European Regulatory Agency Seeks Suspension of Marketing for Medtronic InudctOs

The European Union’s health regulatory agency has called for the suspension of marketing authorization for Medtronic’s InductOs bone growth device over issues at a U.S. plant that manufactures a component in the device.

The European Medicines Agency (EMA) began a review of InductOs—marketed in the in the U.S. as InFuse—after an April inspection by Dutch and Spanish authorities of a site that makes an absorbable collagen sponge that is part of the device, Reuters reports.

The EMA said the manufacturer had not taken adequate measures to prevent particle contamination of the sponges. According to Medtronic, the EMA withdrew a Good Manufacturing Practices certificate, which is mandatory for product licenses in Europe, from a plant operated by a third-party manufacturer. Medtronic says it is working with the manufacturer to address the EMA’s concerns but in a statement sent to Reuters, Medtronic claims the manufacturing issue presents “no risk to patients” and available “supplies of InductOs in the market are safe for use.”

InductOs is used to promote new bone develop in patients with spinal disc problems and leg fractures. The device received approval from the European Commission in September 2002 for use in the treatment of acute tibia fractures in adults and approval for spinal disc problems in April 2005.

InductOs comes in a kit that contains the active ingredient dibotermin alfa, a solvent and an absorbable collagen sponge (ACS). Under EMA classification, InductOs is subject to inspection under EU good manufacturing practice (GMP) guidelines.

The sponge included in the InductOs kit is manufactured by Integra LifeSciences at a plant in the United States, Reuters reports. A January 2014 inspection of the Integra site revealed “a number of major deficiencies.” The agency gave Integra a corrective action plan and Medtronic 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 April 2015 showed Integra had not taken adequate steps to eliminate “contamination of ACS with particulate matter,” according to the Regulatory Affairs Professionals Society (RAPS).

The EMA found no indication of any risk to patients linked to the inspectors’ findings, but the agency said its Committee for Medicinal Products for Human Use considered that the quality of InductOs could not be assured under the current manufacturing process.

In the U.S., Medtronic has been assailed for marketing InFuse for uses not approved by the Food and Drug Administration. Studies that Medtronic claimed were “outside objective reports” were actually written or rewritten by Medtronic agents. Court documents in a lawsuit filed earlier this year allege Medtronic was actively involved in the writing and editing of articles and in decisions about including or excluding critical health and safety information. The lawsuit alleges that Medtronic omitted and concealed information about serious adverse events revealed in the research. Independent experts reviewing the original studies confirmed that InFuse did not provide benefits over traditional bone grafts and, further, exposed patients to serious and undisclosed increased risks and complications including infections, increased cancer risk, male sterility, bone dissolution, and worsened back and leg pain.

 

from Parker Waichman http://www.yourlawyer.com/blog/european-regulatory-agency-seeks-suspension-of-marketing-for-medtronic-inudctos/