Colleen Hall, Digital Managing Editor

	Scott Gottlieb, MD, is President Donald Trump’s pick to head the Food and Drug Administration (FDA), according to several published media reports and a statement from the Senate health committee chairman.

	Gottlieb has held several positions at the FDA, serving as the agency’s Deputy Commissioner under President George W. Bush, as well as serving as a senior advisor to the FDA commissioner, and as the agency’s Director of Medical Policy Development. 

	Prior to joining the FDA, Dr Gottlieb was board director or advisor to several drug companies, including Tolero, GlaxoSmithKline, and Glytec Pharmeceuticals. He was also a partner at New Enterprise Associates and director at TR Winston & Company, both of which have strong ties to health care.

	Based on his previous experience, Dr Gottlieb's ties to the pharmaceutical industry promise to be a hot topic of discussion at hearings on his appointment. 

	A statement from Senate health committee chairman Lamar Alexander (R-Tenn.) noted that "Dr. Gottlieb has impressive qualifications helping American patients as both a physician and in his previous roles at the FDA." Alexander added in the statement that he planned to schedule a hearing to "discuss his plans to implement 21st Century Cures and work with Congress to bring safe and effective drugs and medical devices to patients more quickly and to protect the nation’s food supply.”

	The views of Dr Gottlieb, who has written in various newspapers and other media about the need to expedite drug approvals, fall in line with President Trump’s criticism of the current FDA regulatory process, which he recently described in a statement to Congress as "

," and in need of an overhaul to limit restraints. 

Articles

Expedited drug approvals may become a reality if Scott Gottlieb confirmed as head of FDA. 

Scott Gottlieb May be Selected to Head FDA

Scott Gottlieb, MD, is President Donald Trump’s pick to head the Food and Drug Administration (FDA), according to several published media reports and a statement from the Senate health committee chairman.

Gottlieb has held several positions at the FDA, serving as the agency’s Deputy Commissioner under President George W. Bush, as well as serving as a senior advisor to the FDA commissioner, and as the agency’s Director of Medical Policy Development. 

Prior to joining the FDA, Dr Gottlieb was board director or advisor to several drug companies, including Tolero, GlaxoSmithKline, and Glytec Pharmeceuticals. He was also a partner at New Enterprise Associates and director at TR Winston & Company, both of which have strong ties to health care.

Based on his previous experience, Dr Gottlieb's ties to the pharmaceutical industry promise to be a hot topic of discussion at hearings on his appointment. 

A statement from Senate health committee chairman Lamar Alexander (R-Tenn.) noted that "Dr. Gottlieb has impressive qualifications helping American patients as both a physician and in his previous roles at the FDA." Alexander added in the statement that he planned to schedule a hearing to "discuss his plans to implement 21st Century Cures and work with Congress to bring safe and effective drugs and medical devices to patients more quickly and to protect the nation’s food supply.”

The views of Dr Gottlieb, who has written in various newspapers and other media about the need to expedite drug approvals, fall in line with President Trump’s criticism of the current FDA regulatory process, which he recently described in a statement to Congress as "

Dr Gottlieb supports expedited drug approvals to improve patient access to medications. 

President Trump May Pick Scott Gottlieb to Head FDA

Officials with the FDA have approved an expanded indication for insulin degludec injection 100 U/mL, 200 U/mL, (Tresiba, Novo Nordisk), a once-daily, long-acting basal insulin, to be used in children as young as age 1 with type 1 and type 2 diabetes, according to a press release from Novo.

Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN Young 1 trial, a multinational, 26-week, phase 3b, randomized, controlled, clinical trial in which children were administered either Tresiba once-daily or Levemir (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart. 

The results showed that Tresiba in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia, and hyperglycemia.

Insulin degludec injection 100 U/mL, 200 U/mL is available in Novo Nordisk's latest insulin delivery device — FlexTouch – as a 100 units/mL or 200 units/mL pen. Tresiba

 U-100 FlexTouch can deliver up to 80 units of insulin in a single injection. Tresiba U-200 FlexTouch can dose up to 160 units in a single injection. 

"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," Todd Hobbs, MD, US chief medical officer, Novo Nordisk, said in the press release. 

1. Novo Nordisk receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes [news release]. Plainsboro, NJ. Novo Nordisk. December 19, 2016. https://goo.gl/Vemm4V.

2. Thalange N, Deeb L, Lotova V, et al. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. 

Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, clinical trial.

FDA Expands Treatment for Pediatric Patients with Diabetes

LAS VEGAS — It is important for pharmacists to stay on top of the latest drug safety communications from the FDA, which has provided numerous ways to accomplish that task, according to a presentation at the ASHP Midyear 2016 Clinical Meeting and Exhibition.

Kimberly W. Chiu, PharmD—Consumer Safety Officer in the Division of Drug information at the FDA&mdash;discussed drug safety topics at the meeting. She stressed that it is important for pharmacists to check the administration’s website frequently at 

 for updates such as medication labeling changes and safety warnings to better communicate information with patients. She said the administration also has social media outlets such as their Twitter and Facebook accounts to keep pharmacists up-to-date.

Chiu noted several examples in recent years in which changes, such as ones pertaining to opioid and fluoroquinolone policies, affected the way clinicians prescribe certain medications.

She said the FDA’s Opioid Action Plan aims to “reverse the epidemic while still providing patients in pain access to effective relief.”  The plan has led to several changes in how opioids should be prescribed in recent years, and those changes have all been detailed on the agency’s website, Chiu explained.

Drug safety communications about fluoroquinolones have been ongoing, Chiu noted, adding that, in recent years, the administration has issued several communications relating to safety issues, including the potential for tendonitis, tendon ruptures, and peripheral neuropathy with the use of fluoroquinolones.

She encouraged pharmacists to “use systemic fluoroquinolones for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections only as a last option,” and also to “know the moment it happens,” referring to changes in drug labeling, by frequently visiting 

 and the administration’s Twitter account, @fda_drug_info.

1. Chiu K. Drug safety topics, FDA update 2016: public health and regulatory issues impacting todays practice. Presented at: ASHP Midyear 2016 Clinical Meeting and Exhibition. Dec. 3-8, 2016. Las Vegas.

It is important for pharmacists to stay on top of the latest drug safety communications from the FDA, which has provided numerous ways to accomplish that task, according to a presentation at the ASHP Midyear 2016 Clinical Meeting and Exhibition.

FDA: Stay Alert About Drug Updates to Better Inform Patients

Trained clinical pharmacists can effectively manage patients with hepatitis C virus (HCV), according to research presented at the ASHP Midyear 2016 Clinical Meeting and Exhibition.

Brett Borba, PharmD, and colleagues from the US Department of Veterans Affairs reported data from a program in California where clinical pharmacists were “granted clinical privileges and prescriptive authority to manage HCV infection with direct acting antiviral therapies.” The pharmacists managed 216 patients between the start of 2014 and the end of fiscal year 2015.

The researchers noted that cure rates were high, about 87.6%, in the 198 patients who returned at 12 weeks of follow up; 18 patients didn’t complete therapy, however, due to treatment failure (most of the patients who failed therapy had HCV genotypes 2 or 3) or treatment intolerance.

Dr. Borba and his colleagues concluded that their data support the use of a clinical pharmacist to manage HCV therapy, which they said “can free up specialty provider time for additional patient care needs.” They added that this approach may be particularly beneficial in veteran populations, since “survey data suggest that HCV has a higher prevalence in veterans using the VA system than the US population as a whole.”

The researchers also cited data that showed nearly a 22% HCV antibody prevalence in one VA population.

Borba B, Siilata J, Samara W, et al. Poster 1-023. Initiation and management of hepatitis C therapy in a pharmacist run clinic. B Presented at: ASHP Midyear 2016 Clinical Meeting and Exhibition. Dec. 4-8, 2016. Las Vegas.

Sloan KL, Straits-Troster KA, Dominitz JA, Kivlahan DR. Hepatitis C tested prevalence and comorbidities among veterans in the US Northwest. 

Trained clinical pharmacists can effectively manage patients with hepatitis C virus, according to research presented at the ASHP Midyear 2016 Clinical Meeting and Exhibition.
 

Clinical Pharmacists Have Role to Play in Managing Patients With HCV

Several people were honored this week at Baxter Healthcare Corporation’s Leadership Excellence Awards in Pharmacy, or LEAP, ceremony.

An award program started in 2010, the awards recognize best demonstrated practices and case studies designed to improve pharmacy processes, efficiencies and outcomes in: drug preparation and delivery, pharmacy operations, and pharmacy management.

: Next Step in Antibiotic Stewardship: Pharmacist Provided Penicillin Allergy Testing, Maury Regional Medical Center, Columbia, TN. Submitted by:

: Engaging the C-Suite in the Utility of DoseEdge (Pharmacy Workflow Manager), Allegheny General Hospital, Pittsburgh, Pennsylvania. Submitted by:

: Utilizing Lean Methodology and Radiofrequency Identification Technology (RFID) to Improve the Hospital Crash Cart Process, Mercy St. Rita's Medical Center, Lima, Ohio. Submitted by:

 Scheduled Medication Administration Times- “Giving Nurses the Gift of Time, Peninsula Regional Medical Center, Salisbury, Maryland. Submitted by: