Washington, DC (PRWEB) June 19, 2014
“The promise of personalized medicine will only be achieved when adequate information is available to clinicians to tailor care to the individual and ensure the best health outcomes for all,” said Jane L. Delgado, President and CEO of the National Alliance for Hispanic Health (the Alliance). Citing the “historic and continuing underrepresentation of minorities in clinical trials,” the Alliance and a group of twenty-one health organizations serving diverse communities jointly submitted a letter to FDA Commissioner Margaret Hamburg urging that all biologics, including biosimilars, have distinguishable names to allow for better post-market surveillance of effectiveness.
Biologics represent the cutting edge of medicine, including gene and cell based therapies and are important advances in personalized medicine. The letter to the FDA argues that the “promise for treating and possibly curing debilitating diseases” requires distinguishable names for all biologics as “any potential increase or decrease in the effectiveness of a biologic, along with side effects and adverse reactions, will only be discovered after the treatment is approved for market use.”
The group urges FDA to adopt distinguishable names for all biologics, to “enable the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing [and] assure optimum medical care.”
The letter was signed by the following organizations: National Alliance for Hispanic Health (lead signatory), AIDS Foundation of Chicago, American Liver Foundation, Association of American Indian Physicians, Association of Black Cardiologists, Association of Hispanic Healthcare Executives, Black Women’s Health Imperative, Community Education Group, Fenway Health, HealthHIV, Hispanic Dental Association, Morehouse School of Medicine, National Association of Hispanic Nurses, National Coalition for LGBT Health, National Hispanic Chamber of Commerce on Health, National Hispanic Medical Association, National Medical Association, Pozitively Healthy, Roundtable of Hispanic Professional Health Associations, The San Francisco AIDS Foundation, Sickle Cell Disease Association of America, Inc., and The Wall Las Memorias.
Editors Note: Letter available at http://www.hispanichealth.org/biosimilars-news.html.