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Research doesn’t end on a medicine’s approval

Andrew Powaleny   |     March 16, 2016   |   SHARE THIS

Research is a critical part of the development of new medicines, but it doesn’t stop once the medicine is approved by the U.S. Food and Drug Administration (FDA).  In fact, that’s when post-approval research and monitoring begin and they help all health care stakeholders, including physicians and patients, to better understand the full value of the medicine. Today, PhRMA released a new video about the importance of post-approval research, featuring Dr. Tim Garnett, Chief Medical Officer of Eli Lilly & Company.

Post-approval research utilizes data produced in the practice of medicine, including from patients, providers and payers. This information is known as real-world evidence (RWE) and it helps physicians, patients, payers, health authorities and biopharmaceutical companies better understand the medicine and its appropriate use. Assessment of RWE could lead to the discovery of new potential uses for the medicine and/or to a greater understanding of how the medicine can work with other therapies to deliver greater benefit to the patient.

These findings can lead to expanded treatment options and mean greater hope for patients. For example, medicines initially developed for use in rheumatoid arthritis have been shown to also help treat other autoimmune conditions that share similar molecular pathways, including Crohn’s disease and ulcerative colitis. The same is true in cancer research. Oncology therapies often have clinical value in types of cancers distinct from the original indication(s) for which they are approved. Studies conducted and reported after the initial approval commonly explore additional indications and, in many instances, a therapy demonstrates significant clinical benefit in a different disease.

In addition to post-approval research, biopharmaceutical companies and the FDA have systems in place to ensure patient safety by monitoring medicines for adverse effects, as reported by patients, health care professionals, and others.

Catalyst_Promo4-3Whether discovering a brand new medicine or finding new ways to use previously-approved treatments, biopharmaceutical companies are committed to finding treatments and cures to help patients live longer, healthier lives.

View more videos from scientists and researchers at America’s biopharmaceutical companies here.

Andrew Powaleny

Andrew Powaleny Andrew Powaleny is senior manager of communications at PhRMA. Before joining PhRMA in 2015, he worked in public affairs and legislative communications for a House committee. Andrew came to Washington, D.C. via Connecticut and proudly sings with the Gay Men’s Chorus of Washington, enjoys photography and is the proud father of his poodle-beagle mix Molly.

Topics: Safety, FDA, R&D, member companies, FDA Modernization, Policy Solutions

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