FDA News: Drug Prices, Stem Cell clinic Injunctions, Opioid Crisis and Patient Needs, Drug Compounding, Medical Devices Servicing – Drug and Device Digest

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



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


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


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


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


Image credit: FDA

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