Lobby case and the Conestoga Wood case, about birth control coverage under the Affordable Care Act (ACA).  ACA mandates coverage of several preventative services with no cost sharing, one of which is birth control.  In these cases, the companies asserted that the mandate infringes on their religious rights under the Religious Freedom Restoration Act.  On July 2, 2014 the Court ruled thatsome family-owned or other closely held businesses can opt out of the federal requirement to pay for contraceptives in health coverage for their workers.FORCE supports coverage of oral contraceptives as it is one of the only nonsurgical options for decreasing a women's risk of ovarian cancer.  For the HBOC community, this is a women’s health issue. FORCE joined the Ovarian Cancer National Alliance and others in submitting an amicus brief on this issue. Visit the National Women's Law Center or the Ovarian Cancer National Alliance for more information on this topic.

USPSTF Guidelines for BRCA Risk Assessment, Genetic Counseling, and Genetic Testing

The United States Preventive Services Task Force (USPSTF) is a panel of experts in prevention and evidence-based medicine which conducts scientific reviews of and develops recommendations on the effectiveness of a broad range of preventive services. In December 2013, the USPSTF released new guidelines for Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women. Read more...

Myriad Genetics Patent Infringement Lawsuit

In June 2013, the US Supreme Court invalidated Myriad's patents on the BRCA1 and BRCA2 genes. Since then, a number of laboratories began offering genetic tests for BRCA mutations. Myriad filed suit against most of these companies, alleging that their BRCA tests infringe on patents not invalidated by the Supreme Court decision. Myriad asked the court to block Ambry and Gene by Gene from BRCA testing until the patent infringement case is resolved. Read more...

FDA's Patient-Focused Drug Development Program

The FDA's Prescription Drug User Fee Act (PDUFA) authorized the FDA to choose 20 different disease areas for concentration to expedite drug development and review. The FDA chose breast cancer as one of the disease areas, and they will be holding a meeting on April 2, 2015 to gather patients' perspectives. Read more...

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