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  • User Fee Bill Could be Tabled in Senate After Deluge of Unrelated Amendments

    • 23 May 2012
    The Food and Drug Administration Safety and Innovation Act (FDASIA) may have been deemed by Senate Majority Leader Harry Reid to be a "must pass bill," but that hasn't stopped a cavalcade of congressmen from lining up to offer last-minute-and sometimes unrelated-amendments to the legislation. The Hill reports Reid, a staunch supporter of the bill, is warning Senators to get in line regarding amendments to the bill, which could delay the legislation. Reid "warned t...
  • PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

    The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech. FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, " New FDA Draft Guidance on DTC Television Advert...
  • Republicans Ramp up Pressure on White House Over PPACA Negotiations

    • 16 May 2012
    Republican members of the House Energy and Commerce (E&C) Committee announced in a 16 May statement they have obtained new information regarding the role of the White House in the 2009-10 negotiations with the pharmaceutical industry over provisions in the Patient Protection and Affordable Care Act (PPACA) . The negotiations, which were done quietly to avoid media and political scrutiny, "were never made public," explained Republicans members of the E&C Committ...
  • As User Fee Bill Sails Through House Committee Vote, a Focus on Industry Efforts

    The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012 , a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 members of the House of Representatives. "The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act , and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilar...
  • House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

    • 08 May 2012
    An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...
  • Eli Lilly's Lechleiter Replaces Sanofi's Veibacher as PhRMA Chairman

    • 16 April 2012
    The Pharmaceutical Researchers and Manufactuers of America (PhRMA), the powerful trade organization of the pharmaceutical industry, announced at its annual meeting its members have elected John C. Lechleiter, CEO of Eli Lilly and Co., as its next chairman. Lechleiter will replace outgoing Chairman Christopher Veichbacher, CEO of Sanofi, who has served the organization since 2008. The Chairman of the PhRMA Board-along with PhRMA's President, currently John Castellani-has...
  • Castellani Says PhRMA Looking to Uphold Affordable Care Act to Protect Regulatory Pathway

    • 13 April 2012
    The Pharmaceutical Research and Manufacturers of America was an early-and controversial - supporter of the Patient Protection and Affordable Care Act (PPACA) when the legislation was being formulated. Now under the tutelage of President John Castellani, the group says it is looking to keep the legislation in place, reports Market Watch . The loss of a regulatory pathway for approving biosimilar products, said Castellani, would be a disastrous setback. Likewise a num...
  • 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...
  • Study: Drug Prices Rose 26% in Five-year Period

    A study conducted by the American Association of Retired Persons (AARP) has found that drug prices increased 26% in between 2005 and 2009, outpacing inflation even as an influx of generic drugs depressed the prices of many popular prescriptions. "At a time when our country is contracting economically and inflation is really, really low, inflation in the cost of prescription drugs is going in the other direction," said Cheryl Matheis, the senior vice president for policy ...
  • 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...
  • GOP Request for White House's Healthcare Reform Negotiating Notes Could Prove Explosive for Industry

    • 26 January 2012
    Republican members of the US House Energy and Commerce Committee-the committee that oversees the US Food and Drug Administration, among other agencies-is requesting that the Obama administration turn over "internal memoranda" related to the administration's negotiations with industry groups during the formulation of the Patient Protection and Affordable Care Act (PPACA) in 2010. "The White House has consistently refused our legitimate requests for information regardi...
  • Viehbacher: Diet Pill Guidance Needed To Ensure Investment

    Speaking to Reuters on Thursday, Pharmaceutical Research and Manufacturers of America (PhRMA) Chairman and Sanofi SA CEO Chris Viehbacher said that the US Food and Drug Administration (FDA) needs to offer more guidance on their risk and benefit determinations for diet pills. "To make sure we're not ignoring unmet needs in primary care, we need a lot more clarity around the risk-benefit so there's predictability when we invest in these products," said Viehbacher. FDA...