PDUFA: Funny Name; Vital Program

October 24, 2011 in Policy/Advocacy, Uncategorized

by Ronald Johnson, Vice President of Policy and Advocacy, AIDS United

Today, October 24, 2011, the Food and Drug Administration (FDA) held a public meeting to discuss proposed recommendations for reauthorizing PDUFA, the Prescription Drug User Fee Act.  For many people, PDUFA may be just another funny, “government-speak” acronym but it is in fact a vital initiative in disease treatment that has impacted thousands of lives and was achieved with the strong support of AIDS advocates.

In 1992, Congress passed PDUFA to streamline the drug approval review process and make it more timely and predictable. Under PDUFA, user fees are collected from pharmaceutical companies that apply for approval of new drugs and companies that apply for biologics license. The fees are used strictly to enhance and support FDA’s drug and biologics review process.  The fees supplement and do not supplant FDA funding from the annual appropriation process.  The law also mandates FDA to set a standard goal of reviewing new drug applications within 10 months and a priority review goal of six months.

For Americans living with serious or chronic diseases and disabilities, new treatments can’t come fast enough. As a person living with HIV/AIDS, I’ve certainly benefited from FDA approval of new drugs that have improved HIV treatment regimens dramatically.  Many thousands of people like me are alive and healthy because of treatment advances.  Prior to PDUFA, the FDA’s review process for new drugs was slow compared with other countries.  AIDS activism in the late 1980s, including large protest demonstrations organized by ACT-UP, brought increased attention to the lengthy review process and its impact on delaying approval of medications that could be used to fight HIV and the opportunistic infections that then were responsible for the preponderance of AIDS-related deaths.  PDUFA enactment allowed the FDA to have the funds needed to hire additional reviewers and support staff and to upgrade its information technology systems.  FDA committed to complete reviews in a predictable timeframe.

PDUFA has been reauthorized three times since its original adoption.  The current 5-year period, PDUFA IV, ends September 2012.  The user fees account for about two-thirds of the FDA’s budget for new drugs and biologics review.

PDUFA has improved the new drug approval process significantly, enabling FDA to speed up the review process without compromising high standards for safety, efficacy, and quality of new drugs prior to approval.  This has allowed faster patient access to new drugs and biologics and has enabled the U.S. to be a world leader in introducing new drugs.  In testimony to the House Energy and Commerce Committee’s Subcommittee on Health this past July, Dr. Janet Woodcock, who heads the FDA’s drug review unit, noted that the public has gained faster access to over 1,500 new drugs and biologics since 1992.  The U.S. now leads the world in the initial introduction of new drugs.

Following negotiations with industry and consultations with public stakeholders, FDA issued recommendations for reauthorizing PDUFA for another 5-year period, through FY 2017.  FDA’s recommendations for PDUFA V address concerns and priorities raised by industry and stakeholders, including consumers and include three proposals that were specifically advocated for by patients.  The recommendations include a proposed new review model intended to improve communication between the FDA review team and the applying drug sponsor and to improve the effectiveness of the first cycle review process so as to decrease the number of review cycles needed to review a drug and thus to speed up patients’ access to safe, effective and high quality new drugs and biologics.  This would reverse a creeping increase in review times over the past few years that has compromised FDA’s performance goals.

An important feature of the recommendations is an increase in the user fee revenue to $693 million in FY 2013.  In a time when federal appropriations are being cut and facing even more devastating cuts, the funding stability that PDUFA provides is critical.

Scientific advances over the past 18 months in HIV vaccine research, microbicide research, pre-exposure prophylaxis for HIV infection, and HIV treatment as prevention underscore the need not only for maintaining a robust research and development process but also for maintain a process for timely, efficient review of new drugs.  Once the recommendations for reauthorization are submitted to Congress sometime early in 2012, both houses should move forward quickly towards a clean reauthorization before the September expiration.  AIDS United strongly supports reauthorizing PDUFA and will stay engaged to insure the continuation of this vital program with the funny name.

AIDS United Partner Attends National HIV/AIDS Strategy Implementation Dialogue

October 21, 2011 in National HIV/AIDS Strategy

by Laurie Conratt, Director of the Northwest AIDS Education and Training Center,  Secretary for the National Alliance for HIV Education and Workforce Development

How are we going to meet the escalating demand for HIV care in our country when our waning HIV care workforce already is stretched to the limit?  That was the topic at the second National HIV/AIDS Strategy (NHAS) Implementation Dialogue meeting, hosted by the White House Office of National AIDS Policy (ONAP) on October 4, 2011 in Seattle, WA.  Entitled “Building Capacity within the HIV Workforce so that it Delivers What We Need Today and Tomorrow,” the event brought together representatives from the community, state and federal government; HIV researchers; and healthcare professionals (HCP) to  collect community-driven input about the crisis facing the HIV care workforce.  Jeffrey S. Crowley, Director of the ONAP, presented an overview of the Strategy and the implementation processes currently underway, including community input via these dialogue meetings, and encouraged the audience to share their ideas and suggestions for increasing HIV workforce capacity.

Dr. David Spach, Principal Investigator and Clinical Director of the Northwest AIDS Education and Training Center and Professor of Medicine at the University of Washington’s Division of Infectious Diseases, presented a snapshot of the current HIV workforce and potential solutions for expanding the number and diversity of HCP involved in HIV care.  A defining factor of the current HIV workforce is the increase in the number of individuals living with HIV in the United States due to the success of antiretroviral therapies and expanded efforts to implement the CDC’s 2006 Revised Recommendations for HIV Testing.  This increase in demand for HIV services has outpaced the number of HCP willing and able to manage patients with HIV infection.  Solutions for building the capacity of the HIV workforce rely heavily on recruitment during training in medical schools, residency programs and HIV fellowships as well as continuing educational support for HCP currently in practice.  Innovative financial incentives, co-management and mentoring programs, and the use of technology to support HCP in rural and isolated areas were also identified as solutions to HIV workforce shortages.

Panelists from academic, federal, state, and community settings discussed the role of the Ryan White HIV/AIDS Program in supporting the HIV workforce, ways to attract “new talent” into HIV care and engage “non-HIV” providers (i.e., those not experienced in providing HIV care and treatment) into care, as well as ways to generate local solutions to HIV workforce challenges through private sector and philanthropic resources.

An energetic discussion among panelists and audience members included an acknowledgement of the Ryan White AIDS Education and Training Centers’ role in building the capacity of HCP across the country, as well as an affirmation of the need to target educational efforts to the pre-service “pipeline” as a means of capturing the interest of future HCP before they begin practice.  Involving the entire health care team and evolving roles to support optimal patient care outcomes and clinic efficiencies was also addressed, as was linking prevention and care efforts.  The Ryan White clinic setting also was identified as an exemplary Medical Home model that could be more broadly applied in new clinical care settings that develop within the constructs of health care reform.

These ideas and suggestions will inform the on-going implementation of the NHAS.  If you would like to provide input into the continuing implementation of the NHAS, please contact AIDSPolicy@who.eop.gov.

For more information about this and other National HIV/AIDS Strategy Implementation Dialogue meetings across the United States, please visit the White House Office of National AIDS Policy.

This Is What We Can Do – Team Detroit’s Fast Start

October 17, 2011 in AmeriCorps, HIV/AIDS Awareness Days

The service year in Detroit started with the gathering of all eight AIDS United AmeriCorps teams in Ann Arbor, Michigan. This awesome meeting set the tone for what looks to be an exciting year. It was at this pre-service meeting that teams began to truly form and create bonds. The team building that took place also allowed individuals to grow, with each person having to push him or herself at one point or another (whether it was during the ice-breakers, the condom demonstrations or at Crossroads Adventure Center). Team Detroit left the meeting excited and jumped right into our service year.

9/11 Day of Service

Our first Team 5th Day came in response to President Obama’s call for a day of service in remembrance of 9/11. We took part in one of the largest 9/11 service day events in the nation. The event,  coordinated by Focus: Hope; ACCESS; City Year Detroit (AmeriCorps); and other local non-profits, brought Michigan residents together, creating an impressive scene of unity and diversity. With the goal of honoring those lost while moving forward under a united front, we took part in projects such as neighborhood beautification, school preparation and letter writing to American soldiers.

Detroit AIDS Walk – Steppin’ Out

Listening to the advice of AmeriCorps alumi, Team Detroit looked to start early in raising funds for our Long Term Project (LTP).  Detroit AIDS Walk gave us the opportunity to do so, while at the same time helping out the AIDS Walk as well. We took to the streets in an effort to spread the word about the walk, posting ads at various local businesses and talking to residents we passed along the way. The walk also gave us a great platform to raise funds for our team. We created a walk team and raised just under $1000. In addition to this success, on the day of the walk we had the honor of taking part in the unveiling of a panel from the Names Project  AIDS Quilt. This was the second time we were able to pay our respects to those lost to the epidemic and we are thankful for that.

Latino Family Services

With National Latino HIV/AIDS Awareness Day approaching, the team decided to volunteer at Latino Family Services (LFS) (which also serves as a host agency) in the city of Detroit. We assisted LFS in preparing for an upcoming HIV testing event; setting up the testing area, preparing facilities and arranging outreach materials. The event not only offers testing, but also brings awareness to the Latino community, which makes up 4% of the HIV/AIDS cases, but only 3% of the Michigan population.

The year has just started and the experiences we have already encountered will have lasting impact. We look forward to continuing the year and getting things done in Detroit.

Check us out on Facebook for additional pictures, news and updates. https://www.facebook.com/TeamDetroit

Indy AIDS Walk 2011

October 11, 2011 in AmeriCorps

“Why should society feel responsible only for the education of children, and not for the education of all adults of every age?” ~Erich Fromm

Education is the backboard of awareness.  Awareness is the levy that lifts prejudices away from the minds of individuals.  That awareness and education was ever present at Indianapolis’s AIDS walk 2011.  The sun was out, the tents were raised and the masses marched on in order to show their support and dedication to battling this entity we call AIDS.  That Saturday morning brought people from many different places in life; but all to come together and show their support for fighting HIV/AIDS.  It was an amazing feeling to be able to look out and see quilts recognizing those who had lost the battle to HIV, but also to see men and women fighting the battle at that very moment–while showing an inter-strength that blazed across the park.  The one idea that constantly came to mind during the walk was that HIV doesn’t discriminate.  It doesn’t target just one population or age group;  it is an equal opportunity virus.

The beautiful thing that comes out of all the destruction that HIV can lead to is the simple fact that you are never alone.  You don’t have to go to a certain part of the world to find others that are struggling with the same thing; you can walk down your street.  This walk wasn’t just about the money that was being raised, or the gathering of many businesses–it was the gathering of a community.  That community is the support system of many individuals in the great city of Indianapolis.  For Team Indy, we are blessed to see little working parts of this incredible system during our four days of the week; but what a true honor it was to be in place where all of those little parts came together to form that community.

–Brittany Sichting

Team Indianapolis participates in correctional facility’s inaugural AIDS Walk

in AmeriCorps

Team Indianapolis participated in the first ever New Castle Correctional Facility AIDS Walk on August 27th. The event was organized through Step Up, Inc.’s Tommy Chittenden and the Correctional Facility Chaplain, Joy Pinegar. Each Team Member took a moment to reflect on the time we spent talking with these men, and below are those comments:

“I attended the Prison AIDS Walk at the New Castle Correction Facility with my AmeriCorps Team Indy. We were there to provide support and hand out watermelon and water. When the walk began, the inmates who had volunteered to walk were grateful and appreciative of our presence. As a team, we cheered for them as they completed lap by lap. I remember two inmates whose faces lit up every time we clapped and cheered for them. It brought a sense of humility to know that simple gestures of kindness go a long way and we should never take for granted any support that we have in our individual lives. The day ended well where we were in turn fed hamburgers, hot dogs, chips and punch. I am glad I had the chance to be part of their lives.”

“Handing out watermelon seems like a simple task-one that would take little time and be another piece to a good meal. What I experienced by handing out watermelon was more of a great thankfulness and joy. The men we served were thankful to have fresh fruit before them, and welcomed the fact that we did not have utensils or plates. How beautiful it is to see the simplicity in the watermelon, and to apply that idea to life. I learned that I could be so appreciative of what I had, and that I can see these little things in everyday life.”

“Assisting with the New Castle Correctional Facility’s AIDS Walk was an experience I will not soon forget. Upon entering the facility and beginning work on the walk I quickly realized how different this experience was going to be than I had expected. In order to walk each of the men had given money from their commissary.  Because these men work for all that money or are given it by their family, I found this gesture to be quite the example of charity. After the walk had finished and the men were enjoying some watermelon and water we were able to get to know some of them. One man had been an AmeriCorps member and was very informed about the NGO community of Indianapolis, something I would have never expected. He reminded us to take every memory we can from this experience and to enjoy what this year provides. Other men were speaking about the AIDS quilt that the men in the facility were making, I believe they said there were above 75 squares already made, a number I never would have thought. In the end, I am very happy to have been able to assist in the first of hopefully a new tradition of correctional facility AIDS walks. Meeting and speaking with so many men was an experience I value; it allowed myself and, I believe, my fellow teammates to see a side of these men that is not normally recognized but is important to grow for the better of everyone.”

“I have never had experience working with a prison population, and I have to admit that I was slightly apprehensive about how the men would react to us. However, I was floored at how friendly, polite, and thankful the men acted toward each of us. It surprised me with how quickly many of the men opened up to us. One man in particular sticks out in my mind; he asked several of us for our reasons for joining the AIDS United AmeriCorps program. While we all have our own reasons, none of us mentioned knowing anyone infected or affected by HIV or AIDS prior to joining the organization. He then shared with us that his reason for walking that day was because in the last year, he had an uncle and a cousin both died from AIDS-related complications. This story impacted me so much because it made me realize just how much this preventable disease can ravage an individual life – even if a person is not infected. This man’s story opened my eyes to some of the non-clinical effects of the disease, and I am so grateful that he was kind enough to share his story.”

This experience was an opportunity for team members to reach out and engage a population that is not usually afforded the opportunity to contribute to non-profits and charities. Working with Tommy and Joy, we hope to engage more Indiana prisons and future AmeriCorps teams in many more of these events.

ONAP Starts Strategy Implementation Tour in the South

October 6, 2011 in National HIV/AIDS Strategy

by Kathie Hiers, CEO, AIDS Alabama

AIDS United Policy Partner and  Southern REACH Grantee

On September 27th, 2011, the White House Office of National AIDS policy (ONAP) kicked off its tour of five cities in Birmingham, Alabama.  The tour’s purpose is to both disseminate and gather data around the implementation of the National HIV/AIDS Strategy, which was released in July 2010.  The ONAP staff, including Director Jeffrey Crowley, will explore different topics in each city on the tour.

Nearly 300 people attended the Birmingham meeting, where the topic was on “Incorporating Prevention and Care Research into Programs.”

Dr. Carol Garrison, President of the University of Alabama at Birmingham (UAB), offered welcoming remarks.  The Assistant Secretary of Health and Human Services, Howard Koh, MD, MPH, then presented an update of progress toward the goals of the NHAS.

Promising biomedical findings

Dr. Michael Mugavero of UAB briefly recapped the groundbreaking research that has occurred in various biomedical interventions.  Of particular note was the HPTN 052 study, the hottest topic in the HIV arena, which is shifting the way providers think about HIV treatment.  The HPTN 052 study strongly suggests that antiretroviral therapy (ART) may make HIV-positive persons less contagious.  In serodiscordant couples, transmission was reduced by 96% for the arm of the study in which the HIV-positive person in the couple started ART early as appropriate.  Dr. Mugavero also highlighted the Gardner Cascade, published in 2009, which indicates that only 19% of the country’s HIV-positive population has suppressed viral loads. He was clear this low number indicates that other social determinants of health must be addressed through continued provision of supportive services and housing, as these services are critical to successful medical outcomes.

Get involved!

Participation in the tour is a real opportunity to provide input or ask questions about the topic of the gathering.  Plan your question or comment in advance, make it short and sweet, and stick to the topic at hand!

View the schedule of all the dialogues and register for one of the events.