CreakyJoints to Provide Public Comment at the FDA Public Hearing On Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

UPPER NYACK, N.Y.–(BUSINESS WIRE)–On November 9, 2016, Stephen Marmaras, Director of State and National Advocacy for the Global Healthy Living Foundation and its arthritis support community, CreakyJoints, will provide public comment regarding how unapproved uses of approved or cleared medical products (“off-label” uses) are communicated to patient communities. GHLF supports responsible off-label communications because it could more uniformly educate patients about possible treatment options. However, that support is framed by the need to continue to incentivize pharmaceutical companies to engage in appropriate research across multiple indications to improve understanding of safety and efficacy.

@GHLForg supports responsible off-label communications to uniformly educate #chronicdisease patients @US_FDA

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AVAILABLE FOR INTERVIEW

• Stephen Marmaras, Director of State and National Advocacy, Global Healthy Living Foundation: IN PERSON (Nov. 9) and BY PHONE
• Seth Ginsberg, Co-Founder and President of the Global Healthy Living Foundation: BY PHONE

The November 9 and 10 public hearing convened by the U.S. Food and Drug Administration (FDA) will obtain input related to communications by “manufacturers, packers, and distributors…regarding FDA-regulated drugs and medical devices for humans” and animals. The input from this meeting will inform future FDA policy related to “its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products.”

GHLF works to advocate for improved access to care at the community level and represents patients living with conditions such as arthritis, pain, cancer, diabetes, heart disease and psoriasis. In his comments, Mr. Marmaras will explain why off-label use can benefit chronic disease patients while pointing out that the availability and application of such treatments vary widely at the point of care. He will also recommend how the FDA might structure off-label communications by promoting dissemination of peer-reviewed studies or credible post-marketing comparative effectiveness research and surveillance data.

About Global Healthy Living Foundation

The Global Healthy Living Foundation is a 501(c)(3) non-profit organization whose mission is to improve the quality of life for people living with chronic illnesses by advocating for improved access to care at the community, state, and federal levels, and amplifying education and awareness efforts within its social media framework. The Global Healthy Living Foundation is the parent organization of CreakyJoints, the go-to source for more than 100,000 arthritis patients and their families world-wide who are seeking education, support, advocacy and patient-centered research and the recently launched ArthritisPower, the first ever patient-led, patient-centered research registry for arthritis, bone, and inflammatory skin conditions.