November 5, 2015
Janet Woodcock, MD
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: Follow-up to Meeting to Protect Access to Pain Relief
Dear Dr. Janet Woodcock:
We want to thank the Food and Drug Administration (FDA) for the time that Dr. Whyte and his team afforded the Protecting Access to Pain Relief (PAPR) Coalition on September 21, 2015 regarding the FDA’s January 2014 announcement that it may take regulatory action to limit access to over-the-counter (OTC) acetaminophen.
The PAPR Coalition is a multi-stakeholder group whose mission is to advocate for public policy that supports access to and choice of appropriate over-the-counter (OTC) pain relief while educating the public about responsible use of acetaminophen. Our members include public health organizations, medical professional societies, consumers living with pain, and concerned citizens. Collectively, our organizations can reach millions of patients and health care providers with public health messages.
The Coalition wants to work collaboratively with FDA to address pain management and ensure consumers have access to the OTC pain medication they need, while also promoting safety. Toward that end, the Coalition has serious concerns with FDA potentially issuing a regulation that removes an important pain relief product from the market without considering the impact this would have on the patients we represent. We believe that by working together, FDA and the PAPR Coalition can address our mutual goal of further reducing any unintended acetaminophen overdoses while maintaining patient access to and choice of OTC pain relief.
As you know, nearly 100 million Americans live with persistent pain. Acetaminophen is one of the most widely used medicines and is taken by over 50 million Americans each week. When taken as directed, acetaminophen is a safe product. Over 50 percent of the population– including those with kidney disease, gastrointestinal conditions, and other illnesses – may only take acetaminophen for pain relief because other pain relievers may cause medical complications.
Unfortunately, by limiting access to higher doses of acetaminophen, the FDA’s proposed action may cause consumers to switch to other pain medicines like Nonsteroidal Anti-Inflammatory Drug (NSAIDs) to achieve the equivalent relief, which can lead to an increase in adverse events, higher healthcare utilization costs, and other unintended public health and economic consequences for many patients. In the case of those with impaired kidney function and transplanted kidneys, NSAIDs are actually contra-indicated by medical professionals because they can lead to further reductions in kidney function and or lead to the failure of the transplant.
In 2014, the Alliance for Aging Research commissioned a study to determine consumers’ opinions about pain management. According to this study, when asked if FDA were to change its regulations and require a doctor’s prescription to buy extra-strength Tylenol or acetaminophen, 30 percent of adults aged 60 and older and 40 percent of adults between the ages of 18-59 said that they would stop using the product and change to a different pain reliever. Thus, if products containing the maximum dose of acetaminophen are taken off the market, there’s a high likelihood that consumers will switch to different pain relievers and put their health at risk.
FDA’s January 2014 press release stated the basis for a potential FDA regulation limiting access to higher strength acetaminophen was to address patients who:
- took more than the prescribed dose of an acetaminophen-containing product in a 24- hour period;
- took more than one acetaminophen-containing product at the same time; or
- drank alcohol while taking acetaminophen products.
We respectfully believe that by working together we can develop a strategy to more effectively address these three safety concerns for the patients we represent than a regulation that eliminates access to pain relief. To our knowledge, there is no evidence that restricting access would cause patients to adhere to the prescribed dose, avoid taking more than one acetaminophen-containing product at the same time, or avoid drinking alcohol while taking acetaminophen. Rather, the Coalition believes that a targeted educational approach to address the root causes of these issues is the best way to achieve the agency’s objectives. In addition to a coordinated educational campaign, we urge the FDA to consider requiring OTC pain relievers to include additional warnings about acetaminophen overdose in their label directions or allow an acetaminophen ingredient icon on the OTC label that informs consumers that the product contains acetaminophen and warns them about the danger of acetaminophen overdose.
We also propose additional education initiatives. Over the past several years, advocacy groups have launched educational campaigns emphasizing the importance of taking the recommended doses of acetaminophen. These efforts have proven to be very effective. In July 2015, the National Poison Data System (NPDS) released findings showing a decrease in overdoses of acetaminophen by 24 percent from 2009-2013. In 2014, the Consumer Healthcare Products Association commissioned research that showed a growing number of pain medicine users understand how to use pain medicine safely and are aware of the risks-specifically regarding acetaminophen. The research showed progress from 2010 to 2013 in the areas of label reading, following dosing instructions, awareness of risk, avoidance of “doubling up”, and the impact of education campaigns. From 2010 to 2013, consumer awareness levels reached 90 percent on average in these focus areas, an increase of 7 percent.
FDA has already taken steps to educate the public about taking the appropriate amount of dose of acetaminophen. The agency serves as an advisor to the “Know Your Dose” initiative, which was launched by the Acetaminophen Awareness Coalition. The agency also serves as an advisor to other educational campaigns on the safe use of acetaminophen. There is little doubt these initiatives, utilizing the combined weight and leverage of resources of the non-profit, corporate, and federal sectors, have been major contributors to the decline in acetaminophen overdoses. Also, through FDA’s Safe Use Initiative, FDA has partnered with the National Council for Prescription Drug Programs (NCPDP) and a broad group of stakeholders to form the Acetaminophen Best Practices Task Force. In 2013, NCPDP offered recommendations to improve prescription container labels for medicines containing acetaminophen. Prior to their recommendations, only a fraction of retail pharmacies included the full spelling of acetaminophen for Rx-combination products that included it as the active ingredient. Today, 88.5 percent of retail pharmacies include the full spelling of acetaminophen on these products. To that end, the PAPR Coalition would like to partner with FDA to build on successful initiatives and targeted public education programs.
Coalition members have the valuable resources and communication tools to educate millions of Americans about appropriate acetaminophen use. This, coupled with the FDA’s regulatory authority to include stronger warning labels about acetaminophen, would reduce overdose incidence, ensure the safety of consumers, and allow Americans to have continued access to the pain relievers that they need.
We commend the FDA for its commitment to engage patients through its new Patient Education and Advisory Committee where the patient voice and patient concerns will be more fully represented in the regulatory process. This issue provides an ideal opportunity to work with patients and patient organizations in the development of important FDA policy and agency education efforts.
We strongly believe that educational campaigns and labeling changes of products containing acetaminophen are in the best interest of public health and is a far superior approach to limiting access to needed pain relief.
American Association of Kidney Patients
Alliance for Aging Research
American Association of Colleges of Pharmacy
American College of Preventive Medicine
American Pharmacists Association
Convenient Care Association
National Council on Patient Information and Education
Society for Women’s Health Research
The Coalition Against Pediatric Pain
The Gerontological Society of America
U.S. Pain Foundation
Western Pain Society
CC: Dr. John Whyte
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