FDA Issues Draft Cells, Tissues Guidance, Rattles Stocks

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

By John T. Aquino

Oct. 29 — The FDA Oct. 29 issued a draft guidance on the use of human cells, tissues and cellular-based products (HCT/P), which was immediately followed by a drop in the stock of two tissue-related companies in what they called an overreaction.

In addition to issuing the draft guidance, titled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products,” the Food and Drug Administration reopened the comment periods for three previously issued HCT/P draft guidances covering minimal manipulation, adipose tissue and the same surgical procedure exception. Finally, the agency announced an April 13, 2016, public meeting on the four draft guidances.

Comments on any of the four draft guidances or the public meeting are due April 29, 2016.

Five notices announcing the developments were published in the Oct. 30 Federal Register.

Documents Being Watched Closely

Shortly after the pre-publication release of the notices on Oct. 29, the stock of MiMedx Group fell as much as 21 percent and Osiris Therapeutics stock declined as much as 11 percent. MiMedx is a distributor of human amniotic tissue; Osiris’s product Grafix is a placenta-derived membrane used to treat acute and chronic wounds.

The “Homologous Use” guidance provides requirements for products that would qualify as HCT/Ps and therefore aren't required to file applications to obtain FDA approval. One of the qualification criteria is that the product must be intended for homologous use, which means similarity of position, structure and function. The draft guidance says that amniotic membrane is used for bone tissue replacement to support bone regeneration following surgery to repair or replace bone defects and that “this is not a homologous use because bone regeneration is not a basic function of amniotic membrane.”

Bill Taylor, MiMedx president and chief operating officer, said in a statement, “It [seems] that the market does not understand that the homologous use element of the regulation is related only to marketing. It specifically references that the HCT/P be ‘intended for homologous use only, as reflected by the labeling, advertising, or other indication of the manufacturer's objective intent.' In instances where companies have labeling outside of those requirements, the companies generally have not been required to remove their products from the market if a labeling change could bring them back into compliance with the requirements.”

The same day, MiMedx announced that its third-quarter profit of $6.6 million had met its estimate.

Draft Guidances

The four draft guidances addressed in the Federal Register notices are:

• “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff” (80 Fed. Reg. 66,850; docket no. FDA-2015-D-3581). This new draft guidance provides HCT/P manufacturers, health-care providers and FDA staff with recommendations for interpreting the criterion of “homologous use” as it applies to HCT/Ps.

• “Guidance for Industry and Staff: Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue—Regulatory Considerations” (80 Fed. Reg 66,949; docket no. FDA-2014-D-1856). This guidance was originally released Dec. 24, 2014.

• “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff” (80 Fed. Reg. 66,844; docket no. FDA-2014-D-1696). This guidance also was originally released Dec. 24, 2014.

• “Same Surgical Procedure Exception—Questions and Answers Regarding the Scope of the Exception” (80 Fed. Reg. 66,847; docket no. FDA-2014-D-1584). This draft guidance was originally released Oct. 23, 2014.

 

The FDA said it's reopening the comment period on the earlier-released draft guidances to allow those who are interested additional time to submit comments and any new information.

The original comment deadline was Feb. 24, 2015, for the adipose tissue draft guidance, which is designed to help determine whether HCT/Ps derived from adipose tissue are subject to FDA pre-market review requirements, and the minimal manipulation draft guidance.

Public Meeting 

According to a separate Federal Register notice (80 Fed. Reg. 66845; docket no. FDA-2015-D-3719), the April 13, 2016, public hearing on the four draft guidances will be held at the FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Room 1503), Silver Spring, Md. 20993.

Submit comments on the four draft guidances or the public hearing by April 29, 2016, electronically to http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852. All submissions must include the appropriate docket number

For further information on the notices, contact Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 71, Room 7301, Silver Spring, Md. 20993, (240) 402-7911, e-mail lori.olsenchurchyard@fda.hhs.gov.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

The “Homologous Use” draft guidance is at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-27704.pdf; the Federal Register notice is at http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27704.pdf.

The Federal Register notice reopening the comment period for the “Adipose Tissue” draft guidance is at http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27706.pdf; the notice for the “Minimal Manipulation” draft guidance is at http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27705.pdf; and the notice for the “Same Surgical Procedure Exception” draft guidance is at http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27707.pdf.

The public hearing Federal Register notice is at http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27703.pdf.