• Regulatory NewsRegulatory News

    FDA Raises Concerns With 505(q) Petitions

    In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns. “FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency sa...
  • Regulatory NewsRegulatory News

    Citizen Petitions: FDA Revises Guidance to Block Drugmakers From Abusing the System

    The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance designed to allow for FDA to reject 505(q) petitions if the agency determines the primary purpose of the petition is to delay the approval of an abbreviated new drug application (ANDA). “We believe this will provide an additional deterrent to pursuing these tactics,” FDA said. The new approach to reviewing petitions would also help FDA focus its resources on addressing petitions that...
  • Regulatory NewsRegulatory News

    FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment

    Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide). The decision by FDA was not unexpected and followed recent denials of citizen petitions filed by Novo Nordisk and Allergan . Bernstein biotech analyst Ronny ...
  • Regulatory NewsRegulatory News

    FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics

    The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which first won FDA approval in 1986. “Facing the threat of generic competition to its lucrative franchise, ViroPharma inundated the FDA with regulatory and court filings—forty-six in all—to delay the FDA’s approval of generic Vancocin Capsules. That number is, by far, the mo...
  • Regulatory NewsRegulatory News

    FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals

    The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health. The final rule, which is effective 9 January 2017, implements section 505(q) of the Federal Food, Drug & Cosmetics Act (FD&C Act), which governs the manner in which FDA ...
  • Regulatory NewsRegulatory News

    FDA Reiterates Concerns on Citizen Petitions Delaying Drug Approvals

    Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions. In 2015, FDA notes that it ap...