• DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

    The pharmaceutical industry's reputation has been heavily battered over the course of the last two decades, in part because of a seemingly endless stream of massive multibillion-dollar settlements over charges of off-label marketing claims. Those fines, which have seemingly done little to curb illicit behavior, have been seen by at least some industry analysts as cost of doing business-not a deterrent. But the Department of Justice (DOJ) seems poised to change that dyn...
  • J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever

    The US Department of Justice (DOJ) has announced that Johnson & Johnson will pay at least $2.2 billion to resolve claims that it improperly marketed three drugs for indications not approved by the US Food and Drug Administration (FDA). The amount, which includes fines, forfeitures and settlement fees, amounts to one of the largest healthcare-related civil settlements in US history. Background The settlement between J&J and DOJ has long been in the works. In Jun...
  • EU, Japanese Regulators Launch Expanded GMP Mutual Recognition System

    EU and Japanese regulators are for the first time beginning to share good manufacturing practice (GMP) data between one another in limited cases, the European Medicines Agency (EMA) announced on Monday (7 October 2013). At present, most global regulators receive data regarding not just the drug product for which a company seeks approval, but information on the way in which it will be manufactured as well. Regulators generally take that information and use it to assess th...
  • New FDA Guidance Recommends Use of Quality Agreements to Define Contract Responsibilities

    The US Food and Drug Administration (FDA) has released a new draft guidance regarding contract manufacturing arrangements, establishing the responsibilities of each entity involved in the manufacture of a pharmaceutical product in adherence to current good manufacturing practices (CGMPs). Background The draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements , comes just as FDA has been identifying lapses in contract manufacturing arrangem...
  • The Top 10 Regulatory Stories of 2012 (International Edition)

    • 14 January 2013
    2012 was a momentous year for both the regulatory profession and  Regulatory Focus . In our first year as an online-only publication, we covered a quickly changing landscape, dealing with topics that ranged through the quality of pharmaceutical products, the passage of new legislation, the safety of medical devices and the legal issues surrounding product regulation and marketing. So what happened this year in global regulatory? We're glad you asked. The editors and...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement and the Obama administration's already complicated relationship with the pharmaceutical industry, reports Reuters . The agreement in question is known as the Transpacific Partnership (TPP)-a regional trade policy long under negotiation and periodically subject to trans...
  • EMA to Engage in Cooperative Activities with European Drug Monitoring Agency

    The European Medicines Agency (EMA) is announcing an enhanced cooperation scheme with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) which will see an improved exchange of information on psychoactive medicines or other medicines likely to be abused by some patients and consumers. The program is a part of the recently implemented EU pharmacovigilance legislation , a portion of which called for EMA and EMCDDA to, "Exchange information that they recei...
  • New ISO Standard Released for Characterizing Nanoparticles

    The International Standards Organization (ISO), an international body whose standards are often used by regulatory authorities, has unveiled new guidance on conducting toxicology tests on nanomaterials. ISO's 3 July 2012 technical report, "Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment" (ISO/TR 13014:2012) is intended to be used to help researchers understand a nanomaterial's physicochemical ...
  • US, Mexico Announce Plan to Strengthen Regulatory Cooperation

    US Health and Human Services Secretary Kathleen Sebelius and Mexico's Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation at a meeting in Geneva, Switzerland on 22 May. Sebelius and Chertorivski were at the 65 th World Health Assembly, where both acknowledged their mutual goals in promoting public health. "It is important to strengthen the programs of regulation and surveillance of med...
  • World: Regulatory Agencies Attend WHO Seminar

    Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate. The meeting, an international seminar hosted by the World Health Organization (WHO), included representatives from Australia, Argentina, Brazil, France, India, Portugal, South Africa, the United States and the UK. A total of 30 regulatory agencies attended the meeting. The meeting coincided with the WHO'...
  • Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing

    Pharmaceutical manufacturer Abbott Laboratories has agreed to pay a near-record $1.5 billion in fines for the off-label promotion of its anti-seizure drug Depakote, with the total to be split between the federal government, states and consumers. In a lengthy statement released by the Department of Justice (DOJ), Deputy Attorney General James M. Cole called the settlement a "strong message to other companies" not to engage in fraud. DOJ explained in its statement that ...