FARMINGTON—Getting prescription drugs and vaccines from the lab into the hands of patients is a long and often difficult process that can take years. However, it’s those checks and balances that keep the public safe.

In the case of the COVID-19 vaccine, that was developed at what could be called lightning speed. “It received emergency use authorization,” said Tom Hatch, Director of Business Development at Beech Tree Labs, a company that focuses on the discovery and early development of drugs. “It’s amazing they could remove the process. In as early as November the government reviewed it and they started giving the vaccine in December. It’s moving down in age groups until soon anybody can get the vaccine.”

It was tested on a lot of people, he said. “The FDA requires testing be done over time and not to rush it but under the circumstances they decided it was better to get COVID under control. I believe they did the right thing with emergency approval of that vaccine.”

Normally, drug testing goes through a series of phases before receiving approval, said Hatch. “There’s the preclinical development phase where they test the drug in animal models to make sure it’s safe, with no side effects and it gets the effect you want. That can take three to four years.”

After that a company has to apply to the FDA for permission to evaluate the drug in humans, he said. “Getting approved is a big deal. It shows the drug has been tested sufficiently to be safe and the biological effect it has.”

Phase I proves the drug is safe in humans and there haven’t been any untoward effects and then submitting it to the FDA, Hatch said. “A Phase II study shows proof of concept that the drug will achieve what you want such as controlling blood pressure or pain.”

Phase III studies hundreds and hundreds of patients to show the drug’s effectiveness, he said. “A new drug application takes 18 to 24 months and if the government likes what they see it will be approved. It takes 11 to 14 years to go through all of that.”

The rising cost of medications is a growing concern, said Hatch. “It doesn’t cost billions for success, the failures count too. You really can’t separate out the two.”

Hatch said the primary reason drug costs are so high is because the United States bears the burden of developing drugs for the world. “They get the benefit of our heavy lifting without carrying the burden of safety. It’s not a fair system but that’s the way it’s unfolded over time. Maybe we don’t need drugs to solve all the problems of the world.”