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S. 419 (116th): Protecting Americans from Dangerous Opioids Act

The text of the bill below is as of Feb 7, 2019 (Introduced). The bill was not enacted into law.



1st Session

S. 419


February 7, 2019

introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions


To require the Food and Drug Administration to revoke the approval of one opioid pain medication for each new opioid pain medication approved.


Short title

This Act may be cited as the Protecting Americans from Dangerous Opioids Act.



Congress finds as follows:


Opioids killed more than 33,000 people in the United States in 2015, more than any year on record. Nearly half of all opioid overdose deaths involve a prescription opioid.


According to the Centers for Disease Control, 3 out of 4 new heroin users abused prescription opioids before moving to heroin.


The United States makes up only 4.6 percent of the world's population, but consumes 80 percent of its opioid pain medications.


In 2012, health care providers wrote 259,000,000 prescriptions for painkillers, enough for every individual in the United States to have a bottle of pills.


The amount of prescription opioids sold in the United States has nearly quadrupled since 1999 without a reported increase in pain. At the same time overdose deaths involving opioids have also quadrupled since 1999.


Requirement to revoke approval


In general

Notwithstanding any other provision of law, if the Secretary of Health and Human Services (referred to in this section as the Secretary) approves an application under subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for an opioid drug, the Secretary shall revoke the approval of another opioid drug previously approved under such subsection (b) or (j).



In determining the drug for which the Secretary will revoke approval pursuant to subsection (a), the Secretary shall—


prioritize revocation of non-abuse deterrent formulations of opioid drugs; and


consider the public health impact of the opioid drug being on the market.