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Sandra L. Kweder, M.D.
Deputy Director,
Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
U.S. Department of Health and Human Services
Subcommittee on Criminal Justice, Drug Policy and Human Resources
Committee
on Government Reform
House of Representatives
INTRODUCTION
Mr. Chairman and Members of the Subcommittee, I am Sandra Kweder M.D., Deputy Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA or the Agency), an agency of the U.S. Department of Health and Human Services (HHS). My staff works closely with CDER's Controlled Substances Staff, which coordinates CDER's activities related to controlled substances, and the Drug Enforcement Administration (DEA). I appreciate the opportunity to talk to you today about FDA's role in preventing prescription drug abuse.
The Agency is actively involved in the Administration's efforts to prevent abuse and misuse of prescription drugs, while making sure that needed drugs are available for patients who need them. FDA is strongly committed to promoting and protecting the public health by assuring that safe and effective products reach the market in a timely manner and monitoring marketed products for continued safety.
FDA DRUG APPROVAL PROCESS
The Federal Food, Drug, and Cosmetic (FD&C) Act, requires FDA to ensure that all new drugs are safe and effective. Before any drug is approved for marketing in the U.S., FDA must decide whether the studies submitted by the drug's sponsor (usually the manufacturer) have adequately demonstrated that the drug is safe and effective under the conditions of use proposed in the drug's labeling. It is important to realize, that "safe" does not mean free of risk, and that there always is some risk of potential adverse reactions when using prescription drugs. FDA's approval decisions, therefore, always involve an assessment of the benefits and the risks for a particular product. When the benefits of a drug are determined to outweigh the risks, and the labeling instructions allow for safe and effective use, FDA considers a drug safe for approval and marketing.
During the approval process, FDA assesses a drug product's potential for abuse and misuse. Abuse liability assessments are based on a composite profile of the drug's chemistry, pharmacology, clinical manifestations, similarity to other drugs in a class, and the potential for public health risks following introduction of the drug to the general population. If a potential for abuse exists, the product's sponsor is required to provide FDA with all data pertinent to abuse of the drug, a proposal for scheduling under the Controlled Substances Act (CSA), 21 U.S.C. §801 et seq., and data on overdoses.
Under the FD&C Act, FDA is responsible for the approval and marketing of drugs for medical use and for monitoring products for continued safety after they are in use, including controlled substances. DEA is the lead Federal agency responsible for regulating controlled substances and enforcing the CSA. The CSA separates controlled substances into five schedules, depending upon their abuse potential and medical use. Schedule I controlled substances have the highest potential for abuse and have no medical use while Schedule V substances have the lowest abuse potential. Schedule II substances also have a very high potential for abuse but are approved for medical use. Schedules III, IV, and V substances and drugs have lower abuse potential and fewer controls under the CSA. The U.S. Immigration and Customs Enforcement (ICE) is the lead agency for enforcing transborder smuggling laws. ICE focuses its efforts on individuals and organizations involved in the smuggling of counterfeit pharmaceuticals both controlled and non-controlled, scheduled narcotics, medical devices and medical test kits via the Internet.
The CSA requires the Secretary of Health and Human Services to notify the Attorney General, through DEA, if a "new drug application is submitted for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system, …" because it would then appear that the drug had abuse potential (21 U.S.C. §811(f)). HHS has delegated this function to FDA.
FDA assesses preclinical, clinical, and epidemiological data to determine whether a drug under review requires abuse liability studies, scheduling under the CSA, or a risk minimization action plan (RiskMAP) designed to maximize safe use of a drug in part by reducing abuse, overdose, or misuse. FDA's job is not over after a drug scheduled as a controlled substance is approved. The goal of FDA's post-marketing surveillance is to continue to monitor marketed drugs for safety. This is accomplished by reassessing drug risks based on new data obtained after the drug is marketed and recommending ways of trying to manage that risk most appropriately.
THE IMPORTANCE OF RISK MANAGEMENT
Safety or risk assessment combined with efforts to minimize known risks comprise what FDA calls risk management. Risk management is the overall and ongoing process of assessing a product's benefits and risks, taking action as necessary to decrease known risks, and then tracking safety and making adjustments as necessary to assure that risks are kept in line with benefits.
As part of risk management, FDA may ask companies to collect specific information to improve the speed and sensitivity of detecting suspected safety problems. When this enhanced data collection is requested by FDA, it is called a pharmacovigilance plan. These exist for many long-acting and potent opioid products and contribute to safe use of the product by detecting, as rapidly as possible, adverse outcomes, including misuse, overdose, and abuse. Once problems are detected, there need to be actions to address them.
Actions to minimize risks that go beyond labeling changes are called risk minimization action plans or RiskMAPs. These are strategic safety programs designed to decrease known product risks by using one or more interventions, such as specialized education or restrictions on typical prescribing, dispensing, or use. The small number of RiskMAPs that exist are largely customized programs, although consistent approaches are being sought, for example, in the control of drugs that cause birth defects, such as thalidomide and isotretinoin.
FDA IS CONCERNED ABOUT THE INCREASED ABUSE OF PRESCRIPTION DRUGS
FDA is aware that some consumers are able to obtain controlled substances without a prescription, with many people using the Internet to purchase these drugs. FDA is concerned about the increasing abuse of prescription drugs, including opioid drugs. Abuse of opioid analgesics (controlled drugs that include oxycodone, morphine, fentanyl and hydrocodone), has risen steadily over the past five years. By contrast, overall rates of abuse of illicit drugs have been generally stable over the same time period.
FDA's goal is to assure that patients who require opioids for pain control maintain appropriate access to them through informed providers, while limiting misuse and abuse of these products to the extent possible. FDA takes its responsibility in meeting this goal very seriously. Given the broad scope of factors at issue, to achieve this goal, it is essential that FDA work in concert with other government agencies, professional societies, patient advocacy groups, industry, and others to share information and coordinate activities.
The Substance Abuse and Mental Health Services Administration (SAMHSA), another agency within HHS, annually conducts the National Survey on Drug Use and Health (NSDUH) on a random sample of U.S. households to determine the prevalence of non-medical use of illicit and prescription drugs. The 2004 NSDUH reported that 6.0 million persons, or 2.5 percent of Americans age 12 and older, were current users of psychotherapeutic drugs taken non-medically; 14.6 million persons, or 6.1 percent, had used such drugs nonmedically in the past year; and 48 million persons had used such drugs non-medically at least once in their lifetimes.
Also, according to the 2004 NSDUH, the number of people who had used pain relievers non-medically at least once during their lifetime increased 7 percent from 2002 to 2004, for a total of 31.8 million Americans. The prevalence of lifetime non-medical use of oxycodone-containing analgesics increased from an estimated 11.8 million users in 2002 to 13.7 million users in 2003.
The reported rise of prescription drug abuse is corroborated by data on the consequences of such use. SAMHSA's Drug Abuse Warning Network (DAWN) surveys a national sample of emergency departments (EDs). DAWN captures ED visits associated with substance abuse/misuse, both intentional and accidental, as well as visits related to the use of drugs for legitimate therapeutic purposes.
According to the 2004 DAWN Report, nearly 1.3 million ED visits in 2004 were associated with drug misuse/abuse. Non-medical use of pharmaceuticals was involved in nearly a half million of these ED visits. In addition, opiates/opioid analgesics (pain relievers), such as hydrocodone, oxycodone, and methadone were present in 158,281 ED visits, and benzodiazepines such as alprazolam and clonazepam were present in 144,385 ED visits associated with nonmedical use of pharmaceuticals in 2004. Muscle relaxants, particularly carisoprodol and cyclobenzaprine, were involved in an estimated 28,338 ED visits related to nonmedical use. Finally, over two-thirds of ED visits associated with opiates/opioids, benzodiazepines, and muscle relaxants involved multiple drugs, and alcohol was one of the other drugs in about a quarter of such visits.
The Treatment Episode Data Set (TEDS), also administered by SAMHSA, collects data on admissions to Federally funded drug and alcohol addiction treatment programs. Between 1999 and 2003, treatment admissions for primary abuse of opioids other than heroin increased from 1 percent of all admissions (22,637 admissions) in 1999 to 3 percent in 2004 (63,243 admissions).
FDA ACTIONS TO PREVENT ABUSE AND MISUSE OF PRESCRIPTION DRUGS
Support of National Drug Control Strategy
The President's 2006 National Drug Control Strategy continues to recognize the effectiveness of state prescription drug monitoring programs, and called on the pharmaceutical industry, medical community and state governments to become partners in an effort to prevent the illegal sale, diversion, and use of prescription drugs in a way that does not impede legitimate medical needs.
Collaboration with other Government Agencies
FDA is continuing to meet with DEA, ICE, SAMHSA, the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH), the Office of National Drug Control Policy (ONDCP), the Centers for Disease Control and Prevention, the American Medical Association (AMA), and industry to share information and insights needed to address the problem of prescription drug abuse.
FDA and DEA meet regularly to discuss new ways to prevent prescription drug abuse and misuse. In addition to assisting one another with criminal investigations, as described below, FDA (or other components of HHS) is working on the following initiatives:
Task Force Participation -- FDA participates in a number of task forces and other groups. Agents of FDA's Office of Criminal Investigations (OCI) frequently participate in and/or assist many DEA-led Federal-State task forces throughout the country focusing on the illegal sale of controlled prescription drugs.
FDA is a long-time participant of the Interagency Pharmaceutical Task Force (with participants from DEA, Customs and Border Protection (CBP), and ICE that meets frequently to devise and implement mutually agreed-upon policies and enforcement strategies for the interdiction and disposition of unlawful pharmaceuticals entering the United States. FDA also works with DEA to address the diversion of pharmaceuticals. DEA and FDA have established working relationships with eBay and internet service providers (ISPs) to prevent internet auction sites from being used to facilitate illegal controlled substance and other pharmaceutical product distributions. FDA has, often in conjunction with DEA and other agencies, met with ISPs couriers, and credit card companies to explore ideas for combating illegal internet drug sales that include, and may go beyond, traditional law enforcement methods.
FDA and DEA are members of the following working groups: Cross Border Pharmacy Working Group, Interagency Pharmaceutical Task Force, Permanent Forum on International Pharmaceutical Crime, Interagency Committee on Drug Control, Federal Trade Commission/FDA Health Fraud Working Group, and a working group composed of representatives from HHS (including FDA, SAMHSA, and NIH), DEA, ONDCP, and other agencies to address issues of drug abuse and control under the CSA. ICE and CBP participate in many of these working groups in an effort to collaborate with FDA in reducing the quantity of illegal dangerous drugs imported into the U.S. as well as to improve information sharing, increase public awareness and work cooperatively with industry.
In October of 2004, a cooperative effort with ONDCP, HHS (including FDA and the Office of the Surgeon General), and DEA was announced with the release of the first National Synthetic Drugs Action Plan. The cooperative effort included various programs aimed at addressing prescription abuse, including careful consideration by FDA of labeling and commercial promotion of opiate drug products, additional efforts by FDA, DOJ, DEA and others to investigate and prosecute "pill mills" (Internet pharmacies that illegally provide controlled substances), and various educational efforts aimed at providing safety, use, and disposal information on prescription drugs. FDA created a web site at: http://www.fda.gov/cder/consumerinfo/DPAdefault.htm#Misuse that continues to include updates and alerts on various medications. Consumers also can sign up for specific e-mail alerts.
An important component of FDA's strategic plan is to enable consumers to make smarter decisions by providing them with better information to weigh the benefits and risks of FDA-regulated products. FDA remains committed to ensuring that information on FDA's website is current, useful, and educational and provides consumers with important and timely drug safety information. On FDA's main website (www.fda.gov) there is additional information for patients on drug safety and side effects, public health alerts, and general information about major drugs. These web pages provide important information to patients regarding how to use their drug products safely. For example, in an effort to educate health care providers and consumers about the risks associated with OxyContin, FDA created an OxyContin Drug Information web page (www.fda.gov/cder/drug/infopage/oxycontin/default.htm). This page contains valuable information for consumers including the current approved labeling and approval letter, frequently asked questions, and articles on prescription drug abuse.
FDA worked closely with SAMHSA, NIDA, DOJ, DEA, DHS, ONDCP, and other Federal agencies, as part of the Synthetic Drugs Interagency Working Group (SDIWG), which was established to implement the recommendations of the National Synthetic Drugs Action Plan issued in 2004 and to develop the goals of the Synthetic Drug Control Strategy issued in June 2006. Prescription drug abuse is one of the many topics that both the Plan and the Strategy address.
Assessment of New Products With Abuse Potential -- As required by the CSA, FDA, on behalf of HHS, provides DEA with a scientific and medical evaluation of a drug's potential for abuse and misuse, whether a drug should be controlled under the CSA, and a recommendation as to the schedule.
FDA Seeks Expert Advice From Non-Agency Experts On Medical Use of Opioid Analgesics
FDA routinely convenes panels of non-Agency experts to seek outside advice through the use of its many advisory committees. Outside experts add a wide spectrum of judgment, outlook, and state-of-the-art experience to drug issues confronting FDA. These expert advisers add to FDA's understanding, so that final Agency decisions more likely will reflect a balanced evaluation. Advisory committee recommendations are not binding on FDA, but the Agency considers them carefully when deciding drug abuse issues.
FDA's Anesthetic and Life Support Drugs Advisory Committee, a panel of experts, has met twice within recent years to discuss the medical use of opioid analgesics, appropriate drug development plans to support approval of opioid analgesics, and strategies to communicate and manage the risks associated with opioid analgesics, particularly the risks of abuse of these drugs. The most recent meeting included DEA participation, and the Committee included both pain specialists and addiction experts. At this meeting, Committee members again advised FDA that opioid medications are essential for relieving pain. Members emphasized that a balanced approach should be taken to both meet the needs of patients with pain as well as to minimize opiate analgesic misprescribing, abuse, addiction, and diversion. They expressed a range of perspectives on the question of imposing restrictions on the prescribing of potent opioids. The pain specialists were concerned about hurting legitimate patients and reversing the progress in the appropriate treatment of pain as efforts were increased to address abuse and misuse, while the drug addiction experts urged more constraints on use.
FDA Monitors Advertising and Promotion
FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), in CDER, is responsible for regulating prescription drug advertising and promotion. DDMAC's mission is to protect the public health by ensuring that prescription drug information is truthful, balanced, and communicated accurately. This mission is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering optimal communication of labeling and promotional information to health care professionals and consumers.
FDA continues to monitor promotional materials for controlled substances, particularly for sustained release products, to ensure that claims are not false or misleading. Also, all product promotional materials must include information from "black box" warnings in the approved labeling. For example, the current approved product labeling for OxyContin contains a "black box" to convey serious risks associated with the use of the product. FDA has taken action against sponsors who violate this requirement or otherwise promote their product in a manner that is false or misleading. We will continue to monitor promotional materials for these products and use our regulatory authority to its fullest extent to ensure that healthcare providers and patients are not subjected to false or misleading claims for these products. As well, FDA's Office of Criminal Investigations remains vigilant to the possibility of criminally fraudulent marketing that may contribute to the problem of dependence.
CONCLUSION
FDA recognizes the serious problem of prescription drug abuse. The Agency will continue to take steps to curb abuse and misuse of prescription drugs. Since this is a problem that is broad in its reach and implications, we are committed to collaborating with our partners -- Federal, state and local officials, professional societies, and industry - to prevent abuse and help ensure that these important drugs remain available to appropriate patients.
I would like to thank the Subcommittee again for this opportunity to testify today on this important issue. I would be pleased to respond to any questions.
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