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Would Greater Transparency Improve Drug Safety?

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.

The study, 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.