More from the FDA on generic drug labeling proposal

On Friday, we told you about FDA's proposal to authorize generic drug
manufacturers to update labels to provide new warnings, just like
brand-name manufacturers have been authorized to do since 1982.

Janet Woodcock, the head of FDA's drug research and evaluation division, has written an essay in FDA Voice explaining why the agency wants the new rule. Here it is:

By Janet Woodcock, M.D.

All drug manufacturers are required to keep close tabs on their drugs
once they go to market, reviewing all reports of adverse events
involving their drug and reporting these findings to FDA.

FDA is taking a step today that
is intended to improve the communication of important drug safety
information about generic drugs to both prescribers and patients.

All drug manufacturers are required to keep close tabs on their drugs
once they go to market, reviewing all reports of adverse events
involving their drug and reporting these findings to FDA.

– See
more at:
http://blogs.fda.gov/fdavoice/index.php/2013/11/working-to-improve-the-communication-of-important-drug-safety-information-about-generic-drugs/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.Htb2qCi4.dpuf

But
currently, only brand name manufacturers are able to independently
update and promptly distribute revised drug safety information, also
called labeling, and they can distribute that information before FDA has
reviewed or approved the change. These updates, which are submitted in
changes being effected supplements, ensure that this important safety
information gets to the public as quickly as possible.

Right now generic companies, who are responsible for over 80% of the
prescription drugs dispensed to patients, aren’t able to revise their
drug safety information as quickly as the brand name. They must provide
supporting information to FDA, which then determines whether safety
information for both the brand and generic drugs should be revised
before updates can occur.

Today, FDA is issuing a proposed rule that
would allow generic drug manufacturers to independently update and
promptly distribute revised product labeling — just like brand name
manufacturers – before FDA reviews or approves the change.

Empowering generic drug companies to update their own drug safety
information is intended to provide them the incentive to more actively
participate with FDA in ensuring the timeliness, accuracy, and
completeness of this information.

The brand manufacturer would be expected to consider the information
provided by the generic drug manufacturer as part of its review and
evaluation of adverse drug experience information for its drug.

And to make sure that the drug safety information updates from both
generic and brand name companies are readily available to health care
professionals and the public, FDA plans to post these updates on its
website.

Faster safety updates and easier access to this information should be a win–win for all involved.

Right
now generic companies, who are responsible for over 80% of the
prescription drugs dispensed to patients, aren’t able to revise their
drug safety information as quickly as the brand name. They must provide
supporting information to FDA, which then determines whether safety
information for both the brand and generic drugs should be revised
before updates can occur.

Faster safety updates and easier access to this information should be a win–win for all involved.

– See more at:
http://blogs.fda.gov/fdavoice/index.php/2013/11/working-to-improve-the-communication-of-important-drug-safety-information-about-generic-drugs/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.Htb2qCi4.dpuf