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When accepting or rejecting new drugs, the FDA will be transparent
Key Excerpts from Article on Website of Washington Post
Posted: July 24th, 2025
https://www.washingtonpost.com/opinions/2025/07/11/fda-trans...
The letters the Food and Drug Administration sends to pharmaceutical companies explaining its decisions on drugs are a treasure trove of valuable information. The FDA has begun making drug decision letters public and is publishing past decision letters retroactively. The historical lack of transparency about FDA decision-making has allowed companies to spin the information to investors and shareholders. For example, if an FDA rejection letter explains that the applicant did not meet agency standards and tells the company to perform a new clinical trial to be reconsidered for approval, the firm might mislead shareholders by saying that the FDA had just asked for a few minor things. A 2015 analysis by the FDA found that drug companies avoided mentioning 85 percent of the agency’s concerns about safety and efficacy when announcing publicly that their application had not been approved. In addition, when the FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed about 40 percent of the time. As a result, capital can be wasted on futile therapies or companies misrepresenting their regulatory guidance. It is important to point out that when making decision letters public, the FDA will redact any trade secrets and confidential commercial information. At the same time, the deliberations of agency scientists are not the property of the drug’s sponsor. The FDA does not belong to the industry; it belongs to the American people.
Note: The above was written by Dr. Marty Makary, the US Commissioner of Food and Drugs. For more along these lines, read our concise summaries of news articles on government corruption and Big Pharma profiteering.
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