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  • Regulatory NewsRegulatory News

    Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...
  • Regulatory NewsRegulatory News

    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
  • Regulatory NewsRegulatory News

    Trump’s 2020 Budget Seeks FDA Tweaks to Increase Generic Competition

    With Democrats controlling the House, the specifics of President Donald Trump’s Fiscal 2020 budget, released on Monday, may not matter much, but it does feature new attempts to alter US Food and Drug Administration (FDA) processes in order to increase generic drug competition. Similarly to last year’s budget , the 2020 budget looks to save more than $1 billion in Medicare and Medicaid funds by stopping some generic drug applicants, who file first and win tentative appr...
  • Regulatory NewsRegulatory News

    FTC Backs FDA Draft Guidance to Stem the Tide of Abusive Citizen Petitions

    The Federal Trade Commission (FTC) has offered its support for revised US Food and Drug Administration (FDA) draft guidance that will use additional criteria to determine if a citizen petition was submitted to delay the approval of a competing drug. The revised draft offers new considerations for FDA when reviewing citizen petitions, including if a petition was submitted near the expiration of known patent or exclusivity, if a petition was the same or substantially simi...
  • Regulatory NewsRegulatory News

    FDA Denies Novo Nordisk Petition on Liraglutide Generics

    The US Food and Drug Administration (FDA) on Friday denied Novo Nordisk’s citizen petition that aimed to block generic versions of its blockbuster insulin Victoza (liraglutide) and two other products containing liraglutide. Novo argued that the Type 2 diabetes drugs containing liraglutide are large and complex molecules and that a manufacturing process that differs from its own might have unintended consequences. The company also argued that FDA has not issued guidan...
  • Regulatory NewsRegulatory News

    FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics

    The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion). "This is Allergan's third petition concerning the methods an ANDA [abbreviated new drug application] applicant might use to demonstrate that a proposed generic drug is bioequivalent to Restasis. As in its previous petitions and commen...
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    Petition to FDA Seeks to Modify Trial Regulations Following Deaths

    A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs). In a letter submitted in April, the Center for Responsible Science noted 19 treatment-related deaths in clinical trials from July 2016 through April 2017. Among those were five clinical trial participants w...
  • Regulatory NewsRegulatory News

    Law Firm Challenges FDA on Combination Product Appeals

    Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products. In a citizen petition sent to FDA last week, the firm says that lengthy delays for such appeals negatively affects both product sponsors and patients by delaying the launch of new combination products. Background Combination products, or products that combine two or more diff...
  • Regulatory NewsRegulatory News

    FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition

    The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis. In 2008, FDA approved Sirion Therapeutics' Durezol, a corticosteroid, to treat inflammation and pain associated with ocular surgery. Two years later, Alcon acquired the rights to Durezol from S...
  • Regulatory NewsRegulatory News

    Public Citizen Petitions FDA to Pull Some IV Solutions

    Consumer advocacy organization Public Citizen on Wednesday petitioned the US Food and Drug Administration (FDA) to immediately require the removal of hydroxyethyl starch (HES) intravenous (IV) solutions from the market because their risks outweigh their limited benefits and there are other, safer alternative IV solutions. According to the petition, there are two main categories of IV solutions: crystalloid and colloid. Colloidal solutions, including HES, have largely the...
  • Regulatory NewsRegulatory News

    Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

    Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...
  • Regulatory NewsRegulatory News

    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...