Patient groups join call for data protection

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Biomedical innovation is not only key to our industry’s future, but more importantly, continued medical breakthroughs are vital to patients living with debilitating diseases and their families. Without ongoing progress in our industry, patients of today and tomorrow have limited hope for future cures and therapies. Many patient groups have entered the debate on Capitol Hill over establishing a pathway for approval of biosimilars because they know how critical continued innovation is to finding new therapies and cures for diseases. A number of these groups are asking Congress to ensure biotechnology companies are able to continue to innovate, with many joining BIO in asking for a minimum of 12 years of data exclusivity, the amount of time during which the Food and Drug Administration (FDA) may not rely on an innovator’s proprietary safety and efficacy data to approve a competitor’s product. As the AIDS Institute, Community Access National Network, CAEAR Foundation and National Minority AIDS Council noted in a July 13th letter to Senator Ted Kennedy (D-MA), “innovations have turned what was once a terminal illness into a potentially chronic, manageable condition.” They added, “We believe health care reform should improve quality and reduce costs, but it must be crafted in such a way as to strongly support continued medical innovation. That is why we strongly urge you to include a period of data exclusivity relative to biologics of 12 years.” In a July 16th letter to Rep. Anna Eshoo (D-CA), the ALS Association noted that there is no effective treatment for people with ALS, which is a terrible neurodegenerative disease that erodes a person’s ability to control muscle movement. According to the group, “legislation that reduces costs without promoting new technologies will be of little help to people with ALS whose lives depend on the development of new treatments.” Likewise, the Alliance for Aging Research noted in a letter to Rep. Eshoo that, “The creation of a well-defined process for approving biosimilars will help sustain investment in this vital area of therapy development and allow for these treatments to one day be made widely available to patients who otherwise could not have access to them.” Thanks to billions of dollars in research and development, we are getting closer to discovering cures to diseases we once thought uncurable. HIV/AIDS was once seen as a death sentence. Today, people with HIV/AIDS are living longer, healthier lives – something we didn’t think was possible when the disease was first beginning to spread just a few short decades ago. According to the American Cancer Society, between 1991 and 2006, the cancer death rate decreased by 16 percent. The progress shouldn’t stop here. Biotech companies across the nation have more than 600 new products in the pipeline, and the future is wide open. Let’s hope Congress keeps it that way.