FDA News: Prescription Drug Advertising, Women’s Heart Health Research, Neurovascular Catheters, FDA Vault, US-EU Mutual Recognition – Drug and Device Digest

FDA BRIEF: Week of February 27, 2017

Photo of Kathryn Aikin, Office of Prescription Drug Promotion, Understanding the Influence of Prescription Drug Advertising

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

OPDP Research 

  • 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.


womens health alert - fda office of womens health

FDA’s Commitment to Women’s Heart Health Research

By: Marsha B. Henderson, MCRP, Assistant Commissioner for Women’s Health

Marsha Henderson

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

FDA QT Story GraphicREAD

Related image

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 Guide 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.


Opening the FDA’s History Vault

By Suzanne Junod, Ph.D., and John Swann, Ph.D.,  FDA Historians

Video Link

Suzanne Junod and John Swann

  •  > 10,000 artifacts on nation’s oldest public health agencies
  • Inform, explain, and educate for future decision making
  • Includes deceptive and dangerous foods, medicines, and so-called medical product -sample of Elixir Sulfanilamide, can of Bon Vivant vichyssoise soup, Dalkon Shield intrauterine device, Relaxicisor
  • Tells story of the origins of  laws and regulations
  • Adoption of new technology
  • Hiring of women to be human “computers”
  • Monthly video series


Image result for US and EU
Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

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



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