ANNOUNCEMENTS
Reflections on a Landmark Year for Medical Product Innovation and Public Health Advances and Looking Ahead to Policy in 2018 - FDA Commissioner Scott Gottlieb, M.D.
As we look ahead to 2018, I’d like to take a moment to reflect on an inspiring year of advances in both medicine and public health for FDA — from groundbreaking medical products brought to market this year, to a record number of generic drug approvals that will promote competition, and to the agency’s ongoing efforts to advance policies that promote safe and effective product innovation, and keep Americans safe from food-related illnesses.
Advancing Health through Innovation: New Drug Therapy Approvals of 2017
FDA released Advancing Health through Innovation: New Drug Therapy Approvals of 2017, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2017 important new drug approvals that serve to advance public health. These approvals will benefit patients affected by a wide range of rare diseases, neurological conditions, infectious diseases, cancers, and many other medical conditions. This report also emphasizes the many innovative regulatory tools CDER uses to enhance our efficiency and expedite the review and approval of drug therapies never marketed in the U.S., and explains how CDER’s expansive and collaborative work with a wide range of stakeholders in the scientific, medical, and patient-centered communities is a vital form of external engagement necessary to advance the scientific work that supports our drug therapy approvals.
Update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
A key area of focus for the FDA remains addressing the IV saline shortage, which has impacted patients, health care providers and hospitals. Based on the information we’re receiving from the companies, we expect that the shortage of IV saline fluids will improve in early 2018, with continuing improvements in the weeks ahead. Just before the holidays, Baxter – a leading producer of IV saline fluids – announced that all their facilities on the island have returned to the commercial power grid.
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
FDA posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk.
New steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
The FDA announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.
Evaluating Nicotine Replacement Therapies: FDA Steering Committee, Public Hearing
In support of FDA’s comprehensive new tobacco regulatory plan announced in July, the agency has formed a Nicotine Steering Committee to help develop and implement nicotine policy and regulation. The committee will address the public health crisis of addiction to tobacco products in this country and will focus on nicotine replacement therapies (NRTs), which are designed to help people quit smoking. The committee will hold a public hearing for FDA to obtain feedback on public health, scientific, regulatory, and legal considerations relating to NRT products and how they are used for cessation. The hearing is planned for Jan. 26, 2018, at FDA’s White Oak Campus in Silver Spring, Md. Electronic or written comments will be accepted after the public hearing until Feb. 15.
DRUG SHORTAGES
Drug discontinuations voluntarily reported by manufacturers during the past 2 weeks:
Amlodipine Besylate and Benazepril Hydrochloride Capsules (Discontinuation)
Amlodipine Besylate Tablets (Discontinuation)
Phosphate Injection Products (Currently in Shortage)
Estropipate Tablets (Discontinuation)
Midodrine HCl Tablets (Discontinuation)
Nabumetone Tablets (Discontinuation)
Penicillamine (Depen) Titratable Tablets (Currently in Shortage)
Sinografin Injection Solution (Diatrizoate Meglumine)(Iodipamide Meglumine) (Discontinuation)
Montelukast Sodium Tablets (Discontinuation)
PRODUCT APPROVALS & CLEARANCES
FDA permits marketing of device to treat diabetic foot ulcers
FDA permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
PRODUCT SAFETY
Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial
Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
UPCOMING MEETINGS
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
JANUARY
Antimicrobial Drugs Advisory Committee (Jan 11, 2018)
The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
Public Meeting on FDA Approach to Evaluating Nicotine Replacement Therapies (Jan 26, 2018)
The Agency is committed to increasing access to and use of nicotine replacement therapy that which could help more smokers quit. FDA believes it is critical to obtain input from researchers, health care professionals, manufacturers, interested industry and professional organizations, the public health community, and the public regarding how evolving science could influence FDA’s approach to evaluating the safety and effectiveness of NRT products.
Tobacco Products Scientific Advisory Committee Meeting (Jan 24, 2018)
The Committee will discuss modified risk tobacco product applications (MRTPAs), submitted by Philip Morris Products S.A. for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks.
Opioid Policy Steering Committee - Prescribing Information - Exploring a Strategy for Implementation (Jan 30, 2018)
The purpose of the public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
FEBRUARY
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Feb 14, 2018)
The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved.
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program
Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website.
MedWatchLearn - Practice Reporting to FDA!
This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov.
FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices.
Medical Product Safety Network (Medsun)
Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff.
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