• Hamburg: Quality one of FDA's 'Highest Priorities' in 2013, Agency Creating New Quality Office

    In a wide-ranging speech before the Generic Pharmaceutical Association's annual meeting in Florida, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her regulatory agency will be placing an increased focus on quality issues in 2013, noting its integral role in recurring drug shortages and other problems. The generics industry, Hamburg said, is "playing an increasingly central and transformative role in our nation's health care system," adding that...
  • Industry Program Aimed at Preventing Drug Shortages Obtains FTC Approval

    The Federal Trade Commission (FTC) has announced its approval of a proposed plan by the generic pharmaceutical industry to alleviate and hopefully prevent future drug shortages, saying safeguards built into the plan, "Make it unlikely to harm competition." Unlike the US Food and Drug Administration (FDA), FTC is only concerned about the plan's effect on trade-not the quality or safety of a pharmaceutical product. FTC said it was responding to a letter from the Generic...
  • GPhA: 505(j) Provisions Saved US $1 Trillion Since 2002

    Abbreviated new drug applications-also known as generic drug applications or 505(j) applications-have saved US citizens more than a trillion dollars in the past decade, says a new report out from the health data analytics firm IMS Health and sponsored by the Generic Pharmaceutical Association (GPhA). The report, " Savings: $1 Trillion Over 10 Years ," comes as healthcare costs continue to rise, outpacing inflation on a consistent basis. Generic medicines, says the repo...
  • GPhA: Congress Should Move Ahead on User Fees

    • 09 April 2012
    The Generic Pharmaceutical Association (GPhA) is urging Congress to move forward to proposal for generic drugs and biosimilar products, according to a PharmTech report. Under the Generic Drug User Fee Act (GDUFA), the industry will pay $299 million per year in user fees for the next five years beginning 1 October 2012. The money will supplement what Congress appropriates to the US Food and Drug Administration (FDA) and allow for more scientific resources needed to provid...
  • Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...
  • Generics Pharmaceutical Association Preparing to Launch Drug Shortage Program

    The Generic Pharmaceutical Association (GPhA) is planning to launch a private, third-party program to track and share information about drug shortages, according to the American Medical Association . The program, dubbed the "Accelerated Recovery Initiative," was revealed by GPhA President and CEO Ralph G. Neas during an interview with American Medical News ( AMN ) on 12 March. The program plans to "provide real-time supply and distribution information to manufacture...
  • Hearing on Generic, Biosimilar User Fee Acts Scheduled for 9 February

    The House Energy and Commerce Committee is scheduled to hear testimony from high ranking US Food and Drug Administration and biopharmaceutical industry officials on 9 February. The hearing, Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages , will feature Center for Drug Evaluation and Research Director Dr. Janet Woodcock, Mylan, Inc President Heather Bresch, Generic Pharmaceutical Association Vice President for Reg...