FDA News and Views: Patient Engagement Advisory Committee, Generic Drug Competition, Advancing Digital Healthcare, Supply Chain Security Toolkit, OTC Drugs & Dietary Supplements Misbranding – Drug and Device Digest

FDA BRIEF: Week of July 24, 2017

Meeting Image

FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee

New Patient Engagement Advisory Committee (PEAC)

  • PEAC is a forum for the voice of patients
  • Inaugural Meeting: On Oct. 11-12, 2017
  • Topic: Challenges of clinical trial design, conduct, and reporting identified by patients

Committee Members

  • Nine core voting members, chair and consumer representative
  • All have direct experience as a patient or as a care-partner for a patient
  • American Association of Kidney Patients
  • Consumer Representative – Retired from the University of Pittsburgh
  • National Mammography Quality Assurance
  •  Health Motivations
  • Emory Alzheimer’s Disease Research Center
  • Veterans Administration
  • Diabetes association
  • American Cancer Society and the Cancer Action Network
  • Arthritis Foundation


generic medications

Opening Remarks by Dr. Gottlieb for Public Meeting on Generic Drug Competition

FDA doesn’t have a direct role in how drugs are priced but play a  role in the eventual cost of medicines

  • impact on cost of drug development
  • impact on drug pricing
  • cost of scientific and regulatory risk, time for development and approval, failures
  • can impact drug costs by encouraging competition with focus on generic drugs

Concern with branded companies “gaming” FDA system

  • taking advantage of rules to deliberately forestall generic entry
  • making it hard for generic drug makers to purchase branded drug  for testing
  • raising scientific objections timed to delay approval of ANDA
  • gratuitous price increases on niche products

FDA wants to hear from the public

  • ways to benefiting consumers
  • ways to balance access and innovation
  • market-based incentives to attract entrepreneurship to support new innovation

FDA undertaken “Drug Competition Action Plan” with 3 major elements

  • Identify sources of ‘gaming’ and change rules e.g. REMS
  • Identify scientific and regulatory obstacles to generic entry of generic medicines e.g. improve regulatory framework
  • Focus on the efficiency and throughput of overall generic drug program e.g. review efficiencies, improve scientific knowledge, enhance communication

GDUFA II proposal, currently pending before Congress

  • designed to reduce the number of ANDA review cycles
  • expand frequency and scope of communications between FDA and ANDA filers,  more opportunities to cure deficiencies,  get quick approvals
  • create pre-ANDA program, with a special focus on complex generics
  • issue “Good ANDA Assessment Practices” MAPP for internal policies
  • issue  “Good ANDA Submission Practices” guidance

Continued efforts on Drug Competition Action Plan and ongoing implementation of the Hatch-Waxman Amendments


Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

Additional criteria and procedures for classifying over-the-counter (OTC) drugs as generally recognized as safe and effective (GRASE) and not misbranded

  • OTC drug products without any US marketing experience can be evaluated under the monograph process if active ingredients meet certain “time and extent” criteria
  • If eligible, parties can submit safety and effectiveness information

FDA inviting comments on

  • Necessity of proposed collection of information for proper FDA performance
  • Accuracy of FDA’s estimate of burden of  proposed collection of information
  • Ways to enhance quality, utility, and clarity of information to be collected
  • Ways to minimize burden of collection of information on respondents


APEC Toolkit diagramKeeping the U.S. Prescription Drug Supply Chain Among the Safest in the World

By: Ilisa Bernstein, Pharm.D., J.D. Deputy Director,  Office of Compliance, CDER

Challenging yo keep U.S. prescription drug supply safest in the world

  • 4 billion prescriptions filled last year
  • moving through the U.S. supply chain
  • large percentage made outside of US
  • substandard and falsified drugs are global problems
Supply Chain Security Toolkit for Medical Products


  • Information and resources related to track and trace, internet sales, detection technology, and much more
  • Can be used by industry stakeholders and global regulators
  • PREVENT, DETECT, and RESPOND to medical products that threaten patient health and safety


dietary supplements, bottles image

Dietary supplement concerns? Tell the FTC and FDA

By: Mary Engle, FTC, and Steven Tave, FDA

Federal Trade Commission (FTC) and FDA have enforcement programs to protect consumers from false and misleading claims
  • Oversee Labeling Claims, Content, Purity, Safety
  • Monitor truth and accuracy of advertising claims
  • Monitor claims made on websites or in other online marketing
  • Inform FDA, FTC if false advertising or safety concerns

Safety Reporting Portal

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