Complete Response Letters to be Posted in Real Time: FDA
A day after releasing hundreds of past complete response letters (see earlier story) as part of FDA’s “radical transparency” efforts, FDA commissioner Marty Makary is now pledging to release newer letters in “real time.” Addressing criticism by some FDA watchers that the letters were too old to be useful or that they had already been released as part of new drug approval packages, the commissioner told CNBC in a 7/11 video interview that yesterday’s release was just the “initial batch” due to redaction constraints and that soon the letters should be released in real time.
“This is only part of the stack of all the letters, and we have thousands of letters that we are redacting,” Makary said. “We're going to make them all public and drug developers and inventors are going to be able to go through them and see not just how the FDA thinks… And we’re going to be releasing them in real time as we make decisions, and that way shareholders will be able to see exactly what the FDA said.”
Makary pointed to feedback received during his CEO listening tour that called for more FDA transparency and communications. “We’re about two-thirds the way through,” he said. “When we meet with pharmaceutical CEOs in private, that is where they can be open and honest about their ideas for reforming the FDA without their shareholders listening, they tell us they want more predictability. They want to know exactly how the FDA thinks, and they want better communication so they can, you know, one CEO said, if we could just have a couple 15 minute calls with the FDA review team along the process, it could save us nearly a year of doing things just out of guesswork and trying to figure out what the FDA wants. So we're going to be radically transparent.”
Makary was also asked in the interview to elaborate on his new pilot program on national priority vouchers, which aims to shorten the review time from about 10-12 months to 1-2 months following submission of a final drug application. Products that would qualify for the program must demonstrate an unmet public health need, such as reshoring the manufacturing of a drug product because of a national security issue. He also said that under President Trump’s agenda to lower drug prices for Americans, drug product affordability will also be considered a national priority. “So we have a committee that’s set up that will determine which products and companies will get these vouchers as a part of the pilot,” he said.
Asked to provide other examples of the types of products FDA would like to see in the pilot, Makary said he would like to see a cure for Type 1 diabetes. “I’d like to see more cancer therapies that apply to stage four metastatic disease and cancer therapies that result in what we call in medicine a complete pathologic response, that is, the cancer melts away,” he continued. "There already appears to be some therapies that may enable cancers to shrink and go away completely … without chemo, surgery or radiation therapy. I’d like to see a universal flu shot so we don’t have to try to guess each year which strain is coming. There are candidates out there. And I'd like to see treatments for neurodegenerative diseases and other disabling diseases.”