• After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

    In February 2013, the US Department of Justice (DOJ) announced it would be making the enforcement of the US Food and Drug Administration's (FDA) current good manufacturing practices (CGMPs) one of its "top areas of focus" for 2013. And while the ultimate effects of that effort have yet to be realized, at least one pharmaceutical manufacturer is now feeling the brunt of DOJ's enforcement activities. Bad Inspections In a 26 August 2013 announcement, DOJ said it has file...
  • Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages

    The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials. Background The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing...
  • Brazil Clarifies Informed Consent Requirements

    Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to lea...
  • Citing Consent Decree, Ranbaxy Withdraws Dozens of Generic Drug Registrations

    Indian generic drug manufacturer Ranbaxy announced 22 January that the US Food and Drug Administration (FDA) has, per its request, withdrawn 27 Abbreviated New Drug Applications (ANDAs) for products as part of a Consent Decree signed in January . The Consent Decree , more formally known as a Consent Decree of Permanent Injunction, was the end result of an investigation by FDA into data integrity deficiencies at a number of the company's India- and US-based manufactur...
  • Congress Advances Legislation Limiting Consent Decrees, Settlements

    • 26 June 2012
    A legislative proposal to limit the ease with which regulatory agencies are able to compel companies to enter into consent decrees is rapidly advancing in the House of Representatives. The Sunshine for Regulatory Decrees and Settlements Act ( SRDSA ) of 2012 (H.R. 3862) received approval from the Committee on the Judiciary on 27 March 2012 in a 20-10 vote. As Regulatory Focus reported in February, consent decrees are often used by the US Food and Drug Administratio...
  • Congress Advances Legislation Limiting Consent Decrees, Settlement Agreements

    • 26 June 2012
    A legislative proposal to limit the ease with which regulatory agencies are able to compel companies to enter into consent decrees is rapidly advancing in the House of Representatives. The Sunshine for Regulatory Decrees and Settlements Act ( SRDSA ) of 2012 (H.R. 3862) received approval from the Committee on the Judiciary on 27 March 2012 in a 20-10 vote. As Regulatory Focus reported in February, consent decrees are often used by the US Food and Drug Administratio...
  • Feature ArticlesFeature Articles

    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...
  • Study: Cancer Trial Leaflets Too Long, Confusing to Patients

    • 28 March 2012
    A study published in the journal Sociology of Health and Illness claims patient information leaflets used to inform patients interested in participating in clinical trials are "too long, incomprehensible, and even intimidating," reports Medical News Today . The study looked at the information sheets of 13 cancer trials, and recruited 26 patients associated with the trials to provide additional feedback on their experiences. "These information sheets are poorly aligne...
  • FDA Releases Small Entity Compliance Guide for Informed Consent Elements

    The US Food and Drug Administration (FDA) released a guide to the informed consent process for sponsors, investigators and institutional review boards (IRBs) entitled Questions and Answers on Informed Consent Elements, 21 CFR §50.25(c) on 9 February 2012. The document provides 27 questions and answers regarding FDA's informed consent regulations that govern how patients must be informed of clinical trial information being entered in to a databank maintained by t...
  • Proposed Bill Would Limit Use of Consent Decrees, Settlement Agreements

    A bill introduced in the US House of Representatives by Reps. Ben Quayle (R-AZ), Dennis Ross (R-FL) and Howard Coble (R-CA) would place "limitations on consent decrees and settlement agreements by agencies." Consent decrees are voluntary judicial judgments entered in to by two or more willing parties, usually in return for the dismissal of other charges. The US Food and Drug Administration (FDA) frequently uses consent decrees against manufacturers. A recent example of t...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...