FDA Proposes New Rule: Generic Labeling…the Controversy…and How it Affects Patients

By Anna Meghan Nunn
Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

The U.S. Food and Drug Administration (FDA) proposed a rule that is stirring up controversy, and could have serious implications for recipients of the AIDS Drug Assistance Program (ADAP). In November 2013, FDA recommends included amending a thirty-year old rule adopted by Congress in 1984. In its conception the Hatch-Waxman Act (1984) was designed to speed up the process of generic drug approval, thereby expediting consumer access to affordable prescription drugs. Under the current rule generic drug makers are restricted from making independent changes to their product labeling (also referred to as prescribing information or package inserts). Rather, they must wait for the company that developed the drug to make safety information changes before they are able to update their own labels.

The proposed new rule would allow generic drug makers to update their safety labels in light of new research and information before the FDA is able to review the changes. This is the same process that brand name drug makers have used for decades. Due to limited resources, the process of FDA review and approval of safety labels can often be long and convoluted. It is for this reason that supporters of the rule argue that it will allow consumers more immediate information about the medications they are taking.

In a recent article published by CQ HealthBeat (03/08/14), associate editor Rebecca Adams reported that a bipartisan group of 30 attorneys generals support the proposal, along with many congressional Democrats. The New York Times, in their article “Label Update May Be Allowed for Generics,” quoted Rep. Chris Van Hollen (D-MD) as saying, “This is an important consumer protection provision. It’s a long time in coming.” 

Further, Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, said in a recent press release (11/08/13):

“This proposal will help ensure that healthcare professionals and consumers have access to the latest safety information for the medications they use. More than 80 percent of prescription filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

In 2011, consumer watchdog group Public Citizen filed a petition requesting that the FDA allow generic drug companies to revise and update product safety labeling through the same procedures available to brand name drugs. EArlier this year, Reuters quoted Allison Zieve, general counsel at Public Citizen as saying, “If generic manufacturers are not actively monitoring and proposing safety updates, no manufacture is doing so at all. As generic market share increases, the brand-name manufacturer loses incentive to devote resources to post-approval safety monitoring.”

According to Public Citizen, this statement is in response to the estimated 45% of generic medications that no longer have a brand name counterpart.

However, not everyone is on board with the proposed rule change. The generic drug industry opposes the new change, along with many congressional Republicans, some pharmacists, and several other consumer groups. Their concern centers around three issues: liability lawsuits, patient confusion, and cost increases.

In her article for CQ HealthBeat News (03/18/14), Adams sums up the anxiety of the opposition saying that they fear, “…that patients and medical professionals could become confused by non-uniform labeling based on different levels of information. Makers of generic drugs also say that multiple label changes could increase health care costs and potentially expose pharmacists and other professionals to new liability.”

The issue for generic drug companies is that they will now be susceptible to lawsuits that were historically reserved only for name brand drug companies. In the past, because generic drug makers were prohibited from updating their safety labels, they were not held accountable for failing to warn consumers about new potential risks—the name brand drug companies shouldered that burden. Generic drug companies now argue that this new rule will have unintended consequences, driving up health care costs as they are embattled in litigation and will pass that cost onto consumers.

According to FiercePharma, in their recent article “Generic Makers to FDA: Labeling Rule Risky for Patients, Adds $4B in Annual Costs” (03/03/14), claims that the Generic Pharmaceutical Association (GPhA) cited a study by Matrix Global Advisors, “which estimated that the rule, if enacted would drive U.S. health care costs up by $4 billion a year--$1.5 billion of which would be incurred by Medicare and other government payers, and the rest by private insurers and patients.” 

So what does this mean for ADAP recipients?

Depending on the state, there are a variety of different drug formularies offered to ADAP clients. Some states have more robust formularies, whereas others have limited and reduced access to medications through formularies. This is a way for ADAPs to remain cost-effective and best utilize the funds they receive in an effort to ward off waiting lists. For example, New York's ADAP formularies have a Mandatory Generic Rule, meaning that ADAP will only cover generic forms of “A-rated” or therapeutic equivalent drugs. North Carolina also stipulates in their ADAP Fact Sheet (02/03/14) that “If available, generic medications are dispensed.”

This is just an example of the many ADAP recipients across the country receiving generic drugs as part of their formulary. The proposed rule will certainly effect these ADAP clients, forcing them to navigate an already complex set of FDA standards with regard to their medications. This could turn what use to be a mechanical daily routine of taking trusted medications into a confusing and troublesome process.

Additionally, Dr. Woodcock also noted that the FDA plans to create a webpage where, “safety related changes proposed by al drug manufacturers would be posted” (11/18/13). While this is a noble idea, it raises the question of equity among some groups.

In addition to leading busy lives, most people living with HIV/AIDS are managing their health and trying to sort out the ever-changing world of public health; many more are dealing with the complexities of poverty. It is reported that 80% of ADAP clients live 200% or below the Federal Poverty Level. It begs the question, will many of these clients have access to the technology and internet service often needed to keep up-to-date with these labeling changes? Whereas pharmacists and ADAP staff will likely be able to assist patients with changing safety information, will the FDA’s web portal be sufficient for those patients who cannot access it?

The Generic Pharmaceutical Association (GPhA) assembled a panel of experts at a recent congressional briefing, who argued that changing the labeling laws would endanger patients. The House Energy & Commerce Committee plans to convene a hearing, "Examining Concerns Regarding FDA's Proposed Changes to Generic Drug Labeling," on April 1, 2014. Clearly, there is much more to come on as this debate continues...

President Obama's FY15 Budget Offers Promise & Dismay

By Anna Meghan Nunn

Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

With the implementation of the Affordable Care Act (ACA), Rep. Paul Ryan's recent House Budget Committee Report, and the reemergence of previously eliminated AIDS Drug Assistant Program (ADAP) waiting lists, President Obama’s Fiscal Year (FY) 2015 budget proposal has been highly anticipated by those in the HIV/AIDS community. So how does the President’s budget stack up with respect to the Ryan White CARE Act, in general, and ADAP, specifically? To put it in perspective, it is important to revisit the President’s previous commitments.

On World AIDS Day 2011, President Obama took to the stage of George Washington University and spoke to a packed house about his commitment to ending AIDS, saying:

“We just have to keep at it, steady, persistent, today, tomorrow and every day until we get to zero. And as long as I have the honor of being your president, that’s what this administration is going to do. That’s my pledge — my commitment — to you. And that has to be our promise to each other — because we have come so far; we have saved so many lives. We might as well finish the fight.”

Months later, President Obama unveiled his FY13 budget proposal with a $47 million increase in ADAP funding, or a total of $943 million. The final budget passed by Congress did not include the proposed increase, and ADAP received $886.3 million. In March 2013, the President laid out his FY14 budget, which again requested a $47 million increase in funding for ADAPs. The final funding passed at $900 million later that year. Fast forward...

Earlier this month the President released his FY15 budget proposal. The budget proposal calls for a $4 million increase in Ryan White Care program funding for a total of $2.3 billion. It also proposes flat-funding for ADAP programs at a continued $900 million level. The flat-funding is viewed by some to be a demonstration of the President’s ongoing commitment to the fight against HIV/AIDS in a time of federal budgetary austerity; others view it as falling short because the need is much higher. Some advocacy groups suggest that the proposed budget is $189 million short of the need. 

President Barack Obama signs copies of the FY 2015 Budget as Sylvia Mathews Burwell, Director, Office of Management and Budget, and OMB staff look on in the Oval Office, March 4, 2014. (Official White House Photo by Pete Souza)

Most notably however, it is a testament to the cost-effectiveness of Ryan White programs and ADAPs. Just as Rep. Ryan’s House Budget Committee Report found Ryan White programs to be sustainable, President Obama’s budget proposal also seems to demonstrate an understanding of the success of these programs. 

William Arnold, President & CEO of the Community Access National Network (CANN), and the ADAP Advocacy Association's board co-chair argues that:

“The country is in a state of austerity with many federal programs coming under fire in an attempt to reduce the budget deficit. The fact that Ryan White and ADAPs have fared so well under these circumstances authenticates the proven Return on Investment that these programs have demonstrated.” 

ADAP Education Initiative Director Eddie Hamilton had this to say about the recent budget proposal:

“The President’s proposal to basically flat fund the ADAP Program is a positive step in the right direction even though there is more that needs to be done for the program. With improved testing and the new treatment guidelines that are adding new patients, the Program will begin to struggle yet again after a very brief hiatus from growing nationwide waiting lists.”

Hamilton is echoing a growing number of responses to the proposed budget. While many advocates are pleased that Ryan White and ADAPs are continuing to be funded at a significant level, there are concerns about the future of ADAP programs including the following:

• Uncertainty of Medicaid Eligibility Expansion Among States
• Affordable Care Act (ACA)
• Waiting Lists & Reduced Formularies

According to the Henry J. Kaiser Family Foundation, 26 states (including the District of Columbia) have opted to accept the federal funding for expanding Medicaid eligibility offered by the ACA (as of January 28, 2014). Nineteen states have announced that they will not move forward with the expansion at this time and 6 states are still openly debating the decision. Because there is uncertainty in how many clients will transfer over to Medicaid programs, ADAPs must be flexible and reactive in how they will best disseminate funds and what needs they will have. Further, some states that have chosen not to expand Medicaid eligibility have also announced that they will cut state ADAP funding.

For example, according to Disability Rights North Carolina, Governor Pat McCrory has proposed a budget calling for an $8 million cut to the state’s ADAPs in his FY14-15 budget. Some argue that what is unfolding in North Carolina provides further evidence of why there is a need of additional federal funding of ADAPs is still necessary.

There is also a great deal of uncertainty associated with the intersection of the ACA and ADAPs. Whereas there is some uncertainty about the enrollment numbers, state ADAPs are also unsure how many clients will be transferred into Marketplace insurance plans. Clients moving into these plans may require additional ADAP funds to assist with co-payments, laboratory tests, and other out of pocket expenses. There is now an emerging question surrounding whether these types of wrap-around services will even be covered, thus potentially leaving patients in a bind.

Without additional federal funds ADAPs fear that they may once again become cash strapped and fall short of meeting these needs. In the past when this has happened states have been forced to take drastic measures, creating waiting lists and reducing formularies. A recent press release from The AIDS Institute makes the point that states have struggled in the past to keep up with low-income clients living with HIV/AIDS. They contend that enrollment in ADAP grew by 8 percent in 2013. 

Earlier this year also brought the return of ADAP waiting lists, a problem that had been eradicated in late 2013. The latest ADAP Watch, published by the National Alliance of State & Territorial AIDS Directors (NASTAD), noted these concerns:

• Utah established a new waiting list on February 19, 2014.
• Ten ADAPs have had cost-containment measures in place since April 1, 2013 (reported as of February 4, 2014).
• Louisiana reports considering implementing new or additional cost-containment measures by the end of ADAP’s current fiscal year (March 31, 2014).
• Seven ADAPs reported modifying or eliminating existing cost-containment measures since April 1, 2013 (reported as of February 4, 2014).
• Wyoming eliminated their enrollment cap on November 21, 2013.

Further federal funding would assist with thwarting these anxieties.

The other concern with the President’s budget proposal is the issue surrounding Part D of Ryan White. Part D is devoted solely to “providing family-centered care involving outpatient or ambulatory care for women, infants, children, and youth with HIV/AIDS” (U.S. Department of Health and Human Services). Grantees use this funding to help pay for costs associated with services including:

• Lab, x-ray, and other diagnostic tests.
• Pharmaceutical assistance for HIV-related medications, and vaccines.
• Oral health-care services.
• Mental health services.
• Substance abuse outpatient care.
• Medical nutrition therapy.
• Transportation for clinical care providers to provide care.

Just like the other Parts of Ryan White, funds are used as a cost-effective way to assist low-income individuals. However, unlike other Parts of Ryan White, Part D is aimed directly at assisting women, children, infants, youth, and families affected by HIV/AIDS.  The President’s budget proposes to combine Part D with Part C. The argument for the consolidation, which will administered through the same division under the Health Services & Resources Administration (HRSA), is to achieve "savings" through increased efficiencies and decreased overlap.  Many advocates are concerned that the proposed consolidation will leave these vulnerable groups without the important care they need. This translates into a coverage gap for many low-income families; families that will fall through the cracks of healthcare.

A recent press release from the AIDS Alliance for Women, Infants, Children, Youth & Families raised these concerns last week. Deputy Executive Director Dr. Ivy Turnbull had this to say:

“Ryan White Part D is the lifeline for women, infants, children and youth living with HIV/AIDS. The Part D programs are instrumental in preventing mother-to-child transmission of HIV and for ensuring that women and youth have access to quality HIV care.  Since the program’s inception in 1988, the Part D programs have been and continue to be the entry point into medical care for women and youth and, in many communities or regions, Part D programs are the only perinatal clinical service available to serve HIV-positive pregnant women and youth.  Removing Part D from the federal budget would eliminate a strong safety net for our most vulnerable populations and weaken the system of care these programs have created and invested in for more than 25 years.”

The same press release quoted HIV advocate Janet Kitchen as saying:

“I am shocked that this is happening when the services for women and children are so important and the President has invested so much in promoting health care access in this country.  I believe everyone in the HIV community should be concerned about this and the community should be involved with the administration and congress to discuss and create a system that serves the people in need.”

Although there is concern over Ryan White Part D, Hamilton makes an important distinction saying, “It appears that the reconfiguration of Part D Services will not play any detrimental role to the ADAP Program at this time.” 

This is good news for ADAP recipients who are seeing growing apprehension from the healthcare community with regard to Part D.

The overarching reaction from the public health community and HIV/AIDS advocates is that the President’s budget is congruent with his promised commitment to continue funding programs like Ryan White in an effort to eradicate HIV/AIDS in the U.S. That being said, there is a fear that the lack of additional funding for ADAPs may cause unintended consequences for states programs that are already cash-strapped and will see growing financial needs due to the transferring of clients into Marketplace plans and the uncertainty of how the Medicaid expansion will effect ADAPs. The HIV/AIDS community will continue to closely monitor the budget proposal as it moves through congress and the ADAP Advocacy Association will continue to update its followers with regard to this issue.

Policy Analysis or Political Talking Points: "The War on Poverty: 50 Years Later"

By Anna Meghan Nunn
Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

It has been 50 years since President Lyndon B. Johnson signed the Economic Opportunity Act (EOA), declaring a “war on poverty." The EOA was passed in August 1964 and included programs meant to help lift low-income individuals out of poverty. These included the Job Corps; Neighborhood Youth Corps; Head Start; Adult Basic Education; Family Planning; Community Health Centers; Congregate Meal Preparation; Economic Development; Foster Grandparents; Legal Services; Neighborhood Centers; Summer Youth Programs; Senior Centers; and others.

Over the decades more and more assistance programs have been implemented at the federal level. There are currently 92 federal programs aimed at assisting low-income Americans including food-aid, educational programs, housing programs, and job training and placement programs. Despite the approximate $799 billion being spent annually on these programs the national poverty rate has only fallen 2.3 % since 1965, while the number of Americans living in “deep poverty” has reached its highest level in our nation’s history. [1] This disparity in numbers has left many frustrated with what they believe is a failure of these federal programs and policies.

This week the House Budget Committee Majority Staff released a report entitled “The War on Poverty: 50 Years Later.” The report was released just one day before President Obama laid out his own budget proposal for Fiscal Year 2015. It outlines most of these federal assistance programs and discusses the purpose, history, funding, and evidence of success or failure for each program.

The report is spearheaded by Rep. Paul Ryan (R-WI) and was drafted by the Majority Staff rather than the full committee, and should therefore be evaluated in the context of its partisan spirit. Ryan’s report has already been criticized by many Democrats. The Democratic National Committee (DNC) spokesman, Michael Czin, gave a statement to CNN Politics that read:

“This report is just a rehash of a failed economic agenda that Americans keep rejecting…"Republicans just don't get it. Their plan is to block a minimum wage increase, cut access to higher education, slash early childhood programs, voucherize Medicare and shred the social safety net — a safety net that lifted 45 million Americans out of poverty in 2012 alone” (CNN Politics, 3/03/2014).

Further, Congresswoman Barbara Lee (D-CA) released a statement on Tuesday slamming Ryan’s report, saying:

“This report is nothing more than an ideologically bankrupt battle plan to attack the poor. Not only does this report disregard current and respected data in the field, this is a callous look at the state of our country. Republicans are continuing their attack on the social safety net with tired proposals that fly in the face of the evidence. Republicans continue to try and gut the safety net at the expense of families, children, and the elderly.

What our country needs is investments in job creation and training, proven anti-poverty programs and early childhood education, and to open access to high-quality college education, as laid out in the budget that President Obama released today. In stark contrast to Rep. Ryan’s report, the President’s budget lays out a vision for the future that supports families, encourages growth, and creates opportunity for all.”

Given the partisan nature of the report, it is encouraging to find that two of the most progressive HIV/AIDS programs faired relatively well: “Ryan White HIV/AIDS Program” (i.e. state ADAPs) and the “Housing Opportunities for Persons Living with AIDS” (HOPWA).

The report estimates Ryan White Care Act funding to be at $2.367 billion for the 2012 fiscal year. It identifies the services included in the funding appropriations to be the following: “medical care, drug treatments, dental care, home health care, and outpatient mental-health and substance-abuse treatment.” According to the report, Ryan White funds serve more than half a million people, 29% of which are uninsured and an additional 56% that are underinsured.

The report goes on to cite empirical studies which lend validity to the efforts of Ryan White-funded programs. The first acknowledges that Ryan White programs have been successful in filling in gaps in Medicaid’s HIV/AIDS services and points to a study which has shown high satisfaction rates among RW recipients.[2] It goes on to clarify stating that, “…Ryan White–funded facilities offered more clinic, non-clinic, and adherence support services than non-RW–funded facilities.”[3]

Additionally, the report recognizes the strides that Ryan White funding has made in addressing comorbidity with regard to persons living with HIV/AIDS and the Hepatitis B or C virus stating that, “The Ryan White program is funding two programs to test a new model of integrating hepatitis C treatment into their clinical practices.”[4]

Finally, the report contends that Ryan White programs have helped to reduce mortality and morbidity rates [5]:

“In 2010, 546,156 individuals received RW services. Of these: o Seventy-nine percent had documentation and received RW case management/outpatient care; o Of those who received RW funded medical care and had dates available, 76 percent were retained in medical treatment; and o Similar performance outcomes were demonstrated across the continuum of RW services.”

Ryan White-funded programs were not the only HIV/AIDS programs assessed by the report. The Housing Opportunities for Persons with AIDS program (HOPWA) was also evaluated by the House Budget Committee Majority Staff. HOPWA was created to provide housing assistance and supportive services for low-income individuals living with HIV/AIDS and their families. Specifically, funds are used for “acquisition and rehabilitation of housing units, rental assistance, and homelessness prevention,” according to the report. Additional supportive services are said to include, “case management, substance-abuse treatment, and job training programs.”

The Office of Management and Budget Program Assessment Rating Tool (OMB PART) evaluated this program in 2008. The report states that it found the program to be “effective” saying that its specific mission is, “…high levels of results in assisting a vulnerable population to achieve beneficial outcome.” [6] It went on to claim that recent studies have shown that providing housing to persons living with HIV/AIDS reduces the use of medical care, showed improvement in overall stability, and led to improved health outcomes.” [7]

The estimated budget for this program was $334 million in the 2012 fiscal year.

NEWSWEEK Photo:
The budget negotiations are a conspicuous test of faith for the former conservative darling
Chip Somodevilla/Getty Images

Republicans like Rep. Paul Ryan have taken a lot of heat for their criticism of entitlement programs. This recent report will likely serve to continue to fuel the fire of debates with regard to the war on poverty. However, it is reassuring for those working in the field of HIV/AIDS-related public health and advocacy that Ryan White-funded programs, such as ADAP, and other assistance programs, like HOPWA, continue to demonstrate their cost-effectiveness in the public sector.  

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[1] A household living in “deep poverty” makes less than 50 percent of the poverty line (according to the House Budget Committee Report: The War On Poverty: 50 Years Later

[2] “The Study of Medicaid and Ryan White Program Coordination: Where Does the Responsibility Lie?” The Center for Public Policy Research and Ethics, the AIDS Institute for The Florida Department of Health, Bureau of HIV/AIDS, Accessed 28 Feb. 2014.

[3] E. Valverde, C. Del Rio, L. Metsch, P. Anderson-Mahoney, C. S. Krawczyk, L. Gooden, and L. I. Gardner, “Characteristics of Ryan White and Non-Ryan White Funded HIV Medical Care Facilities across Four Metropolitan Areas: Results from the Antiretroviral Treatment and Access Studies Site Survey,” AIDS CARE, Vol. 16, No. 7, Oct. 2004.

[4] Rupali K. Doshi and Laura W. Cheever, “Ryan White Program Addressing Coinfection with Viral Hepatitis,” U.S. Department of Health and Human Services, Health Resources and Services Administration, AIDS.gov, 2 May 2013.

[5] “Continuum of HIV Care Among Ryan White HIV?AIDS Program Clients. U.S., 2010,” U.S. Department of Health and Human Services, Health Resources Administration, HIV/AIDS Program, Accessed 20 Feb. 2014.

[6] “Program Assessment: Housing Opportunities for Persons with AIDS” ExpectMore.gov, Accessed 11 Feb. 2014

[7] Richard Wolitski, Daniel Kidder, Sherri Pals, Scott Royal, Angela Aidala, Ron Stall, David Holtgrave, David Harre, Cari Courtenay-Quirk, “Randomized Trial of the Effects of Housing Assistance on the Health and Risk Behaviors of Homeless and Unstably Housed People Living with HIV,” AIDS and Behavior, Vol. 14, No. 3, Jun. 2010.