THE BLOG
10/28/2014 02:34 pm ET Updated Dec 28, 2014

Battling Breast Cancer: FDA Focuses on Progress for Patients

National Breast Cancer Awareness Month is a time when we remember those who have been diagnosed and are living with breast cancer, and the loved ones we have lost to this terrible disease. But while this time of reflection can be somber, we must also recognize the considerable progress we have made in screening for and treating patients with breast cancer.

The Food and Drug Administration is at the forefront of breast cancer detection and treatment, playing a key role in developing a range of medical interventions, including screening technologies and important new therapies. Early treatment, with a range of therapeutic options, increases a patient's chance of survival. This is vital for the care of patients and underscores why the FDA believes that accurate, reliable and available screening is essential for doctors to determine if a woman has breast cancer.

We are dedicated to making available breast imaging tools that will aid healthcare providers to detect breast cancer in its earliest stages. In 2013, the FDA approved a device with software to generate 2D mammograms using data from 3D, X-ray images. This technology helps physicians maximize the benefit of low-dose, X-ray imaging for detecting breast cancer while reducing the amount of radiation to which patients are exposed.

And each year, approximately 30 million mammograms are used to help detect breast cancer early on in the United States. The FDA implements the Mammography Quality Standards Act (MQSA), which is designed to ensure that all women have quality mammography available for the detection of breast cancer in its earliest, most treatable stages. The MQSA requires mammography facilities across the nation to meet uniform baseline quality standards.

For those who are diagnosed with breast cancer, promising treatments are increasingly becoming available. Today, our deeper understanding of the underlying mechanisms of disease and human biology is enabling more effective approaches. With new insights into molecular pathways of cancer, we are seeing the development of new, targeted cancer therapies tailored to the specific characteristics and needs of patients and their disease. To date, there are more than 20 FDA-approved drug treatments for breast cancer. Through continued engagement with patients, oncologists, researchers and drug developers, I am confident that we will continue to identify and develop more effective, life-extending therapies for breast cancer patients -- and hopefully prevention and cures.

In order for us to make continued progress, we must ensure the drugs we approve are properly studied in the patients who will use them. We are learning a great deal more about important differences in breast cancer treatment and response based on differences in tumor type. This represents exciting and meaningful progress. But breast cancer is a disease that transcends age, ethnicity, socioeconomic background and even gender. In that regard, we also need to understand possible differences in how the disease affects different groups. Participation in clinical trials allows us to assess a drug's safety and efficacy in a given population.

Understanding how drugs affect diverse populations is important to the FDA's efforts to ensure drugs are safe and effective for all patients who intend to use them. This is why we released an action plan in August outlining recommendations for improving the completeness and quality of data submitted to the FDA for review. Specifically, the action plan focuses on how to improve inclusion of clinical trial data representing a diverse sample of the general population.

Research shows that individuals from medically underserved populations are more likely to be diagnosed with late-stage diseases that might have been treated more effectively or cured if diagnosed earlier. In the United States, white women have the highest incidence rate for breast cancer but African American women are most likely to die from the disease. These sobering facts are why FDA has undertaken concerted efforts to reach underserved populations.

We have made considerable progress, but there is still much to learn about this life-altering disease that affects many Americans. FDA is deeply committed to applying the best available science to develop the best tools, treatments and opportunities for patients, bringing us closer to a cure.