A new report suggests that keeping the public in the dark when the U.S.
Food and Drug Administration (FDA) fails to approve a new drug could compromise
patient safety. In many cases, patients and doctors never learn about
the FDA’s concerns over effectiveness or safety when drugmakers
announce that their drugs have been rejected.
which appears in the
British Medical Journal, compared non-public letters issued by the FDA when it denies marketing
applications from pharmaceutical companies with the content of any subsequent
press releases issued by those drug makers. It found that the press releases,
which are often the public’s only source of information regarding
the FDA’s rationales for not approving marketing applications, frequently
fail to convey a complete picture of why the drug was not approved.
Out of 191 concerns about drug efficacy raised in the letters, the pharmaceutical
companies disclosed a total of 30 in press releases. Meanwhile, the drug
companies shared 22 of 150 safety concerns raised by the FDA. Publicly-traded
companies that are required to make certain disclosures were the most
forthcoming, according to the study.
“Only a minority of the press releases clearly stated that receipt
of a complete response letter meant that marketing could not commence,
and most findings associating the drug with a higher mortality rate went
unmentioned,” lead study author Dr. Peter Lurie, FDA associate commissioner
for public health strategy and analysis,
told Reuters Health.
The researchers highlight that making complete response letters available
to the public would increase transparency regarding the FDA drug-approval
process and provide valuable information to patients and healthcare providers.
In an editorial accompanying the study findings, Barbara Mintzes, a professor
of pharmacy at the University of Sydney, notes that insight into the FDA’s
decision-making process is particularly important with regard to new uses
of previously approved drugs.
“Doctors who are considering prescribing a drug for a specific use
would likely reconsider if they knew the FDA had rejected an application
for marketing for that specific use,” Mintzes said.
She added, “Medicines are important treatments but they are capable
of causing harm as well as benefit, and harmful drug reactions are a leading
cause of death and hospitalizations.”
If you or someone you love has been seriously injured by a dangerous or
defective drug, don’t hesitate to
contacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.