PhRMA Statement on Recent Comments to Drug Enforcement Administration

Regarding the Secure and Responsible Drug Disposal Act of 2010

Washington, D.C. (January 20, 2011) — The Pharmaceutical Research and Manufacturers of America (PhRMA) recently had the opportunity to provide comments to the Drug Enforcement Administration (DEA) regarding the development of procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities:

“Regarding regulations surrounding the implementation of the Secure and Responsible Drug Disposal Act of 2010, PhRMA shares the DEA’s concern on the growing non-medical use of prescription drugs. At the same time, however, it is critical that any policies aimed at preventing prescription drug abuse do not unintentionally create barriers to or limits on patient access to needed medicines.

“Potential barriers to patient access include poor or insufficient training of health care workers regarding appropriate prescribing practices, unnecessarily restrictive drug control regulations and practices which may impede good clinical care, and fear among health care workers of the potential for legal sanctions for legitimate medical practice which may lead to under treatment.

“There is an identified need for broad stakeholder engagement to help respond to this public health issue. National data on prescription drug abuse reinforces the notion that all stakeholders – the federal government, PhRMA, the Generic Pharmaceutical Association, American Medical Association, and relevant health care and law enforcement organizations – have an important role in helping improve communications between providers and patients, as well as the need to improve patient monitoring among all health care stakeholders.

“PhRMA believes strongly that a secure and responsible disposal program must not create new avenues for diversion and must be coupled with a comprehensive consumer educational effort that instructs all stakeholders on protection against diversion of controlled substances, appropriate use of medication and medication adherence, secure and responsible storage of prescription medicines, prompt and safe disposal of any unused medicines, and includes adequate recordkeeping and data collection efforts.”

“America’s biopharmaceutical research companies have a long history of supporting partnerships like SMARxT Disposal and the DEA’s National Take Back Day that highlight consumer education about safe medication disposal. PhRMA partners with the Department of Fish and Wildlife and the American Pharmacists Association on the SMARxT Disposal Program (www.smarxtdisposal.net). This program informs people how to safely dispose of medicines in the trash, and notes the environmental risk posed by flushing medicines down the toilet. PhRMA recommends that all unused medicines, unless specified otherwise by the Food and Drug Administration, should be mixed with water; sealed in an opaque container safely secure from children, pets, and others; then discarded in household trash to be later incinerated or placed in a government approved solid waste landfill. Consumers may also take part in the DEA’s National Take Back Day as a way to safely dispose of medications in a way that prevents diversion or potential for abuse.


The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

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