Sunday, April 5, 2015

Pharmaceutical companies continue to challenge the plan to require generic drug companies to update their labels

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.  Go here for my original post and the background on the controversy. 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.  Go here for a recent post on generic drugs by the PopTort.

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).

Because the prevailing rules result in immunity for the generic drugs manufacturers, the issue has led to another interesting question: whether the manufacturers brand name drugs can be held liable for injuries caused by generic drugs.  In August of last year, the Alabama Supreme Court held they could.

Not much has happened since apparently and a few days ago the New York Times published a story with the latest news. You can read the story here. It starts by 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.

. . . .

Under current rules, generic drug makers are not allowed to update such health warnings unless the F.D.A. orders them to do so — a peculiarity of the 1984 law that governs the generics. Brand-name producers make changes as they discover risks, and the F.D.A. approves them later, prompting changes in generic labels.

In 2013, the F.D.A. proposed a rule giving generic drug makers the same control over their labels that brand-name drug makers have.

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