FDA No Longer Pursuing Rule Update to Require Generic Drug Makers To Warn Of Known Side Effects

Back in November, 2013, I posted that the FDA proposed a new regulations that would allow (and presumably encourage) generic drug manufacturers to add or update the safety warnings on their products.  In a nutshell, the key is that generics are required to use the exact same label and warnings as the brand name manufacturers.  They can't deviate and update the warnings on their own. 

You would think that manufacturers interested in making sure their products are safe would welcome the new rule.  However, because the current system works to immunize generics manufacturers, a change that would work to make the products safer would also open the door to possible liability.  Thus, as you would expect from those who are more interested in profits than safety, the manufacturers hired a consulting firm  to conduct a cost-beneift analysis of the consequences of the new rule.  And, not surprisingly, the analysis concludes that the change is not good for consumers.  You can read the report here.  Then, go here for a report by Center for Justice & Democracy (called "America’s Unaccountable Generic Drug Industry; How Legal Immunity Could Be Making You Sick") which explains how deficient the current system is. You can then form your own opinion.  For more on this issue go here, here, here, here and here (video).

In April 2015, the New York Times published story stating that

The pharmaceutical industry mounted a new challenge on Friday to a federal plan that would require generic drug companies to take the initiative to update their labels to warn consumers whenever health risks were discovered, a shift that would expose the companies to legal liability.

During a public meeting at the Food and Drug Administration, the industry proposed instead that the F.D.A. itself should decide whether new warnings on drug labels are required and, if so, order companies to make the changes. But consumer advocacy groups said the companies were trying to shift responsibility to an agency that lacks the resources to track the vast array of drugs on the market.

Not much has happened since. The rules were supposed to have been finalized in December 2015, but the FDA delayed taking action until July 2016.  Yet, no action was taken, and two weeks ago, despite years of work, and calls from both inside and outside of the agency to ensure accurate and up-to-date warnings are provided to consumers by generic drug manufacturers, the FDA posted a notice announcing the withdrawal of the proposed rule involving label changes.

AboutLawsuits has the story here.