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The coronavirus pandemic has disrupted more than just daily life.
The pandemic postponed the start of clinical trials for potentially life-changing, new medicines and now may delay the time in which some of those drugs will reach the market as the U.S. Food and Drug Administration faces a potential surge in applications amid a pandemic.
The coronavirus has infected 8.5 million people worldwide and killed more than 450,000 in a little over five months, according to data compiled by Johns Hopkins University.
While Covid-19 cases slow in places such as Europe, outbreaks are forming across South America, Africa and Southern Asia and some parts of the U.S. Public health specialists also warn that a slow burn of infection through the summer could lead to a massive resurgence this fall.
Early in the pandemic, biotechnology and pharmaceutical companies temporarily abandoned the start of new trials, allowing doctors and hospitals enough time to deal with a surge in patients sickened with Covid-19. Other drugmakers also shifted their focus to discovering treatments and developing potential new vaccines to fight the deadly virus.
While some drugmakers have since resumed their clinical trials, the full impact of the postponements for testing new drugs, treatments and vaccines for ailments besides Covid-19 may not be known for months, analysts and experts who follow the industry say. A near-term impact could be at the FDA, where the delays may create a backlog at the agency once drugmakers finish their clinical trials and submit their drugs for regulatory approval, analysts say.
‘A burst of activity’
“You might see a burst of activity start to hit the regulatory authorities,” former FDA Commissioner Dr. Scott Gottlieb, also a member of the boards of Pfizer, genetic-testing start-up Tempus and biotech company Illumina, told CNBC. “The agency has been keeping up” so far, he added.
Reviews for new drug applications can take anywhere from several months to a year as the FDA determines whether the drug is safe and effective in its proposed use and whether the benefits of the drug outweigh the risks, according to the agency’s website.
The last time the FDA risked huge delays was during the partial government shutdown in early 2019. At the time, Washington was in gridlock over President Donald Trump‘s demand for a wall along the southern U.S. border with Mexico. The health agency was able to keep most of its lights on, but the shutdown forced it to furlough almost half of its workforce and it was not able to accept new applications or fees.
“We were able to keep up with it, but [the shutdown] was only a month, month and a half,” said Gottlieb, who was leading the agency at the time.
FDA working around the clock
The FDA has already warned about potential delays because of the pandemic. Last month, the agency put out new guidance that said it might need to prioritize resources moving forward as its staff is stretched thin.
“With many staff members working on Covid-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely,” the agency wrote in the document dated May 26.
Acknowledging the impact of the virus, the agency has created a website intended to help companies with clinical trials. In response to a question about a potential bottleneck at the agency, the FDA told CNBC that it continues to “perform our medical product review activities as well as contribute to other vital functions of the agency.“
“We are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators, and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak,” an FDA spokesperson said. “Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation and will continue to be flexible and as transparent as possible.”
Cancer drugs likely to see no impact
Mike Bailey, director of research at FBB Capital Partners and a former health-care analyst at Stifel, said it appears the FDA has fared better than expected through the pandemic even though the risk of a backlog remains.
He said he doubts there will be substantial delays for new cancer drugs and medicines for rare diseases as those continue to be a high priority for the agency.
He said that may not be true for lower priority pharmaceutical areas such as generics, and he’s heard some concerns from those in the medical device industry about deadlines slipping.
“There’s definitely some lingering concerns about FDA reviews taking a little bit longer,” he said. “Especially for medical devices. … That is a whole another layer because of the Covid delays.”
There could also be winners and losers as a result of the virus, Bailey said. While drugmakers that are looking to compete in a niche market wait for their applications to be approved, some companies with drugs already on the market will remain entirely unopposed, he said.
Brian Skorney, a biotech analyst at Robert W. Baird & Co., said the FDA may face delays down the road “as we see a need for the FDA to evaluate clinical trial data in a background where participants may be dropping out of studies or a much larger number of data points in a study will be missing.”
He said he would not anticipate major advances being delayed, echoing Bailey’s comments. He added the U.S. “could see a slowdown in approvals for marginally effective drugs because of prioritization.”
“How much of a headwind this becomes for the industry will probably be determined by how Covid spread occurs over the next few months,” he said. “A major spike would slow things down more and a successful reopening without a major rebound in cases would probably see a very limited impact on regulatory approvals.”
To be sure, drug development is already inherently risky, according to Salim Syed, a senior biotech analyst at Mizuho Securities. There can be no assurances that the company’s clinical candidates will be successful in clinical trials, at regulatory checkpoints and as commercialized products, he said in a recent note to clients.
That being said, delays could end up hurting smaller companies that may be low on cash and were working to push new, innovative drugs to the market, he and other Mizuho Securities analysts suggested.
“How the biopharma sector returns to the ‘new normal’ remains to be seen,” they told clients.