Generic Drug Labels Frequently Differ from Branded Equivalents

Published Online: Friday, January 11, 2013
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More than two-thirds of generic medications have safety-warning labels that differ from their branded equivalents, according to the results of a study published online on October 8, 2012, in Pharmacoepidemiology and Drug Safety. These results are particularly striking given that the FDA requires that generic medication labels be identical to their branded equivalents.

The researchers reviewed 9105 product labels for 1540 drugs on an online storehouse of labeling information, of which 1040 drugs had more than 1 manufacturer represented. Of these, 68% had discrepancies in the adverse drug reactions (ADRs) listed on the generic label compared with the branded equivalent label. The mean deviation in the number of ADRs listed was 4.4 and the median was 0.8, indicating that most labels had relatively minor differences and a small number of labels had significant variation. Indeed, 9% of the labels had differences of more than 10 potential side effects. Common causes of the inconsistencies included missing tables, missing or incomplete post-marketing reports, and formatting issues.

In general, the researchers note, branded labels have the widest range of adverse effect information because they are updated before generic equivalents and because they tend to be approved for the broadest range of indications. The FDA requires generic manufacturers to update labeling within 30 days to reflect new changes, but the researchers note that this may not always be feasible.

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Today Reps. Doug Collins (R-Ga.) and Dave Loebsack (D-Iowa) introduced H.R. 5815, The Generic Drug Pricing Fairness Act, which creates greater transparency in how pharmacy benefit managers reimburse pharmacies for generic prescription drugs under Medicare Part D, and the Federal Employees Health Benefits Program. The National Community Pharmacists Association endorsed the bill, which goes further than legislation the same two Congressmen introduced earlier year that has the same remedies, but only applied to Medicare Part D.
“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
Generics saved $239 billion in 2013 (a 14% increase in savings from 2012) and more than $1.46 trillion over the recent decade. Further, the Express Scripts 2013 Drug Trend Report issued in 2014 shows that since 2008, the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half.
The prices for brand-name prescription medications commonly used by older adults increased by an approximate average of 13% last year, more than 8 times faster than the general inflation rate.
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