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  • Regulatory NewsRegulatory News

    Burr chastises FDA at second Senate user fee hearing

    Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.   On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to ...
  • Regulatory NewsRegulatory News

    MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

    The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...
  • Regulatory NewsRegulatory News

    Legislators have mixed views on whether to classify fentanyl as a schedule I substance

    Members of the House Energy and Commerce’s Subcommittee on Health heard testimony 2 December from a US Food and Drug Administration (FDA) official urging congressional support of an administration plan to permanently place fentanyl in the most restrictive category allowed under the Controlled Substances Act (CSA).    The plan addresses the “pressing need” of the public health crisis posed by fentanyl and its related compounds by placing them by default into schedule ...
  • Regulatory NewsRegulatory News

    House Dems press Becerra on FDA LDT oversight

    In a letter to Department of Health and Human Service (HHS) Secretary Xavier Becerra earlier this week, top Democrats on the House Energy and Commerce Committee pressed the health secretary to reverse a Trump-era policy that removed laboratory developed tests (LDTs), including those for COVID-19, from US Food and Drug Administration (FDA) oversight.   “Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliabili...
  • Regulatory NewsRegulatory News

    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...
  • Regulatory NewsRegulatory News

    House Committee Proposes 6% Increase in FDA Funding for FY 2020

    The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...
  • Regulatory NewsRegulatory News

    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...
  • Regulatory NewsRegulatory News

    Lawmaker Seeks Answers to OIG’s Findings on FDA’s Cybersecurity Policies

    A recent report from the Office of the Inspector General (OIG) “highlighted some very important issues” where the US Food and Drug Administration (FDA) “has room for improvement,” Sen. Chuck Grassley (R-IA) argued in a letter to FDA Commissioner Scott Gottlieb.   The 9 November letter from Grassley, chairman of the Senate Judiciary Committee, follows on the heels of the findings and recommendations OIG at the US Department of Health and Human Services outlined in a...
  • Regulatory NewsRegulatory News

    Democrats, Republicans Prep to Take Up Drug Prices Together

    Following the House’s transition Tuesday to a Democratic majority, Senate Majority Leader Mitch McConnell (R-KY) said Wednesday that he will work with House Democrats on crafting a plan to tackle high prescription drug prices.   “I can’t imagine that won’t be on the agenda,” McConnell said regarding prescription drug prices. Potential House speaker Nancy Pelosi (D-CA) also further indicated that representatives and senators on both sides of the aisle will look to find ...
  • Regulatory NewsRegulatory News

    Opioids Compromise: What’s in it for FDA

    The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA). Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guid...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA

    Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it. The 996-page bill includes major tweaks to the way in which the US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more qu...
  • Regulatory NewsRegulatory News

    Congressional Spending Deal Offers $132m More for FDA in 2016

    As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year. The proposed agreement, which is expected to face a vote on Friday, includes increases of $104.5 million for food safety related activities; $5 million for implementation of the Food and Drug Administration Safety and Innovation Act ( FDASIA ); $8.7 million for ...