Trump administration’s efforts to speed up the regulatory review process of therapeutic drugs and vaccines for COVID-19 is unprecedented, according to Rep. Andy Harris (R-Md.), who has spent three decades practicing medicine.
Harris told The Epoch Times’s Jan Jekielek that therapeutics, such Regeneron’s “antibody cocktail” designed to imitate and boost the immune response to the CCP virus, could take three to five years to proceed from initial authorization of clinical trials to FDA approval. The lengthy process is now expected to be reduced to eight or nine months while still maintaining existing quality standards.
“A drug like this could take three, four, or five years to get approved and we’re talking now, eight months, nine months,” Harris said. “It’s phenomenal. And all we’ve done is we’ve cut the red tape. We haven’t shortchanged on safety, we haven’t shortchanged on efficacy, we’ve just cut through the red tape and encouraged production and in some cases pay for production.”
When asked how exactly the red tape reduction works, Harris said the key is that protocols for trials are now being overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies develop their own protocols.
“When you’re developing a drug and you’re developing a trial, there’s usually back and forth with the FDA: What is the FDA going to require? Do they agree with your protocol?” Harris explained. “If the FDA works hand in hand up front with the company, then that back and forth is eliminated.”
The coordinated government support also allows companies to focus on research rather than finance. “When when you’re doing a study, for instance, when some of these vaccine studies with 30 to 40,000 patients in them, that requires a lot of capital,” Harris said. “The government’s Operation Warp Speed is saying, ‘No, we’re going to give you the capital, don’t worry about the capital, just design the study, recruit the patients, get the results. Don’t worry about things like that.’”
“And then again, we’re going to pay for production while you are in the approval process,” he continued. “And that and all these things just cut literally cut years off the time, it is so unprecedented, that we are probably going to have a vaccine within 10 to 11 months of the Chinese releasing the genotype of COVID.”
Harris also expressed confidence that the antibody cocktail, which was taken by President Donald Trump during his brief hospitalization, will be distributed to the American public for free once it becomes available.
“The government has invested tens of billions of dollars in developing these therapeutics and producing the therapeutics,” he said. “We’ve paid to help with the research and development, we’ve paid to produce it. So for a while, it could be available at no cost. I think that'd be perfectly reasonable.”
Trump recently revealed that Regeneron’s antibody cocktail played an important role in his rapid recovery after contracting the CCP virus, likening it to a “cure” rather than a therapeutic treatment.
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