2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with several memorable and noteworthy regulatory topics to review. From the COVID-19 pandemic and global health crisis, to the Food and Drug Administration’s (FDA) deadline for Premarket Tobacco Applications (PMTAs) for e-cigarettes, and the European Union’s (EU’s) postponement of the medical device regulation (MDR), it is safe to say regulators across the world kept busy during 2020.
Here are a few of the year's most noteworthy stories:
COVID-19 Pandemic
The biggest issue across the pharmaceutical, biotechnology, and medical device industries this year was the COVID-19 pandemic. Although many of us were not fully aware of the situation until closer to March, FDA Commissioner Stephen Hahn, MD, began working with a number of domestic international health partners in January in an attempt to combat and prevent additional outbreaks of the novel coronavirus.
In March, the focus was on increasing the availability of personal protective equipment (PPE) for healthcare professionals, postponing foreign inspections, reviewing and approving numerous Emergency Use Authorizations (EUAs), converting all scheduled face-to-face meetings to teleconferences, and so much more. From there, each month has been busier than the last for the FDA; the Agency hasn’t slowed down at all this year or had a chance to catch their breath.
Much like the FDA, the European Medicines Agency (EMA) has been keeping busy as well, holding weekly video conferences to share information and coordinate activities for the effective management of the COVID-19 crisis.
In spite of the restrictions, the EMA remained focused on expediting the development and approval of safe and effective treatments and vaccines, supporting the continued availability of medicines in the EU, and providing reliable information to patients and healthcare professionals. To this end they put together a Task Force. The aim of the COVID-19 EMA pandemic Task Force is to help EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorization, and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19.
The MDR was published in the EU in 2017 with the intent of taking the place of the current medical device directive (MD directive or directive). When it was initially published, the European Commission announced that there would be a three-year transition period during which the directive and the MDR would both be in place. The three years period ended on May 26, 2020 at which time the MDR was supposed to take full effect and the medical device directive would be repealed. However, due to the COVID-19 pandemic among a number of other reasons, on April 24th, the European Parliament announced that the transition period would be extended for an additional year, pushing the MDR’s effective date to May 26, 2021.
Deadline for FDA’s PMTA Submission Requirements Passed
All non-grandfathered tobacco products are required to obtain premarket authorization from the FDA. As such, any company “marketing a deemed tobacco product that is new and that was on the market as of August 8, 2016,” was required to submit a marketing application by September 9, 2020.
This means that, within one year, FDA should make a determination on which e-cigarettes and flavors can continue to be marketed. However, based on the number of applications that were submitted, it’s unlikely that FDA will be able to review them all in the statutory timeframe. The deadline was originally set for May 12, 2020 but was extended to September due to the COVID-19 pandemic. Furthermore, the deadline was long-awaited after the constant storylines last year about flavor bans, youth vaping, etc.
COVID-19 Vaccine Development
In December of this year, the Pfizer-BioNTech COVID-19 vaccine was authorized for emergency use in the United Kingdom (Dec. 2) and the United States (Dec. 11). These approvals mark a monumental achievement for all of the scientists, drug developers, regulators, and industry professionals who worked on the development of the vaccine. Although the EMA has not yet adopted the vaccine, the Agency is scheduled to meet on Monday, December 21st to make a decision on the vaccine’s approval in Europe.
In addition to the Pfizer-BioNTech vaccine, Moderna Therapeutics, headquartered in Cambridge, Massachusetts, has also developed a vaccine to fight COVID-19 that has been found to be highly effective. Although the product has not yet been authorized for use, the company is meeting with the FDA on December 17th and expects the vaccine to obtain emergency use authorization before the year is over.
Stephen Hahn, M.D., Completed First Full Year as FDA Commissioner
December 17, 2020 marks Dr. Stephen M. Hahn’s one-year anniversary as the Commissioner of the FDA. Dr. Hahn was sworn in as the 24th Commissioner of the FDA on December 17th, 2019. The first year in a new position is challenging for even the most qualified but what a year it has been for the head of the FDA!
Although it has been a challenging and trying year, Dr. Hahn has stood up for science and accomplished a number of notable feats along the way, one of which includes a program that has led to vaccines being approved for emergency use in record time.
New Biomedical Research Agency was Created by the EU
On September 16, 2020, the president of the European Commission, Ursula von der Leyen, announced plans to form a Biomedical Research Agency in the EU. The agency is being modeled after the United States Biomedical Advanced Research and Development Authority (BARDA) and will help support and reinforce the EMA as well as the European Center for Disease Prevention and Control. Furthermore, the organization will also “support the EU’s capacity and readiness to respond to cross-border threats and emergencies – whether of natural or deliberate origin.”
Moving forward to October 19, the European Commission published its work plans for 2021. The Commission notes that the proposal extends through the fourth quarter of 2021 and will be accompanied by an impact assessment.
Finally, in November, the Commission released a set of proposals aimed at strengthening the EU’s health security framework and reinforcing the crisis preparedness and response role of the UE agencies. In its announcement regarding the proposals, the European Commission states that, drawing lessons from the current COVID-19 crisis, the “proposals will ensure stronger preparedness and response during the current and future health crises.”
In September of this year, both the FDA and the EMA released regulations regarding the control of nitrosamine impurities. The recent focus on nitrosamine regulation comes after a nitrosamine impurity was detected in a batch of the active pharmaceutical ingredient (API) valsartan in 2018. The product, which is indicated for the regulation of blood pressure, originated from a Chinese manufacturer. Since then, Nitrosamines have also been detected in other angiotensin II receptor blockers, ranitidine, nizatidine, and metformin, resulting in recalls of selected lots from the market and implementation of strict regulations to the manufacturing of these specific products.
As such, the new regulations require Sponsors of approved drug products to complete a risk assessment regarding the possibility of their products containing nitrosamine impurities.
- In the EU, these risk assessments must be completed by:
- March 31, 2021 – chemical medicines
- July 1, 2021 – biological medicines
- In the US, FDA is requiring the risk assessments by completed by March 1, 2021
This was a crazy, busy, demanding, and interesting year to say the least; and while we know this quick summary does not come close to doing 2020 justice, this is just a look at a few of the monumental and noteworthy events that happened in the pharmaceutical, biotechnology, and medical device industries throughout the last 12 months.
Furthermore, while we know it is important to reflect on the year as it comes to a close, it is equally as important to plan and prepare for the year that lies ahead. Ready to start planning for the new year? Check out our tips on how to achieve regulatory success in 2021.
