SEPTEMBER 2021 INDUSTRY NEWS
Consultation on framework for medical devices in UK
On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support safe innovation and ongoing access to products”. The current framework for medical devices in the UK is set in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has now been substantially updated by the Medical Devices Regulations. Whilst the new Medical Device Regulations 2017/745 have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law.
Industry calls for withdrawal of FDA electronic tracing guidance
Pharmaceutical distributors urge the US Food and Drug Administration (FDA) to immediately withdraw its guidance setting parameters for establishing electronic systems to trace products through the supply chain. A trade association for distributors claims the agency overreached its statutory authority in seeking access to private electronic tracing information among trading partners.
The guidance, published in June, laid the groundwork for the data architecture systems needed to build the electronic, interoperable systems called for in the Drug Supply Chain Security Act (DSCSA), scheduled for implementation on 27 November 2023. In August, the agency granted the industry a 30-day extension to comment on the guidance.
What does the e-commerce boom mean for pharma supply chain security?
The problem of pharmaceutical counterfeiting is arguably greater than it’s ever been before. And the reason for this? In short, e-commerce. While there is no doubt that digitization has brought many positives for the healthcare sector – increasingly personalized service, greater accessibility for older or disabled people, greater speed and efficiency of ordering, to name just a few – the internet also provides many spaces for counterfeiters to exploit and online security measures are still lagging behind. With the internet, the consumer base for counterfeiters is direct and practically limitless; the dark web allows for anonymous transactions between manufacturers, distributors and consumers, while it is easy for online pharmacies selling faked medications to pose as legitimate.
EU extends GMP, GDP certificates through 2022 as pandemic effects linger
European regulators on Thursday announced that good manufacturing practice (GMP) and good distribution practice (GDP) certificates, as well as other time-limited authorizations, will be extended through 2022. In April 2020, in light of new safety measures and travel restrictions imposed at the outset of the pandemic, the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission issued a notice extending GMP and GDP certificates, as well as time-limited manufacturing, import and wholesale authorizations, through the end of 2021 to ensure the availability of medicines for the region. Now, a year and a half later, the agencies are once again extending the validity of those certificates as the pandemic shows little signs of abating as the more infectious Delta variant runs its course and travel restrictions are still present in many regions.
MedTech Europe calls for urgent clarification of EU artificial intelligence proposal
MedTech Europe has called for the urgent clarification of a proposed artificial intelligence regulation because it uses an overly broad definition and is misaligned with existing regulatory frameworks. The European Commission outlined its plans to regulate AI, including medical devices and in vitro diagnostics that feature the technology, earlier this year. Under the proposal, the European Union would require high-risk AI systems to “comply with certain mandatory requirements” before coming to market. The Commission acknowledged a risk of overlap with existing regulations but envisioned the framework complementing requirements such as the Medical Devices Regulation. However, MedTech Europe contends the proposal falls short of that vision.
AUGUST 2021 INDUSTRY NEWS
FDA shifts to regulating some drugs as devices
The US Food and Drug Administration (FDA) is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices. In April, FDA lost a court battle (Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928) in the US Court of Appeals for the District of Columbia Circuit when it argued it had the ability as a regulatory authority to classify some barium sulfate contrast imaging agents as drugs when they also met the definition of a device under the Federal Food, Drug, and Cosmetic Act.
EU builds out MDR, IVDR guidance ahead of flurry of implementing acts
The push to back implementation of the EU’s new medical device and looming in vitro diagnostic regulations is coming at a steady pace this summer, with the European Commission releasing nine documents in July and August. The stream of new documents, coming ahead of the anticipated release of a flurry of implementing acts in the third quarter, is meant to guide med-techs as they work to comply with the recently live MDR and the IVDR, which goes into effect next year. Work in Europe typically slows down amid vacations over the summer months, particularly in August.
FDA report: Drug quality tops OPQ’s list of product defects
A new report from the US Food and Drug Administration’s (FDA’s) Office of Pharmaceutical Quality (OPQ) details the top drug quality issues seen in from 2016-2020, with questions of product quality topping the list. In all, just over a quarter (27%) of all Product Quality Defect (PQD) reports were related to product quality issues, while device and packaging issues together made up another third of the PDQ reports over the 5-year period. The PQD reports came from 11,932 MedWatch reports, 4,308 field alert reports, 253 consumer complaints, 263 biological product deviation reports, and 2,623 tested samples, explained OPQ in its report on the state of pharmaceutical quality for FY 2020. The number of reports of all types except consumer complaints climbed annually over the 2016-2020 time period, according to the report.
Janet Woodcock reportedly out of the race for permanent FDA commissioner
Now seven months into Joe Biden’s presidency, the administration is no closer to appointing a permanent head of the Food and Drug Administration, as Bloomberg reports that the White House has officially ruled out Dr. Janet Woodcock for the full-time gig. Woodcock, who has served as acting commissioner for the FDA since January when former commissioner Dr. Stephen Hahn stepped down, began her career with the agency in 1986. She joined with the agency’s Center for Biologics Evaluation and Research and held the position of Center for Drug Evaluation and Research director multiple times throughout her career. Despite her history with the FDA, “officials have privately concluded that she won’t be the nominee,” according to Bloomberg.
JULY 2021 INDUSTRY NEWS
MDCG posts guidance on UDI integration within a QMS
“The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s quality management system (QMS) to meet requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
The 10-page guidance calls for manufacturers to have a plan for implementing UDI, as assignment of UDI-DI and management of UDI-related processes “can impact many other lifecycle QMS processes.”
FDA Under Pressure to Restore “Normal” Drug Inspections
“Congressional leaders, as well as regulated industry, want more information from FDA on its strategy for resuming inspections of manufacturing facilities to better assure the quality, safety and efficacy of medical products. The suspension of in-person field inspections in March 2020 has resulted in a huge backlog of delayed site visits, as FDA sent investigators only to those operations deemed “mission critical.”
FDA’s regulatory affairs head previews Inspectional Affairs Council
“The top regulatory affairs official at the US Food and Drug Administration (FDA) gave a preview of a soon-to-be-launched council within the agency that will focus solely on inspection-related matters. We will soon stand up an agency-wide decision-making body; it’s called the FDA Inspectional Affairs Council,” said Judith McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA), speaking at a virtual webinar hosted Wednesday by the Alliance for a Stronger FDA.”
Secure by Design: Developing Cybersecure Medical Devices
“Medical devices are becoming increasingly connected to other devices, the Internet, or hospital networks to serve functions that improve healthcare and enhance treatment options. According to estimates, one in four medical devices is already connected to the Internet or hospital network. In 2017, they totalled an estimated 337 million, with an expected compound annual growth rate (CAGR) of 20.8% through 2030—including digital health apps. Their development is driven by the German Digital Healthcare Act (DVG) and similar initiatives across Europe. 1 Digital health apps are playing increasingly important roles in healthcare with approximately 200 new health apps being added to the app stores every day. “
JUNE 2021 INDUSTRY NEWS
“According to a recent report by international growth partnership company Frost and Sullivan, Western Europe’s medical device market is on track to recover from the COVID-19 pandemic by 2023. The report, titled ‘Impact of COVID-19 on Elective Procedures in Western Europe, 2020–2023’, projects that the market for selective medical devices for elective procedures will reach $16.8 billion (€13.76B) by 2023. according to an aspirational compound annual growth rate of 29.2%. Because of COVID-19, there was a 45.5% decline in the selective medical devices market for elective procedures from the pre-COVID projections for 2020. However, the restrictions and challenges raised by the pandemic have forced medical device manufacturers to think in new ways, creating growth opportunities in the sector.”
FDA lays out device cybersecurity efforts
“Kevin Fu, acting director of medical device cybersecurity at the FDA’s Center for Devices and Radiological Health, warned last month that cyber threats to the healthcare and medtech industries, including ransomware and other malware, are growing in sophistication potentially putting patient safety at risk. “Everything is hackable,” Fu told the Food & Drug Law Institute annual conference in May, noting that medical devices infected by ransomware can be disabled from properly performing critical clinical functions, which could lead to patient harm.”
FDA explains when device ‘servicing’ becomes ‘remanufacturing’
“At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall. The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) in announcing its availability. The guidance is intended to clarify, rather than to change, the regulatory requirements to which remanufacturers must adhere. “It is not intended to adopt significant policy changes,” according to CDRH.”
FDA Advisory Committees Under Scrutiny
“FDA is looking for greater consistency and fewer surprises in discussions by and decisions from its cadre of expert, independent advisory committees. These panels are formed to provide scientific and medical expertise to help shape FDA decisions in all regulatory areas, most notably to evaluate, approve, or reject applications for new drugs, biologics, and medical products. To gain a more efficient and transparent advisory system, the Center for Drug Evaluation and Research (CDER) has launched an initiative to gain more efficient and transparent operations of its advisory panels, says CDER director Patrizia Cavazzoni.”
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