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...