• Regulatory NewsRegulatory News

    Senate Committee to Vote on FDA User Fee Reauthorizations

    Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements. The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices. The proposed reauthorizations, grouped ...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Gottlieb Nomination as FDA Commissioner

    The Senate Health, Education, Labor & Pensions committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA). The 14-9 vote, a day after a delay , was largely along party lines (Democrat Sens. Michael Bennet (D-CO) and Sheldon Whitehouse (D-RI) voted aye) and follows a back and forth on Gottlieb’s experience seen in the hearing to consider his nomination. Prior to the vote, Sen. Lamar Alexander (R-TN) praised ...
  • Regulatory NewsRegulatory News

    Senate HELP Committee Delays Vote on Gottlieb Nomination

    Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA). Alexander said the vote was being delayed to give senators more time to "consider whatever information they want to consider and fit the schedules of senators who are all over the capital." According to Committee Ranking Member Patty Murray (D-WA), senators would need the extra time to review Gottli...
  • Regulatory NewsRegulatory News

    FDA Commissioner Nominee Faces Limited Opposition From Senate Committee

    The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA). While Democrats focused their questions in the hearing on Gottlieb’s conflicts of interest, how he’ll bring down drug prices and solve the opioid crisis, his work as a consultant and employee of pharmaceutical and biotech companie...
  • Regulatory NewsRegulatory News

    CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee

    The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals. All three officials highlighted the past successes of the user fee programs, and overall, it did not seem as though user fee goals letters would be reworked or that further negotiations would be needed before the b...
  • Regulatory NewsRegulatory News

    Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses

    The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market. Background The bill, known as the CREATES Act and introduced last week , focuses on two tactics often employed by the branded drugmakers to...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Five More Bills as Part of Medical Innovation Package

    The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill. Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats. “With its 21st C...
  • Regulatory NewsRegulatory News

    Senators Slam Execs of Shkreli's Former Company Over Arbitrary Price Hike on Lifesaving Drug

    The Senate’s Special Committee on Aging held its second hearing on pharmaceutical pricing on Thursday, this time taking shots at executives of Martin Shkreli’s former company Turing Pharmaceuticals, which only exists because of a monopoly and 5,000% price hike on a toxoplasmosis drug first approved more than 50 years ago. The first panel of witnesses included a couple whose newborn was diagnosed with toxoplasmosis but after their insurers denied coverage for the drug, kn...
  • Regulatory NewsRegulatory News

    FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

    Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday. Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s  approval of the us...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Seven Bills Linked to Drug, Device Regulations and Research

    The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year. The swath of new bills would, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs and aid the Nationa...
  • Regulatory NewsRegulatory News

    FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II

    Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017. Since 2012, when the first GDUFA was created to provide FDA with indu...
  • Regulatory NewsRegulatory News

    Senate HELP Committee Votes in Favor of Califf for FDA Commissioner

    The US Senate Committee on Health, Education Labor & Pensions (HELP) on Tuesday voted in favor of letting the full Senate vote to approve Robert Califf as the next Food and Drug Administration (FDA) commissioner. HELP Committee Chairman Lamar Alexander (R-TN) called Califf “the right man to lead the FDA,” as others offered their support. Sen. Lisa Murkowski (R-AK), who said back in November she would put a hold on Califf’s nomination, said at the hearing that she “g...