With the COVID-19 pandemic hitting countries around the world hard, the United States Food and Drug Administration (FDA) has its work cut out for it. The agency has been working to balance safeguarding public health with the desire for timely product reviews. According to the FDA, staff members at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are working to keep all timelines on track, but “with many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely” and that it is “difficult to speculate on what the exact impact will be on incoming submissions moving forward.”
As of the end of May 2020, the FDA had approved 22 novel drugs in 2020. When compared to 2019, the FDA had approved just eleven new drugs at that same time, and by the end of 2019, the agency had approved 48 novel drugs. This is in line with a Reuters article from January 2020 that stated “the average annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009 and 41 from 2010-2018. The proportion of drugs approved with the Orphan Drug Act designation increased from 18% in 1984-1995 to 41% in 2008-2018.”
Clinical Trial Complications
One set of complications are the ones faced by clinical trials because of the pandemic. Clinical trial subjects may have difficulty getting to clinics for the administration of drugs and necessary testing protocols. An April 6th report highlights that, finding that globally, clinical trial enrollment has decreased 65% when compared to 2019 numbers – that number is elevated in the United States to 67%.
Marketing Complications
Then, there is the complication of once a drug is approved, how is it marketed? Currently, most pharmaceutical representatives cannot visit doctor offices in person, and as such, some pharmaceutical companies have decided to delay new drug launches until those in-person visits can continue so the doctors can understand the medication.
There is at least one company, though, that has a new drug and is actively marketing it. Biohaven’s migraine medicine, Nurtec ODT, was approved by the FDA on February 27, 2020. Recently, Biohaven CEO Vlad Coric discussed the company’s decision to begin a direct-to-consumer (DTC) compaign in the midst of the pandemic.
“Companies often have sales forces in the field for a few months before starting direct-to-consumer messaging, but we did accelerate because we had to get the message out to patients throughout this time of social distancing. We’re part of the drug supply chain and we have to get treatments to people with migraines. This can be the worst time to have a migraine,” Coric said.
Will 2020 Continue the Uptick?
Whether the upward tick will continue for 2020 will remain to be seen. Currently the FDA and private industry seems to have turned their focus to clinical trials and reviews for potential COVID-19 treatments and vaccines. As countries around the world slowly begin to reopen after the COVID-19 pandemic, we may start to see clinical trials and novel drug marketing pick back up again. This may help the drug approval timeline to continue its upward tick. However, given the industry focus on finding a solution to the COVID-19 virus, it will be interesting to see how the interests are balanced.