H.R. 6160House112th Congress (2011-2013)In Committee

Stop Tampering of Prescription Pills Act of 2012

Legislative Activity

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Referred to the Subcommittee on Health.

Health Subcommittee

July 20, 2012

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HouseIntro Referral

Introduced in House

July 19, 2012

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

July 19, 2012

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

July 20, 2012

Floor Debate

1 member

What members said about H.R. 6160 on the floor

1 Democrat

Rep. William R. KeatingD-MA-10 · Aug 1, 2012

I would like to thank Congressman Rahall for organizing this morning-hour on prescription drug abuse. I would also like to thank Chairman Rogers for his work as well as Congresswoman Mary Bono Mack,…

Prescription drug abuse is defined now as an epidemic in this country, and the cost of this epidemic is more than $70 billion a year. This is by no means just a criminal issue, and that's where the stigma sometimes makes this issue more difficult. It is, indeed, a public health issue, and for this reason Congress needs to step in.

Painkillers account for the country's fastest growing area of drug abuse, which is ahead of cocaine, heroin, and methamphetamine. Throughout my 12-year career as a Norfolk County district attorney in Massachusetts, the susceptibility of new users, particularly of teenagers, to these drugs has been a recurring theme. As district attorney, I have seen in concrete terms that this scourge goes across every social and economic boundary that exists.

I have seen law enforcement officials, while on duty and who were involved in automobile accidents, take these painkillers, become addicted and actually go out with their guns and rob--armed robbery-- banks and other institutions in order to just try and feed their habits. I've seen real estate professionals get involved and go to open houses just to search medicine cabinets in order to fulfill their habits. I have also seen young people begin addictions and abuses of prescription drugs from their families' medicine cabinets, finding that later on they cannot afford their habits, and move to a cheaper, purer form of heroin.

I've seen the public health effects of this as well. I've seen the HIV disease spread to people. I've seen 14-year-old girls with hepatitis C as a result of trying to deal with this scourge that is an epidemic around our country.

In Massachusetts alone, 1.7 people every day die of an opiate- derivative overdose. In 2010, the National Institute of Drug Abuse showed that 2.7 percent of eighth-graders, 7.7 percent of 10th-graders, and 8 percent of 12th-graders abused Vicodin. Over 2 percent of eighth- graders, almost 5 percent of 10th-graders, and over 5 percent of 12th- graders abused OxyContin for nonmedical purposes at least once in the year prior to that survey. This is why I've introduced the Stop Tampering of Prescription Pills Act, the STOPP Act of 2012, with Chairman Rogers, Congresswoman Bono Mack, and my other colleagues.

Currently, tamper-resistant mechanisms are in use for some drugs, but this bill is the first of its kind Federal legislation to put a clear pathway for others to come to market. The process outlined in the bill applies both to brand name and generic drugs, both to time-release and to immediate-release pills. Initially, we will incentivize the use of these tamper-resistant processes. Then, in time, they'll be required. This bill is not a silver bullet by any stretch of the imagination, but

it is a very important piece in preventing new users from abusing painkillers and safeguarding against overdose. Just as seatbelts and airbags in cars cannot prevent all car accidents, tamper-resistant formulations will not prevent all instances of drug abuse, but it is a necessary tool in protecting vulnerable populations like the adolescents I have spoken about.

With this bill, we're also preparing for the potential onslaught of pure hydrocodone pills. These are currently being developed, and without proper physical and pharmaceutical barriers in place to prevent the tampering of these painkillers, this potential advent of pure hydrocodone will dramatically increase the already alarming rates of abuse and addiction. The bill would mandate the tamper resistance of these pills, as well as many others.

These pills provide great relief for many Americans in terms of extreme pain, but we must do something about another type of pain, a terminal pain, a pain that family members and loved ones feel when they have lost someone to the disease that results in this type of addiction.

I encourage all my colleagues in the House to cosponsor H.R. 6160, and further encourage the development of these tamper-resistant mechanisms. It's not a silver bullet, but it's an important first step.

Bill Text

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Introduced in HouseIssued July 19, 2012

112th CONGRESS

2d Session

H. R. 6160

IN THE HOUSE OF REPRESENTATIVES

July 19, 2012

Mr. Keating (for himself, Mrs. Bono Mack, Mr. Rogers of Kentucky, Mr. Lynch, Mr. Rahall, Mr. Towns, and Mr. Tierney) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to incentivize the development of tamper-resistant drugs.

Short title

This Act may be cited as the Stop Tampering of Prescription Pills Act of 2012.

Tamper-resistant technology

(a)

Definition

Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

(ss)

The term tamper-resistant drug means a drug that—

(1)

contains as an active moiety a controlled substance that has been classified as opium, an opiate, or a derivative thereof, as such terms are defined or used in section 102 of the Controlled Substances Act;

(2)

has been formulated for oral administration; and

(3)

(A)

exhibits physicochemical properties (demonstrated by in vitro, in vivo, or other testing, or some combination thereof, as determined appropriate by the Secretary) that make product manipulation significantly more difficult or ineffective in altering the characteristics of the drug for purposes of misuse or abuse when compared to drugs without such properties; or

(B)

contains one or more additional active or inactive ingredients that are intended to deter abuse through potential pharmacological effects, the effectiveness of which has been demonstrated by at least one adequate and well-controlled investigation.

(b)

Required information in application for approval of brand name drugs

Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the following:

(7)

Tamper-resistant drugs

If an application submitted under this subsection is potentially subject to refusal under subsection (d)(7), the application shall include such information as the Secretary determines necessary to demonstrate that the application is not subject to such refusal.

(c)

Approval of new brand name drugs

Section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended—

(1)

by inserting (7)(A) such drug has been formulated for oral administration; (B) such drug contains as an active moiety a controlled substance that has been classified as opium, an opiate, or a derivative thereof, as such terms are defined or used in section 102 of the Controlled Substances Act; (C) such drug is not a tamper-resistant drug; and (D) the Secretary has previously approved pursuant to an application submitted under subsection (b) or (j) a drug that (i) contains the same active moiety; (ii) is a tamper-resistant drug, and (iii) has not been discontinued from marketing; or after (6) the application failed to contain the patent information prescribed by subsection (b); or;

(2)

by striking (7) based on fair and inserting (8) based on fair;

(3)

by striking clauses (1) through (6) and inserting paragraphs (1) through (7); and

(4)

by inserting The Secretary may issue an order approving an application, even if paragraph (7) applies, upon a finding that paragraphs (1) through (6) and paragraph (8) do not apply and that such approval is necessary either to prevent or alleviate a drug shortage or to otherwise address a significant unmet public health need. before As used in this subsection and subsection (e).

(d)

Generic drugs

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended—

(1)

in paragraph (2)—

(A)

subparagraph (A)—

(i)

in clause (vii), by striking and at the end;

(ii)

in clause (viii), by striking the period at the end and inserting ; and;

(iii)

by inserting after clause (viii) the following:

(ix)

if the listed drug is a tamper-resistant drug due to its physicochemical properties, information from comparative in vitro, in vivo, or other testing, or some combination thereof, as appropriate based on the type of data submitted for the listed drug, that demonstrates the new drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug.

; and

(iv)

in the continuation text at the end of the subparagraph, by striking clauses (i) through (viii) and inserting clauses (i) through (ix);

(B)

in subparagraph (C)—

(i)

in clause (i), by striking or at the end;

(ii)

in clause (ii), by striking the period at the end and inserting ; or; and

(iii)

by adding at the end the following:

(iii)

that the listed drug is a tamper-resistant drug and one or more of the new drug’s active moieties differ in any material respect (in amount or otherwise) from those of the listed drug.

;

(2)

in paragraph (5), by adding at the end the following:

(G)

If a drug has been approved pursuant to an application submitted under paragraph (2), and thereafter the listed drug referred to in the application becomes a tamper-resistant drug, the drug so approved shall not be considered to be bioequivalent to, or to have the same therapeutic effect as, the listed drug (as described in paragraph (2)(A)(iv)) unless and until the drug so approved has been found by the Secretary to meet the requirements of paragraph (2)(A)(ix).

; and

(3)

in paragraph (6)—

(A)

by striking (6) If a drug and inserting (6)(A) If a drug;

(B)

by striking (A) for the and inserting (i) for the;

(C)

by striking (B) if the and inserting (ii) if the; and

(D)

by adding at the end the following:

(B)

For purposes of this paragraph and paragraph (7)(C), a withdrawal or suspension of a drug formulated for oral administration shall be considered to have been for safety or effectiveness reasons if—

(i)

the approval of a listed drug, which is not a tamper-resistant drug, is withdrawn or suspended, or a listed drug, which is not a tamper-resistant drug, is withdrawn from sale; and

(ii)

the Secretary has previously approved pursuant to an application under subsection (b) a drug that—

(I)

is in the same dosage form;

(II)

contains the same controlled substance as an active moiety;

(III)

is a tamper-resistant drug; and

(IV)

has not been discontinued from marketing.

(e)

Withdrawal of previously approved brand name and generic drugs

Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended—

(1)

by inserting or (6)(A) the drug contains as an active moiety a controlled substance that has been classified as opium, an opiate, or a derivative thereof, as such terms are defined or used in section 102 of the Controlled Substances Act; (B) the drug is formulated for oral administration; (C) the drug is not a tamper-resistant drug; and (D) the Secretary has previously approved pursuant to an application submitted under subsection (b) or (j) a drug that contains the same active moiety, is a tamper-resistant drug, and has not been discontinued from marketing before : Provided,; and

(2)

by adding at the end the following: The Secretary may waive the application of paragraph (6) of the first sentence of this subsection in the case of a drug intended for use in a special needs population. In withdrawing (under paragraph (6) of the first sentence of this subsection) the approval of an application with respect to any drug, the Secretary shall, on a case-by-case basis, delay the effective date of such withdrawal for a period deemed sufficient by the Secretary to give the sponsor an opportunity to obtain approval under this section for a formulation of the drug meeting the criteria described in paragraph (2) of the definition of a tamper-resistant drug in section 201(ss)..

(f)

Listed drugs

Section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

(D)

Beginning 60 days after the date of the enactment of the Stop Tampering of Prescription Pills Act of 2012, the Secretary shall—

(i)

include in the list under subparagraph (A) a list of each drug or category of drugs which the Secretary has found to be tamper-resistant drugs; and

(ii)

update the list under subparagraph (A)—

(I)

to remove from the list of tamper-resistant drugs any drug the Secretary later determines is not a tamper-resistant drug; and

(II)

as required by subparagraph (C) to reflect the application of paragraph (6)(B) to drugs that are withdrawn or suspended.