Briefs: Communications for value-based care, New reimbursement model to fight antibiotic resistance, Patient Voice in regulatory decision-making, CDER organizational improvements – Drug and Device Digest


New efforts to advance medical product communications to support drug competition and value-based health care

HHS blueprint proposes measures for access to underinsured or uninsured

  • Prices to reflect the value in how medicines are prescribed and the outcomes they deliver
  • Control rising spending and reduce the burden of drug costs for consumers
  • Models to tie price of drugs closely to usefulness of  clinical setting in which they are prescribed. We want to encourage competitive contracting based on measures of value that matter most to purchasers and patients, not get in the way of these competitive negotiations

FDA will provide clear guidance to pharmaceutical companies about open, responsible communication with payors, formulary committees and others

First  guidance document

  • Inform market participants developing value-based contracts
  • Communication of outcomes important to purchasers like a health plan or hospital
  • Endpoint may not be expressly described in drug’s approved labeling

Second guidance document

  • Manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling
  • Such as data from post-market studies and surveillance
  • Additional information from the pre-market studies that were used to support approval of the product



FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Increase in serious antimicrobial drug resistant infections is critical public health concern

  • At least 2 million people become infected with bacteria that are resistant to antibiotics and 23,000 people die each year as direct result
  • Need for good antibiotic stewardship and use in appropriate clinical scenarios

In discussions with CMS, idea to change reimbursement model

  • For certain new, anti-microbial drugs that meet critical, public health needs
  • Move to licensing model – instead of paying for drugs that meet a narrow set of criteria on a per use basis
  • Acute care institutions would pay a fixed licensing fee to use a certain number of annual doses



New agency efforts to advance the PATIENT VOICE in medical product development and FDA regulatory decision-making

Need for systematic, methodologically-sound approaches to collect patient input to  inform regulatory decision-making

New guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

  • Sampling methods for collecting patient experience – throughout the medical product lifecycle
  • How to operationalize and standardize the collection, analysis and dissemination of patient experience data



Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

FDA Patient-Focused Drug Development Guidance Series 

  • To address, in a stepwise manner, how stakeholders can collect and submit patient experience data
  • Intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input



Proposed modernization of FDA’s drug review office

CDER undertaking steps to modernize the organization and functions of  Office of New Drugs

  • Elevate role of scientists and medical officers to take on even more thought leadership
  • More time, better tools and greater support to advance the clinical and regulatory principles
  • Develop hundreds of new clinical guidance documents and make sure they stay up-to-date to reflect latest science

Allow review staff to have more time for reviewing and providing feedback to sponsors

  • Engage sponsors earlier in the development process
  • Ensure trial designs are efficient and  effectively structured for benefit/risk assessment
  • Ability to engage external stakeholders, such as disease specialists, academic researchers and regulatory partners at other agencies
  • Ongoing relationships and interactions with patient groups
  • Creating many new therapeutic-specific divisions to engage in discrete areas of medicine

Improve FDA review process

  • Integration around a common review process, common review template
  • Integrated across  discrete areas of science and regulatory expertise
  • Better organization of review process and development of key review memos

New alignment and processes will improve efficiency by 20% at a minimum overall


Image credit: FDA


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