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Which of FDA's Drug Advisory Committees Were Most Active in 2014?

Posted 22 January 2015 | By Jessica Adams Tarius 

Which of FDA's Drug Advisory Committees Were Most Active in 2014?

Each year, the US Food and Drug Administration's (FDA) various advisory committees offer the agency dozens of recommendations on whether to approve new drugs, whether new policies are needed to better regulate drugs and whether an existing product should remain on the market.

In 2014, some of those committees were more active than others. This article looks at FDA's pharmaceutical and scientific advisory committees and asks: Which committees were the most (and the least) active in 2014, and what did they recommend FDA do?

The Most Active: The Cardiovascular and Renal Drugs Advisory Committee (CRDAC)

Total Meetings in 2014: 8

Breakdown of Votes:

3 Yes (recommending approval) votes:

  • 16-1 vote for Chelsea Therapeutics, Inc.’s Northera (droxidopa) for neurogenic orthostatic hypotension
  • 10-1 vote for Merck Sharp & Dohme Corp. Inc.’s Zontivity (vorapaxar) for reduction of atherothrombotic events in patients with a history of myocardial infarction but no history of stroke or transient ischemic attack
  • 9-1 vote for Daiichi Sankyo’s Savaysa (edoxaban) to prevent stroke and systemic embolism in non-valvular atrial fibrillation patients.

4 No (not recommending approval) votes:

  • 11-0 vote against Novartis’ serelaxin to improve the symptoms of heart failure
  • 10-0 vote against Janssen Pharmaceuticals Inc.’s Xarelto (rivaroxaban) to reduce cardiovascular (CV) events in patients with acute coronary syndrome
  • 7-2 vote against The Medicine Company’s cangrelor to reduce CV events in patients with coronary artery disease undergoing percutaneous coronary intervention
  • 6-4 vote against Forest Laboratories, Inc.’s nebivolol/valsartan for hypertension

1 non-voting meeting:

  • A review of the potential clinical utility of a polypill containing an antihypertensive, aspirin, and a statin

The Second Most Active: The Drug Safety and Risk Management Advisory Committee (DSRM)

Total Meetings in 2014: 6

Breakdown of Votes:

2 Yes votes:

  • 11-7 vote to retain the Chantix Boxed Warning and reassess when ongoing randomized clinical trial has been completed (Joint meeting with PDAC)
  • Testosterone replacement therapies (TRTs ) (Joint meeting with BRUDAC)
    • 20-1 vote to narrow the appropriate indicated population for TRTs
    • 16-5 vote to require a cardiovascular outcomes trial for TRTs to treat age-related hypogonadism
    • 17-4 vote to not require cardiovascular outcomes trials for all TRTs, regardless of indication

2 No votes:

  • 18-3 vote against Clarus Therapeutics’ testosterone undecanoate (Joint meeting with BRUDAC)
  • 16-9 vote concluding that naproxen does not have a lower risk of cardiovascular thrombotic events as compared to other NSAIDs (Joint meeting with AAC)

2 non-voting meetings:

  • Minor changes to the Risk Evaluation and Mitigation Strategies (REMS) for Alexion’s Soliris (eculizumab)
  • One meeting was “Closed to permit discussion of whether FDA should permit further clinical development of an existing investigational drug product, which will include the review of trade secret and/ or confidential information.” (Joint meeting with BRUDAC)

The Third Most Active: The Nonprescription Drugs Advisory Committee (NDAC)

Total Meetings in 2014: 5

Breakdown of Votes:

2 Yes votes:

  • 12-0 vote for standards proposed by the FDA to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective (GRAS)
  • 15-5, with 1 abstention, vote to remove hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma from the monograph

2 No votes:

  • 11-4 vote against a new nasal indication for Merck’s OTC Singulair Allergy (montelukast)
  • 18-6 vote against approval for OTC use of Armstrong Pharmaceuticals’ Primatene HFA (Inhaled epinephrine) for asthma

1 non-voting meeting:

  • Safety testing for over the counter sunscreens

The Blood Products Advisory Committee (BPAC)

Total Meetings in 2014: 4

Breakdown of Votes:

2 Yes votes:

  • 15-1 vote for Baxter Healthcare Corporation’s immune globulin infusion with human hyaluronidase for primary immune deficiency disorders

Also included votes:

    • 9-7 vote against restricted labeling
    • Unanimous vote for risk communication about potential immunogenicity. 1
    • 10-6 vote against requiring routine monitoring for emergence and/or increasing levels of anti-PH20 antibodies
  • 12-0 vote for BioArray’s Molecular BeadChip Assay to determine human erythrocyte antigen phenotypes in the Rh blood group

2 non-voting meetings:

  • Review of the blood donor deferral policy for men who have sex with another men
  • Review of the Chikungunya/MERS/Ebola viruses, in the context of blood bank safety

Anesthetic and Analgesic Drug Products Advisory Committee(AADPAC)

Total Meetings in 2014: 3

Breakdown of Votes:

1 Yes vote:

  • 15-7 vote for adding a contraindication to the labeling of injectable corticosteroids (ICs) for use in epidural administration. The committee specifically supported a contraindication only for suspensions of ICs to the cervical spine by way of an approach called the transforaminal approach.

2 No votes:

  • 17-7 against requiring cardiovascular outcomes trials for peripherally active mu-opioid receptor antagonists being developed for the treatment of opioid-induced constipations in patients with chronic, non-cancer pain.
  • 14-0 vote against QRxPharma’s Moxduo (morphine and oxycodone capsules)

Oncologic Drugs Advisory Committee (ODAC)

Total Meetings in 2014: 3

Breakdown of Votes:

1 Yes vote:

  • 8-3 vote for Rockwell Medical’s Triferic for iron maintenance in chronic kidney patients (half-day session)

2 No votes:

  • 5-2 vote against Novartis’ Farydak (panobinostat) for multiple myeloma (half-day session)
  • 12-2 vote against AstraZeneca’s olaparib for refractory ovarian cancer patients. The committee opted to wait for upcoming data from the SOLO-2 trial

1 non-voting meeting:

  • Pediatric written requests for Synta’s Ganetespib, Nektar’s Etirinotecan, and Roche’s RO5503781

Anti-Infective Drugs Advisory Committee (AIDAC)

Total Meetings in 2014: 3

Breakdown of Votes:

3 Yes votes:

  • 12-0 for Durata Therapeutics’ dalbavancin for acute bacterial skin and skin structure infections (half-day meeting)
  • 14-0 for Trius Therapeutics’ tedizolid for acute bacterial skin and skin structure infections (half-day meeting)
  • Cerexa’s Ceftazidime-Avibactam
    • 11-1 for the combination to treat complicated intra-abdominal infections (cIAI), when limited or no alternative treatments are available
    • 9-3 for the combination to treat complicated urinary tract infections (cUTI), including acute pyelonephritis, when limited or no alternative treatments are available

1 No vote:

  • Cerexa Inc.’s Ceftazidime-Avibactam
    • 12-0 against the combination to treat aerobic gram-negative Infection, when limited or no alternative treatments are available
    • 11-1 against the combination to treat aerobic gram-negative infections when no alternative treatments are available

1 non-voting meeting:

  • The AIDAC discussed issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options. They reviewed ways in which to streamline development.

Endocrinologic and Metabolic Drugs Advisory Committee(EMDAC)

Total Meetings in 2014: 3

Breakdown of Votes:

3 Yes votes:

  • 8-5 for NPS Pharmaceuticals Inc.’s Natpara (recombinant human parathyroid hormone) for hypoparathyroidism
  • 14-1 for NovoNordisk Inc.’s Saxenda (liraglutide) for weight management in certain adults
  • 13-1 for MannKind Corporation’s Afrezza (inhaled insulin)

Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)

Total Meetings in 2014: 3

Breakdown of Votes:

1 Yes vote:

  • Testosterone replacement therapies (TRTs ) (Joint meeting with DSRM)
    • 20-1 vote to narrow the appropriate indicated population for TRTs
    • 16-5 vote to require a cardiovascular outcomes trial for TRTs to treat age-related hypogonadism
    • 17-4 vote to not require cardiovascular outcomes trials for all TRTs, regardless of indication

1 No vote:

  • 18-3 vote against Clarus Therapeutics’ testosterone undecanoate (Joint meeting with DSRM)

1 non-voting meeting:

  • One meeting was “Closed to permit discussion of whether FDA should permit further clinical development of an existing investigational drug product, which will include the review of trade secret and/ or confidential information.” (Joint meeting with DSRM)

Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC)

Total Meetings in 2014: 3

Breakdown of Votes:

3 non-voting meetings:

  • Oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility and an update on CBER’s draft guidance for the design of early-phase clinical trials of cellular and gene therapy products
  • Draft Guidance for Industry entitled "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and the Dear Gene Therapy IND or Master File Sponsor Letter
  • Updates of research programs about monoclonal antibodies and therapeutic proteins at the FDA

Pulmonary-Allergy Drugs Advisory Committee (PADAC)

Total Meetings in 2014: 3

Breakdown of Votes:

2 Yes votes:

  • 10-3 vote for Boehringer Ingelheim Pharmaceuticals’ Spiriva Respimat (inhaled tiotropium) for chronic obstructive pulmonary disease (COPD)
  • 13-2 vote for Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for cystic fibrosis patients aged 6 years and older with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene

1 No vote:

  • 18-6 vote against over the counter use for Armstrong Pharmaceuticals’ Primatene HFA (Inhaled epinephrine) for asthma

Three Committees Only Met Twice in 2014

Risk Communication Advisory Committee

2 non-voting meetings:

  • Input into methods of communicating about eating more fish, especially for the target audiences of women who are pregnant or nursing or for those who prepare food for young children
  • Methods for identifying the impact and increasing the reach of communications on topics of interest to consumers through FDA’s “Consumer Updates.”

Pediatric Advisory Committee

2 non-voting meetings:

  • Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2 meeting dates)

Vaccines and Related Biological Products Advisory Committee

2 non-voting meetings:

  • Updates of the research programs in the Laboratory of Respiratory and Special Pathogens, Division of Bacterial, Parasitic and Allergenic Products, and in the Laboratory of Hepatitis Viruses, Division of Viral Products, CBER
  • Recommendations on the selection of strains to be included in the influenza virus vaccine for the 2014 to 2015 influenza season

Four Advisory Committees Only Met Once in 2014

Dermatologic and Ophthalmic Drugs Advisory Committee

1 Yes vote:

  • 7-0 vote for Novartis’ Cosentyx (secukinumab) for plaque psoriasis

Psychopharmacologic Drugs Advisory Committee

1 Yes vote:

  • 11-7 vote to retain the Chantix Boxed Warning and reassess when ongoing randomized clinical trial has completed (Joint meeting with DSRM)

Allergenic Products Advisory Committee

1 Yes Vote:

  • Merck’s Ragwitek (ragweed pollen allergen extract) for allergies (6-2, with 1 abstention, for efficacy;8-0, with 1 abstention, for safety

Arthritis Advisory Committee

1 No vote:

  • 16-9 vote concluding that naproxen does not have a lower risk of cardiovascular thrombotic events as compared to other NSAIDs. (Joint meeting with DSRM)

Advisory Committees With no Meetings in 2014

Total Meetings in 2014: 0

Seven of FDA's pharmaceutical and scientific Advisory Committees held no meetings in 2014. They are as follows:

  • Antiviral Drugs Advisory Committee
  • Transmissible Spongiform Encephalopathies Advisory Committee
  • Pharmacy Compounding Advisory Committee
  • Pharmaceutical Science and Clinical Pharmacology Advisory Committee
  • Peripheral and Central Nervous System Drugs Advisory Committee
  • Medical Imaging Drugs Advisory Committee
  • Gastrointestinal Drugs Advisory Committee

 

The following FDA SACs are not covered in this material: Food, Medical Devices, Radiation-Emitting Products, Tobacco Products, Science Board to the NCTR, and Veterinary Medicine.

To contact the writer of this article directly, please send an email to sactracker@tarius.com.


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