FDA News and Views: Opioid Public Health Emergency, Biosimilars, Medical Device Innovation, Medical Device Development Tool, Drug-Drug Interactions – Drug and Device Digest

FDA BRIEF: Week of October 23, 2017


Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis

Epidemic of opioid addiction – new declaration of a public health emergency

  • Aggressive steps to prevent new addictions and opioid-related deaths; help currently addicted regain control
  • Reframing pre- and post-market benefits and risks of opioids
  • Promoting development of abuse-deterrent opioids and non-opioids
  • Increase use of and access to antidote naloxone
  • Safe adoption of FDA-approved medically-assisted treatments
  • Working with federal and international partners to stop the flow of heroin, fentanyl
  • Break stigma associated with addiction and the use of sobriety medications


Biosimilars Education Campaign

Biosimilars are Potentially Cost-Saving Options

Biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product

  • May offer more affordable treatment options to patients.
  • Abbreviated approval pathway that does not lower approval standards
  • Evaluation does not include determination of interchangeability; substitution dependent on state pharmacy law

Several approved biosimilars (reference product)

  • Zarxio (Filgrastim-sndz)
  •  Inflectra (Infliximab-dyyb)
  •  Erelzi (Etanercept-szzs)
  •  Amjevita (Adalimumab -atta)
  •  Renflexis (Infliximab-abda)
  • Cyltezo (Adalimumab-adbm)
  •  Mvasi (Bevacizumab-awwb)

FDA has developed educational materials   for health care providers


Capture.JPGStatement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies

Medical Innovation Access Plan to keep pace with quickly evolving medical technology

  • First qualification of a Medical Device Development Tool (MDDT) to provide objective platform for developing devices in cardiovascular health
  • Breakthrough Devices Program for quicker access to devices that diagnose or treat life-threatening or irreversibly debilitating diseases
  • Guidances on when to submit new 510(k) prior to making a change to a legally-marketed device or software – to enhance predictability and consistency for innovators


Medical Device Development Tools imageMedical Device Development Tools: Helping to Speed Medical Device Evaluation and Approval

FDA’s voluntary Medical Device Development Tools (MDDT) program can “qualify” tools for use in medical device development

  • Tool can be used to provide more efficient and accurate ways to measure risk/ benefit as part of the medical product development process
  • Lead to more efficient and robust development, e.g. minimizing animal use,  reducing testing duration or sample sizes, optimizing patient selection
  • Three categories: Clinical Outcome Assessment, Biomarker Test, Nonclinical Assessment Mode
  • Offers developers opportunities to discuss early concepts of tool development, foster collaboration, increase potential that tools will be used and adopted

First MDDT Tool qualified – 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

  • Clinical Outcome Assessment- measures patient-reported outcomes from patients with congestive heart failure or weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes
  • Can be used in clinical trials by medical device industry to support both device submissions and post-approval studies

MDDT Webpage


Zineh_Issam_Drug_InteractionsCDER Conversation: Evaluating the Risk of Drug-Drug Interactions

What is a drug-drug interaction? 

  • Occurs when co-administration of two or more drugs alters absorption, distribution, metabolism, elimination
  • Can decrease or increase the action of either drug or both drugs, cause adverse effects, unintended consequences
  • Certain foods, vitamins and supplements can also interact

Risk for drug-drug interactions? Anyone – older population  at higher risk

Why important to assess drug-drug interactions? Risk-benefit balance can be altered

How many people are taking more than one drug? About 20% U.S. adults take three or more drugs

When and how to evaluate drug-drug interactions? 

  • In vitro studies to assess the investigational drug’s metabolism pathways
  • Clinical drug interaction studies completed before phase 3 clinical studies
  • Some drug interaction data may be collected after drug approval – for Breakthrough drugs

Drugs pulled from the market due to drug-drug interactions? terfenadine, asteminzole, cisapride, cerivastatin, mibefradil

FDA communication of drug-drug interactions? Drug labels, drug safety communications, Clinical Pharmacology Corner

New draft guidances. Federal Register Notice


Image credits: FDA



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