Asia-Pacific Roundup: TGA takes Philips to court, alleging company unlawfully supplied devices in Australia

Australia's Therapeutic Goods Administration (TGA) has accused Philips of selling respiratory devices that did not comply with essential principles. TGA made the accusations in a lawsuit that alleges the unlawful sale of devices posed a potential risk of harm to patients.

The lawsuit centers on 44,000 separate instances of alleged unlawful supply of Philips devices across two time periods. The first period covers two years in which Philips supplied ventilators and continuous and bi-level positive airway pressure devices that contained a polyester-based polyurethane foam for sound abatement. The foam was the cause of a global recall of Philips’ respiratory devices.

In the lawsuit, TGA said the potential for the foam to degrade and harm users that inhaled or ingested the resulting particles meant the respiratory devices were noncompliant with seven essential principles. Philips’ Respironics unit learnt that the foam could degrade in 2015, TGA said, and was notified of multiple reports of potential harm to patients between 2016 and 2021.

As such, TGA argued Philips knew or should have known by at least June 2019 that the foam could degrade and result in short, intermediate or long-term harm to patients. Yet, TGA said, the company did not perform any, or any adequate, risk analysis, implement design changes or take any other corrective actions until early 2021.

The second part of the lawsuit focuses on the silicone sound abatement foam that Philips added to its Trilogy 100 ventilators to replace the foam. Philips provided its Australian company with silicone foam and adhesive tape to install the new sound abatement material. By around October 2022, the company installing the foam had identified that the silicone could separate from its housing, TGA said.

“Once the foam became detached from the housing, it could move loosely in the inlet airpath housing, potentially obstructing that path. This defect could manifest within 30-90 days of use,” TGA said. “It could obstruct the airpath (thus decreasing the amount of air flowing into the device) or completely block it (preventing air from flowing into the device).”

TGA said Philips “did not conduct adequate risk analysis of the use of the silicone foam with the adhesive and did not eliminate or reduce the risks posed by the Silicone Delamination Defect to the extent possible by adopting a policy of inherently safe design.” The processes used to identify potential failures “were insufficient to ensure that risks were effectively mitigated once identified.”

The regulator has asked the court to impose whatever financial penalties it believes is appropriate for each of the alleged contraventions of the rules. TGA also asked the court to consider whatever further orders it considers appropriate.

TGA Notice

Indian Pharmacopoeia Commission responds to questions about impurity limit rules

The Indian Pharmacopoeia Commission (IPC) has clarified the rules on applying impurity limits to the development and regulatory approval of new drugs.

IPC said it has received questions from “various stakeholders” about the application of the limits. The commission said it is solely responsible for setting official drug standards in the IP and has no role in the regulatory review and approval of drugs in India. Central and state-level licensing authorities take all regulatory decisions.

The commission said it “does not have a mandate to approve or endorse impurity specifications” for drug substances or drug products. Being a standard setting organization, IPC is “also not responsible to express opinion or recommendation in such regulatory matters.”

IPC said compliance with its general chapter on impurities “may be desired by the concerned regulatory authority from manufacturers seeking regulatory approval.” Regulators may consider deviations from the limits set in the chapter, IPC said, if they are “supported with valid scientific justification and relevant data.”

The impurity limits in individual IP monographs may serve as a reference for establishing specifications in new drug products, including fixed-dose combinations (FDCs), that are not part of the IP. Regulators are responsible for approving impurity specifications for new drugs or FDCs, IPC said.

IPC Notice

Malaysia’s MDA shares update on registering devices with expired CE marks from EU

Malaysia’s Medical Device Authority (MDA) has provided more information to help companies manage upheaval related to the European Union’s move to a new medtech regulatory regime.

MDA accepts European CE marks as conformity assessment evidence for the verification process it uses to authorize certain medical devices for use in Malaysia. The agency sent a letter about the policy in March, in which it listed certificates issued under the old EU regulatory directives among valid evidence for the verification process. MDA provided an update on its policy last week.

The “ongoing and unpredictable challenges associated” with the EU’s transition to the new regulations has led MDA to accept expired CE mark certificates issued under the old directives as evidence. MDA said the temporary policy is designed to ensure uninterrupted device availability.

Companies can use expired certificates if their devices continue to comply with the directives, they have not made significant changes to the design or intended purpose of the product and there is no evidence of unacceptable risk to patients or public health. MDA is also asking for supporting documents.

The agency published the policy alongside details of the process for manufacturers that let registration certificates lapse. The online system automatically deactivates expired certificates, forcing companies to submit new registration filings.

MDA Notice, More

Australia and New Zealand post notices about the safety of GLP-1 receptor agonists

Regulatory agencies in Australia and New Zealand have published notices about the safety of GLP-1 receptor agonists used in the management of diabetes and obesity.

TGA added warnings to the Australian labels of drugs including Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro. The medicines can delay the passage of food through the stomach, creating risks for patients during anesthesia or deep sedation.

Healthcare professionals ask patients to fast before anesthesia or sedation to minimize the risk of them accidentally inhaling the content of their stomachs. Because GLP-1 drugs slow stomach emptying, the normal fasting period may be too short to mitigate the risk. TGA added details of the risk to the labels of all GLP-1 drugs.

Separately, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) alerted doctors to the importance of hydration for people taking GLP-1 drugs. Vomiting and diarrhea are common side effects of the drugs, Medsafe said, putting patients at risk of dehydration and renal impairment.

TGA Notice, Medsafe Notice

Philippine FDA secures temporary suspension of order to increase regulatory fees

The Philippine Food and Drug Administration (FDA) has secured the temporary suspension of an order that would have raised the fees for registering facilities and products.

FDA Director General Paolo Teston asked the Department of Health to approve a 60-day suspension of the order in late May. The FDA leader, who took office after the increase was agreed, made the request as part of a push to ensure any changes to regulatory fees are supported “by visible improvements in service delivery and operational efficiency.”

Last week, FDA said it was working on a circular that will temporarily suspend the fee increase order. The circular is scheduled for publication by 10 June. The agency is yet to share details of the terms of the fee suspension.

FDA Notice

Asia-Pacific Roundup: TGA takes Philips to court, alleging company unlawfully supplied devices in Australia

Related topics

Recommended content

Welcome to the new RAPS Digital Experience