Frequently Asked Questions about REMS and FDA Regulation of Prescription Pain Medication

Why is the government involved in regulating pain medication to address medication safety?

Regulatory bodies govern various industries, develop guidance and have the power to impose restrictions and fines if regulations are not met. They are usually government agencies. In the United States, the federal regulatory body that oversees the drug and medical device industry is the Food and Drug Administration (FDA). FDA is a division of the Department of Health and Human Services. From a medication standpoint, FDA regulates new drug approvals, product labeling for both prescription and over-the-counter (OTC) medications and the manufacturing process. New laws also give FDA authority to regulate products after they have been approved.

Because of its role in regulating controlled substances, including ingredients in pain medication, the Drug Enforcement Agency (DEA) is also influential in shaping federal pain policy and regulations. Prescription drug abuse is a serious public health issue. FDA and DEA are involved with pain medication regulation to attempt to curb its misuse and abuse, while at the same time ensuring access to people who need it.

What are REMS?

REMS stands for Risk Evaluation Mitigation Strategies. One component of the 2007 Food and Drug Administration Amendments Act (FDAAA) expanded FDA’s authority to regulate drugs after they are approved. As a part of this charge, FDA is working with the pharmaceutical industry and consumer stakeholders to develop REMS for certain classes of medication, including opioid medications. If you are a person with pain, a caregiver or health care professional who treats pain, you are a stakeholder who can play a role in the development of this policy.

When FDA reviews new drug applications, they must weigh the benefits and risks of each medication. As of March 2010, there are more than 100 medications that have REMS. Strategies for reducing risk of harm or misuse can range from providing basic patient and prescriber information and education packets, to restricting channels of distribution, to mandating continuing education for pharmacists and prescribers, to requiring patients to sign on to a registry. 

Opioid medications, a leading prescription option to manage moderate to severe pain, have a high potential for abuse and misuse. New opioid medications now require REMS in an effort to assure that the benefits outweigh the risks, such as those related to misuse, abuse and overdose. The long-acting and rapid-onset opioids that received FDA approval in the past and are currently available by prescription may soon require REMS too.

How will REMS affect people with pain?

While well-intentioned, REMS have the potential to further limit access to opioid pain medication. There is no evidence that several proposed strategies will reduce abuse or misuse of prescription medication. Such strategies may result in people living with pain, not receiving the medications that are most appropriate for their needs. As FDA evaluates risks versus benefits of opioid medication, it is important to recognize that the lives and livelihoods lost to uncontrolled pain are worth no less than those who misuse or abuse prescription medications.

Currently, REMS are recommended by the FDA to be required for only for long-acting opioids – not short-acting. This can affect prescribing choices. By making it more difficult for a health care provider to prescribe one class of medication and easier to prescribe another, prescribers may gravitate toward less stringently-regulated products. In some cases where a long-acting opioid could greatly improve a person with pain’s life, they may be prescribed a short-acting opioid because it is “easier.” This is not optimal pain care and may diminish the quality of life for the person in pain. It also does not address the underlying problem of prescription drug abuse, as abusers will simply move to products that have fewer restrictions and are easier to obtain.

Additionally, from a health care provider standpoint, why treat people with pain who may appropriately require opioid therapy when burdensome requirements reinforce the fear that their medical license and livelihood are at risk each time they write a prescription? Regulations can be so restrictive that they deter health care professionals from the practice of pain care altogether. 

Prescription drug abuse is a serious public health issue that makes it more difficult for people with pain to access medication that can make their lives worth living; ideally, REMS can be a part of the solution in terms of making abuse and misuse of pain medication more difficult. However, regulations designed to reduce prescription drug abuse should not come at the expense of people with a legitimate medical need. Therefore, it is imperative that people who live with pain and their loved ones speak up and make sure that regulators take their point of view into account when creating pain policy.

What is the American Pain Foundation’s position on REMS?

APF has testified before FDA and has submitted comments about REMS several times over the past few years. In May 2009, APF prepared a position statement that can be found in our newsroom: http://www.painfoundation.org/newsroom/position-statements/fda-rems.html

What can you do to make a difference in the REMS debate?

First, be more informed about REMS and its potential impact on you and your ability to access the medications you need. Reading this FAQ is a step in the right direction. Next, think about how you, your loved ones or those in your care may be affected by the enactment of a REMS, not only for pain medications, but for any other medicine that is needed for appropriate medical management. All medications have risks as well as benefits. Failure to treat pain has risks, just like failing to treat other medical conditions has risks. How can you be well-informed enough to make a rational decision about what risk is acceptable to achieve the desired benefit for a quality life?

Thirdly, be ready to act. APF will issue a call to action soon. This will be the perfect time for you to voice your opinion to the FDA that will be part of the public record.

What are key points for pain advocates to communicate about REMS?

It is important that your comments to FDA are personal and heartfelt. APF has developed the following consumer-oriented talking points that are in line with views expressed by the larger pain community. Please consider incorporating these themes into your written testimony.

TALKING POINTS:

• The abuse and misuse of opioid medicines is a serious issue with devastating consequences; approaches to mitigating this abuse must be balanced with the fact that there are millions of people who rely on prescription opioid medication to live “normal” lives.
• REMS must protect and not interfere with patient access to these important medicines.  Negative stereotypes about individuals with pain and fear of ramifications of opioid prescribing can prevent early and effective treatment. Current state, legal and regulatory policies must not interfere with the legitimate medical use of appropriate opioid medicines for pain relief. The FDA should not implement any strategies that further interfere with the ability of prescribers and other appropriate health care practitioners to responsibly develop, provide and adjust pain management regimens for their patients, including regimens that use opioid medication.
• The cost of pain not only includes direct costs associated with health care provider visits, diagnostics and medication, but indirect costs such as lost wages and productivity of people with pain as well as family members and caregivers. Aside from stealing livelihoods, untreated pain has been shown to shorten the lives of those who suffer. Some, who no longer consider their lives worth living, see suicide as their only option.  These lives and livelihoods lost to pain are worth no less than people who misuse or abuse drugs.
• The REMS should cover the entire class of opioid medications, not just long-acting opioids. Any attempt to regulate only a portion of the opioid class of medications will drive health care professionals who prescribe for legitimate reasons as well as misusers of these medications to the other, less stringently regulated drugs in this class of medications. This will not diminish abuse or misuse and will very likely result in some individuals not getting the medications that are most appropriate for their needs. If the FDA applies a REMS to long-acting opioids, a separate REMS for short-acting opioids should be addressed quickly. The REMS created for rapid-onset opioids should be consistent as its own category as well.
• Educational efforts directed to the prescriber, the dispenser and the intended end user need to focus on the safe use, safe storage and safe disposal of medicines to prevent prescription opioid medication from entering illicit channels of distribution. Restrictive, punitive systems such as patient “registries” further stigmatize people with pain and create additional hardships and new barriers to effective pain care.

How did REMS come about?

The Prescription Drug User Fee Act (PDUFA) is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain human drug and biological products. The original PDUFA (PDUFA I) was enacted in 1992 and had a five-year life. When PDUFA I expired in 1997, Congress passed the FDA Modernization Act (FDAMA, Public Law 105–115) which extended PDUFA (PDUFA II) for an additional five years. Then, in 2002, Congress extended PDUFA again through fiscal year 2007 (PDUFA III) through the Public Health Security and Bioterrorism Preparedness and Response Act (Public Law 107–188).

Most recently, Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110–85) reauthorized PDUFA through fiscal year 2012 (PDUFA IV). PDUFA’s intent has been to provide additional revenues so that FDA could hire more staff, improve systems and establish a better managed human drug review process to make important therapies available to the public more quickly without compromising review quality or approval standards.

Provisions in the 2007 FDAAA expanded FDA’s authority to regulate drugs after they are approved. This gave FDA the authority to require Risk Evaluation Mitigation Strategies (REMS) for a number of classes of medication. FDAAA also states that these strategies should NOT place undue burden on access to care for those with legitimate need.

Last Updated: 07/20/10