Table 5.
Examples of Discordant Advisory Committee Recommendation and FDA Action Pairs, 2008‐2015
| Meeting | Product | Voting Question | Final Action Date |
|---|---|---|---|
| Less Restrictive FDA Action After Unfavorable Advisory Committee Recommendation | |||
| CDER Pulmonary‐Allergy Drugs (12/11/2008) | LABAs | Risk‐benefit analysis for treatment of asthma in adults | 6/25/2010 (561 days) |
| CDER Oncologic Drugs (7/20/2010) | Avastin (bevacizumab) | Withdrawal of indication for initial treatment of patients with metastatic breast cancer | 12/20/2011 (518 days) |
| CDER Reproductive Health Drugs (9/9/2011) | Bisphosphonates | Label modification for osteonecrosis of the jaw and atypical femur fractures that may be associated with long‐term use of bisphosphonates | NA |
| CDER Anesthetic and Analgesic Drug Products (12/7/2012) | Zohydro ER (hydrocodone bitartrate ER) | Approval for management of moderate to severe chronic pain when a continuous, around‐the‐clock opioid analgesic is needed for an extended period of time | 10/25/2013 (322 days) |
| CDER Oncologic Drugs (11/6/2014) | Farydak (panobinostat) | Approval for treatment of patients with multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone | 2/23/2015 (109 days) |
| More Restrictive FDA Action After Favorable Advisory Committee Recommendation | |||
| CDER Psychopharmacologic Drugs (7/10/2008) | Chronically administered antiepileptic drugs | Warning for suicidality | 12/16/2008 (159 days) |
| CDER Cardio‐Renal Drugs (3/19/2009) | Xarelto (rivaroxaban) | Approval for prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery | 7/1/2011 (834 days) |
| CDER Psychopharmacologic Drugs (4/8/2009) | Seroquel XR (quetiapine fumarate) | Supplemental indication for treatment of major depressive disorder as a monotherapy | NA |
| CDER Anti‐Infective Drugs (4/3/2012) | ciprofloxacin | Supplemental indication for treatment of pneumonic plague | 2/2/2015 (1035 days) |
| CDER Psychopharmacologic Drugs (3/21/2013) | Probuphine (buprenorphine HCl and ethylene vinyl acetate subdermal implant) | Approval for maintenance treatment of opioid dependence | 5/26/2016 (1162 days) |