FDA BRIEF: Week of May 8, 2017
Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs
Dr. Scott Gottlieb was sworn in as the 23rd FDA Commissioner on May 11
- Physician, medical policy expert, public health advocate
- Previously served at FDA and CMS
- Senate appointment to serve on Federal Health Information Technology Policy Committee
FDA and NIH Release Final Template for Clinical Trial Protocols
NIH-FDA Joint Leadership Council issued protocol template for drugs and medical devices:
- Describing trial objectives, trial design, methodology, statistical considerations, and trial organization
- Standard protocol format to facilitate review by regulators and others (e.g., institutional review boards)
- Following ICH E6 Good Clinical Practice guidelines
- Contributing to important time and money-saving efficiencies
Depression: FDA-Approved Medications May Help
Major depressive disorder/ unipolar depression affects 350 million people worldwide and leading cause of disability
Antidepressant classifications:
- selective serotonin reuptake inhibitors (SSRIs): examples -Prozac (fluoxetine), Celexa (citalopram), and Paxil (paroxetine)
- serotonin norepinephrine reuptake inhibitors (SNRIs): examples- Effexor (venlafaxine) and Cymbalta (duloxetine)
- tricyclic antidepressants (TCAs): examples- Elavil (amitriptyline), Tofranil (imipramine), and Pamelor (nortriptyline)
- monoamine oxidase inhibitors (MAOIs): examples- Nardil (phenelzine) and Parnate (tranylcypromine)
- other: Remeron (mirtazapine), Wellbutrin (bupropion)
Effectiveness:
- regular doses for several weeks prior to full effect
- significant percentage may not respond; need to switch
Serious Risks:
- Suicidal thinking
- Birth defects
- High blood pressure
Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing
- improve product quality
- address drug shortages and recalls
Batch vs. Continuous Manufacturing:
- Batch Manufacturing: Multiple discrete steps with “hold times” ; requires time for scale up
- Continuous Manufacturing: Fully integrated components, no hold times, run for longer period of time, may reduce likelihood of drug shortages
- Same QC standards
Benefits of Continuous Manufacturing:
- Monitoring automated and more frequent
- Detect issues long before failure
- Predict life expectancy of equipment, proactive maintenance
- Flexible tracking and tracing, isolate smaller amount of defective material, less waste and less chance of shortage
Transition:
- Still in its early stages – initial cost of equipment and training, availability of technology, regulatory uncertainty
- FDA partnering with BARDA to fund and support research
- Multidisciplinary team under CDER’s Emerging Technology Program for new technology such as 3D printing, novel dosage forms, novel container systems
- FDA Guidance
Photo Credits: FDA, NIH, Google