FDA BRIEF: Week of May 15, 2017
Dr. Gottlieb’s First Remarks to FDA Staff
Remarks by Commissioner Scott Gottlieb, M.D. at FDA All Hands Meeting
- People’s lives depend on what FDA does
- Great promise with scientific advances to make regulatory process more modern and efficient
- Immediate challenge – opioid abuse and FDA’s role in minimizing use
- Also help address challenge of prohibitive drug pricing – even though FDA does not have a direct role
- Overall, need for risk-based, patient-centric, science-based approach and maintaining gold standard for regulatory science and independent, science-led decision-making
Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone
By: John J. Whyte, M.D., M.P.H. , Director of Professional Affairs and Stakeholder Engagement, CDER
Harm from medications also may come from known risks that could have been prevented
- 1.5 million preventable adverse drug events occur each year
- Prescribers and other providers struggle with intricacies of health care system
- Patients have difficulty following detailed directions
- Manufacturers need careful packaging and labeling to avoid confusion
Reducing preventable harm from medications is a big part of FDA’s mission
- Hosting a one-day public meeting “Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.”
- Meeting with all stakeholders to discuss sources of preventable harm from drugs in outpatient setting
Accreditation Scheme for Conformity Assessment Pilot Program
Voluntary consensus standards establish safety & performance criteria for medical device design and manufacturing
- Support claims of safety and quality in FDA premarket review
- Sponsors include a `Declaration of Conformity” to attest to standards
Challenge
- Appropriate use of FDA recognized consensus standards not consistently applied
- Require substantial specialized knowledge to interpret and apply correctly
Addressing Challenge
- FDA and Industry to establish an FDA Accreditation Scheme for Conformity
Assessment (ASCA) Program - Recognize accredited testing laboratories that evaluate medical devices according to FDA standards
- Ease industry regulatory burden by allowing them to use recognized accredited test laboratories to ensure accurate conformance with the consensus standard
- FDA requesting comments on proposal by June 30
Sunscreen: FDA Regulated Product
Sunscreen is an FDA-regulated product, for protection from sunburn, skin cancer, early skin aging and other risks of sun overexposure
Sun protection factor (SPF) in Label
- Indicates level of sunburn protection: Amount on UVB and UVA radiation to cause sunburn with sunscreen vs without
- Higher SPF values (up to 50) provide greater sunburn protection
- “Broad Spectrum SPF [value]” in label indicate protection from both
Other Label Information
- List of acceptable active/inactive ingredients
- Expiration dates based on stability testing
- Ex-US products may not have same label standards as FDA
Image credits: FDA