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Patient Safety Paramount for Cutting Edge Medicines

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Today's advanced medicines, known as biologics, treat some of the most serious and costly medical conditions like cancer, diabetes, and kidney disease. Though it is impossible to make generic versions of these drugs, the 2010 Affordable Care Act has instructed the FDA to figure out how to approve biosimilars -- the imitative versions of biologics -- for the healthcare marketplace. There is potential for biosimilars reduce healthcare costs, but enacting smart biosimilar regulation will be crucial to ensure patient safety.

Patient safety is duly important for the minority community. At the National Minority Quality Forum, we are focused on improving health care for racial and ethnic communities at higher risk for disease and illness than the general population. We believe in leveraging data and new information to combat disparities in health outcomes with better treatment.

And we believe there are several steps the FDA must take to ensure that these drugs help underserved patients rather than introduce them to new risk.

This will be the challenge for the FDA as they attempt to define the biosimilars pathway, with draft guidance to be released soon. To establish an approval pathway for biosimilars, the FDA must first mandate rigorous clinical trials for these new drugs. Because biosimilars are unique unto themselves owing to differences in raw material, cell lines or the production process, they must be evaluated with sufficient scrutiny on an individualized basis. These trials and tests must also be geared toward different patient groups such as minorities rather than the "one-size fits all" approach that too often biases this process.

On the back end of the drug approval pathway, the FDA must set up strong monitoring systems to track and trace products for adverse side effects in patients. Any malfunction in the drug needs to be reportable.

Requiring unique names and clear product labels will help this cause and powerful and complex medications need to be user-friendly to reduce their risk of being mishandled. In addition, the FDA and the medical community must be careful to evaluate these extended therapeutic options like they would the biologic they attempt to replicate.

By the end of this decade, 40 percent of the people in this country will belong to minority groups. It is crucial that the health care communities in both the public and private sector transform their data collection and testing approaches to account for the overall changing face of the American population. New products like biosimilars, which harness the potential to treat serious diseases in a less costly way, will be a welcome addition to 21st century health care. But we must make sure they do not compromise safety in the goal of better health outcomes for our diverse nation.