Proposed guidance from the U.S. Food and Drug Administration (FDA) is receiving
significant criticism from patient safety advocates. It would allow pharmaceutical
companies to inform doctors that the prescription labels approved by the
FDA overstate a medication’s risks by distributing peer-reviewed
articles and by having discussions with doctors.
As Reuters reports, the FDA maintains that the
revised drug label guidance accounts for the fact that the risks associated with a particular medication
change over time. Under the proposal, drug companies could provide health
care providers with data suggesting that side effects are less severe
than stated on the label or even “call into question a causal relationship
between a drug and an event in the approved labeling.”
Pharmaceutical companies would not be able to distribute information about
new risks or side effects, as any changes must be directly reported to
the FDA. Nonetheless, critics of the proposal maintain that it would still
undermine the legitimacy of FDA-approved drug labels.
“[This proposed guidance is reckless and seriously undermines FDA
authority,” Dr. Sidney Wolfe, founder and senior adviser of Public
Citizen’s Health Research Group,
wrote in a recent letter to the Department of Health and Human Services. “The FDA is supposed to be the government shield that protects
patients when the industry pushes products that might not have a favorable
benefit-to-risk ratio in order to line their own pockets. This guidance
completely undermines that safety shield.”
According to Public Citizen, 99 percent of the 1,782 comments submitted
to the FDA also oppose the proposal. It offered the following examples:
- “This is a misguided FDA proposal that could result in physicians
relying not on approved warning labels but on information provided by
drug companies that may be more concerned with profits than patients.”
- “Drug reps stretch the truth more than enough.”
- “How can this be considered in any way? Where I come from you do
not let the fox in the hen house.”
The FDA has stated that it is considering all of the feedback it has received.
We will be closely tracking the status of the proposed guidance. Please
check back for updates.
If you or someone you love has been seriously injured by a dangerous or
defective drug or medical device, don’t hesitate to
contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.