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  • Feature ArticlesFeature Articles

    OTC monograph reform is now law: What’s next?

    This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act . Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the...
  • Regulatory NewsRegulatory News

    FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns

    The US Food and Drug Administration (FDA) on Wednesday requested that all manufacturers of drugs containing ranitidine (commonly known as Zantac and used for heartburn) remove all prescription and over-the-counter (OTC) versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures. The announcement is the most serious in a chain of FDA safety advisories related to NDMA ...
  • Regulatory NewsRegulatory News

    Senate Committee Advances OTC Monograph Reform Bill

    The Senate Health, Education, Labor and Pensions Committee on Thursday advanced a bill by voice vote that would reform the way over-the-counter (OTC) drugs are brought to market by creating a user fee system like the ones used for prescription drugs and devices. The bill, introduced by Sens. Johnny Isakson (R-GA), who’s resigning from the Senate at the end of the year, and Bob Casey (D-PA), aims to speed up the antiquated approval process for OTC drugs and would create ...
  • Regulatory NewsRegulatory News

    CDER Warns Chinese, Indian Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released two warning letters sent recently to India-based active pharmaceutical ingredient (API) manufacturer CTX Lifesciences Private Ltd and China-based drug manufacturer Ningbo Pulisi Daily Chemical Products Co. Following a six-day inspection at CTX Lifesciences, FDA found that the firm did not ensure that the water used for parenteral grade APIs was suitable for its...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule for Sunscreen Products

    The US Food and Drug Administration (FDA) proposed a new rule on Thursday to update regulatory requirements for most sunscreen active ingredients currently on the US market. The 264-page proposed rule was decades in the making, with collaborators ranging from agency staff and outside scientific experts to patient advocacy groups. The new regulatory framework it describes is aimed at providing better assurance of the safety, efficacy and preventive qualities of over-the-...
  • Regulatory NewsRegulatory News

    FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

    The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test systems (BGMS) for point of care (POC) and over-the-counter (OTC) use and prepare 510(k) submissions for both device types. Both draft guidances propose changes to 2016 final guidances “based on feedback from stakeholders requesting more clarification on language,” FDA spokesperson Jennifer Rodriguez said...
  • Regulatory NewsRegulatory News

    FDA Bars Use of 24 Ingredients in Antiseptic Washes

    The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings. The rule was first proposed in 2015 , and finalizes a 1994 tentative final monograph for OTC antiseptics as amended by the 2015 proposed rule. "Ensuring the safety and effectiveness of over-the-counter h...
  • Feature ArticlesFeature Articles

    Marketing Exclusivity for Over-the-Counter Switched Products

    This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...
  • Feature ArticlesFeature Articles

    Overview of the US Rx-to-OTC Switch Process

    This article provides an overview of the US prescription (Rx) to Over-the-Counter (OTC) switch process, including full switch and partial switch, speaks to the importance of self-care for consumers, and discusses potential areas of opportunity for sponsors and/or industry. Introduction Nonprescription products empower consumers to make informed decisions in selecting appropriate Over-the-Counter (OTC) product(s) for their condition. By increasing the number of produ...
  • Feature ArticlesFeature Articles

    The Challenges and Strategies for Today's Rx-to-OTC Switch Programs

    This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in th...
  • Regulatory NewsRegulatory News

    Public Citizen Sues FDA Over OTC Drug Risks

    Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine. The lawsuit, filed on the grounds that FDA is in violation of the Administrative Procedures Act for "withholding or unreasonably delaying action" on a citizen petition filed by Public Citizen in 2014 that calls on the agency to add a warning that benzocaine can cause ...
  • Regulatory NewsRegulatory News

    Congress Takes First Look at User Fee Program for OTC Drugs

    The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products. A bipartisan discuss draft of the bill, developed by Reps. Bob Latta (R-OH), Diana DeGette (D-CO), Brett Guthrie (R-KY), Debbie Dingell (D-MI), Gene Green (D-TX) and Subcommittee o...