Pseudoephedrine is the active ingredient in many cold medications. Pseudoephedrine is also a key ingredient in methamphetamine, a highly addictive illegal drug that is imported into the United States primarily from Mexico and is also produced in homemade "laboratories" that have sprung up throughout the United States. States, in response to both the growing problem of methamphetamine abuse and the inability of traditional law enforcement to adequately deal with that problem, have targeted the pharmaceutical industry to stem the tide of methamphetamine abuse by restricting the sale of certain pseudoephedrine-containing products.
Congress is considering similar restrictions that would greatly impact the pharmaceutical industry. Congress is also considering a foreign-policy based approach to the methamphetamine crisis that focuses on reducing the amount of methamphetamine that comes into the United States from Mexico and other countries.
As a result of legislative activity, some manufacturers have begun producing pseudoephedrine-free versions of their traditional cold medications. Many retailers, including Target, Rite-Aid, Wal-Mart, CVS, and Walgreens, have voluntarily moved certain pseudoephedrine-containing products behind the counter. Joining the trend, the on-line auction site eBay recently banned the sale of pseudoephedrine-containing medication. Both directly and indirectly, the pharmaceutical industry is being impacted by the inability of federal, state, and local governments to prevent the spread of methamphetamine abuse.
Methamphetamine is a highly addictive central nervous system stimulant that increases energy and alertness and decreases appetite. There are an estimated 1.3 million regular methamphetamine users in the United States today. Users experience a powerful, intense rush after taking the drug. Methamphetamine users can quickly become addicts, despite side effects that include, among other things, convulsions, stroke, stomach cramps, and shaking. Chronic use can lead to violent behavior, anxiety, confusion, insomnia, hallucinations, mood disturbances, delusions, paranoia, and brain damage.
Historically, the primary sources of methamphetamine were clandestine laboratories in California and Mexico with methamphetamine abuse originally concentrated in the western, southwestern, and central United States. Outlaw motorcycle gangs controlled much of the methamphetamine distribution in the United States until the mid-1990s. At that time Mexican drug trafficking organizations became involved in the production and distribution of the drug. However, as use of the drug expanded across the United States, production sites also spread across the central, southern and eastern United States. Enforcement efforts also expanded. In 1995, the United States Drug Enforcement Agency ("DEA") seized 162 American methamphetamine "laboratories" in 1995, whereas last year the DEA seized 9,797. At this time, federal officials estimate that Mexican drug cartels produce 65% of the methamphetamine consumed in the United States, while homemade "laboratories" in this country produce 35% of the methamphetamine.
Part of the reason for the increase in the number of smaller clandestine American "laboratories" - those that are not controlled by outlaw motorcycle gangs or Mexican drug cartels - is their ability to produce methamphetamine easily and inexpensively. A methamphetamine "cook" can use common consumer goods, i.e. mason jars, coffee filters, plastic tubing, and gas cans, in place of actual laboratory equipment. Similarly, the ingredients used to make the drug are consumer goods such as cold medicines, drain cleaners, lithium batteries, lantern fuel, and starter fluid. The Internet, with its readily available methamphetamine "recipes," contributes to the ease of production. The ease by which the drug can be manufactured and its highly addictive nature has generated the methamphetamine epidemic.
The consequences of methamphetamine abuse are not limited to the deaths and addictions of users. "Laboratories" where the drug is produced create hazardous waste and pose health and environmental hazards. Smaller "laboratories" usually located in residences or mobile units create six pounds of toxic waste for every pound of methamphetamine produced. The average cost of a clean-up of a "laboratory" is $5,000, but it can easily rise to over $100,000 for larger "laboratories."
As the negative societal consequences of methamphetamine abuse became more prevalent and intractable, states began to think of novel ways to deal with the problem. Oklahoma was the first state to pass legislation establishing strict guidelines for the sale of certain pseudoephedrine-containing products. Oklahoma's 2004 law, among other things, added products that contain pseudoephedrine in tablet form to the Schedule V class of drugs regulated by the Oklahoma Bureau of Narcotics and Dangerous Drugs. The law places restrictions on the sale of pseudoephedrine by requiring that only licensed pharmacists can sell such products in tablet form and only after the customer provides identification and signs a log book recording the sale. The law also limits the amount of pseudoephedrine that a person can purchase within a thirty-day period to nine grams.
As a result of the law, Oklahoma experienced an 80% drop in the number of methamphetamine lab seizures. Because of this success, many other states have looked to Oklahoma as a model and have enacted legislation restricting the sale of pseudoephedrine-containing products. To date, 26 states have passed pseudoephedrine laws, while 17 others are considering such legislation.1
However, questions have been raised regarding how successful the Oklahoma law has been in fighting the methamphetamine epidemic. Oklahoma law enforcement officials have acknowledged that there has been a large influx of methamphetamine into the state from Mexican "laboratories," and that as a result the supply of methamphetamine remains the same as it was prior to the passage of Oklahoma's law. Furthermore, the number of users of the drug has not declined. Passage of the law seems to have eliminated one supply source of the drug, but has not affected the overall availability of the drug since Mexican suppliers have filled the void created by Oklahoma's attempt to eliminate local "laboratories." Nonetheless, as a result of having fewer local "laboratories," Oklahoma officials have recently been able to turn their investigative attention to stopping the importation of methamphetamine into the state.
Although 26 states have passed laws restricting the sale of certain pseudoephedrine-containing products, producers of methamphetamine can evade those laws by driving to a neighboring state that does not have such restrictions. Thus, despite the growing trend among the states to pass pseudoephedrine laws, supporters of federal legislation argue that Congress must nonetheless act and impose a uniform standard to govern the entire country. Moreover, because the state laws generally differ in at least some aspects such as in the amount that can be sold, the requirements imposed upon retailers, and the exceptions or exemptions in the laws, some supporters of federal legislation are urging Congress to pass a uniform standard. In that regard, retailers that have voluntarily moved certain pseudoephedrine-containing products behind the counter have cited the difficulty of complying with various state laws. The National Association of Chain Drug Stores, which initially opposed federal legislation, has reversed its position and expressed its support for federal legislation to create a national, uniform standard to govern the sale of pseudoephedrine-containing products that would preempt state laws.
The problem of methamphetamine abuse, and the clamor for federal legislation, has not gone unnoticed by Congress. The several bills introduced in Congress concerning pseudoephedrine take different approaches to fighting methamphetamine abuse. One of the more prominent bills is S.103, the "Combat Meth Act of 2005." It is modeled on the Oklahoma law.2 (The companion bill to S.103 in the House of Representatives is H.R. 314.) Among other things, this bill would add pseudoephedrine to Schedule V of the Controlled Substances Act and would require pseudoephedrine products to be sold only by licensed pharmacists or licensed pharmacy technicians from behind the counter.3 In addition, the bill would require a person purchasing pseudoephedrine to produce a photo identification showing date of birth and sign a written log indicating the date of the transaction and the name and the amount of the substance purchased. The bill also provides that within any thirty-day period an individual can purchase only a maximum of nine grams of pseudoephedrine.4 In September 2005, the Senate passed the bill by unanimous consent, but the House has not yet considered it.
Despite the Senate's passage of S.103, some members of the House are advocating a different approach to the problem of methamphetamine abuse. Rather than placing pseudoephedrine products behind the counter, H.R. 3889, the "Methamphetamine Epidemic Elimination Act," addresses the problem primarily by targeting foreign suppliers of methamphetamine. H.R. 3889, which was introduced following the Senate's passage of S.103, is sponsored by both Democrats and Republicans. Among other things, H.R. 3889 would: 1) allow federal officials to track the sales of pseudoephedrine from the factories that produce the chemical worldwide; 2) allow the DEA to set import quotas for the United States for pseudoephedrine and impose harsher penalties for methamphetamine trafficking; and 3) reduce the amount of pseuoephedrine-containing products that could be sold to one customer. Beyond that, the bill requires the Secretary of State to "take such actions as are necessary to prevent the smuggling of methamphetamine into the United States from Mexico." Several House members want to empower the State Department to withdraw aid from countries that import excessive amounts of cold medicines.
Senators Talent (R-Mo.) and Feinstein (D-Ca.), co-sponsors and strong advocates of S.103, argue the bill will greatly reduce the number of local "laboratories" by depriving them of their main source of pseudoephedrine. In contrast, sponsors of H.R. 3889 contend that Congress should focus on ending the ability of Mexican traffickers to produce methamphetamine and export it to the United States. After the introduction of H.R. 3889, Senator Talent expressed concern that the bill did not contain a provision that would move pseudoephedrine-containing products behind the counter and opined that the bill did not do enough to limit the sale of pseudoephedrine. However, Representative Souder (R-Ind.), a sponsor of the bill and the chairman of the House Government Reform Committee's subcommittee on criminal justice, drug policy, and human resources, which has held a number of hearings on the problem of methamphetamine abuse, does not believe that placing pseudoephedrine-containing products behind the counter is necessary or effective and has expressed concern that such restrictions could put small retailers out of business. Thus, he and his co-sponsors have focused their legislative efforts on reducing the amount of methamphetamine brought into the country from Mexico.
At this time it is unclear what path Congress will take. S.103 is awaiting negotiations with the House, and if the House passes H.R. 3889, the Senate would have to consider it as well. There are several things that could happen in Congress, including: 1) one of the bills may become the favored approach and the other bill will not be enacted; 2) S.103 and H.R. 3889 could both pass, with Congress treating them as complementing approaches to the problem of methamphetamine abuse; or 3) neither bill could be enacted. Some sponsors of H.R. 3889, including Representative Blunt, the new House majority leader, also support S.103. Of course, even if the Congress passes either or both bills, President Bush must still sign such legislation into law. To date, the White House has not taken a position on these bills.
Consequently, it is possible that Congress might pass S.103 and establish a national standard governing the sale of pseudoephedrine products from behind the counter, or it may enact legislation that would impose different restrictions on the sale of such products. Alternatively, Congress may focus its efforts on blocking methamphetamines from being brought into the country. Regardless of what Congress does, the pharmaceutical industry must be aware of the ever-changing landscape on the state level because, depending on the state, the sale of such products is already restricted or may be restricted in the future. The current situation, whereby different states impose different solutions, is unworkable. Although the pharmaceutical industry and retailers would prefer a uniform federal standard, it is possible that Congressional intervention could further complicate the situation because the states might still be free to enact more rigorous restrictions. Therefore, the pharmaceutical industry, retailers, and other affected entities would be well-advised to stay abreast of the current debate in Congress and the states and participate in the debate to protect their interests.
1 The number of states that have passed or are considering such legislation is likely to change by the date of publication of this article.
2 S. 103, 109th Cong. (2005).
3 Id. § 104(a)-(b).
4 Id. § 104(b).
Christopher P. DePhillips is a Principal of Porzio, Bromberg & Newman, P.C., in Morristown, New York City, and Brick Township. He is Co-Chairman of the firm's Product Liability and Mass Tort Group and is a Member of the firm's Governmental Affairs Practice. Brian P. Sharkey is an Associate of the firm concentrating in products liability and mass torts.