News & Views: Measles vaccine, Interchangeable biosimilars, Warning for vaping social influencers, Project Facilitate for expanded access, Enhancing diversity of clinical trials, Fixed-quantity packaging for opioids, Safety throughout drug’s lifecycle, Participation in Pre-Cert program, Better prescription drug advertising, Global drug quality – Drug and Device Digest

CaptureVaccination Is the Best Protection Against Measles

Measles, Mumps, and Rubella Virus Vaccine Live (M-M-R II, commonly called MMR)

  • For people ages 12 months and older
  • Two doses of the vaccine is about 97% effective at preventing measles

Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad, commonly called MMRV)

  • For children ages 1 through 12 years.
  • Also prevents chickenpox


CapturePolicy advancements to help bring interchangeable biosimilars to market

Pathway for “interchangeable” biologics

  • Substituted without the involvement of the prescriber
  • Similar to how generic drugs are routinely substituted for brand name drugs

 Final guidance on the pathway for “interchangeable” biologics

  • Overview of important scientific considerations in demonstrating interchangeability
  • Biological product is biosimilar to reference product and produces same clinical result
  • Risk of safety or diminished efficacy of alternating or switching will not be greater than the risk of using the reference product without such alternation or switch


Capture.JPGActions for violations by online posts on flavored e-liquids by social media influencers

FDA and FTC  warning letters to four firms that manufacture, sell, advertise flavored e-liquid products for social media influencers

  • Violations related to online posts by social media influencers on each company’s behalf, including failure to include the required nicotine warning statement
  • Enforcement action to address increased popularity of e-cigarettes among youth leading to health concerns, nicotine addiction, and more likely to transition to conventional cigarettes


Capture.JPGProject Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer

New pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer

  • New call center called Project Facilitate as a single point of contact
  • Help submit Expanded Access request for an individual patient, including follow-up of patient outcomes
  • Expanded Access is pathway for treatment by investigational treatment outside of clinical trials for immediately life-threatening or serious disease or condition
  • Expanded Access requests help weigh whether potential benefit of investigational treatment justifies the potential risks



Draft Guidance for Industry on Enhancing the Diversity of Clinical Trial Populations

  • More inclusive trial practices, trial designs, and methodological approaches to broaden eligibility criteria
  • Increase enrollment of more diverse populations in clinical trials
  • Maximizes generalizability of trial results
  • Better understand therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice, without jeopardizing patient safety
  • Reflects FDA policy encouraging inclusion in clinical trials of participants representative of the broad population of patients including minorities


CaptureFixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

Misuse of prescription opioids by getting them from a friend or family member


  • >191 million opioid prescriptions dispensed to ~ 60 million patients, either as first-time prescriptions or refills; ~ 90% patients reported not finishing what was prescribed to them

Special opioid packaging for reducing unused doses available for misuse, abuse, inappropriate access, accidental poisoning or overdose- considertions

  • Actual opioid use compared to prescribed amounts for common surgical procedures and acute pain conditions

  • 5-, 10-, and 15-Count Blister Packages of Certain IR Opioid and IR Opioid/Acetaminophen Products

  • New Packaging/Disposal REMS Element

  • Safety-Enhancing Benefits of Fixed-Quantity Blister Packaging for Opioid Analgesics for Treatment of Acute Pain

  • National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance guideline development

Remove the Risk” campaign


Capture.JPGTracking and Acting on Safety Data Throughout a Drug’s Lifecycle

Agency tracks, analyzes and acts on the adverse event data collected over time to discover and communicate new risks associated with approved drugs 

  • Reports from patients, health care professionals and manufacturers about adverse events in  FDA Adverse Event Reporting System (FAERS)
  • Monitor FAERS database to identify safety signals, analyze and interpret data, combine with other scientific information for decision-making
  • If new risk confirmed, require addition to product’s label and may require a Risk Evaluation Mitigation Strategy (REMS) to ensure benefits outweigh risks
  • From 2002 through 2014, new safety issues discovered and added to labels for 278 drugs


CaptureParticipation in 2019 Test Plan for Digital Health Software Precertification (Pre-Cert) Program

Agency seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD)  to meet the goals of the Test Plan

  • Small and large software development firms
  • Companies that develop a range of products, including both low- and high-risk SaMD
  • Companies that are not considered to be traditional medical device manufacturers but who intend to make SaMD


Capture.JPGHelping to Better Communicate the Risks and Benefits in Prescription Drug Advertising

Direct-to-consumer advertising influence awareness of prescription drug treatments, influence patients and doctors

  • Using eye-tracking technology, researchers are examining elements of these ads that can affect the viewer’s ability to understand risks and benefits
  • With high-distraction ad – less able to recall or recognize risks described, spent less time on written statement of risks
  • Objective to help drug companies develop ads that better inform public


CaptureAssuring Drug Quality Around the Globe

Programs to address the challenges to drug quality posed by globalization to protect patients and consumers

  • Tools to assure continued safety, effectiveness, quality post-approval
  • Same quality for both domestic and foreign manufactured products
  • Addressing quality inspections and issues


Image credit: F DA 


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