[Congressional Record Volume 164, Number 46 (Thursday, March 15, 2018)]
[Senate]
[Pages S1766-S1767]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. GRASSLEY (for himself, Mrs. Feinstein, Mr. Corker, Mr.
Menendez, Mr. Hatch, Ms. Harris, and Mr. Leahy):
S. 2559. A bill to amend title 17, United States Code, to implement
the Marrakesh Treaty, and for other purposes; to the Committee on the
Judiciary.
Mr. GRASSLEY. Mr. President, I rise today to introduce legislation
that would implement the Marrakesh Treaty to Facilitate Access to
Published Works for Persons Who are Blind, Visually Impaired, or
Otherwise Print Disabled (``Marrakesh Treaty''). I'm pleased that
Senators Feinstein, Corker, Menendez, Hatch, Harris and Leahy are
joining me as original cosponsors.
The Marrakesh Treaty was signed by the United States in October 2013.
It seeks to help address the global ``book famine'' and facilitate
access to printed works for visually impaired individuals by providing,
with appropriate safeguards, that copyright protection should not
impede the creation and distribution of accessible format copies,
including the exchange of such copies internationally.
The Marrakesh Treaty Implementation Act represents a consensus
approach developed by the Senate Judiciary and Foreign Relations
Committees with stakeholders within the publishers, libraries and print
disabilities communities, in consultation with the U.S. Patent and
Trademark Office and the U.S. Copyright Office as well as other
interested industry and public interest stakeholders. I particularly
want to commend the National Federation of the Blind, the Association
of American Publishers and the Library Copyright Alliance for working
with us in reaching an agreement on legislative text and proposed
legislative history. We would not be here today without their efforts.
I look forward to working with my colleagues on the Foreign Relations
Committee, Chairman Corker and Ranking Member Menendez, on ratification
of the Marrakesh Treaty in the Senate, and with Judiciary Committee
Ranking Member Feinstein on passing the Marrakesh Treaty Implementation
Act.
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By Mrs. FEINSTEIN (for herself and Mrs. Capito):
S. 2561. A bill to authorize the Attorney General to suspend a
controlled substances registration if there is a likelihood of a threat
of diversion of a controlled substance, and for other purposes; to the
Committee on the Judiciary.
Ms. FEINSTEIN. Mr. President, I rise today with my colleague, Senator
Capito, to introduce the Stopping Suspicious Orders of Opioids Act.
In 2016, the opioid epidemic caused more than 42,000 deaths in the
United States.
In 2017, this epidemic was declared a public health emergency.
Now, more than 400 State, local, and Tribal governments have filed
suits (some consolidated, some individual) against opioid manufacturers
and distributors for their alleged roles in fueling and perpetuating
this devastating crisis. The U.S. Justice Department, or DOJ, has filed
a statement of interest in these lawsuits, which are currently pending.
As our Nation struggles to effectively address the opioid epidemic,
one thing is clear: there is no silver bullet.
Yet, it is also clear that law enforcement can play a critical role
in preventing and reducing overdose deaths.
That is why we must ensure that law enforcement has and uses the
necessary tools to hold opioid manufacturers, distributors and others
accountable when they fail to properly disclose to the Drug Enforcement
Administration, or the DEA, opioid orders that are suspicious because
of their size, frequency, or patterns. This simple disclosure could
prevent millions of prescription opioid pills from ending up on the
black market.
Unfortunately, current law has inadvertently created a standard that
is too high for DOJ to meet in order to take immediate action against
those who fail to make these disclosures to the DEA or who fail to
adequately protect against diversion.
For instance, the DEA has told my staff that under current law, in
order to immediately stop a drug manufacturer or distributor from
distributing opioids, a pharmacy from dispensing opioids, or a
practitioner from prescribing opioids, it must prove that the
distribution, dispensation, or prescription of the drugs directly
resulted in an immediate and substantial likelihood that death, serious
bodily harm, or abuse of a controlled substance occurred.
For this reason, the bill Senator Capito and I are introducing today
would change the standard in current law to make it easier to
immediately stop potentially dangerous shipments of prescription
opioids. It would allow DOJ to take action when it can demonstrate that
an opioid manufacturer or distributor's lack of control over a
prescription opioid would likely result in the drugs winding up in the
hands of someone other than the intended recipient or on the black
market.
This change will compel opioid manufacturers and distributors to be
more vigilant in their efforts to report and stop the delivery of
suspicious orders of opioids as well as to protect against diversion.
In the absence of such vigilance, our bill would allow DOJ to
immediately stop the delivery of opioids.
Our bill further ensures that bad actors are held accountable by
establishing backstops and consequences for when opioid manufacturers,
distributors, dispensers, and prescribers fail to take corrective
action.
Under current law, if there is no immediate threat to the public
health or safety, opioid manufacturers, distributors, dispensers and
prescribers can submit a corrective action plan to DOJ before their
registrations can be revoked or suspended. DOJ does not have to accept
this plan, but if it does, current law does not outline a timeframe by
which the plan must be fully implemented or consequences for failure to
do so.
Given the magnitude of the opioid epidemic, this is unacceptable.
That is why our bill would require those who manufacture, distribute,
dispense or prescribe opioids to fully implement any plan that is
accepted by DOJ within 30 days. Failure to do so will result in the
immediate suspension of a registration until the reinstated proceedings
to deny, revoke, or suspend the registration permanently have
concluded.
Mr. President, I have been struck by the seemingly countless examples
of opioid manufacturers and distributors that have done little to
safeguard
[[Page S1767]]
against diversion that have been raised in hearings, roundtables, and
in the news over the last several years.
The example most often cited is that of Kermit, West Virginia, where,
over a two year period nine million opioids were delivered to a single
pharmacy. Between 2007 and 2012, 780 million oxycodone and hydrocodone
pills were delivered to pharmacies throughout that state. This resulted
in 1,728 fatal overdoses that were largely preventable.
We cannot allow this to happen again.
The bill Senator Capito and I are introducing today will strengthen
current law by providing law enforcement with the additional tools it
needs to better and more proactively combat the opioid epidemic and
hold bad actors accountable.
I hope my colleagues will join us in supporting this important
legislation.
Thank you, Mr. President. I yield the floor.-
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