News & Views: COVID-19 updates, Rare Disease efforts, Fraudulent DTC genetic tests & review, Stopping illicit medical products from India, Updated Insulin regulatory pathway, Directory for approved drugs (since 1985)
FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad
Active partner in Novel Coronavirus (COVID-19) response, working closely with Department of Health and Human Services, as well as with international counterparts
- Active Supply Chain Surveillance: Closely monitor domestic and global supply chain
- Inspections and Monitoring Compliance of FDA Products Manufactured Overseas: Risk-based surveillance testing of imported products, including those from China
- Safety of Consumer Products: Close monitoring of fraudulent products and false product claims related to COVID-19
- Efforts to Diagnose, Treat and Prevent: Expedite development and availability of medical products needed to diagnose, treat and prevent disease
- Next Steps: Collaborating with interagency partners, international partners, medical product developers and manufacturers to help advance response efforts combat this virus
Rare Disease Day 2020: FDA Continues Important Work on Treatments for Rare Diseases
Commemorating Rare Disease Day by efforts to get treatments to patients with rare diseases across the thousands of identified rare diseases
- Public meeting with stakeholders to address challenges and opportunities surrounding rare disease product development
- New request for applications (RFA) for the Orphan Products Grants Program
- Additional information on orphan “exclusivity protected uses.”
- Enhanced rare disease patient website
Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications
Concerns with DTC genetic tests making claims about genetic test results to manage medication treatment that are NOT supported FDA-approved drug labeling or other scientific evidence
- Steps to help ensure that claims are grounded in sound science to avoid inappropriate management of patients’ medications
- New web-based resource including table describing some of the gene-drug interactions for altered drug metabolism, differential therapeutic effects, differences in risks of adverse events
- Continue to review various professional guidelines e.g. Clinical Pharmacogenetics Implementation Consortium
- Continue participation in community-based collaborative approach for ongoing evaluation of the evolving science
Table of Pharmacogenetic Associations, READ
FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products
Operation Broadsword targeted packages entering the U.S. through International Mail Facility from Jan. 28 through Jan. 30
- Investigators from both governments examined > 800 shipments, ~50 different FDA-regulated products, many transshipped through third-party countries to conceal point of origin and avoid detection
- Stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers
- FDA provided consumer information : BeSafeRx: Know Your Online Pharmacy. and encouraged to report any unlawful sale of medical products online to FDA.
Smooth Regulatory Transition of Insulin and Other Biological Products to Increase Patient Access and Potentially Lower Prices on Insulin
Steps to ensure a smooth transition to new regulatory pathway
- Final Rule for Biosimilars Action Plan
- Incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020
- Intended to balance innovation and competition and facilitate the development and approval of biosimilar and interchangeable product
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
New resource to assist external and agency researchers collecting historical information about FDA’s drug approvals
- Provide researchers with curated data regarding drug products approved by CDER since 1985 through 2019
- Facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug
- Derived from FDA internal databases and document records, and reflects the state of each application at the time of initial regulatory approval
- CDER will manage the compilation and will update it periodically with the latest drug approval data
Compilation of CDER NME and New Biologic Approvals 1985-2019
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals – Data Dictionary
Image credit: FDA