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Generic Drug Industry Pushback Over New FDA Regulations

Posted in FDA Regulation

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced.  The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and have ‘harmful consequences for patients.’”

This sentiment comes as a result of a report by independent consulting firm Matrix Global Advisors stating “the rule change would needlessly complicate the market and add $4 billion a year to already bloated healthcare costs.”

Alex Brill, lead author of the aforementioned report, states that this increase in cost would come as “‘Higher insurance premiums, self-insurance costs and reserve spending on product liability will likely force generic drug manufacturers to raise prices’” in an interview with the LA Times.  That same LA Times piece also notes that the Matrix report was “sponsored” by none other than the Generic Pharmaceutical Association.

Obviously, the generic pharmaceutical industry wants to keep its costs down, but it is sad that this end seems valued over consumer safety.  As it currently stands, the manufacturers of brand name drugs are required by the FDA to inform the public of newly-discovered hazards related to their medications.  This does not apply to generic drugs manufacturers.

In 2011, the US Supreme Court ruled that “at generic-drug companies don’t share the same level of responsibility as makers of brand-name equivalents to update their warning labels when a new risk comes to light.”  And, in 2013, the Court ruled that because generics manufacturers are simply following manufacturing guidelines from brand-name producers, generics manufacturers cannot be held legally accountable for defective or dangerous products.

LA Times states that in response to this most recent ruling, the FDA has chosen to “empower generic makers to update their warning labels any time new risks become known, rather than wait for federal authorities to require a change.”

The reason that generics manufacturers are opposed to this change is that when label changes weren’t under their purview, companies could sit on data showing a health risk associated with their products without the legal obligation to act.  Now, these companies would be obligated to make timely, effective label changes, which could hurt sales of the drug in question — as it should.