Two-Thirds Of The Generics Did Not Have Identical Labeling, And Up To 9% Showed Differences Of More Than 10 Side Effects
A disturbing new study about drug labeling for generic medications reveals that warnings for some adverse reactions are different from brand name prescription drugs, causing a potential drug safety problem and having possible legal liability ramifications for the generic manufacturers.
These study findings were reported in this article, "Consistency in the safety labeling of bioequivalent medications", which was published in the Pharmacoepidemiology and Drug Safety medical journal. From the Abstract:
Purpose: Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real-world consistency of electronic labeling for bioequivalent drugs from different manufacturers....
Results: 68% of multi-manufacturer drugs had discrepancies in ADR labeling.... Overall, 77.9% of generic manufacturers produced labels differing from brand. Causes of inconsistency included missing tables, outdated post-marketing reports, and formatting issues.
Conclusions: Despite FDA mandate, bioequivalent drugs often differ in their safety labeling. Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels.
A December 13, 2012 Indiana School of Medicine press release concerning this recent article, "Regenstrief study finds that generic drugs often have incorrect safety labeling", provides us with some commentary from the lead author of this new generic drug study:
The majority of generics showed relatively small differences across their labels, but nine percent showed differences of more than 10 side effects. Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.
"Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions. They need to know about side effects, drug interactions and other safety issues," said Regenstrief Institute investigator Jon Duke, M.D., M.S., assistant professor of medicine at the Indiana University School of Medicine, who led the study. "We found that generic drug labels may contain incomplete or incorrect safety information. Until this problem is resolved, physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug."...
Safety studies are conducted by the brand name manufacturer before the medication goes on the market. The FDA does not require that the generic manufacturer duplicate these studies....
"The solution to the problem of labeling inconsistency may be a centralized listing of drug side-effects, maintained independently of individual manufacturer labels. Drug labels would simply reference this common repository rather than attempting to maintain all the information within a single document. Clinicians could refer to this resource for the most up-to-date safety information regardless of generic manufacturer," Dr. Duke said.
The findings of this new pharmacoepidemiology study bring to mind the "consensus" label idea which was discussed in another relatively recent article "Risk, Responsibility, and Generic Drugs", published in November 2012 by The New England Journal of Medicine (NEJM).
Earlier this month I wrote a piece concerning that recent NEJM article: "Generic Drugs Post-Mensing Ruling: One Proposed Solution To The Legal Compensation And FDA Drug Safety Problems Supreme Court Created".
As some may be aware, the Pliva, Inc., et al. v. Mensing case decided by the Supreme Court of the United States in 2011 estabalished that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims. Accordingly, the Supreme Court ruled in favor of the generic drug company and against the injured patient, such that at the present time any "failure to warn" lawsuit involving a generic drug would be dismissed based on this Mensing case ruling.
In more detail, generic-drug companies successfully argued in the Mensing case that they should not be held to the same legal standard as brand-name manufacturers -- which can be sued in drug-injury "failure to warn" state court lawsuits -- because federal law requires the label, or package insert, for a generic medication be the exact same as the package insert for the equivalent brand-name drug, i.e., identical.
Put otherwise, the generic manufacturers took the position that federal law should prohibit (by means of the federal preemption legal doctrine) drug injury lawsuits in state courts seeking to hold generic-drug companies legally liable for using the identical warning that the FDA and federal law required.
So what about when the generic drug company fails to use the identical label and a patient suffers from one of the serious side effects that was missing from the generic label?
It seems that this new study published by the Pharmacoepidemiology and Drug Safety medical journal -- finding that generic drugs often have different, or not identical, safety labeling -- would put some momentum behind efforts aimed to "fix" the current situation created by the Mensing decision.
Here are two past articles about this Mensing preemption problem which I have written:
- "March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling"
- "Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling"
Of course, we will continue to monitor both the drug safety and the legal compensation aspects of this generic drugs warning labels issue.
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