• Regulatory NewsRegulatory News

    Quality Metrics: Industry Reaction to FDA's Draft Guidance

    On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July . While many questions about the program remain, the agency provided some clarification for industry and said it would not be releasing its final guidance until 2016. The agency is also ...
  • Regulatory NewsRegulatory News

    Generic Drug Companies Call for Fixes to GDUFA, Citing Few Returns on Investment

    Several of the generic drug industry's most prominent groups are calling on the US Food and Drug Administration (FDA) to make major changes to the program supporting one of its marquee funding sources, the Generic Drug User Fee Act (GDUFA). Background GDUFA is modeled off several other conceptually similar user fee programs, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). The concept behind the programs is relatively st...
  • Regulatory NewsRegulatory News

    Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System

    In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks. Background In November 2013, FDA  proposed a rule to allow  generic drug manufacturers to temporarily update their labels if they were made aware of n...
  • Regulatory NewsRegulatory News

    Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

    The generic pharmaceutical industry's most prominent trade body, the Generic Pharmaceutical Association (GPhA), is threatening to sue the US Food and Drug Administration (FDA) if the agency finalizes a change in its labeling regulations that would make it easier for generic drug companies to update their product's labels in response to adverse events. Background Under the Federal Food, Drug and Cosmetic Act (FD&C Act) , generic drug products must—with minor exceptions—...
  • Regulatory NewsRegulatory News

    Using Patient Safety Schemes to Delay Generic Drugs Costs Consumers Billions, Study Finds

    A new report sponsored by the generic pharmaceutical industry claims that branded pharmaceutical companies are using Risk Evaluation and Mitigation Strategies (REMS) to great effect—just not the effect that regulators had intended. Background: What are REMS? REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products. In plain terms, they are meant to keep...
  • Could FDA's New Drug Shortage Rule Make Shortages Worse? Generic Drug Industry Says 'Yes'

    The US' generic pharmaceutical manufacturing industry is taking issue with one of the core components of a new drug shortage strategy laid out by the US Food and Drug Administration (FDA), calling it well-intentioned but infeasible and even harmful in some cases. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drugs experiencing supply shortages. Investigations into the matter brought to light a number of reasons...
  • GPhA Targets FDA's ANDA Stability Guidance, Saying New Answers Raise New Questions

    In comments submitted in October 2013 to the US Food and Drug Administration (FDA), the Generic Pharmaceutical Association (GPhA) said its member companies need additional clarity on a recent guidance document published by FDA, Abbreviated New Drug Applications; Stability Testing of Drug Substances and Products: Questions and Answers . Background Stability testing is necessary to obtain approval for an abbreviated new drug application (ANDA), more commonly known as...
  • GPhA-Sponsored Report Says Diminished Pay-for-Delay Deals Threaten Entry of Generic Competition

    The benefits and adverse effects associated with patent settlements in the pharmaceutical industry - more commonly known as "pay-for-delay" settlements - have been the subject of a considerable amount of debate in recent weeks after a Supreme Court decision made it easier for the Federal Trade Commission (FTC) and other public interest groups to sue companies that engage in the practice. Background The practice, for the uninitiated, involves two companies: an innovator ...
  • GPhA Report Outlines Best-Case Scenario for Patent Settlements, Claiming Billions in Savings

    The US Supreme Court may have already weighed in on the issue of so-called "pay-for-delay" deals - patent settlements in which an innovative company pays its generic competition not to market a product - but that isn't stopping the Generic Pharmaceutical Association (GPhA) from weighing in on the deals again, arguing they have saved US consumers more than $25 billion since 2005. Background On 17 June 2013, the Supreme Court ruled in the case of Federal Trade Commission...
  • Industry Calls for Changes in Biosimilars Meeting Guidance to Protect Data, Provide Clarity

    In April 2013, the US Food and Drug Administration (FDA) released the fourth in a series of draft guidance documents related to the emerging regulatory framework for biosimilar products, a product classification first passed into law in 2010. Now industry is weighing in on that guidance, saying it needs several major changes in addition to a host of minor clarifications. Background Biosimilars were first identified as a unique regulatory classification under the 2010 P...
  • PhRMA, GPhA Call for Revival of Pharmaceutical Track and Trace Measures

    The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press...
  • GPhA to Supreme Court: Pay-for-Delay Settlements in Best Interest of Consumers

    • 05 March 2013
    An Amicus Curiae brief filed by the Generic Pharmaceutical Association (GPhA) with the Supreme Court of the US seeks to uphold patent settlements-otherwise known as "pay-for-delay" settlements-arguing that the Federal Trade Commission's (FTC) claim that they are anti-competitive is contrary to their actual effects. Background The brief, filed on 1 March 2013, relates to an upcoming court case, FTC v. Actavis , which is scheduled to be heard by the court on 25 March 2...