• Regulatory NewsRegulatory News

    US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

    US and EU trade negotiators are reportedly hung-up over how—or if—to rely on the results of one another's regulatory inspections of drug manufacturing facilities, threatening to derail part of the Trans-Atlantic Trade and Investment Partnership (TTIP), The Wall Street Journal reports . At issue, the Journal 's Matthew Dalton writes, is that while the US Food and Drug Administration (FDA) is willing to cooperate closely with the European Medicines Agency (EMA) on drug...
  • Is FDA Approving Too Many Drugs Starting with 'X' and 'Z'?

    Regulators with the US Food and Drug Administration (FDA) had a few things to clarify with industry and medical practitioners in the latest issue of the New England Journal of Medicine . Namely: No, they don't believe that industry has an "insatiable proclivity to include the letters X and Z" in their proprietary names, as some have suggested. Background FDA approves final trade names submitted by companies, and among its approval criteria for names is whether t...
  • 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...
  • Pharmacovigilance Concerns Lead Group to Call for Unique Names for Biosimilars

    • 17 September 2012
    A new survey released by the Alliance for Safe Biologic Medicines (ASBM), a group supported by branded biologics companies, says that biosimilar medicines should be required to use distinct names to differentiate themselves from their innovative biologic counterparts. Biosimilar medicines are effectively generic biologics, but have some key differences relative to their chemical drug generic counterparts. For one, biologic medicines are not exactly reproducible by gene...
  • FTC Raises Concerns About Quality, Authenticity of Pet Medications

    The Federal Trade Commission (FTC) has released the draft agenda for an upcoming meeting that could shake up the veterinary pharmaceutical sector. The meeting, "Competition & Consumer Protection Issues in the Pet Medications Industry," was first announced in June 2012, and was called in response to FTC's perception that consumer-focused veterinary medications were subject to anti-competitive pricing and access issues. "American consumers spend a tremendous amount ...
  • Rising UK Drug Shortages Highlight MHRA's Oversight Problems

    The UK is facing increasing shortages of vital medicines as supplies are exported to other countries in the EU in a case of medicinal pricing arbitrage, reports Reuters . Other countries in the EU are willing to purchase the drug for more than UK purchasing groups are, which is causing parallel trade to occur and drug shortages to emerge. While the case is hardly unique to Britain-Greece is also suffering the effects of parallel trade after austerity measures slashes r...
  • Report: Second Instance of Fake Avastin Highlights MHRA Troubles

    Another incident involving lots of fake bevacizumab (Avastin/Altuzan)-the second in as many months-is drawing attention to resource shortages at the UK's Medicines and Healthcare product Regulatory Agency (MHRA), reports Reuters . The British healthcare product regulator currently oversees 1,800 wholesalers in the country-second in amount only to Germany, which oversees more than 3,000 wholesalers. "We are concerned that the MHRA doesn't have sufficient resources to in...
  • FTC Considering New Guidance on Social Media, Advertising

    The US Federal Trade Commission (FTC), the governmental body that oversees advertising regulation in the US, is considering new guidance for disclosures in online advertisements, particularly advertisements in social media platforms. FTC will hold a workshop on 30 May to discuss the topic with stakeholders, as well as discuss the possibility of updating existing guidance known as the "Dot Com Disclosures." FTC anticipates discussing: "How can effective disclosures be ...
  • Defying Ban, Lobbyists De-Register to Serve on Advisory Committees

    A 2009 order by the Obama administration meant to ban registered lobbyists from serving on federal advisory committees-including those used by the US Food and Drug Administration (FDA) to provide it with expert opinions-has instead caused to those same lobbyists to cancel their lobbying registrations in order to continue to serve on the advisory committees, reports The Hill . At least 22 current federal advisory committee members serving on Industry Trade Advisory Commi...
  • Obama to Call for Reorganization, Merger of 6 Federal Agencies

    • 13 January 2012
    US President Barack Obama plans to issue a statement this morning calling for the reorganization of six federal agencies dealing with trade and commerce, reports The Associated Press. The report quotes an unnamed senior administration official who says that the President will call for the Commerce Department, Small Business Administration, Office of the US Trade Representative, the Export-Import Bank, the Overseas Private Investment Corporation and the Trade and Deve...