• Regulatory NewsRegulatory News

    Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule

    The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices. The industry groups call for this final rule to be stayed indefinitely and reconsidered because FDA failed to give fair no...
  • Regulatory NewsRegulatory News

    ICH Offers Updates on New Members, Progress on Guidelines

    The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday. New members approved at the meeting were Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the US industry group Biotechnology Innovation Organization (BIO) and Korea’s Ministry of Food and Drug Safety (MFDS). In terms of observers, ...
  • Regulatory NewsRegulatory News

    Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals

    The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program. The finalization of the rule, first proposed in 2010, follows fierce criticism of the plan from industry groups PhRMA, BIO and companies including Bayer and Teva. The final rule calls on drug companies to: calculate the 340B ceiling price on a quarterly...
  • Regulatory NewsRegulatory News

    BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump

    The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration. Speaking at the FDA/CMS Summit in Washington, DC last week, Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization (BIO), said she's concerned that the user fee agreements, which were negotiated under the Obama Administration, will be reviewed by a new Congress and new administration, each of which mi...
  • Regulatory NewsRegulatory News

    BIO Chair: Trump Should Re-Appoint Califf to Head FDA

    In a phone interview with Focus on Thursday, Ron Cohen, MD, president and CEO of Acorda Therapeutics and chair of industry group BIO, offered his views on increasing funding for the US National Institutes of Health (NIH), what the future may hold for the US Food and Drug Administration (FDA), as well as some new ideas and possible solutions to help contain rising drug prices. NIH and FDA For NIH, Cohen echoed sentiments circulating on Capitol Hill around the 21s...
  • Regulatory NewsRegulatory News

    FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies

    The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation. “FDA has reconsidered our position on this issue and deemed our concerns from 2001 outdated. We will continue to ...
  • Regulatory NewsRegulatory News

    Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics

    The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA. Background The long-awaited draft guidance, released in July , was in the works for more than a decade and is meant to be a practical guid...
  • Regulatory NewsRegulatory News

    PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals

    More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a  46-page document  outlining how the agency ...
  • Regulatory NewsRegulatory News

    EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot

    The European Medicines Agency’s (EMA) Executive Director Guido Rasi and senior medical officer Hans-Georg Eichler sent a letter on Thursday to clarify some assumptions called into question by a group of nine professors who are criticizing aspects of the agency’s adaptive pathways pilot program. Background First announced in March 2014, EMA’s pilot program seeks to accelerate patient access to drugs for patients with pressing medical needs and after approval for a narrow...
  • Regulatory NewsRegulatory News

    PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition

    The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked. On the one hand, these cost-saving biosimilars will need to be clearly distinguished from their reference product so that regulators can track any adverse events and ensure they are safe, though on the other side of the coin, any new labeling requirements coul...
  • Regulatory NewsRegulatory News

    Industry Calls for Clarity, Phased Approach for Quality Metrics

    Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) plan to request quality metrics from drugmakers, but they also call on the agency to clarify what it wants and implement a phased-in approach. Background In July, FDA released its long-awaited draft guidance , Request for Quality Metrics , which outlined the agency's plans to collect quality metrics to "further develop FDA's risk-based inspection scheduling." While the draft g...
  • Regulatory NewsRegulatory News

    Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance

    Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews. Challenges in Orphan Drug Development In August, FDA released a draft guidance intended to address the most common issues faced by drugmakers developing treatments for rare diseases . The guidance notes that FDA's "regulations provide flexibility in applying regulatory standards" a...