Some drugs are approved by the U.S. Food and Drug Administration (FDA), while others are rejected. The FDA sends letters detailing their concerns to the firms applying for new drug approvals. In the past, these letters were never made public unless drugmakers chose to release them to the public. When the information was released, firms often only redacted portions of the letters, often concealing any FDA concerns. Critics have complained that decisions made secretly do not provide the public – or other drugmakers – with information we should have access to.
“For far too long, drug developers have been playing a guessing game when navigating the F.D.A.,” Dr. Marty Makary, the agency’s commissioner, said in a statement.
“Drug developers and capital markets alike want predictability,” Dr. Makary said. “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 FDA recently made the decision to publish a published a database with more than 200 letters to drug companies explaining why the agency initially refused to approve their products. All have subsequently gained approval.
The documents, referred to as “complete response letters,” are akin to rejection letters. Some outline problems with an experimental drug that cannot be remedied; those letters are never made public.
Notably absent from the new database were rejection letters for drugs that never ended up winning approval.
Those letters would have revealed details about the agency’s reasons for rejecting drugs that may have been so serious that the manufacturer could not address them. Generally, neither the agency nor the companies tend to release those letters, as was the case with the high-profile rejection of a psychedelic drug last year.
But the letters released on Thursday described the agency’s early concerns about drugs that were eventually approved.
Even when a drug is approved firms do not always release all the information to the public.
In a 2015 analysis, federal researchers discovered that the companies avoided publicly describing 85 percent of the agency’s concerns about safety and efficacy when a drug eventually gained approval.
The move to boost transparency is long overdue. Warning letters are released to the public but not Form 483s when the FDA inspects a facility. Form 483s are issued as part of an investigation and it is the FDA’s policy not to release preliminary information. Other information is only available through freedom of information requests. However, some letters for drugs the FDA declines to approve are never released. These too would seem to contain important pieces of information for both rival drug companies, scientists, and consumers.
The release of letters sent to drugmakers about drugs being considered for approval is a crucial step for transparency about drug safety and efficacy. However, information about drugs not rejected would be valuable information as well. At least it’s a start.
New York Times: F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs