• Regulatory NewsRegulatory News

    FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions

    On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from FDA are eligible for varying degrees of market- (rather than patent-) based exclusivity. For New Chemical Entities (NCEs), that means five years of protection during which time FD...
  • Regulatory NewsRegulatory News

    New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

    The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination  (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from...
  • Regulatory NewsRegulatory News

    Are New Policies Needed to Help Regulate Generic Drugs? FDA Wants to Know

    US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that could stand to benefit from additional regulation. Background In a new Federal Register notice posted on 18 August 2014, FDA said it will soon hold a meeting to focus on the implementation of the Generic Drug User Fee Act (GDUFA), a program passed as part of the 2012 Food and...
  • Regulatory NewsRegulatory News

    FDA Sets Policy for Granting New Biologic Medicines Extensive Market Exclusivity

    The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS Act) are given periods of market exclusivity. Background Under the Patient Protection and Affordable Care Act's (PPACA) Biologics Price Competition and Innovation Act (BPCI), new biological products are eligible for 12 years of market exclusivity during which time the US...
  • Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

    Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...
  • New FDA Guidance Tries to Define When Antibody Products are 'The Same'

    A new guidance document released this week by the US Food and Drug Administration (FDA) aims to clarify the interaction of the 2012 Biologics Price Competition and Innovation Act (BPCI) and the 1983 Orphan Drug Act with respect to monoclonal antibody products. Background FDA's orphan drug regulations are intended to create market-based incentives for manufacturers of products for populations with rare diseases. Per the  Orphan Drug Act , a rare disease is defin...
  • FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

    • 23 October 2012
    The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...
  • 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...
  • Watson Files Suit Against FDA over 180-Day Exclusivity

    Generics manufacturer Watson Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) in an attempt to compel the agency to grant it 180-day generic marketing exclusivity for its generic version of anti-diabetes drug Actos (pioglitazone). Under a 2010 settlement between Actos' manufacturer, Takeda Pharmaceuticals of Japan, Watson, Mylan Inc and Ranbaxy Laboratories all received what Watson referred to as "shared exclusivity." Under normal c...
  • Orphan Drug Marketing Exclusivity Revoked from Product as FDA Admits Error

    In a groundbreaking move, the US Food and Drug Administration (FDA) moved to rescind marketing exclusivity for an orphan drug product manufactured by OctaPharma used for the treatment of von WIllebrand disease (VWD), a hereditary bleeding disorder. OctaPharma's VWF drug Wilate, a Factor VIII concentrate, received approval from FDA on 30 November 2009 for the treatment of severe VWF and mild to moderate VWF in patients where an existing therapy, desmopressin, proved ine...
  • FDA Approves Generic Lexapro

    The US Food and Drug Administration (FDA) today approved Israeli pharmaceutical manufacturer Teva Pharmaceutical Industries to legally market generic Lexapro for depression and generalized anxiety disorder in adults. Teva has been granted 180 days of marketing exclusivity, during which FDA is not allowed to approve any other generic version of Lexapro, originally manufactured by Forest Laboratories. Teva's Abbreviated New Drug Application (ANDA) for Lexapro was original...
  • Administration Budget Forcefully Against 'Pay-For-Delay,' Industry

    The Fiscal 2013 federal budget released on 13 February by the Obama administration laid out more than just the proposed spending levels for dozens of federal agencies, including the US Food and Drug Administration (FDA). Buried in the several-hundred page budget document are indications that the Obama administration intends to forcefully move against 'pay-for-delay' settlements that the Federal Trade Commission (FTC) considers to be "anticompetitive," biologic exclusivity...