• 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...
  • NICE Fires Back at Study, Claims its Approval Times Are Steadily Falling

    The National Institute for Health and Clinical Excellence (NICE) is aggressively firing back at a study released which claimed the health technology assessment (HTA) body was taking an average of five years to approve new drug products for reimbursement. The study, published 15 March in The Daily Mail , also said some drugs took up to nine years to get approved, with NICE not even starting to assess many drugs until a year after they have been approved by the Medici...
  • User Fee Bill Delayed in Senate as Cloture Vote Forced

    • 18 May 2012
    The long-running and surprisingly quick saga of the Food and Drug Administration Safety and Innovation Act (FDASIA) may have just encountered its first, albeit minor, setback. Senate Majority Leader Harry Reid (D-NV) said he was forced to set up a procedural vote for Monday, 21 May after apparent disagreement emerged over which amendments would be permitted to be debated, reports The Hill . The 21 May vote will be to end debate on FDASIA , otherwise known as clotur...
  • Proposed Bill Would Mandate Passage of Device Identifier, Data Collection

    A new piece of legislation introduced in the House of Representatives by Rep. Lois Capps aims to expand postmarket tracking of medical devices and implement a mandate for the passage of a Unique Device Identification (UDI) rule by the end of 2012. The bill, the Sentinel Assurance for Effective Devices (SAED) Act of 2012 , was referred to the Energy and Commerce Committee on 7 May 2012. SAED would amend section 522 of the Federal Food, Drug and Cosmetic Act (FD&amp...
  • FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

    The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products. FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claim...
  • Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication

    • 18 April 2012
    The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources. "At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes  Pharmalot . Caraco's lawsuit a...
  • Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB

    Two rules continue to languish at the US Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), according to records. The Unique Device Identification (UDI) rule, which was mandated under the FDA Amendments Act of 2007, would establish a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier. The economically significant rule has been held up at OIRA since 11 July 2011...
  • Bill Would Restrict Co-Pays, Other Cost-Sharing Measures

    • 20 March 2012
    Co-pays, cost-sharing, coinsurance and other methods used by pharmaceutical companies as an incentive for patients to purchase their drugs would be restricted under a new bipartisan bill introduced in the House of Representatives on 19 March. H.R. 4209 - Patient's Access to Treatments Act of 2012 , introduced by Reps. David McKinley (R-WV), Lois Capps (D-CA), Barney Frank (D-MA), Henry Cuellar (D-TX) and C.W. Bill Young (R-FL), would do away with preferential treatmen...
  • AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • California Supreme Court Looks to Take Up 'Pay for Delay' Case

    The California Supreme Court is set to review a case on so-called 'pay for delay' settlements that see pharmaceutical manufacturers pay generic manufacturers to secure additional months of market exclusivity for their products. The court will review a decade-old class-action lawsuit against Bayer over its pay for delay settlement to Barr Laboratories. Barr was reportedly planning to sell a generic version of Bayer's antibiotic, Cipro (ciprofloxacin). The lawsuit alleges...
  • GSK's Witty: UK Delaying New Cancer Drugs Due to Cost

    Andrew Witty, the chief executive of pharmaceutical manufacturer GlakoSmithKline, said in an interview with the BBC on 25 February he believes the UK's National Institute for Health and Clinical Excellence (NICE) is purposefully delaying new drugs in order to save the government money . It's bad enough that reimbursement amounts are being systematically reduced across Europe, said Witty, "[but] governments are now delaying the approval of innovative new drugs." Witty...
  • 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...