Figuring out whether readily available drugs can blunt COVID-19 can be done quickly. But getting any of those treatments approved by the U.S. Food and Drug Administration cannot be. The reason: The agency remains wedded to its decades-old model for assessing medications even in the midst of a global pandemic, said Dr. Joseph Gulfo, a longtime critic of the FDA’s drug approval process and author of the book Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances.
What is lacking is an appropriate sense of urgency, he said.
Proving a drug works to the satisfaction of the FDA takes time. It also requires statistical certainty.
In the midst of the global pandemic that has already killed more than 139,000 people worldwide, and roughly 31,000 in the United States, time and absolute certainty are two things we cannot afford, said Gulfo, who has more than 30 years of experience in the biopharmaceutical and medical device industries and was on President Trump’s original short list to be FDA commissioner.
In a new article, Goldwater National Investigative Journalist Mark Flatten reports on America’s drug approval process and how reforms — including those developed by the Goldwater Institute — could help ensure we get treatments when we need them. Read more here.
|
|
