H.R.2335 - Stop Tampering of Prescription Pills Act of 2015114th Congress (2015-2016)
|Sponsor:||Rep. Keating, William R. [D-MA-9] (Introduced 05/14/2015)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 05/15/2015 Referred to the Subcommittee on Health. (All Actions)|
This bill has the status Introduced
Here are the steps for Status of Legislation:
Summary: H.R.2335 — 114th Congress (2015-2016)All Information (Except Text)
Introduced in House (05/14/2015)
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Approval of a generic oral opioid is withdrawn if the brand name drug is not abuse-deterrent and not available and there is an approved abuse-deterrent drug available that contains the same opioid in the same dose.Approval of an oral opioid is withdrawn if the drug is not abuse-deterrent and there is an approved abuse-deterrent drug available that contains the same opioid.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.