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Public Citizen: Generic Drug Labels Need Revision

August 29, 2011 — Consumer interest group Public Citizen petitioned the Federal Food and Drug Administration (FDA) to revise current policy, so as to allow generic drug manufacturers the ability to update their own drug labels with more accurate drug risks and side effects.

Public Citizen, a 225,000 member and supporter organization that operates out of Washington, D.C., was founded in 1971 to represent consumer interests in Congress. The non-profit organization brings voice to citizens by challenging the pharmaceutical, nuclear and automobile industries.

Public Citizen’s Petition: An Overview

Today, Public Citizen is asking for increased responsibility from the FDA and generic drug manufacturers. Public Citizen hopes to equalize the playing field between generic drug manufacturers and name-brand drug manufacturers by making sure both groups adequately warn patients about possible drug side effects — especially side effect information released following a drug’s initial market approval.

With 78% of US prescriptions made out for generic drugs, they are being sold more frequently than ever before. Yet, generic drug labels must remain the same as their name-brand counterparts — even if the generic drug risks a different adverse side effect than the name-brand. Generic manufacturers cannot change their labels.

Recently, FDA regulations on generic drug labels have stayed relatively unchanged. In fact, while name-brand manufacturers are being held more accountable for post-approval drug safety by the FDA, generic brand manufacturers are scraping though relatively unharmed.

Due to the constraints of current policies, the U.S. Supreme Court was forced to rule in the June case of PLIVA v. Mensing that patients harmed after taking generic medications cannot sue the manufacturer, while patients who take name-brand versions of the same medications can.

In order to reverse this illogical policy, Public Citizen is asking the FDA to enforce procedures calling for generic manufacturers to initiate their own drug label changes, as well as report any safety concerns to the FDA.

As the petition states:

“[Generic manufacturers] are likely the main recipients of adverse event reports, may be best informed regarding risks unique to off-label use, and already must compile information about risks on a periodic basis under post-approval reporting regulations. Drug safety would benefit if generic manufacturers who already have access to much of the relevant information were able to use CBE and PAS procedures to revise labeling.”

While some label changes require the FDA to approve the changes beforehand (prior-approval supplements, or PAS), other label changes can be implemented by the manufacturer, notifying the FDA at the time the change is enacted (changes-being-effected, or CBE).

This means that the FDA — with its limited resources, funding and staff — does not bear the burnt of the burden of monitoring post-approval drugs. Instead, Public Citizen’s mandate is pushing increased responsibility back into the hands of generic manufacturers, ensuring label information is up to date and accurate in its reporting of adverse side effects.

Public Citizen Recommendations

In its petition to the FDA, Public Citizen recommended the following steps for generic manufacturers to take in monitoring post-approval drugs:

  • Promptly review adverse event information (from marketing experience, clinical investigations, survey studies, publish reports in scientific literature, and from unpublished studies)
  • Report any serious and unexpected drug experience to the FDA within 15 days, with the manufacturer immediately investigating
  • Adverse event reports need to be submitted to the FDA quarterly for the first three years after a drug’s approval, then annually after that (reports should include actions taken last reported adverse events)
  • Labels must be revised to include warning about clinically significant hazards as soon as reasonable evidence associates it with the drug
  • Use changes-being-effected (CBE) and prior-approval-supplement (PAS) procedures in order to change or update drug labelings

Why Post-Approval Information is Important

While drugs undergo research before they are initially approved by the FDA, pre-approval tests do have their limits. Namely, pre-approval tests cannot detect rare or delayed side effects. Additionally, as a drug becomes mainstream, it may start to be used for “off-label” functions it was not initially approved for.

As a result, the information that is discovered post-approval is just as important as the information discovered during initial testing. Because of its importance, it should be included on a drug’s warning label, so patients may be aware of all possible risks and side effects.

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