http://www.raredr.com/conferences/gg2017/pharma-fda-and-patients
Pharma, the FDA, and the Patient's Voice

Andra Stratton



Earlier this year, Lipodystrophy United met with the FDA to educate the regulatory agency on what patients are seeking in a drug to treat lipodystrophy.

Lipodystrophy is a group of rare diseases characterized by the lack of fat tissue. It can be a widespread (generalized lipodystrophy) or a limited (partial lipodystrophy). While these patients may look healthy, the lack of fat tissue leads to multiple organ problems that are currently not being addressed with treatment.

At the Global Genes Patient Advocacy Summit in Irvine California, we talked with Andra Stratton of Lipodystrophy United about the meeting she had with the FDA and her advice for other patient organizations wanting to work more closely with industry and regulatory bodies.

While the FDA and the pharmaceutical industry have recognized the importance of the patients’ input in developing drugs and designing clinical trial, Stratton said it is the responsibility of the patient community to let the pharmaceutical industry and the FDA know what is important to patients.

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