FDA addresses GDUFA at recent GPhA meeting; association launches online GDUFA resource
ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs’ acting director Kathleen Uhl on Thursday highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.
The Generic Pharmaceutical Association also launched a new digital library and online educational resource, GDUFAnow.org, a new tool to enhance awareness and ease industry familiarity with GDUFA responsibilities, on Thursday.
“GDUFA is a historic achievement and shared commitment for the FDA and our industry,” stated Ralph Neas, president and CEO, GPhA. “GDUFA is supported 100% with industry generated funds. Indeed, efforts to ensure safety, increase access to generics and enhance transparency are top priorities for the Association. This new online resource highlights regulatory developments, compliance requirements and more — putting all of the critical information in one easy to find location.”
As FDA Commissioner Hamburg relayed from India in a recent FDA Voice post: “FDA is working quickly to fulfill one of our commitments under [GDUFA] — reducing the backlog of generic drug applications. As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45% of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs. GDUFA also requires that we step up our number of foreign inspections and gives us the funding to do so.”
Avella Specialty Pharmacy: Study finds that pharmacist intervention saves almost $30,000 monthly
PHOENIX — As part of a study conducted with the University of Arizona, Avella Specialty Pharmacy proved the value of pharmacist intervention in improving patient outcomes, at least in renal transplant patients, to the tune of $27,852 per month, Avella announced Thursday. The study found that participants in the intervention group had a statistically significant improvement in adherence rates over patients in the control group who did not have a contract or receive support to ensure adherence to their monthly medication therapy. The study also found that patients who complied with their medication regimens had fewer inpatient and outpatient visits and were 78% more likely not to be hospitalized, hence the monthly savings.
Avella Specialty Pharmacy partnered with researchers at the University of Arizona on a National Institute of Health study to assess the effects of a year-long behavioral contract intervention among patients on a specific medication regimen.
“Avella Specialty Pharmacy realizes the importance of optimal patient outcomes,” stated Eric Sredzinski, EVP clinical affairs and quality assurance for Avella Specialty Pharmacy. “We believe that to deliver clinical excellence, we need to provide more than just prescription medications. Participation in this study allowed us to see the value of behavioral contracts as a tool to improve outcomes and make a difference in patients’ lives.”
The study sample included renal transplant recipients who were at least one year post-transplant and served by Avella Specialty Pharmacy. Participants included in the intervention group each signed a behavioral contract that included a desired outcome they wanted to achieve by the end of the study. The remaining participants were placed in a control group and were not given a behavioral contract. Over the year-long study, clinical pharmacists and participants in the intervention group regularly collaborated to identify adherence barriers including disruptions in medication therapy routine such as occasional work-related travel. The patients and pharmacists worked together to develop patient-centered solutions to barriers. Participants in the control group were monitored to determine their level of adherence.
A video explaining the study can be found at Avella.com/adherence.
Former Mississippi governor Haley Barbour to keynote PAC breakfast at NACDS Annual Meeting
ARLINGTON, Va. — The National Association of Chain Drug Stores has announced that Haley Barbour, former governor of Mississippi and former chairman of the Republican Governor’s Association, will be the keynote for the NACDS Chain Members and Political Action Committee Breakfast at the 2014 NACDS Annual Meeting.
The 2014 NACDS Annual Meeting will be held April 26 to 29 in Scottsdale, Ariz. Barbour will address breakfast attendees on April 28.
“We are pleased that NACDS members will have an opportunity to hear Governor Barbour’s experiences as a Mississippi public servant and leader of his political party. His leadership and tenacity – both in the national political arena and working for the people of Mississippi – emphasize his commitment to advocacy and action on behalf of others,” stated NACDS president and CEO Steve Anderson.
Barbour also served two terms as chairman of the Republican National Committee. In 1994, under Barbour’s chairmanship, Republicans won the greatest midterm majority sweep of the 20th century, winning GOP control of both houses of Congress for the first time in 40 years.
Barbour was first elected in 2003, marking the largest voter turnout in Mississippi gubernatorial history, and he was re-elected in 2007. During his two terms as chief executive, he concentrated on civil justice reform, controlling spending, management of the state health care program and refocused Mississippi as an energy-producing state to help meet America’s energy needs in the future.
As former governor of Mississippi, Barbour has been praised for his handling of both the Gulf Oil Spill and Hurricane Katrina. He worked with local, state, and national leadership to tap into many resources of assistance for victims of Hurricane Katrina. He created the Governor’s Commission on Recovery, Rebuilding, and Renewal to develop opportunities for South Mississippi to rebuild.
Barbour assumed the role of chairman of the Republican Governors Association in 2009 until after the November 2010 elections. During his chairmanship, Republicans increased from 22 to 29.
For his leadership after Hurricane Katrina, Barbour was awarded the Thomas Jefferson Freedom Award, and the Gulf Guardian Award by the U.S. Environmental Protection Agency for his work to rebuild and protect sensitive Coast ecosystems. Barbour also received the 2008 Adam Smith Medal from BIPAC for his pursuit of the principles of free enterprise as Mississippi’s 63rd governor.