Introduction
The purpose of this paper is to discuss the formulation and implementation of drug abuse policies in the US. Specifically, the paper will focus on the rules that regulate the use of perampanel in the US.
The role of the Drug Enforcement Administration (DEA) in the formulation and implementation of laws that regulate the use of various drugs will also be discussed. In addition, the paper will highlight the role of the Congress, presidential transition, the courts, and the head of DEA in the process of making the rules that regulate the use of perampanel.
Drug Policy and DEA
The US drug policy focuses on reducing the abuse of various drugs and controlled substances. The policy is meant to address three issues namely, addiction, rehabilitation of addicts, and reducing the criminal activities associated with drug and substance abuse. Generally, the use of various drugs is controlled to protect public health. Perampanel is a “new chemical entity with central nervous system depressant and hallucinogenic properties” (GPO, 2014).
It was approved by the Food and Drug Administration (FDA) in 2012 to be used in the US for treatment of partial-onset seizure in epileptic patients.
However, uncontrolled use of perampanel can lead to negative health effects such as addiction (GPO, 2014). DEA enhances public health by ensuring that drugs that have abuse potential such as perampanel are used appropriately. To achieve this goal, DEA collaborates with FDA and the Human and Health Services (HHS) to analyze and classify drugs before approving their use (DEA, 2014).
The Controlled Substances Act (CSA)
The CSA was enacted to regulate the production and use of various substances and chemicals that have abuse potential. The aim of the CSA is to promote legitimate use of controlled substances and chemicals for medical, scientific, and industrial applications in the US. It provides a framework for classifying (listing) controlled substances into five different categories.
The categories are referred to as schedules and are identified by roman numbers, which range from one to five. The classification takes into account, a substance’s “potential for abuse, currently accepted medical use, and the degree of dependency that it can cause” (DEA, 2014).
The Attorney General has the power to classify various substances in the appropriate categories if he is sure that they can be abused. DEA has been granted the authority to list controlled chemicals on behalf of the Attorney General. The CSA allows any interested party to request DEA to classify or list various substances in the appropriate schedule.
The Role of DEA in Implementation of the CSA
DEA enforces the CSA by identifying the drugs and substances that must be controlled. After conducting preliminary investigations, DEA solicits advice from the HHS on whether the use of a given substance has to be controlled.
The HHS, on the other hand, seeks advice from FDA concerning the abuse potential of the substance. DEA uses the recommendations from the HHS and FDA to determine the drugs and substances whose use must be regulated (DEA 2014). In order to make an objective determination, DEA augments the findings of FDA and the HHS with its own scientific research on the substance or drug.
DEA uses a closed distribution system to control possession of listed chemicals and controlled drugs. This involves registering individuals and organizations such as clinics and pharmacies that intend to sell or prescribe the drugs to patients. Generally, the CSA requires all individuals who “manufacture, distribute, dispense, import, or export controlled substance to register with DEA”.
Rules Made by DEA
In order to regulate the use of perampanel, DEA created and executed the following rules. First, DEA classified perampanel as a schedule III substance (GPO, 2014). This means that the use of perampanel has to be guided by the regulations that apply to all substances in schedule III.
In particular, the individuals who handle the drug in various ways such as production or distribution must register with DEA. As a result, the company that manufactures perampanel had to stop distributing it before seeking the approval of DEA. This rule was meant to prevent misuse of perampanel by selling it to patients who did not qualify to use it.
Second, DEA decided that perampanel is subject to the security regulations that are outlined in the CSA. In particular, all individuals and organizations that handle perampanel are required to put in place effective controls to prevent theft or diversion of the drug to the illicit market (GPO, 2014).
DEA enforces this rule by taking into account several factors that determine the level of security that is required for effective handling of perampanel. The factors include location of the handler’s premises, the type of building used to store perampanel, and the type of activity conducted (manufacturing, distributing or prescribing the drug).
Third, all the packaging materials used to distribute perampanel have to comply with the requirements of the CSA (GPO, 2014). In this regard, every container that carries the drug must have a printed label that bears the symbol of the schedule in which it belongs.
The label has to be fixed on the part of the container that can be seen easily by the person who is dispensing the drug. The rationale of enforcing the labeling rule is to ensure that handlers and users of perampanel have sufficient information about its ingredients and the side-effects of using it. This will prevent misuse of the drug, thereby protecting public health.
Enforcement of the Rules
DEA intends to use several ways to enforce the rules outlined in the foregoing paragraph. To begin with, DEA has so far ensured that the company that manufactures perampanel is registered as a producer (DEA, 2014). In addition, DEA has ensured that the company has adequate control mechanisms to prevent diversion of the drug. DEA is currently registering the individuals and organizations that intend to handle perampanel in the US (DEA, 2014).
As the drug becomes available in the market, DEA will use asset forfeiture as a mechanism to control its distribution (DEA, 2014). This will involve taking possession of the assets of organizations that will be found to be selling or manufacturing the drug illegally. Generally, DEA is likely to confiscate and destroy the stock of perampanel that is being sold or manufactured illegally in the US (DEA, 2014). Asset forfeiture will disrupt the supply chain of unregistered handlers of perampanel, thereby preventing its diversion to the illicit market.
DEA will also take legal action against organizations that handle perampanel without complying with its rules (DEA, 2014). The organization has established investigation systems to acquire information about the activities of those who are handling perampanel. For example, DEA encourages members of the public to be its whistleblowers by reporting individuals and organizations that are handling the drug illegally or without complying with the security and labeling rules (DEA, 2014).
Mechanisms of Accountability
The rules made by the Drug Enforcement Administration were submitted to the Congress for discussion and assessment. The aim of the submission was to enable Congress to perform its oversight function by determining whether DEA complied with all the provisions for rulemaking at the agency level.
Upon reviewing the submissions, Congress found that the rules were not major (DEA, 2014). Specifically, they were not expected to have an effect on the economy of at least $100 million per year (GPO, 2014). In addition, they were not expected to cause a significant increase in costs and prices in the country or to hinder competition. As a result, the rules were approved for implementation.
The president used Executive Order 13563 to perform his oversight function. In order to comply with the order, DEA allowed all interested parties to file a request for hearing to present their views concerning the suitability of the rules. However, there were no requests from the public apart from the few individuals who urged DEA to control the use of the drug. Lack of opposition from the public implied that the rules were appropriate.
Influence of Presidential Transition
Presidential transition did not have much influence on the rules made by DEA to regulate the use of perampanel. This is explained in part by the fact that the rules were made after President Obama had been elected and assumed office for a second term in 2012. Another reason for the little influence of presidential transition is that both the democrats and the republicans agreed that drugs with high abuse potential have to be controlled.
Thus, both parties had developed comprehensive polices that they promised to use to curb distribution of illicit drugs in the country. In future, presidential transition is likely to influence DEA’s rulemaking initiatives. Given the slow growth of the economy, each party is likely to support rules that not only prevent drug trafficking, but also promote commercial production of controlled substances that have medicinal and industrial applications.
Influence of the Head of DEA
The head of DEA is likely to influence the process of making rules that regulate the use of perampanel and other substances that have abuse potential in future in two ways. First, the head is likely to promote collaboration among various state, federal, local, and foreign agencies that are involved in regulating the use of drugs (DEA, 2014).
Collaboration will enable the head of DEA to convince various agencies to support his or her stance on the rules that have to be adopted to control drugs and other substances. Second, the head of DEA will play a critical role in publicizing the rules that will be proposed to control drugs such as perampanel. This will involve explaining the position of DEA concerning various rules in order to avert opposition from the public.
Challenges in Rulemaking and how they were Resolved by the Court
The major challenge to DEA’s rulemaking came from Eisai, the company that manufactures perampanel. Although FDA approved “the use of perampanel in October 2012, it could not be marketed before being listed by DEA” (Eisai, 2013). By October 2013, DEA had not taken any action to classify perampanel.
As a result, Eisai lost almost one year before starting to manufacture and to sell the drug in the US. In order to avoid losing more time, Eisai filed a “petition for a writ of mandamus in the US Court of Appeals for the District of Columbia Circuit to compel DEA to issue a Notice of Proposed Rulemaking (NPRM)” (Eisai, 2013).
In response to Eisai’s petition, DEA argued that the delay was necessary to conduct adequate scientific research to determine the effects of perampanel before scheduling it. Moreover, the Drug Enforcement Administration pledged to publish a NPRM within 30 days. Fortunately, DEA kept its promise and issued the NPRM within the required timeline. Thus, the Courts of Appeals for the D.C Circuit declined to grant the writ as requested by Eisai.
In making this determination, the court asserted that the time that was required by DEA to schedule the drug was not too long or too short. Thus, it did not warrant granting a writ of mandamus to compel DEA to schedule the drug immediately. This ruling enabled DEA to complete its scientific research in order to schedule perampanel and to make appropriate rules to regulate its use.
The second challenge was filled by a physician who wanted DEA to make the rules effective on the day of their publication. This would enable doctors and patients to access the drug as soon as possible. In response to this challenge, DEA argued that an early effective date was not necessary because the CSA requires it to issue effective dates that allow for at least 30 days for compliance after publishing a rule (GPO, 2014).
DEA also argued that reducing the compliance period would not have any significant public health effects since there were other drugs that were already being used to treat epilepsies. As a result, DEA won the case and made the rules effective 30 days after publishing them.
Influence of the News Media
The news media created awareness about the medical application of perampanel and the side effects of using it. This led to a debate on whether the drug should be controlled or not. In order to end this debate, DEA had to conduct its own research in order to make the appropriate decision concerning the use of perampanel. The news media also publicized the challenges that faced the rulemaking process such as the petition filed by Eisai. DEA had to act swiftly to deal with the challenges in order to avoid negative publicity (DEA, 2014).
Conclusion
DEA is responsible for enforcing the CSA in order to prevent abuse of drugs. DEA’s officials make rules to regulate the use of various drugs and substances as required by the CSA. Since perampanel has abuse potential, DEA classified it as a schedule III drug.
Consequently, the rules that were enacted to regulate the use of the drug included registration of its handlers, ensuring security to prevent its diversion, and labeling it appropriately to avoid confusion. In order to avoid challenges in rulemaking in future, DEA should avoid unnecessary delays in issuing a NPRM.
References
DEA. (2014). Operations. Web.
Eisai. (2013). Citizen petition. Web.
GPO. (2014). Schedules of controlled substances: Placement of perampanel into schedule III. Web.
Kleiman, M., Caulkins, J., & Hawken, A. (2011). Drugs and drug policy: What everyone needs to know. New York, NY: McGraw-Hill.