FDA BRIEF: Week of July 24, 2017
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
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
Keeping 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
- 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 supplement concerns? Tell the FTC and FDA
By: Mary Engle, FTC, and Steven Tave, FDA
- 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