European Medicines Agency Conducting a Review of InductOs, Bone-Growth Product

The European Medicines Agency (EMA) is conducting a review of Medtronic’s implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a manufacturing site in the U.S. that makes one of its components.

InductOs was authorized for by the European Medicines Agency in 2002 and is marketed by Medtronic BioPharma B.V., headquartered in the Netherlands. InductOs is used to promote bone growth in patients undergoing lower back spinal fusion and surgery to repair broken tibia, Regulatory Affairs Professionals Society (RAPS) reports. The product is marketed in the U.S. under the name InFuse.

InductOs is sold as a kit containing the active ingredient dibotermin alfa, a solvent, and an absorbable collagen sponge (ACS). EMA has classified the ACS as an excipient (an inert substance used to bind components of a medicine), and it is thus subject to inspection under EU good manufacturing practice (GMP) guidelines, according to RAPS. The ACS is manufactured by Integra LifeSciences at a U.S. facility. A January 2014 inspection of the site uncovered “a number of major deficiencies.” Integra was given a corrective action plan and was restricted from importing the ACS to the EU, until inspectors could “assess the progress in eliminating the major deficiencies.”

A follow-up inspection in 2015 determined that Integra had not taken adequate steps to eliminate “contamination of ACS with particulate matter.” The Netherlands notified the European Commission (EC) and EMA’s Committee for Medicinal Products for Human Use (CHMP). The commission has the authority to request EMA to conduct an assessment of a manufacturer or importer in relation to non-compliance issues raised by national regulators, according to RAPS. EMA says it expects a shortage of InductOs to occur as a result of the ongoing import restriction.

InFuse has been controversial in the U.S. The device received Food and Drug Administration (FDA) approval in 2002 for lower-back spinal fusion procedures, but has been widely used “off-label” for upper (cervical) spine procedures. In 2008, the FDA warned of life-threatening complications in off-label uses of InFuse. The controversy culminated in a 2011 special issue of The Spine Journal, devoted entirely to reports critiquing research by surgeons paid millions by Medtronic. The journal said the research overstated InFuse’s benefits and failed to report serious complications, including male sterility, infections, increased cancer risk, bone dissolution, and worsened back and leg pain, according to Reuters.

The EMA will begin its review of InductOs in light of the contamination issues and will make recommendations for any changes necessary to InductOs’ marketing authorization. EMA has presented a series of questions for Medtronic to address. In particular, the agency wants to know if there have been any “safety reports or complaints . . . related to the contaminating particulate matter,” and if there are “any patient population(s) for whom there is no other treatment option available.” EMA is asking Medtronic for a timeline for steps taken to “ensure that the manufacturing of the ACS will be GMP compliant.” The agency is also requesting the batch numbers of InductOs already distributed in the EU, and for information on InductOs’ use by each EU member state, RAPS reports.

 

 

 

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