House and Senate Consider Amending the Controlled Substances Act to Facilitate
Drug Take-back

With the introduction of legislation by Reps. Jay Inslee (D-WA) and James Moran (D-VA) in February 2009, Congress officially took up the issue of amending the Controlled Substances Act to create new and better options for the safe disposal of controlled substances. Reps. Bart Stupak (D-MI) and Lamar Smith (R-TX) introduced a bill with the same aim in March. Today, the two bills in the House are mirrored by Senate legislation introduced in June by Sen. Patty Murray (D-WA) and Sen. Amy Klobuchar (D-MN). The bills represent two different approaches to facilitating safe drug take-back options:

• HR 1359 and S 1292 would require the Drug Enforcement Administration (DEA) to create regulations to allow an ultimate user or long-term care facility to deliver unwanted drugs to another, authorized person for the purposes of disposal.
• HR 1191 and S 1336 would require the Drug Enforcement Administration (DEA) to design five models, or types, of drug disposal options for controlled substances. Other types of drugs could be disposed of using these programs as well. States would be required to pass legislation to adopt one or more of the DEA-approved models, or they could propose an alternative. The models must be cost effective, environmentally-sound, convenient for both urban and rural populations, and run without law enforcement participation. Anyone with unwanted controlled substances (in a state that has adopted one or more of the models) could access the new disposal options.

While these bills would change the framework that determines how drug take-back programs can operate when controlled substances are involved, they do not specify who should manage or pay for drug take-back programs. The status of the bills is summarized below.

• HR 1191, the Safe Drug Disposal Act of 2009 was referred to the Committee on the Judiciary in the House of Representatives, where it has now been assigned to the Subcommittee on Crime, Terrorism, and Homeland Security. This bill has also been referred to the House Committee on Energy and Commerce because, in addition to addressing the controlled substances issue, it would amend the Food, Drugs, and Cosmetics Act to eliminate the use of flushing recommendations in Food and Drug Administration-approved drug labels. The companion bill, S 1336, was introduced by Sen. Murray on June 24, 2009. It has been referred to the Senate Judiciary Committee.
• HR 1359, the Secure and Responsible Drug Disposal Act of 2009, was referred to the Subcommittee on Crime, Terrorism, and Homeland Security in the House Committee on the Judiciary. S 1292 the companion bill introduced by Senator Klobuchar on June 18, has also been referred to the Senate Judiciary Committee.

A Subcommittee hearing was scheduled for June 18 but then cancelled due to activity on the House floor. However, Subcommittee and Congressional staffers have taken the opportunity to discuss the legislation and confer with DEA representatives.

Stakeholders in PSI’s National Dialogue on Waste Pharmaceuticals have been weighing the merits of the two approaches. Some stakeholders appreciate the much less-prescriptive approach taken in HR 1359 and S 1292, including the fact that state legislation would not be required to access the new disposal options as it would be in HR 1191 and S 1336. Others are concerned that this bill language could result in only one type of disposal option, and are concerned that there is nothing to require that that single option be more cost effective or convenient
than the current requirement that law enforcement be directly involved in take-back programs involving controlled substances. Other stakeholders, however, prefer HR 1191 and S 1336 specifically because they require that new drug disposal options meet criteria related to cost, convenience, and the environment. Many stakeholders also like the fact that HR 1191 and S 1336 would allow a wider range of individuals to access new disposal options.

Bill status, including co-sponsors, can be tracked using http://thomas.loc.gov/.