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    House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

    A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group. Background In November 2013, FDA unveiled a new proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products . The rule wou...
  • House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

    A large group of House Republicans is once against raising questions about the US Food and Drug Administration's development of a rule that would change the way generic drug labels are regulated, saying it has "significant questions" about the involvement of a group of trial lawyers in the process and is interested in proposing its own "alternative approaches." Interested in learning more about FDA's generic drug labeling rule? Check out our Regulatory Explainer o...
  • In Response to Legislators, FDA Defends Proposed Generic Drug Labeling Rule

    The US Food and Drug Administration (FDA) is defending itself against critics of its proposed generic drug labeling rule, which would change the way generic drug manufacturers are able to update their labels to reflect emerging or established safety risks. Background Regulatory Focus  has written extensively about the  proposed rule , including its  legal background , initial  calls by legislators for reform , FDA's  early plans for a rule chan...
  • House Legislators Gear Up to Directly Challenge FDA's Generic Drug Labeling Rule

    House legislators will soon hold a hearing on their and industry's "concerns" about the US Food and Drug Administration's (FDA) recent proposal to change the way generic drug labels are updated in light of new and emerging safety risks. Background: The Rule In November 2013, FDA  proposed to allow  generic drug manufacturers to temporarily update their labels if they were made aware of new safety issues that might pose a risk for consumers. Those updates, whic...
  • Generic Drug Industry Claims FDA's Labeling Rule will Cost $4 Billion per Year

    As the battle over the US Food and Drug Administration's (FDA) proposed generic drug labeling rule has continued to heat up, an odd point of contention seems to be the source of increasing debate: the rule's cost. Background In November 2013, FDA proposed to allow generic drug manufacturers to temporarily update their labels if they were made aware of new safety issues that might pose a risk for consumers. Those updates, which would be done through the submission of a...
  • Generic Industry Slams FDA's Proposed Generic Drug Labeling Rule

    The Generic Pharmaceutical Association (GPhA), the US generic pharmaceutical industry's main trade group, has released a whitepaper calling the US Food and Drug Administration's (FDA) proposed rule to overhaul generic drug labeling safety updates seriously flawed. Background Generic drugs are those submitted to the agency through an abbreviated new drug approval (ANDA) application and approved under the 505(j) pathway of the Federal Food, Drug and Cosmetic Act (FD...
  • As Legislators Join with Industry in Opposition, is FDA's Generic Drug Labeling Rule Dead on Arrival?

    The US Food and Drug Administration's (FDA) ambitious attempt to allow generic drug manufacturers to temporarily update their labeling to reflect newly discovered safety risks has unleashed the wrath of dozens of Republican lawmakers, who say the proposed rule is illegal. Background Generic drugs are those approved under the 505(j) pathway of the  Federal Food, Drug and Cosmetic Act (FD&C Act)  and submitted to the agency through an abbreviated new drug ap...