POLITICO Pro reporters on Thursday, 4/2 held the fourth in a series of conference calls for subscribers to discuss the coronavirus pandemic.
Pro Health Care’s Joanne Kenen, David Lim and Sarah Owermohle joined by Agency IQ senior director of research Alec Gaffney discussed what the FDA has done so far and what the agency is expected to do in the coming weeks as the U.S. continues to deal with the mounting coronavirus case load.
The life sciences industry and the FDA are quickly developing products for Covid-19. Alec said it’s rare to see such an “extraordinarily quick” development into just one particular disease area. Agency IQ research found that there are more than 75 therapeutic medical products and more than 33 vaccines being developed. Among those, 34 therapies and six vaccines are already in clinical development or being tested.
While a lot of these products will go through the clinical development and testing phases, only a small percentage will actually get approved. Alec noted that for infectious diseases, 26.7 percent of all investigational drugs are approved, based on Agency IQ analysis. But because we don’t know a lot about Covid-19, these numbers might not be as accurate for what’s in the pipeline.
“We’re trying to throw everything at the wall and see what sticks,” Alec said.
So far, the FDA has been “extremely lenient” in terms of what products patients have access to through emergency use authorizations.
The FDA has also been releasing a lot of regulations related to the virus, like permitting labs to develop and use their own diagnostic tests without first receiving approval from the FDA, issuing emergency use authorizations for in vitro diagnostic devices and diagnostic testing platforms and allowing protective gear to be made without meeting FDA requirements.
When it comes to testing, one aspect to watch for is what the agency is doing to coordinate supplies needed to administer the tests, David said.
One of the key challenges for the FDA during this pandemic is how to move as quickly as possible when there isn’t a lot of data yet about the disease, as well as the products and their effects.
Sarah pointed out that a lot of the data we have from treatments — like the malaria drugs President Donald Trump is touting or Gilead’s remdesivir — is very preliminary. It’s also hard to get answers fast from off-label uses because data isn’t collected for those the way it would be in clinical trials.
But even data quality in clinical trials for these products could be really difficult to maintain. Alec said the question for companies is: Will they be able to determine whether a patient died or had adverse effects because of the product or because of the virus? Clinical trials are really small, so it’s hard to tell if a vaccine or drug will really be safe.
With employee travel halted, Alec said there’s also a concern about whether drugs will be properly reviewed and approved because a key part of drug reviews involve inspectors going to the facility for a preapproval inspection.
The FDA is also facing enormous pressure from lawmakers, the president and the general public to move quickly. Alec said the political interference could be hurting the agency’s decision-making in terms of what products get approved or authorized.
As for what’s next for the FDA, the panelists note that they’re looking to see what other guidance and regulations the agency will come out with; how the agency will test drugs and what outcomes they care about; how the FDA will handle the testing backlog; and what will fall by the wayside as Covid-19 occupies the agency’s time.