Regulatory Focus™ > News Articles > 2021 > 9 > Asia-Pacific Roundup: TGA takes Medtronic to court over alleged unlawful supply of medical device

Asia-Pacific Roundup: TGA takes Medtronic to court over alleged unlawful supply of medical device

Posted 07 September 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA takes Medtronic to court over alleged unlawful supply of medical device

Australia’s Therapeutic Goods Administration (TGA) has begun legal proceedings against Medtronic Australasia over the alleged unlawful supply of the Infuse Bone Graft Kit. TGA is accusing Medtronic of unlawfully supplying 16,290 kits to 108 hospitals between September 2015 and January 2020.
 
Medtronic registered the kit in the Australian Register of Therapeutic Goods (ARTG) in 2005 for use in spinal fusion procedures in skeletally mature patients with degenerative disc disease. However, the entry only covered its supply with a metallic spinal infusion cage, LT Cage. According to TGA, the kit, which housed a recombinant human bone morphogenetic protein and other components designed to stimulate bone growth, was never approved for use without the LT Cage.
 
TGA’s court filing states the ARTG registration only permitted Medtronic to supply the kit as part of a package with LT Cage. As TGA sees it, the supply of the kit without LT Cage was unlawful because it was not registered and, if Medtronic had applied for inclusion in the ARTG, it would not have been classed as a medical device.
 
Medtronic supplied kits that were used in procedures that could not be performed using LT Cage such as interventions targeting the clavicle, hand, scapula and arm, according to TGA. In August 2018, Medtronic allegedly withdrew LT Cage from the Australian market but continued to supply the kit until the end of January 2020.
 
TGA accuses Medtronic of actions that collectively carry a maximum civil penalty of AU$19.5 million ($14.4 million). The legal filing sets out the alleged harm caused by the supply of the kits in Australia.
 
“Medtronic profited from the supply of thousands of units of the Kit in circumstances where the safety and efficacy of the Kit had not been established by the Secretary. In the absence of that evaluation, Medtronic put the health and safety of patients at risk, and undermined the integrity of the regulation of therapeutic goods in Australia,” TGA’s lawyer wrote in the legal filing.
 
TGA published a frequently asked questions document on the off-label use of medical devices the day after starting legal proceedings against Medtronic. The document defines off-label use and sets out the requirements and restrictions that apply to sponsors.  
 
TGA Notice, More
 
Malaysian NPRA releases guidelines on good pharmacovigilance practices
 
The National Pharmaceutical Regulatory Agency (NPRA) has posted guidance about the requirements and procedures of good pharmacovigilance practices (GVP) in Malaysia. NPRA’s guidelines address topics such as the submission of reports of adverse reactions to drugs and vaccines.
 
In creating the guideline, NPRA has built on a text it published in 2016 and drawn on documents adopted by the European Medicines Agency and other regulatory agencies. Changes to the earlier text include the addition of a new section about the content and maintenance of pharmacovigilance system master files (PSMFs).
 
The PSMF provides a detailed description of the pharmacovigilance system that registration holders use to monitor the safety of their products. The PSMF therefore reflects a product registration holder’s (PRH) “readiness and competency in pharmacovigilance.” NPRA can require PRHs to submit master files when it needs to assess their pharmacovigilance systems.
 
In the guideline, NPRA describes how to structure a PSMF, the content to include and the need to track all changes made to the file. The publication of the information precedes the expected release of details of GVP inspections in Malaysia, which will use the PSMF to evaluate the compliance of PRHs. NPRA released the PSMF guideline alongside a manual for healthcare providers about the submission of adverse event reports.
 
NPRA Guidelines, More
 
TGA sets out regulatory reform priorities in business plan for the coming year
 
TGA has published details of its regulatory reform objectives in its business plan for the 2021 to 2022 financial year. The Australian regulator plans to start local good clinical practice inspections and wrap up the implementation of processes for the conformity assessment of medical devices.
 
In recent years, TGA has made a range of changes in response to an independent review of the regulation of medicines and medical devices in Australia. The reform agenda is set to continue in the coming year, with TGA planning to implement the long-discussed good clinical practice inspection program and update its guidance on medicines manufacturing quality.
 
TGA is focusing on a clutch of medtech reforms, with the conformity assessment work advancing alongside preparations for the introduction of a unique device identifier system and a push to improve post-market monitoring systems. The agency is also starting new initiatives, with consultations about the requirements for medical devices to be used in clinical trials and other topics in the pipeline.
 
Other sections of the business plan are dominated by COVID-19. TGA will continue to prioritize COVID-19 medicines, vaccines and diagnostics and monitor the safety of authorized products.
 
Business Plan
 
DRAP updates guidelines on the conduct of clinical trials in Pakistan
 
The Drug Regulatory Authority of Pakistan (DRAP) has updated its guidelines on the conduct of clinical trials. DRAP used the update to provide new information about importing investigational medicinal products (IMPs) and the timelines for clinical trial applications.
 
Version 2.0 of the guidelines state authorities will evaluate applications to run clinical trials for up to 30 working days before deciding whether the filing has shortcomings or can proceed to a review by another body. Applicants will learn if their filings have been approved 10 to 15 working days after the finalization of the minutes of the meeting to discuss the submissions.
 
The process goes faster in public health emergencies, with filings being checked for shortcomings within seven days. Applicants that need to share more information will be contacted electronically within three days.
 
Another new section describes the process for applying for a license to import IMPs. Licenses last two years and clinical trial sponsors need to file to renew the clearance if their studies last longer than that. DRAP published the guidance alongside an example list of standard operating procedures at sites that run bioavailability and bioequivalence studies.
 
DRAP Guidelines, More
 
TGA puts out call to developers of COVID-19 self-tests ahead of new guidance
 
TGA has asked developers of at-home COVID-19 tests to register their interest in supplying products to the Australian market. The request comes ahead of the anticipated publication of guidance on a self-testing regulatory framework later this month.
 
Reforms over the past seven years have permitted limited self-testing for other infectious diseases, but the at-home COVID-19 kits available in other countries remain prohibited in Australia. TGA said the government will decide when to allow self-testing for the coronavirus “in the coming months” based on the vaccination rate and presence of state-level systems for reporting the results.
 
Ahead of the lifting of the ban, TGA is developing a framework to support self-testing and talking to potential providers of the kits about the documentation they will need to come to market when the rules change. TGA expects to ask test providers for “evidence of appropriate certification for the manufacturer,” instructions for use and studies of the usability and clinical performance of the kits.
 
TGA Notice
 
Other News:
 
Malaysia’s NPRA and Singapore’s Health Sciences Authority have begun the second project under their generic medicines work-sharing initiative. The collaborators have stopped accepting new applications while they work on the project. NPRA Notice

 

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