Opioid Review Modernization Act of 2016

Bill: 114-hr-4976
Sponsor: Rep. Maloney, Sean Patrick [D-NY-18]
Introduced: 2016-04-18 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Advisory bodies
Child health
Congressional oversight
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Drug trafficking and controlled substances
Food and Drug Administration (FDA)
Prescription drugs

Summary:
action_date: 2016-04-18
text: 

Opioid Review Modernization Act of 2016

 
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.
 
The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.
 
As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.
 The FDA must finalize the draft guidance entitled &quot;General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.&quot;
action_date: 2016-05-10
text: 
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)
 

Opioid Review Modernization Act of 2016

 
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.
 
The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.
 
(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.
 (Sec. 4) The FDA must finalize the draft guidance entitled &quot;General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.&quot;
action_date: 2016-05-11
text: 
(This measure has not been amended since it was introduced. The expanded summary of the House reported version is repeated here.)
 

Opioid Review Modernization Act of 2016

 
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.
 
The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.
 
(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.
 (Sec. 4) The FDA must finalize the draft guidance entitled &quot;General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.&quot;

Legislative actions:
action_date: 2016-05-12
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2016-05-11
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2016-05-11
text: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256)
action_date: 2016-05-11
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H2254-2256)
action_date: 2016-05-11
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 4976.
action_date: 2016-05-11
text: Considered under suspension of the rules. (consideration: CR H2254-2256)
action_date: 2016-05-11
text: Mr. Guthrie moved to suspend the rules and pass the bill.
action_date: 2016-05-10
text: Placed on the Union Calendar, Calendar No. 431.
action_date: 2016-05-10
text: Reported by the Committee on Energy and Commerce. H. Rept. 114-557.
action_date: 2016-05-10
text: Reported by the Committee on Energy and Commerce. H. Rept. 114-557.
action_date: 2016-04-27
text: Ordered to be Reported by Voice Vote.
action_date: 2016-04-27
text: Committee Consideration and Mark-up Session Held.
action_date: 2016-04-26
text: Committee Consideration and Mark-up Session Held.
action_date: 2016-04-25
text: Committee Consideration and Mark-up Session Held.
action_date: 2016-04-20
text: Forwarded by Subcommittee to Full Committee by Voice Vote .
action_date: 2016-04-20
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2016-04-18
text: Referred to the Subcommittee on Health.
action_date: 2016-04-18
text: Referred to the House Committee on Energy and Commerce.
action_date: 2016-04-18
text: Introduced in House
action_date: 2016-04-18
text: Introduced in House