WASHINGTON _ The FDA may ease the regulatoryburden on manufacturers of autologous cells and tissuesused for surgical reconstruction so that the firms are notrequired to clear premarket approval requirements; theywill, however, have to obtain establishment licenses.

Phil Noguchi, head of the FDA's Center for BiologicsEvaluation and Research's Division of Cellular and GeneTherapies, told BioWorld Today that the FDA is seekinga better way to regulate autologous implant tissue and hasscheduled a public hearing to obtain views of the industryand other interested parties.

According to a notice published in the July 18 FederalRegister, the hearing was scheduled in response to anumber of reports that have appeared in the scientificliterature on the clinical use of autologous cells andtissues manipulated out the patient's body and thenimplanted. Several companies, including Genzyme Corp.,had asked the FDA to sort out whether it intended toregulate these cells and tissues as biologics or as medicaldevices regulated by the FDA's Center for Devices andRadiological Health.

The FDA expects interest in autologous implants to growamong clinicians and biotech firms. "The promise ofproducts that use autologous cells for implantation isgreat and the demand for them is expected to becorrespondingly high," according to the FDA.

"In light of the potential public health significance of thenew products, the growth of the commercial industry, andthe need to develop an appropriate regulatory frameworkfor products comprised of autologous cells forimplantation for repair or reconstruction," the agencydecided to hold the hearing the FDA, according to therecent notice.

Genzyme is taking credit for nudging the FDA toschedule the hearing. "The public hearing was scheduledin response to a petition filed by Genzyme Tissue Repair,a subsidy of Genzyme Corp., said Steve Push, Genzyme'svice president for corporate communications. Genzyme isbased in Cambridge, Mass.

"We filed the petition after the Center for BiologicsEvaluation and Research told us the that the autologousarticulator cartilage that was implanted in a patient inMarch 1995 as an unregulated medical device wasperhaps a biologic and therefore subject to CBER'sregulation," said Push.

The procedure involves taking a biopsy from the patient,culturing it and growing millions of cells, then implantingthe autologous cells back into the patient's injured knee.The cells integrate into surrounding tissue and matureinto normal cartilage, restoring nearly frictionlessmovement of the knee. (See BioWorld Today, April 3, p.3.)

The tissue implant has been performed on seven patientsso far. Genzyme Tissue Repair has trained 35 physiciansto perform the procedure in the U.S. and Europe.Surgeons are refining the procedure, now performed as anopen orthopedic surgery, so that it can be performedarthroscopically, said Push.

Push is optimistic that CBER will subject the tissue to anappropriate level of regulation. "CBER told us that thecenter does not want to subject the tissue to premarketapproval requirements and would rather regulate theproduct using an establishment licensing application(ELA)."

However, the agency lacks the legal authority to regulatea product with an ELA and no corresponding productlicensing application, said Push, and so the centerscheduled the public hearing on Nov. 16-17 to build apublic record for the regulatory change, Push toldBioWorld.

The FDA's 1993 interim final rule for banked humantissue does not require premarket review and approval oftissue as regulated drugs, devices or biological products.However, many somatic cell products made by biotechfirms are subject to premarket review and approval and toall other pertinent requirements, including provisionsgoverning misbranding and adulteration. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.