United States 114th Congress Status: Died 1 R cosponsors

HR 2335 — Stop Tampering of Prescription Pills Act of 2015

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

Stop Tampering of Prescription Pills Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to deny approval to a new oral opioid (a drug with effects similar to opium, such as morphine) that does not have properties that make the drug significantly more difficult to abuse if an abuse-deterrent drug containing the same opioid is available. The FDA may approve an opioid drug that is not abuse-deterrent if approval is necessary to prevent or alleviate a drug shortage or to address a significant unmet public health need. To be approved by the FDA, a generic version of an abuse-deterrent brand name drug must be at least comparably abuse-deterrent and its active components must not differ in any material respect from the brand name drug. An approved generic drug is not bioequivalent to, and does not have the same therapeutic effect as, a brand name drug that becomes abuse-deterrent unless the generic drug is at least comparably abuse-deterrent. Approval of a generic oral opioid is withdrawn if the brand name drug is not abuse-deterrent and not available and there is an approved abuse-deterrent drug available that contains the same opioid in the same dose. Approval of an oral opioid is withdrawn if the drug is not abuse-deterrent and there is an approved abuse-deterrent drug available that contains the same opioid. Withdrawal of approval may be waived by the FDA for a drug intended for a special needs population. The FDA must delay withdrawal to give the drug sponsor an opportunity to obtain approval for an abuse-deterrent formulation of the drug.

Bill Text

We don't have the full text on file for this bill yet.

Read HR 2335 on the official United States source →

Action History

  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

  3. Introduced in House

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 2335 do?
Stop Tampering of Prescription Pills Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to deny approval to a new oral opioid (a drug with effects similar to opium, such as morphine) that does not have properties that make the drug significantly more difficult to abuse if an abuse-deterrent drug containing the same opioid is available. The FDA may approve an opioid drug that is not abuse-deterrent if approval is necessary to prevent or alleviate a drug shortage or to address a significant unmet public health need. To be approved by the FDA, a generic version of an abuse-deterrent brand name drug must be at least comparably abuse-deterrent and its active components must not differ in any material respect from the brand name drug. An approved generic drug is not bioequivalent to, and does not have the same therapeutic effect as, a brand name drug that becomes abuse-deterrent unless the generic drug is at least comparably abuse-deterrent. Approval of a generic oral opioid is withdrawn if the brand name drug is not abuse-deterrent and not available and there is an approved abuse-deterrent drug available that contains the same opioid in the same dose. Approval of an oral opioid is withdrawn if the drug is not abuse-deterrent and there is an approved abuse-deterrent drug available that contains the same opioid. Withdrawal of approval may be waived by the FDA for a drug intended for a special needs population. The FDA must delay withdrawal to give the drug sponsor an opportunity to obtain approval for an abuse-deterrent formulation of the drug.
Who sponsors HR 2335?
HR 2335 is sponsored by William Keating (Republican).
What is the current status of HR 2335?
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 2335?
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