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PDUFA: Funny Name; Vital Program

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.

Reducing Harm and Building Communities: Addressing Drug Use in the South

by Robert BB Childs, MPH, Executive Director, North Carolina Harm Reduction Coalition (NCHRC)
Melicia Laroco-Molter, member, NCHRC


On September 8th and 9th, 2011, around 200 people from all corners of the South converged in Durham, NC for the first conference to discuss issues surrounding drug use, sex work and harm reduction in their communities. The attendees represented many groups including representatives of the military, law enforcement, Republicans and Democrats the North Carolina House of Representatives, outreach workers, health professionals, academics, sex workers, people of transgender experience and drug users. The conference kicked off with a blessing from Rev Dr. Tamsey Philips Hill, a chaplain at Duke University Hospital and a staff member of Partners in Care of the Carolinas. Deon Haywood of New Orleans’ Women with a Vision and Robert Childs of the North Carolina Harm Reduction Coalition led an overview of the conference.

Rep. Verla Insko (D-56) touched upon her experience as a health program administrator at the University of North Carolina as she spoke about the need for more harm reduction practices in North Carolina and throughout the South. Rep. Glen Bradley (R-49), an admirer of Fredrick Douglass’ vision of the Constitution, then spoke about the need for political advocacy for syringe decriminalization and the lack of effectiveness of the war on drugs. Daniel Raymond, the Policy Director of the Harm Reduction Coalition, then gave an eloquent overview of harm reduction. Daniel spoke about those that touted the idea “if they [drug users] don’t want to get HIV, it’s just that simple – stop using drugs.” Noting their ignorance of drug use, he pointed out the true meaning: “If you are using drugs, you’re life isn’t worth saving.” Harm reduction, in effect, shows people, “[r]ight here, right now, your life is worth saving.”

Several testimonials followed. Perry Parks, a Vietnam War veteran, recipient of the Distinguished Flying Cross, and current President of the North Carolina Cannabis Patients’ Network, recounted his experiences with chronic pain and pain management through the use of cannabis, and his subsequent loss of his hard-won military reputation. Bob Scott, a former captain of the Macon County Sherriff’s Office in Franklin, NC, described his experiences with the war on drugs in rural North Carolina. Patrick Packer of the Southern AIDS Coalition, testified to the lack of attention and services given to Southerners living with HIV/AIDS. Leigh Maddox, a retired captain of the Maryland State Police and current Special Assistant State’s Attorney for the State of Maryland, gave a deeply personal testimonial on how her own personal and professional losses to the war on drugs fueled her advocacy to view substance abuse as a health problem and her anti-prohibition stance. In addition, Human Rights Watch released an in-depth report on the status of human rights and HIV in the Southern United States, which will be released on their website soon.

Video of the opening session of the conference can be found here, compliments of Richard Cassidy.

This provided an inspiring platform for the rest of conference. The panels ranged from building alliances with law enforcement and faith-based communities to fundraising and program implementation to the rising use of crack cocaine and prescription drugs in the South. Prof. Sam MacMaster of the University of Tennessee’s College of Social Work highlighted the high prevalence of crack cocaine use in the South and how it intersects with HIV/AIDS. The conference provided, not just a learning experience, but also as a place to meet others in the South that are working on the same issues. Many participants are from organizations that are not based in the hubs of Atlanta, New Orleans, Durham or DC and often do not meet others in the field. As one participant pointed out, “Finally, I do not feel alone.”

Beyond the Debt Ceiling: A Way Forward in HIV

Jimmy Schneidewind

by Jimmy Schneidewind, Public Policy Associate

Sitting around and waiting for the outcome of the debt ceiling circus can be a bit maddening in more ways than one, particularly if you don’t derive pleasure from witnessing dysfunction  or if you work in a field like public health and HIV programs that are likely to suffer at the hands of deep spending cuts. As Congress continues to back their way into a debt ceiling compromise, one thing has become quite clear: deep spending cuts will be made. Although it is easy to get caught up in every twist, turn, and non-action by our elected representatives, this type of behavior will likely increase your blood pressure and can also be disempowering if you overlook the progress that has been made in the fight against HIV when funding streams unpredictable. Certainly money is what makes it possible to scale up effective programs and interventions as well as protect essential safety net programs like the Ryan White Care Act that serves as the payer of last resort for low-income people living with HIV. However, it is clear that at least for the foreseeable future as we continue to struggle through a stark economic climate and an even starker political climate, we need to be ready to move forward and make the most with whatever resources we have available to us.

Here is a list of 5 ways to maximize the impact of your organization or your own personal advocacy efforts without having to rely on Congress:

1. Align your goals and work with the goals of the National HIV/AIDS Strategy (NHAS)

For the first time in our country’s history, we have a comprehensive strategy to fight HIV that includes metrics, a timeline, and specific jobs for specific governmental agencies. The Strategy sets some ambitious goals, including lowering the incidence of HIV by 25%, and increasing the number of diagnosed Blacks, Latinos, and gay and bisexual men by 20%, all by 2015. HIV organizations and advocates around the country have an important opportunity, nay, an obligation, to be faithful to the principles of the Strategy. In four short years, we could all see a major difference in the epidemic if we work toward a common vision.

2. Concentrate your efforts on the areas and populations that are hardest hit by HIV

Although this is a component of NHAS, it warrants being highlighted. Based on evidence and data, the Strategy identified certain demographics that are disproportionately at risk for HIV. Among the most prominently mentioned were Blacks, Latinos, and gay and bisexual men (MSM). MSM account for 53% of new HIV infections in the United States, though they only make up an estimated 4% of the general population. Hispanics and Blacks combined make up 27% of the general population but together carry 63% of the burden of new infections. It is simply not possible to make a noticeable dent in the epidemic if we do not focus our efforts on these and other vulnerable populations.

3. Share, Collaborate, and Coordinate with other like-minded organizations

An implicit and explicit purpose of NHAS is to ensure that all HIV organizations and advocates, as well as other sectors like housing and education are working together to achieve the goals of NHAS. The days of combating HIV as a makeshift hodge-podge of disconnected HIV organizations are over. In order to win this battle, we must become leaner, smarter, more effective, and wider-ranging with our efforts as an HIV community, and we can only do that if we begin to look to each other for support in areas where we do not specialize. Unlike our lawmakers in Washington, we must realize that “collaboration” and “coordination” are not dirty words. The Ryan White Care Act has been so effective at providing care to people living with HIV because it acknowledges that people living with HIV require a breadth of services including treatment, housing, dental care, nutritional services, transportation, education, and more. It may be a tall task for a single organization to encompass all of this, but if we act as a community, it is quite possible for us as a community of multi-sector organizations and agencies to provide the services and advocacy that people living with HIV deserve.

4. Strengthen, inform, and enlarge your base

There are currently 1.1 million people living with HIV in the United States. Add this to the countless others who are not HIV positive but are deeply invested in the fight against HIV, and you have a caucus that is not small by any definition. Think of what a difference it would make if all these people were educated, inspired, and armed to go out and make their voice and presence heard. Just imagine what we could do! Regardless of the way in which you or your organization engages in HIV issues, an area of concentration has to be growing your base of constituents and then capacitating them to go out, find others, and advance our national HIV agenda.

5. Support successes and effective interventions

Successes and advances in the field of HIV are made all the time and we need to make sure that the whole world knows about it. Over the past year we have seen significant progress in biomedical research like microbicides, PrEP (pre-exposure prophylaxis), and treatment as prevention, all of which have made people think that a functional cure or a safe, effective vaccine is actually possible. Policy advancements have also made a difference, including the lifting of the federal ban on syringe exchange programs, which helped lead to a noteworthy reduction in incidence in Washington DC, the reauthorization of the Ryan White Care Act, the passage of the Affordable Care Act, and the unveiling of NHAS. As organizations and advocates, it is our job to act as a megaphone for HIV communities and report their success stories and if lawmakers are unaware of the benefits of HIV funding or the important impact of their policy decisions, then we have no one to blame except ourselves.

Surely more needs to be done and more funding is always welcome and necessary, but there will be no time to despair if funding streams shrink; we need to move forward with the vehicles available to us, just as we always have and always will.

Finding a Way to Get Through This: My Story of Being Tested for HIV After Exposure

Jimmy Schneidewindby Jimmy Schneidewind, Public Policy Associate

The most difficult three months of my life were the three months I spent wondering if I was HIV positive. I suspect that similarly, they were also three of the most difficult months my family has ever endured. Though I had volunteered in numerous HIV testing clinics and had trained hundreds of HIV educators on the values of getting regularly tested for HIV, there was nothing that could have prepared me or my family for the stress, anxiety, and heartache that we felt when my own status was in doubt.  Nearly three years later, I can still recall with extraordinary vividness the thoughts and emotions that ran through me during those months, and the pain that I felt as I considered what the rest of my life would be like if I were to contract HIV at age 24.

I had been living in Mozambique, a Portuguese-speaking country found on the south-eastern most part of Africa, for 14 months when I was exposed to HIV. I lived in a small rural village called Nicoadala (pronounced: nick-wa-dah-la) where I worked as a consultant to a civil group of Mozambicans who were working in collaboration with an international non-governmental organization to build up the health infrastructure of the town. Overall, I was enjoying my experience, though I would often be consumed in my private time by feelings of isolation as the only American.

Although I was aware that I had been exposed to HIV, the notion that I might have contracted the virus was not one that immediately dawned on me, strangely enough. It started as a small seed of doubt and ultimately morphed into an overwhelming panic, the intensity of which was almost paralyzing. I think I was hoping to wake up one day and realize that it had not really happened or that I would eventually succeed in convincing myself that it wasn’t really as serious as other cases of HIV exposure. After a month, I was completely taken over by fear, and belatedly took the two kilometer walk from my house to the local hospital where I had encouraged hundreds of Mozambicans to get tested for HIV, but had never once been tested myself.

The only available HIV tests in Mozambique are rapid tests. This testing method returns results in about 20 minutes, however, there is usually a latency period of between six weeks to three months for the virus to become detectable in most peoples’ bodies. When the nurse took my blood (note that the vast majority of rapid tests in the United States use a mouth swab) and dripped it onto the rectangular testing area, I turned my head away, unable to watch as my results emerged. The irony was not lost on me that as a white, heterosexual, upper-middle class, college-educated, American male, from an overly-supportive two parent family, I was probably the least likely person on the planet, statistically, to become infected with HIV. And yet, there I was, half a world away from family and friends, waiting and wondering; scared.

Though my initial test results came out negative, I spent the next two months in a state of melancholy while I waited for the three month mark post-exposure when I could finally be sure of my status. I wondered if my family would accept me. I wondered which of my friends would still hug me. I wondered who would want to marry me, and how I would ever become a father. Who would love me if I had HIV? As I contemplated what life would be like if I had HIV, I remember feeling as stripped down to my fundamental core as I imagine a human can feel and thinking that these are the same fears that everyone has when they are uncertain about their health status.

The reasons why I was terrified to get my test results then are the same reasons why I choose to get tested now. The faces of people who I love and for whom I care deeply drift into my mind whenever I am waiting to get tested or awaiting my results: My parents, my brother, my aunts, uncles, cousins,  and my friends. I realize in those moments when I am most scared that my life is valuable primarily because of the love given to me by all those faces I see and my decision to get tested derives purpose from that realization.

When I called my parents to tell them that I knew for certain that I had been exposed to HIV, my mom spoke first, after a slight pause, and said, “Whatever the results are, we will find a way to get through this.” I will never forget that. In varying degrees, I am still afraid every time I go to get tested, but I think the fear is good because it is a reminder of why I now get tested regularly and what is truly important to me. I continue to get tested for HIV because I want to be proactive and responsible about my health; I find meaning in my testing because I recognize the love people have for me, and the love I have for myself.

Although this blog was written in recognition of National HIV Testing Day, June 27, it appears on our website and in our Weekly Update after the day as a reminder that it is important to get tested no matter what day it is. AIDS United encourages everyone to find out their HIV status by getting tested today and by making it a regular part of your health check-up routine. To learn more about National HIV Testing Day, please visit the National Association of People Living With AIDS (NAPWA) website. To find the testing site closest to you, please use this link.

Final Funding Details of FY11 Budget

by Donna Crews, AIDS United Government Affairs Director

The funding details for fiscal year 2011 (FY 11) were released May 16. Although the general appropriations process was completed on April 14, when President Obama, Senate Majority Leader Harry Reid (D-NV), and Speaker of the House John Boehner (R-OH), reached a deal in the final hour to avoid a government shutdown, the work of allocating funds to programs within governmental agencies remained unfinished.

Public health programs as well as programs and agencies that specifically benefit people living with HIV were impacted by the final funding details. The majority of the cuts seen below are the result of the across the board 0.2% cuts that were implemented in all governmental agencies. Here is an update with final numbers.

  • Funding for syringe exchange programs (SEPs) remains available for use at the federal level and at the local level for the District of Columbia
  • The Centers for Disease Control (CDC) is funded at $5.66 billion, a $740 million cut across the agency.
    • The HIV/AIDS, Viral Hepatitis, STD and TB Prevention Center received an increase of $27,650 million
      • Health Departments $7,442,000
      • Surveillance $8,027,000
      • Enhanced testing $21,000
      • Improving HIV Program Effectiveness $13,015,000
      • HIV – National, Regional, Local, Community, and Other Orgs $3,037,000
      • Viral Hepatitis $6,000
      • STD  $49,000
      • Tuberculosis minus $3,947,000
  • Health Resources and Services Administration (HRSA), the primary Federal agency for improving access to health care services for people who are uninsured, isolated, or medically vulnerable, is funded at $6.27 billion, a $1.2 billion cut below FY10 level.
  • For the Ryan White Care Act (RWCA),
    • Part A, grants to eligible metropolitan areas, minus $358,000
    • Part B, grants to states and ADAP got an increase of $26,163,000.
      • AIDS Drug Assistance Program (ADAP) will total $885 million, an increase of $25 million, with $50 million set aside for the program that targeted the ADAP crisis (waitlist, decreased eligibility, and decreased formularies)
    • Part C, grants to HIV/AIDS clinics nationwide, funding will total $205,564,000, minus $819,000
    • Part D, grants to organizations for children, youth, women and families, is funded at $77,313,000, minus $308,000
    • Part F, AIDS Education & Training Centers (AETCs) grants for training and workforce development, is funded at $34,607,000, minus $138,000
    • Part F, dental grants for Dental Education, is funded at $13,511,000, minus $54,000
  • Housing Opportunities for Persons with AIDS (HOPWA) is funded at $334,330,000, minus $670,000 from FY 10 level.
  • Title X, funding for family planning, remains. It is appropriated at $299,400,000 million, minus $17,432 million from FY 10 level.
  • Teen Pregnancy Prevention Initiative is funded at $104,790,000, minus $5,189,000 from FY 10 level.
  • The Social Innovation Fund received $50 million in funding for FY 11
  • AmeriCorps State and National received $349 million in funding for FY 11

The Senate is expected to vote on both the House and Presidential FY 12 budget proposals as soon as tomorrow. Please e-mail your Senator TODAY and urge them to reject the House proposal, which would make severe cuts to Medicare and Medicare, programs that are essential to providing care to people living with HIV.

Asian-Pacific Islander HIV Awareness Day

By Julia Cheng, Zamora Fellow, AIDS United

Two AIDS Awareness Days in a week?  Yes!   Yesterday was HIV Vaccine Awareness Day and today is Asian-American and Pacific Islander HIV/AIDS (API HIV) Awareness Day.  Since we’ve already covered the importance of finding an HIV vaccine, I’d like to speak on API HIV Awareness Day.

I know that AIDS Awareness Days can feel somewhat perfunctory to some.  However, the importance of AIDS Awareness Days is in highlighting specific populations and issues.  Awareness days  remind us that AIDS isn’t an equitable disease, that all forms of discrimination precede negative health outcomes.  I have also heard it said often the HIV is a series of epidemics in the United States.  The point being: different communities, whether distinct by region or other social markers, face different barriers and challenges.

Why a day focused on APIs?  While currently APIs have low rates of HIV prevalence relative to other groups, APIs face increasing HIV infection rates along with consistently low testing rates according to the CDC’s latest data.  The API community is extraordinarily diverse, so just as we need to treat HIV in the U.S. as a series of epidemics, such is true within the API community as well.  At the same time, there is a vital conversation about Pan Asian-American needs, which is why, as much as I am loathe to speak about needs of a dynamic group, I am writing this blog piece.

Here is a brief description of just some of the key issues and barriers that I think face the API community in regards to HIV.

Sexuality: Though this is often discussed in our community, I feel as if many conversations about sexuality remain focused around politics and stereotypes.  More forthright conversation about sexual needs and health is needed but without forgetting the position of those who may not be able to open up about their needs.

LGBT: Issues of gender and sexual orientation may clash with perceived cultural values.  As in many places, sexual orientation continues to be perceived as a Western innovation despite a varied history of sexual orientation, sexual practice, and gender identification within Asian cultures.  Homophobia and transphobia are dangerous to the health of communities and individuals.

Mental Health: Asian American’s have low indicators of mental health and are unlikely to seek help for mental health problems.   Though there remains little research about Asian-American mental health, studies have suggested higher levels of depressive symptoms and API women ages 15 to 24 lead in the highest suicide rate among all ethnic groups in the nation according to the Department of Health and Human Services.  According to the Asian Counseling and Referral Service, forty percent of Southeast Asian refugees suffer from depression. For a population already under stress, stigmas around sex, being gay, being positive, can only exacerbate poor mental health and put individuals at greater risk for HIV.  Furthermore, poor indicators of mental health may also correlate with drug use that puts individuals at risk through the use of non-sterile syringes.

Culture and Language: Similar to other racial and social minorities, mistrust of the establishment and lack of cultural competency and language are barriers to positive health outcomes.  Asian-Americans face issues similar to other migrant communities.  While cultural specific attitudes depend on the individual; the ideas of “saving face” and not “making waves” are prominent among API communities.  In addition, conflicts of traditional versus modern medicine can present an unhealthy dichotomy of choices.

Unity: The API community should celebrate and recognize our diversity and understand it is in our own common interests to advocate and understand the wide range of needs within our community.  We also have unified needs, of which preventing and treating HIV are vital.

Lastly, own the issue.

It’s interesting to me that despite a rich and burgeoning field of scholars on Asian-American sexuality that the API community seems to lack ownership of HIV issues.  This morning I did a brief peruse of blogs that focus on (non-HIV specific) Asian-American issues and didn’t find much of anything on HIV Awareness Day.  This includes blogs that often dissect and examine Asian-American sexuality (which I feel is most, as the history and current perception of Asian-Americans is uniquely shaped by sex and gender).  While the Banyan Tree Project, the lead organization behind API HIV Awareness Day, is doing a great job to raise consciousness, it seems to me that a great challenge is taking that message and owning the issue, as evidenced by the low rates of testing among the APIs.  So while there are many key issues and barriers that face the API community you might feel like can’t take on yourself, you can own the issue.  Consider your risk for HIV, get tested, and encourage others to do the same.