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.
Latest
Latest News
Each news summary is created according to strict standards. Here's how we do it.
Each summary is created using a consistent editorial procedure. The target length is approximately 16 lines of 11-point Arial text in a 650-pixel-wide column. Up to 25% of a summary may be set in bold to emphasize the most important ideas. Summaries are composed of verbatim excerpts presented in the same sequence as they appear in the original news source, with very minor editorial additions. Where material has been omitted between excerpts, the omission is indicated with ellipses (...). Any words added by an editor for clarity or context appear in [brackets]. Our original news editor was Fred Burks. Tod Fletcher edited most summaries from 2007 through 2014, and Mark Bailey has served as news editor since 2014.