FDA Brief, Week of Jan 4th, 2016 – Drug and Device Digest

FDA Voice

2015: Another Strong Year for Patients in Need of New Drug Therapies

By: John K. Jenkins, M.D. Director of the Office of New Drugs, CDER


Strong year for novel new drug approvals:  45 novel new therapies vs. average of 28 over the previous nine years

  • Cancers : Multiple myeloma (4), lung, skin, breast, brain, colorectal, and other cancers.
  • Heart failure, high cholesterol, cystic fibrosis, irritable bowel syndrome
  • Rare Diseases

Approval Highlights

  • 36% : “First-in-class,” : Addyi, Bridion, Corlanor, Cosentyx, Darzalex, Empliciti, Entresto, Ibrance, Kanuma, Nucala, Orkambi, Praluent, Praxbind, Strensiq, Unituxin, Xuriden
  • 40% : rare or “orphan” diseases: Alecensa, Cholbam, Cotellic, Cresemba, Darzalex, Empliciti, Farydak, Kanuma, Lenvima, Natpara, Ninlaro, Orkambi, Portrazza, Praxbind, Repatha*, Strensiq, Tagrisso, Unituxin, Uptravi, Xuriden, Yondelis
  • First reversal agent for a blood thinner: Praxbind
  • 60% : Designated in one or more categories for Expedited Development and Review methods
    • Fast Track 31%
    • Breakthrough 22%
    • Priority Review 53%
    • Accelerated Approval 13%
  • 64% approved first in the US
  • 96% PDUFA goal dates met
  • 87% “first cycle” approval
  • Qualified Infectious Disease Product (QIDP, GAIN Act): 2


FDA 2015: A Look Back (and Ahead) – Part 2: Medical Product Safety and Oversight

By: Stephen M. Ostroff, M.D., Acting Commissioner of Food and Drugs

Reflection on FDA’s impact on medical product safety and oversight.

Responding to Ebola : Expediting availability of diagnostic tests, investigational therapeutics, vaccines;  investigating fraudulent products

Addressing Transmission of Infections from Duodenoscopes : Safety communication, public Advisory Committee meeting, Warning letters,  Postmarket surveillance studies on reprocessing in real-world clinical settings.

Compounding:  Policy documents, meetings with stakeholders, including pharmacy, physician, and consumer groups, and collaborations with state governments.

Addressing the Opioid Abuse Crisis:  Multipronged approach to balance availability of medical treatments vs tragic consequences of abuse and misuse. Guidance for development of abuse-deterrent opioid formulations, options for medication-assisted treatment of opioid-dependence, treat consequences of overdoses.


FDA approved


Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers

Integra LifeSciences Corporation of Plainsboro, New Jersey

Indication for Use : Treat certain diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care.

Unmet need :

  • 29 million people in US diagnosed with diabetes; 25% will experience foot ulcer during their lifetime
  • Chronic diabetic foot ulcers associated with tissue and bone infections and result in 50,000 amputations each year.
  • Need for new innovation in diabetes care with the potential to improve the number of foot ulcers that heal

Reg Pathway : PMA Supplement

– PMA (1996) : Treatment of life threatening burn injuries when the use of a patient’s own skin for a graft was not possible

– PMA Supplement (2002) : Treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts

Effectiveness :

  • Study, a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). Omnigraft  vs. standard of care (includes cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer)
  • 51 percent of patients treated with Omnigraft had healed ulcers after 16 weeks compared to 32 percent of patients treated with standard diabetic foot ulcer care alone

Safety :  Adverse events included infections, increased pain, swelling, nausea, and new or worsening ulcers


fda guidances


Draft Guidance : Hearing Aid Devices and Personal Sound Amplification Products

  • New efforts to balance patient safety vs encouraging advancements in hearing aid technology and patient access
  • Hearing aids often underutilized medical device
  •  Most hearing aids are Class I (low-risk);  possible modifications to regulation to a “decrease in cost and improvement in capability, convenience and use of assistive hearing devices.”
  • Public workshop :  “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” April 21, 2016 : Alternative regulatory models to accelerate innovation while enabling quality design and manufacturing
  • Re-opened Public Comment period on draft guidance: Through May 19, 2016





Noxafil (posaconazole)

  • Dosing errors when switching between different oral formulations of antifungal
  • Drug labels revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in doseP
    • Prescribers – Specify the dosage form, strength, and frequency
    • Pharmacists – Request clarification from prescribers when the dosage form, strength, or frequency not specified
    • Patients – Talk to their health care professional before switching


Surgical Mesh for the Transvaginal Repair of Pelvic Organ Prolapse

  • Strengthened data requirements for  to address safety risks
  • Two final orders to manufacturers and the public
    • Reclassify from class II (moderate-risk) to class III (high-risk)
    • Require manufacturers to submit PMA application for safety and effectiveness


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