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Regulatory Focus™ > News Articles > 2019 > 12 > 2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020

2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020

Posted 20 December 2019 | By Zachary Brennan 

2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020

As 2019 comes to a close, Focus takes a look back at what articles received the most attention as well as what to expect for the coming year.

MDR/IVDR

Six of the top 10 most-read articles this year were devoted to the incoming Medical Devices Regulation (MDR) in the EU, which has a deadline of 26 May 2020, and the In Vitro Diagnostic Regulation (IVDR), which is coming two years after MDR.

Last summer, the US urged the EU to push back the MDR deadline by three years, although the EU commissioner for health has since said the deadline is not going to change (beyond the four-year pushback for some Class I devices in the second corrigenda).

With the May deadline in mind, the designation of notified bodies (NBs) has also been of paramount concern for Focus readers, as the rollout of the designations has been slower than planned and as some NBs have decided to not pursue designation under MDR.

A RAPS/KPMG survey unveiled in September also shows how device companies may not be ready for MDR, especially as the launch of the device database under MDR, known as Eudamed, was delayed by two years.

Meanwhile, the European Commission and Medical Device Coordination Group released several MDR guidance documents in 2019 on persons responsible for regulatory compliance and implant cards, Class I devices, sampling and MDR codes, classifying software, safety and clinical performance summaries, transitional provisions, unique device identifiers and more on what’s coming.

The Year of the PRV

The most-read article this year (as it is almost every year) is the updated Focus explainer on priority review vouchers (PRVs). FDA issues PRVs to companies that win approvals for certain rare pediatric, tropical disease or medical countermeasure treatments, and then the companies can sell the vouchers or use them to speed the review of new treatments.

FDA in 2019 issued 10 PRVs, including the latest for Merck’s Ebola vaccine, which is a record for one year, and which is more than the number of PRVs issued in 2015 and 2016 combined.

FDA in 2019 also approved seven new treatments (also a record) that saw speedy reviews because of a PRV.

And lastly, and perhaps a good sign for buyers of PRVs, there are now more unused PRVs than ever before (at least a dozen by our count, although companies sometimes do not disclose when a PRV has been bought or sold and PRVs can be bought or sold more than once).

Turnover at the Top Isn’t Stopping Speedy FDA Drug Approvals

2019 saw four FDA commissioners: Scott Gottlieb resigned in April, Ned Sharpless took over as acting commissioner, then Brett Giroir took over for about a month as acting commissioner, and finally, Stephen Hahn was confirmed as commissioner, although little is known about how he plans to direct the agency.

Underneath the high-level upheaval, the Center for Drug Evaluation and Research (CDER) continued with its reorganization of the Office of New Drugs, which moved forward in 2019 and was a priority for CDER Director Janet Woodcock. The review process for new drug applications will also be altered over the next two years.

But hiring at FDA continues to be a sore spot, especially for foreign inspectors of manufacturing sites. Although US and EU inspectors are now working more closely together.

The commissioner turnover and hiring issues have not stopped FDA from approving new treatments well ahead of their PDUFA goal dates. However, the total number of novel drug approvals in 2019 (43) will not match 2018's total of 59.

With the rise of single-arm trials, the agency is taking a serious look at the use of real-world evidence (RWE), even drafting guidance in 2019 on how to submit RWE. Companies may look to RWE to help win new indications for approved drugs or even use it as confirmatory evidence, according to a new draft guidance, when a new treatment’s approval is based on a single trial. The push comes as a growing share of new drugs coming to market are based on a single trial.

FDA also has floated the idea of allowing trials to use p values higher than 0.05 for serious diseases with no available therapies or rare diseases where the sample size might be limited.

And as manufacturing woes and impurities led to numerous recalls of a popular heartburn medicine and others in 2019, FDA is debating whether to create a new manufacturing quality rating system to incentivize companies to upgrade their sites. FDA's Office of Manufacturing Quality has issued 40 warning letters so far in 2019, which compares with 56 warning letters in 2018.

Brexit

As the deadline for Brexit was pushed back in 2019, but now seems set in stone for the end of January 2020, the UK’s Medicines and Healthcare products Regulatory Agency released a series of guidance documents to help pharmaceutical and medical device companies.

The UK is also doing what it can to ensure that drug shortages are not a problem once the exit takes place. The European Medicines Agency, meanwhile, has said shortages are less likely to be a concern on its end, and Brexit expenses in 2019 for EMA amounted to €59.6 million ($66 million).

Looking Ahead to 2020

Several important FDA rulemakings and guidance documents are expected to come in 2020, along with a better understanding of Hahn’s aims for FDA, in addition to the stressful lead-up to MDR and a better understanding of how Brexit is impacting drug and device supplies in the UK.

For instance, in April 2020 (pushed back from last September), FDA expects to publish a proposed rule on the modernization of the quality system regulation for medical devices. To help with the transition, the Association for the Advancement of Medical Instrumentation released a technical information report to help the industry prepare for the revision of 21 CFR 820, which will harmonize with ISO 13485:2016.

Other rulemakings expected in 2020 includes ones on: post-approval changes to approved drug and biologic applications, pediatric study plan requirements, excluding certain medical software functions from the definition of a device, clinical holds in medical device investigations, which is due in February 2020, biologics regulation modernization, which is slated for December and one on patent term restoration due in February 2020.

An Office of Inspector General report on postmarket surveillance of medical devices is also expected next year. FDA, meanwhile, is expected to release two revised draft guidances on the postmarket surveillance of devices and post-approval studies.

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