News and Views: Coronavirus medical countermeasures, 2019 New Therapies, Gene Therapy innovation, Deter anti-competitive business for biologics, Heart Health education for women, HIV Drugs mobile database, Warning for nicotine toothpicks – Drug and Device Digest


Advance Development of Novel Coronavirus Medical Countermeasures (MCM)

FDA collaborating with interagency partners, product developers, international partners and global regulators to
  • Expedite development and availability of MCM to diagnose, treat, mitigate, prevent
  • Utilize pathways, including Emergency Use Authorization (EUA) to more rapidly make MCM available
  • Provide regulatory advice, guidance, and technical assistance to  sponsors developing investigational MCMs
  • Provide review and feedback on development proposals including design and set-up of clinical trials
  • Protect safety of nation’s blood supply and human cells, tissues,cellular/tissue-based products for transplantation
  • Enable access to investigational MCM through EUA or expanded access mechanisms
  • Protect consumers against fraudulent products by monitoring fraudulent products and false product claims and taking appropriate action

READ , 2019-nCOV website 


2019 CDER New Drug Approvals Report

Annual report entitled Advancing Health Through Innovation: New Drug Therapy Approvals

  • Variety of novel drugs for advancing patient care – never approved in US
  • Overview of other notable approvals — new uses of uses for approved drugs
  • Treat new population of patients, such as children
  • Innovative ways to enhance efficiency and expedite review and approval

Innovation and Access areas

  • Rare Diseases
  • Neurological and Psychiatric disorder
  • Infectious diseases
  • Heart, Lung, Circulatory, Endocrine diseases
  • Autoimmune conditions
  • Women’s and Men’s specific health issues
  • Cancers and blood disorders
  • Biosimilars



Strong Support of Innovation in Development of Gene Therapy Products

FDA efforts  to support innovators developing new gene therapy products, which insert new genetic material into a patient’s cells

  • 4 products approved
  • > 900 investigational new drug (IND) applications for ongoing clinical studies
  • will serve to improve therapeutic choices

Publication of guidances issued to provide recommendations for product developers



New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans

FDA and FTC to collaborate to curtail and discourage anti-competitive behavior to faciliate robust competition and bring down cost for biologics

  1. Promote greater competition in biologic markets
  2. Deter behavior that impedes access to samples needed for the development of biologics, including biosimilars
  3. Take appropriate action against false or misleading communications
  4. Review patent settlement agreements involving biologics, including biosimilars, for antitrust violations


CaptureHeart Health Education for Women

FDA Office of Women’s Heath (OWH) initiatives is support of American Heart Month
  • Heart health educational video ‘Getting a Beat : On what women know about heart health
  • New KNOWH the Difference initiative, which focuses on sharing important knowledge and news on women’s health (KNOWH)
  • OWH research and extramural funding opportunities

Mobile-Friendly Database with Information on Life-Saving HIV Drugs

Interactive database  on critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program

  • Empower public and health care providers by enhancing the amount and availability of information and data provided on each drug
  • Health care providers, consumers, procurer access to FDA-reviewed product labeling and essential scientific information for safe and effective use of drug
  • Information on pediatric drugs, where manufactured, shelf-life, storage requirements
  • Ability to export reports, collect metrics, readily access on mobile platforms


FDA Warns Maker of Nicotine-Containing Toothpicks of Several Violations, Including Illegal Sales 

  • Warning letter to Smart Toothpicks LLC,  Tempe, Arizona, for selling dissolvable tobacco products, including Peppermint Ice Nicotine Toothpicks
  • Three specific violations:
    • selling a tobacco product to a minor through the company’s website
    • selling unauthorized modified risk tobacco products
    • failing to include required nicotine warning statements on both packaging and advertising
  • Written response to this letter within 15 working days on corrective actions
    • discontinue violative labeling, advertising, sale, and/or distribution
    • plan for maintaining compliance with the FD&C Act

Action is part of the agency’s Youth Tobacco Prevention Plan, to prevent and reduce youth tobacco use 


Image credits: FDA

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