20/02/2015
Attention all Maryland Society of Plastic Surgeons members:
The FDA is considering guidance which would effectively prohibit fat injections/grafts not done in a study environment. See below:
ASPS ADVOCACY ALERT
FDA Proposal Will Negatively Impact Procedures Involving Adipose Tissue
In December 2014, the FDA released draft guidance that would dramatically change the regulation of human cells, tissues, and cellular or tissue-based products (HCT/Ps) from adipose tissue. If your members use adipose tissue in common fat grafting procedures, then they would be required to register and report as manufacturers.
In some cases, such as fat grafting in breast reconstruction and stromal vascular fraction, HCT/Ps from adipose would be treated as biological drugs and subjected to even more stringent regulations, and physicians using these adipose-derived products would have to file an application for premarket FDA approval of the products and a license to distribute biologic drugs. Such licenses are only granted after the FDA investigates the personnel, processes, facilities, equipment, and record keeping involved in the manufacture, processing, packing, holding and distributing of a batch or lot of a drug.
Simply put - this is a very, very heavily regulated area.
A team of ASPS subject matter experts has reviewed the FDA's guidance and found that it is biologically inaccurate and erroneously depicts some common procedures. ASPS is working hard to get the FDA to revise this flawed guidance, but the FDA needs to hear from state and regional plastic surgery societies as well.
If your organization would like to contact the FDA and share comments about how these regulatory burdens will negatively impact physicians and patients, ASPS has further information you can use in developing those comments.
Please contact ASPS Senior Manager of Advocacy and Government Relations Patrick Hermes at phermes@plasticsurgery.org to access this information and find out more about how you can submit comments to the FDA.
All comments are due by 11:59 pm EST on Monday, February 23, 2015, so please act now.
WHAT TO DO?
I am going to contact the ASPS Senior Manager of Advocacy and Government relations, Patrick Hermes, to find out how best to proceed with regard to expressing our opposition to this draft language. I will not do it until Monday in order to give the members of MSPS a chance to contact me with their opinions. But email or call me ASAP, because this is very time sensitive.
James Chappell, MD FACS
President
Maryland Society of Plastic Surgeons