• Feature ArticlesFeature Articles

    A deep dive into OPDP’s position on public health emergencies in the US

    This article explores the Office of Prescription Drug Promotion’s (OPDP’s) views on public health emergencies, including COVID-19, and how this affects drug promotion. The author reviews trends in past enforcement letters and concludes that promotional materials relating to current public health emergencies are heavily scrutinized by OPDP, which regulatory advertising and promotion reviewers should bear in mind.   Introduction The COVID-19 pandemic has caused innumer...
  • Regulatory NewsRegulatory News

    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
  • Regulatory NewsRegulatory News

    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
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    FDA Inspection Finds Minnesota Hospital Violated Informed Consent, IRB Rules

    In an inspection report obtained by Public Citizen, the US Food and Drug Administration (FDA) cites the Hennepin County Medical Center over its institutional review board’s (IRB) oversight of clinical trials that involved dosing emergency patients with ketamine and other sedatives without the patients’ consent.   The inspection, which ran from 7-24 August, came after the Star Tribune reported on clinical trials conducted by the hospital and just weeks after Public C...
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    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance

    Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect. The 20-page draft explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how F...
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    FDA Launches Searchable Adverse Event Database for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics. Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths , whether they were linked to the drug's safety...
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    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 ...
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    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
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    Trump Administration Officials Huddle at White House to Discuss Drug Pricing

    A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients." The confirmation follows reports from several media outlets citing sources who say the meeting, with US Food and Drug Administration Commissioner Scott Gottlieb among other officials in atten...
  • New Study Says 63% of US Adults Trust FDA

    A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them. In a study of more than 5,000 adults and 1,100 adolescents, the researchers from the University of North Carolina found that among adults, awareness of CDC and FDA was high (83.6% and 94.3%, respectively) but adults’ trust in the agencies was lower, with 64.6% reported...
  • Regulatory NewsRegulatory News

    Public Citizen Warns 'Right to Try' Gives Patients False Hope

    Advocacy nonprofit Public Citizen is calling on members of Congress to oppose several "right to try" bills, warning that the bills would undermine the US Food and Drug Administration (FDA) and provide false hope to patients. In recent years more than 30 states have adopted right to try laws that seek to provide terminally ill patients access to unapproved drugs, with several new congressional efforts to create a federal right to try program. The White House has signaled...