FDA BRIEF: Week of February 27, 2017
Understanding the Influence of Prescription Drug Advertising
By: Kathryn Aikin, Ph.D., Senior Social Science Analyst and Research Team Lead, Office of Prescription Drug Promotion, Office of Medical Policy, CDER.
CDER’s Office of Prescription Drug Promotion (OPDP)
- Ensures prescription drug marketing is truthful, balanced, accurately communicated
- Upholds Guidance for Industry on Consumer-directed Broadcast Advertisements, 1999
- Communication of important risk information and consumer sources for prescribing and risk information for the drug
- Evaluate Direct-to-Consumer (DTC) Ads: Provide science-based information, commitment to public health, social science data to inform regulatory actions
- Social Science Research : Focus questions, methods, findings, effects of DTC ads, print ads, broadcast ads, animation etc.
FDA’s Commitment to Women’s Heart Health Research
By: Marsha B. Henderson, MCRP, Assistant Commissioner for Women’s Health
Research on cardiovascular diseases in women and drug effects women’s heart health
- Connection between certain drugs and Torsade de Pointes (TdP) and QT prologation
- Evaluation of better ways to screen drugs for their potential to cause TdP
- Understanding mechanism of sex differences
- Developing FDA Guidance on QT prolongation assessment, Thorough QT (TQT) study
- Improving predictive accuracy of drug’s potential for heart rhythm problem early in development
Neurovascular Thrombus Retrieval Catheters and Neurovascular Guide Catheters
Used During Neurological Interventional Procedures
- 510(k) premarket review and cleared indications are significantly different with differences in device design
- Differences in FDA Review and Intended Use
|Thrombus Retrieval Catheters
|Product Code: NRY
|Product Code: DQY
|Indications: Typically cleared with the indication for restoring blood flow or removal of thrombus within a blood vessel in the brain during an acute ischemic stroke within 8 hours of symptom onset in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy.
|Indications: Typically cleared with the indication of introducing interventional devices into the neurovasculature or as a conduit for retrievers.
|Performance Data: Typically, clearance of neurovascular thrombus retrieval catheters for this type of indication is based on non-clinical (e.g., bench and animal) performance data and, when necessary, clinical performance data. CDRH reviews these data to evaluate the ability of the device to safely navigate into the tortuous neurovasculature in close proximity to the thrombus and remove the thrombus to revascularize the blood vessel.
|Performance Data: Typically, clearance of neurovascular guide catheters for this type of indication is based on bench performance data to support the use of the catheter for the introduction of other interventional devices. Review of animal or clinical data is usually not required. In addition, neurovascular guide catheters are not reviewed for use in aspiration within the vessel for removing thrombus.
Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement
- U.S. and EU regulators able to utilize each other’s GMP inspections of pharmaceutical manufacturing facilities
- Avoid the duplication of drug inspections, lower inspection costs
- Enable regulators to devote more resources to higher risk other parts of the world