• Regulatory NewsRegulatory News

    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
  • Regulatory NewsRegulatory News

    CBO: Pelosi Bill Will Save Hundreds of Billions, Reduce Number of New Drugs to Market

    The Congressional Budget Office (CBO) late Friday announced that House Speaker Nancy Pelosi’s (D-CA) drug pricing bill would reduce federal direct spending for Medicare by $345 billion from 2023 to 2029, but it would also lead to a reduction of approximately 8 to 15 new drugs coming to market over the next 10 years. The CBO report comes as rhetoric on both sides of the aisle has picked up in recent weeks, with industry group PhRMA referring to the bill, known as HR 3, a...
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    CBO Releases Cost Estimate for User Fee Bill

    The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill. The estimate is based on the version of the FDA Reauthorization Act of 2017 that was advanced by the Senate Committee on Health, Education, Labor & Pensions in May. Notably, t...
  • Costs of Proposed Pharmaceutical Track and Trace System Come into Focus for FDA, Industry

    House legislators have for months been pushing through a piece of legislation that would overhaul the security of the pharmaceutical supply chain, putting into place a series of provisions known more generally as "track and trace." And after being made aware of the legislation's language, the pharmaceutical industry and US Food and Drug Administration (FDA) are now getting a glimpse of something else: Its cost. Pharmaceutical Industry: Cost Drivers In an estimate releas...
  • House Version of user Fee Legislation Gets Major Boost from CBO

    What a difference a week and some amendments make. The Congressional Budget Office (CBO) has re-scored the House's amended version of the Food and Drug Administration Reform Act (FDARA) and has found that instead of costing taxpayers $250 million, it will now save taxpayers $370 million. The distinction is important, and not just because of the fiscal implications for taxpayers. Under legislation commonly known as PAYGO , any normal legislation found to add to the def...
  • Senate Easily Clears Amended User Fee Bill

    The US Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on 24 May, advancing the bill for an eventual merger with the House of Representatives' parallel legislation. The bill, which would fund FDA through a series of user fee agreements between FDA and regulated industry, was approved with near-unanimous consent. Only Sen. Bernie Sanders (I-VT) voted against the legislation. The Congressional Budget Office (CBO) provided a boos...
  • User Fees Expected to Save Taxpayers $358M Over Next Ten Years

    • 14 May 2012
    The US Senate's Food and Drug Administration Safety and Innovation Act (FDASIA) is a expected to save taxpayers $358 million over the coming decade, with $71 million in savings in the next five years according to an analysis conducted by the Congressional Budget Office (CBO). The bill, whose primary purpose is to reauthorize a variety of user fee programs used to fund the US Food and Drug Administration (FDA), contains a number of reforms and adjustments that would imp...