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The agency stated that the letters were made public to promote transparency.
Current FDA leadership is promoting transparency in its process.
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One of the major complaints levied against FDA by the current administration is that the approval process is too complicated, takes too long, and needs to be modernized. The new leadership pledged to take various steps to rectify this and improve the drug approval process.
Another element that the administration claims to be focused on is transparency. In an effort to promote this, FDA leadership issued a statement announcing the publication of over 200 complete response letters.1 According to the agency, these letters were sent in response to applications filed between 2020 and 2024.
The agency also stated that the letters will be publicly available in order to promote transparency.
In a press release, FDA commissioner Marty Makary, MD, MPH, said, “For far too long, drug developers have been playing a guessing game when navigating the FDA. Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”
The statement continues to explain that, according to current FDA leadership, sponsors would misrepresent to their stakeholders the reasons why FDA failed to approve an application and would avoid mentioning the majority of the agency’s concerns for safety and efficacy.
The completed CRLs can be downloaded from openFDA.com, although it appears that they are only available as one entire batch. Some CRLs have reportedly not been made public in order to protect trade secrets.
Markary also issued a statement discussing his first 100 days in the role.2 It says, “As I mark my hundredth day on the job at the FDA, I’m proud to celebrate the agency’s accomplishments in the bipartisan effort to Make America Healthy Again. I came here with big questions: Why does it take ten years for a drug to reach patients? How can we fix America’sfood supply so it is not filled with harmful chemicals and additives? Why are childhood chronic diseases so prevalent? We are taking bold action to address these big, obvious problems, and more, which have been staring at us for years.”
The statement continues, “The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American. Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science and common sense.”
Makary listed several items he considered to be accomplishments, including:
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