Capture.JPGStatement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices 

Drug Competition Action Plan (DCAP) to address the rising cost of drugs

  • Strengthen and enhance the overall generic drug review process
  • Calling out abuses of the system that impede competition and fixing them
  • Adopting strong policies and taking action against anticompetitive strategies to delay development and approval of important generic drug

Biosimilar Action Plan to facilitate development and approval of biosimilars

  • Help address patient access to costly biological products
  • Address Risk Evaluation and Mitigation Strategies (REMS) “gaming” abuses that can delay the entry of generic drugs

BLUEPRINT

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CapturePermanent injunctions against two stem cell clinics

Permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from cGMP requirements

  • Unapproved treatments that put patients’ health at risk
  • US Stem Cell Clinic LLC of Sunrise, Florida
  • California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California

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Capture.JPGAddressing Needs of Patients While Stemming the Tide of the Opioid Crisis

FDA goals to develop new policy solutions to

  • Reduce overall exposure to opioids
  • Prevent new addictions
  • Support development and use of medications to treat e with opioid use disorder

Need to address concerns of Americans living with chronic pain

  • Continued access to necessary pain medication
  • Fear of being stigmatized as an addict
  • Challenges in finding health care professionals willing to prescribe opioids
  • Increased thoughts of or actual suicide because crushing pain

Strike right balance between reducing new addiction while providing appropriate access

  • Upcoming public meeting focused on needs of those suffering from chronic pain
  • Allow appropriate prescribing for those in need
  • Encourage medical professional societies to develop evidence-based prescribing  guidelines
  • New guidances on efficient, modern pathway for development of pain drugs

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Capture.JPGHuman Drug Compounding and Policies

Preserve access to appropriately compounded drugs for patients who have a medical need while protecting patients from poor quality compounded drugs causing harm

  • Risk-Based Approach to Manufacturing Standards for Outsourcing Facilities
  • Restricting Compounding of Drugs that are Essentially Copies of FDA-Approved Drugs
  • Regulating Compounding from Bulk Drug Substances
  • Solidifying FDA’s Partnership with State Regulatory Authorities
  • Finalization of Biological Products Guidance and Clarifying Other Policies on Activities that Compounders Undertake
  • Compliance

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CaptureFDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices

FDA’s conclusions based on information related to quality, safety, and effectiveness of medical device servicing 

  • Evidence not sufficient to conclude whether or not there is a widespread public health concern
  • Indicates that many original equipment manufacturers (OEMs) and third party entities provide high quality, safe, and effective servicing of medical devices
  • Majority of comments, complaints, and adverse event reports alleging inadequate
    “servicing” actually pertain to “remanufacturing” and not “servicing”
  • Continued availability of third party entities to service and repair medical devices is critical

Formal regulatory action is not warranted; will pursue the following actions

  • Promote the Adoption of Quality Management Principles
  • Clarify the Difference Between Servicing and Remanufacturing
  • Strengthen Cybersecurity Practices
  • Foster Evidence Development to Assess the Quality, Safety and Effectiveness

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Image credit: FDA

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