H.R. 4586, Lali's Law

H.R. 4586

Lali's Law

Date
May 11, 2016 (114th Congress, 2nd Session)

Staff Contact
John Huston

Floor Situation

On Wednesday, May 11, 2016, the House will consider H.R. 4586, Lali’s Law, under suspension of the rules. H.R. 4586 was introduced on February 23, 2016, by Rep. Bob Dold (R-IL), and was referred to the Committee on Energy and Commerce, which ordered the bill reported by voice vote on April 28, 2016.

Bill Summary

H.R. 4586 authorizes grants to States for developing standing orders for naloxone prescriptions and educating health care professionals regarding the dispensing of opioid overdose reversal medication without person-specific prescriptions. The bill authorizes the appropriation of $5 million for the period of fiscal years 2017 through 2019.

Background

The United States is experiencing an epidemic of drug overdose deaths. Since 2000, the rate of deaths from drug overdoses has increased 137 percent, including a 200 percent increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin). During 2014, a total of 47,055 drug overdose deaths occurred in the United States, with more than 28,000 deaths involving some type of opioid, including heroin.[1]

Naloxone is a medication called an “opioid antagonist” used to counter the effects of opioid overdose from both prescription pain killers and illegal opioids.. Specifically, naloxone is used in opioid overdoses to counteract life-threatening depression of the central nervous system and respiratory system.. Naloxone is a nonscheduled (i.e., non-addictive), prescription medication with little to no side effects if taken by someone who is not experiencing an opioid overdose. [2].

Naloxone is regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA), which gives the Food and Drug Administration (FDA) responsibility for ensuring the safety and effectiveness of prescription and over-the-counter pharmaceuticals sold in the United States. At present, naloxone is not approved as an over-the-counter (OTC) drug.[3] However, many states allow OTC-like access to the antidote for certain individuals.[4]

The bill is named after Alex Laliberte who died from a drug overdose in his childhood home at the age of 20. Laliberte played sports at Stevenson High School, did well in school and cared about his friends and family, but during his sophomore year of college he began being hospitalized for a mysterious illness. Unknown to his family and doctors, Laliberte had an addiction to prescription drugs and was being hospitalized for his withdrawal. He would stay in the hospital until his symptoms subsided only to leave the hospital and repeat the cycle. Laliberte continued this pattern until he died of an opioid/benzodiazepine overdose a few days before his final exams. Shortly after Alex’s death, his family founded substance use and overdose awareness and advocacy organization Live4Lali.[5]

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[1] See CDC: Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014
[2] See Harm Reduction Coalition website, Understanding Naloxone
[3] See CRS Report, “Heroin and Prescription Opioid Abuse: Access to Naloxone to Treat Overdose,” April 25, 2016.
[4] See Regulatory Affairs Professionals Society website, “OTC Opioid Overdose Antidote: Why is it not FDA Approved?” February, 24, 2016.
[5] See Rep. Bob Dold Press Release, “Lali’s Law Unanimously Passes House Committee, Heads to House Floor for Vote,” April 28, 2016.

Cost

A Congressional Budget Office (CBO) cost estimate is currently not available. However, authorizes the appropriation of $5 million for the period of fiscal years 2017-2020. . The bill is cut-go compliant.

Additional Information

For questions or further information please contact John Huston with the House Republican Policy Committee by email or at 6-5539.