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  • Regulatory Moratorium Bill Passes House

    The US House of Representatives passed a bill that would freeze many regulations, including those introduced by the US Food and Drug Administration (FDA), until unemployment falls to pre-recession levels. The legislation, the Regulatory Freeze for Jobs Act , was introduced in the House in February and passed the House in a 240-178 vote largely on party lines on 26 July. Among the bill's numerous provisions is a title stripping federal agencies of their power to pas...
  • Major Regulatory Changes Proposed in House Bill

    The House of Representatives is scheduled to vote on a piece of proposed legislation next week that would overhaul vast sections of the federal regulatory process. Importantly, the bill would also freeze all major regulatory activities-including many mandated by the recently-passed Food and Drug Administration Safety and Innovation Act -until the national unemployment rate falls below 6.0%. Stopping all 'Significant' Regulatory Actions The Regulatory Freeze for Job...
  • Proposed Regulatory Freeze Advances in US House

    • 21 March 2012
    A bill that would freeze many regulatory actions advanced in the House Judiciary Committee this week, bringing it one step closer to passage. The Regulatory Freeze for Jobs Act of 2012 was first introduced to the House of Representatives on 17 February, and first reported by Regulatory Focus on 27 February . The proposed legislation would prevent many regulatory actions from being passed by federal agencies until unemployment falls below 6%, including: any regulat...
  • Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

    Proposed legislation introduced in Congress on 7 March would encourage the US Food and Drug Administration (FDA) to seek and receive advice from experts in the field of rare diseases. The Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 ( EXPERRT Act ) would allow a consultation programs to be established for the purpose of allowing an exchange of expert information. The goal of the program is to allow FDA staff to better inform and strengthen...
  • Shuren: Predicate Device 'Loophole' Must Be Closed

    The head of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is calling for the end to a so-called "loophole" in the 510(k) medical device approval pathway . In remarks to Bloomberg News , CDRH Director Jeffery Shuren said that the agency needs new authority to reject new devices that are seeking approval based on being substantially equivalent to predicate devices that were subject to safety recalls. The 510(k) application...
  • Bill Would Freeze Major Regulatory Actions Until Unemployment Rate Falls

    • 27 February 2012
    A bill introduced in the US House of Representatives 17 February aims to halt the passage of any regulations that have economic costs of more than $100 million until the unemployment rate falls below 6%. The Regulatory Freeze for Jobs Act of 2012 (HR 4078) would also prevent any regulatory actions that creates inconsistencies with another agency, "raise novel legal or policy issues", or "materially alter the budgetary impact of entitlement, grants, user fees or loa...
  • New Bill Looks to Assist the Visually Impaired's Understanding of Drug Labeling

    A new bill introduced on 24 February by Rep. Ed Markey (D-MA), the Prescription Drug Labeling Promotion Act of 2012 (H.R. 4087) , aims to ensure that visually-impaired and blind individuals are able to read the labeling on prescription drug products. H.R. 4087 would establish a working group to develop guidance on best practices for making drug labeling accessible to the blind and visually impaired. Considerations by the group will include: The use of braille in al...
  • User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing

    Legislation establishing the user fee programs for generic drugs and biosimilar products was introduced in the House of Representatives on 9 February . The bill, To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars (H.R. 3988) , now goes before the House Energy and Commerce Committee for markup. The Committee is set to meet on 9 February to hear testimony from numerous government and industry officials, incl...
  • Proposed Bill Would Limit Use of Consent Decrees, Settlement Agreements

    A bill introduced in the US House of Representatives by Reps. Ben Quayle (R-AZ), Dennis Ross (R-FL) and Howard Coble (R-CA) would place "limitations on consent decrees and settlement agreements by agencies." Consent decrees are voluntary judicial judgments entered in to by two or more willing parties, usually in return for the dismissal of other charges. The US Food and Drug Administration (FDA) frequently uses consent decrees against manufacturers. A recent example of t...