Between August 11, 2008 and June 27, 2013, the U.S. Food and Drug Administration (FDA) declined to approve a new drug seven times because patients were more likely to die when taking the drug than those in a control group; however, only one of the drug companies told investors and the public exactly why.
According to an article in the new issue of the British Medical Journal (BMJ) viewed by The Wall Street Journal (WSJ), FDA researchers led by Peter Lurie, the Associate Commissioner for Public Health Strategy and Analysis at the FDA and a former researcher at the consumer gadfly group Public Citizen found a work-around to determine how little information manufacturers willingly offer investors and the world.
The FDA is not required by law to publish its rejection letters, or complete response letters, and drug companies are only required to release bare bones information about why their product was rejected. BMJ found the industry’s communications concerning product rejections to be insufficient and misleading, even downright lies. The researchers broke up the complete response letters, resulting press releases and filings to the U.S. Securities and Exchange Commission (SEC) into discrete statements, counted how often the statements appeared in the press release (or, in a separate analysis, the SEC filing) and matched what was in the rejection letter, according to WSJ
Twenty-one percent (13) of the press releases contained no details from the letters. Press release statements matched only 14 percent (93) of the 687 statements about reasons for rejection contained in the FDA letters. When the analysis of the SEC filing was included, that number increased to 15 percent (101). Press releases typically include less information than response letters, Forbes reported.
Manufacturers say the letters ought to remain confidential, but as Forbes wrote, “One of the best ways to understand what you need to do to get your drug approved is to know where others went wrong.”
In an interview seven years ago with Forbes, John Jenkins, director of the FDA’s Office of New Drugs, said: “One thing I’ve said now for several years is, if a company is telling you about the letter, I would ask to see the letter, because that’s the only way to know what the FDA said.”
Forbes wrote that “investors faced with an FDA rejection should never believe anything that executives have to say unless those executives make public the full text of the rejection letter – something that, in the time span of this analysis, no company has done.”