The coronavirus pandemic violated not only everyday life.
The pandemic has delayed the start of clinical trials of potentially life-changing new drugs and can now delay the time when some of these drugs hit the market as the U.S. Food and Drug Administration faces a potential upsurge in pandemic use.
According to data collected by Johns Hopkins University, coronavirus infected 8.5 million people worldwide and killed more than 450,000 people in just five months.
While cases of Covid-19 are slowing down in places like Europe, outbreaks are occurring in South America, Africa, and South Asia, and some U.S. public health experts also warned that a slow tide of infection during the summer could lead to a massive resurgence the fall.
At the beginning of the pandemic, biotechnology and pharmaceutical companies temporarily refused to start new trials, which gave doctors and hospitals enough time to cope with the growth of patients with an aversion to Covid-19. Other drug manufacturers have also turned their attention to finding treatments and developing potential new vaccines to fight the deadly virus.
In March, Eli Lilly, Bristol Myers Squibb, Pfizer, and many others announced that they would delay the start of new clinical trials and enrollment in some ongoing studies in a pandemic.
While some drug manufacturers have since resumed their clinical trials, the full impact of delays in testing new drugs, treatments and vaccines for treating diseases other than Covid-19 may not be known for several months, analysts and experts monitoring for the industry. The short-term effects could be in the FDA, where delays could lag behind the agency after drug manufacturers complete their clinical trials and submit their drugs for regulatory approval, analysts say.
“Burst of activity”
“You might see a surge in regulatory activity,” former Scottish FOT Commissioner Dr. Scott Gottlieb, also a member of the board of directors of Pfizer, a Tempus genetic testing startup and Illumina biotechnology company, told CNBC. “The agency is keeping up,” he added.
Reviews of new drug uses can take anywhere from a few months to a year, as the FDA determines whether the drug is safe and effective for the intended use and whether the benefits of the drug outweigh the risks. according to the agency’s website.
The FDA last time runs the risk of huge delays during the partial closure of the government in early 2019. At that time, Washington was at a standstill because of President Donald Trump’s demand for a wall along the southern border of the United States with Mexico. The health agency was able to keep most of its bulbs on, but the stop forced him to fire almost half of his workforce, and he could not accept new applications or fees.
“We were able to keep up with this, but [the shutdown] it’s only been a month, a month and a half, “said Gottlieb, who at the time headed the agency.
FDA works around the clock
The FDA has already warned of possible delays due to the pandemic. Last month, the agency released a new guide that said it might need to prioritize resources because its staff is too narrow.
“Since many employees are working on the activities of Covid-19, it is entirely possible that we will not be able to maintain our current level of performance in accordance with target dates for an indefinite period.” The agency writes in a document dated May 26.
Recognizing the effects of the virus, the agency created a website designed to help companies with clinical trials. When asked about a potential bottleneck in the agency, the FDA told CNBC that it continues to “carry out our health product review activities, as well as contribute to the agency’s other vital functions.“
“We work around the clock to monitor and mitigate emerging problems associated with coronavirus, with our federal partners, international regulators, as well as developers and manufacturers of medical products, to step up efforts to combat the outbreak of coronavirus disease (COVID-19),” said FDA Representative. he said. “Our application analysis teams are still focused on their work, and we are doing everything possible to maintain business continuity in a very dynamic situation and will continue to be flexible and as transparent as possible.”
Cancer drugs probably have no effect
Mike Bailey, research director at FBB Capital Partners and a former health analyst at Stifel, said the FDA appears to be doing better than expected thanks to the pandemic, although the risk of lag remains.
He said that he doubted that there would be significant delays for new cancer drugs and drugs for rare diseases, as they remain a priority for the agency.
He said this might not be the case for lower-priority pharmaceutical areas, such as generics, and he heard some concerns from medical equipment manufacturers about shorter lead times.
“There are definitely some problems with the fact that the FDA checks take a little longer,” he said. “Especially for medical devices. This is a completely different layer due to delays in Covid. ”
According to Bailey, there can be winners and losers as a result of the virus. According to him, while drug manufacturers who seek to compete in a niche market are waiting for approval of their applications, some companies that already have drugs will be left without resistance.
Brian Scorney, a biotechnology analyst at Robert W. Baird & Co., said the FDA may face delays in the future, “because we see the need for the FDA to evaluate clinical trial data against the backdrop of when participants may drop out of studies or a much larger number there will be no data points in the study. “
He said he would not expect a delay in major achievements, repeating Bailey’s comments. He added that the US “may see a slowdown in permits for marginally effective drugs due to prioritization.”
“How much the industry will meet will likely depend on how Covid spreads over the next few months,” he said. “A serious surge will further slow down the situation, and a successful reopening without a serious rebound in cases is likely to have a very limited impact on regulatory approvals.”
Of course, drug development is already risky initially, according to Salim Sayed, a senior biotechnology analyst at Mizuho Securities. There can be no guarantee that the company’s clinical candidates will be successful in clinical trials, at checkpoints and as commercial products, he said in a recent note to clients.
At the same time, delays can ultimately harm small companies that may have little cash and are working to market new, innovative drugs, he and other Mizuho Securities analysts say.
“How the biopharma sector is returning to the“ new standards ”is not yet known,” they told customers.