[Congressional Record Volume 163, Number 166 (Monday, October 16, 2017)]
[Senate]
[Pages S6387-S6388]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
Ensuring Patient Access and Effective Drug Enforcement Act
Mr. HATCH. Madam President, over the weekend, the Washington Post ran
an article about a piece of legislation I helped negotiate last
Congress. It was entitled the ``Ensuring Patient Access and Effective
Drug Enforcement Act'' and was intended to encourage greater
collaboration between DEA and the regulated community in the fight
against opioid abuse. The Post article was sharply critical of this
legislation, suggesting that it effectively gutted DEA's ability to do
its job. It also suggested the pharmaceutical industry put one over on
Congress. I rise to set the record straight on these allegations and to
provide a fuller account of how this legislation passed the Senate and
became law.
First, some background. The Controlled Substances Act requires drug
distributors to obtain a ``registration'' from DEA in order to
distribute controlled substances, including prescription drugs. The act
further authorizes DEA to suspend a distributor's registration in
certain circumstances, such as where a distributor has been convicted
of a crime involving controlled substances or had a State license
suspended. Before suspending a registration, DEA must issue a show
cause order directing the distributor to explain why its registration
should not be suspended. A court then decides whether DEA has met its
burden to suspend the registration.
The Controlled Substances Act empowers DEA to bypass this standard
suspension process in cases where DEA determines there is ``an imminent
danger to the public health or safety.'' In such cases, DEA can issue
an immediate suspension order that immediately and without court
process terminates the distributor's ability to distribute prescription
drugs. Prior to last Congress, the Controlled Substances Act did not
define what constitutes an imminent danger to the public health or
safety. This left DEA's ability to immediately suspend a party's
ability to distribute prescription drugs essentially unfettered. Such
unfettered discretion concerned the patient advocacy and drug
manufacturing community because an immediate suspension order cuts off
all drugs from a distributor, including those intended for legitimate
users. A balance is needed to ensure that individuals who need
prescription drugs for treatment receive them but that such drugs are
not diverted for improper purposes.
So the bill I helped negotiate last Congress, for the first time,
defined what constitutes an imminent danger to the public health or
safety. In doing so, it created a standard for when DEA may suspend a
party's registration to distribute prescription drugs without any prior
court process, and that standard is that there must be a ``substantial
likelihood of an immediate threat'' that death, serious bodily harm, or
abuse of a controlled substance will occur in the absence of an
immediate suspension.
In both committee and floor statements, I made clear that this
standard is intended to cover situations where evidence of diversion
indicates there is a substantial likelihood that abuse of a controlled
substance or of any controlled substances will occur.
The Washington Post article glosses over much of this background. It
does not explain that the immediate suspension order is intended to be
an extraordinary measure. It does not explain that prior to the bill,
DEA had basically carte blanche authority to impose this measure. It
does not explain the DEA has other enforcement tools available,
including show cause orders which are supposed to be the agency's
standard operating procedure. Equally problematic, the article barely
even mentions the patient advocacy concerns that motivated the bill to
begin with.
I want to quote from a letter that a coalition of patient and health
advocacy groups sent to Congress in support of the legislation:
Federal agencies, law enforcement, pharmaceutical industry
participants and prescribers each play a role in working
diligently to prevent drug abuse and diversion. However, it
is also imperative that legitimate patients are able to
obtain their prescriptions without disruption. Your
legislation addresses both goals by fostering greater
collaboration, communication and transparency between
industry stakeholders and regulators, leading to more
effective efforts to combat abuse while protecting patients.
The letter was signed by, among others, the American Academy of Pain
Management, the Fibromyalgia & Chronic Pain Support Network, and the
Drug Free America Foundation.
Madam President, I ask unanimous consent that the letter be printed
in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
March 4, 2015.
Hon. Orrin Hatch,
U.S. Senate,
Washington, DC.
Hon. Sheldon Whitehouse,
U.S. Senate,
Washington, DC.
Dear Senators Hatch and Whitehouse: On behalf of the
patient and health professional groups listed below we would
like to express our support for the Ensuring Patient Access
and Effective Drug Enforcement Act of 2015 (S. 483). We
appreciate your leadership and commitment to combating the
inappropriate use of prescription medicines. Your legislation
will help improve the balance between effective enforcement
against prescription drug diversion and abuse, while ensuring
patients who are appropriately prescribed medications
continue to have access to their treatments.
As patient advocacy and health professional organizations,
we are committed to combating illegal use of prescription
drugs. Millions of Americans depend on prescription drugs to
treat and cure illness, alleviate pain, and improve quality
of life, yet prescription drug abuse remains a persistent
problem that requires collaboration from all those with a
stake in improving patient care and protecting against abuse.
In considering the burden on patients, it is important to
remember that the vast majority of patients who use
prescription drugs do so legitimately to address a variety of
health issues. Efforts to prevent drug abuse should also
consider legitimate users so that actions do not impede
patient access or lessen the effectiveness of patient care.
Federal agencies, law enforcement, pharmaceutical industry
participants and prescribers each play a role in working
diligently to prevent drug abuse and diversion. However, it
is also imperative that legitimate patients are able to
obtain their prescriptions without disruption. Your
legislation addresses both goals by fostering greater
collaboration, communication and transparency between
industry stakeholders and regulators, leading to more
effective efforts to combat abuse while protecting patients.
We commend you for including a report to congress, which will
illuminate the issue and ultimately benefit patient care.
Including patient advocacy groups in the process will ensure
those involved in patient care will be able to identify
challenges and will emphasize appropriate and workable policy
approaches to preventing diversion and abuse of controlled
substances.
We commend you for your leadership on this important issue.
Sincerely,
Alliance for Patient Access; American Academy of Pain
Management; American Pharmacists Association; American
Society of Consultant Pharmacists; American Society for Pain
Management Nursing; Center for Lawful Access and Abuse
Deterrence; Drug Free America Foundation, Inc.; Fibro
Warriors Living Life; Fibro Friends of Tennessee;
Fibromyalgia & Chronic Pain Support Network; Fibromyalgia-ME/
CFS Support Center, Inc; Florida Fibromyalgia & Chronic Pain
Network.
Hematology/Oncology Pharmacy Association; Interstitial
Cystitis Association; Kentuckiana Fibromyalgia Support Group;
Lake Oswego Health Center; National Association of Chain Drug
Stores; National Community Pharmacists Association; National
Fibromyalgia & Chronic Pain Association; The Pain Community;
Pain Connection-Chronic Pain Outreach Center, Inc.; Project
Lazarus; Richmond Fibromyalgia & Chronic Pain Association;
Save Our Society From Drugs; U.S. Pain Foundation; Virginia
Fibromyalgia & Chronic Pain Support Group.
Mr. HATCH. Madam President, the Washington Post article discusses
virtually none of this. Rather, it baldly asserts that Congress cut out
DEA's legs from underneath it through a sinister conspiracy of deep-
pocketed drug companies and their cunning allies in Congress. Nothing
could be further from the truth.
[[Page S6388]]
To begin with, I have spent 40 years of my life in the Senate
fighting the scourge of drug abuse. I stood side by side with Ronald
Reagan in the War on Drugs. In 2000, I coauthored the Drug Addiction
Treatment Act, or DATA 2000, one of the first efforts in Congress to
address the opioid epidemic. Last year, I led conference negotiations
on the Comprehensive Addiction Recovery Act, a landmark piece of
legislation that is making a real difference in the fight against
opioid and heroin abuse. Currently, I am working on legislation to
address opioid addiction in the veteran community. I am no patsy when
it comes to drug abuse--prescription or otherwise--and neither are my
colleagues.
Indeed, forget me for a moment. Let's take Senator Whitehouse, who
helped me negotiate the bill with DEA and DOJ. Are we to believe that
Senator Whitehouse, a former Rhode Island attorney general and a former
U.S. attorney, a crusader against corporate interests, is somehow in
the pocket of the drug companies? Of course not. The charge is
laughable on its face.
How about the fact that this bill passed both Houses of Congress by
unanimous consent? Did the entire U.S. Congress decide to shield its
eyes to the true sinister intent of this legislation? Did the Senate
Judiciary Committee, which approved the bill by voice vote, decide to
look the other way? This is a committee that includes former
prosecutors, state attorneys general, and U.S. attorneys who, at the
time, included both the current Attorney General of the United States
and the current Senate minority leader.
Are we seriously to believe that Jeff Sessions, the toughest foe of
illegal drugs I have ever known in my entire life, sat on his hands
while Congress eviscerated the DEA's enforcement authority? No, of
course not.
To merely state these allegations is to make clear how utterly
ridiculous they really are. Not one Senator or Member of the House
opposed this bill. Do you know why? Because DEA, the very agency the
bill impacts, the very agency that supposedly can no longer do its job
because of this legislation, agreed to let it go forward.
Let me be clear. The DEA could have stopped this bill. They could
have stopped it at any time. In fact, they did stop a previous version
in 2014 that had different language. I spent months negotiating with
DEA and with DOJ until they were at a point they were comfortable
allowing the bill to proceed. If they had asked me to hold the bill or
to continue negotiations, I would have done so.
I brought the bill to markup only after DEA and DOJ agreed with me on
a path forward. Anyone who claims that I or anyone else steamrolled DEA
and DOJ on this bill is either ignorant or woefully misinformed.
That brings me to another point that was largely lost in all the
insinuations in the Washington Post article. The language that
purportedly eviscerated DEA's enforcement power--that is, the
requirement that the DEA show a substantial likelihood of immediate
threat before issuing an immediate suspension order--was written by DEA
and DOJ lawyers and provided to Hill staff as a proposed compromise.
So let's get this straight. Congress took language that DEA and DOJ
wrote, inserted it into the bill, and now Congress is the bad guy? I
should note that other aspects of DEA and DOJ's proposed language
changed, but that key phrase ``substantial likelihood of an immediate
threat''--the phrase that critics now point to as gutting DEA's
enforcement authority--came from DEA and DOJ. And lest we forget,
President Obama signed the bill into law on the advice of his own DEA
Administrator.
I think we need to be candid about what is going on here. Opponents
of the current administration are trying to derail the President's
nominee to be head of the Office of National Drug Control Policy,
Representative Tom Marino, by mischaracterizing and trying to rewrite
the history of a bill that he championed. They are being aided in their
efforts by a group of former DEA employees who took an extremely hard
line against drug companies when they were at the Agency and who are
upset that the DEA chose to pursue a more collaborative approach after
they left. I don't fault these individuals for their passion, but I do
reject the notion that there was some sort of sinister conspiracy at
play. And I find it unconscionable that critics of the bill and of
Representative Marino would flat-out ignore the very real patient
concerns that motivated this bill and motivated my personal involvement
with it. You think this bill was a sop to the drug industry? Tell that
to the Fibromyalgia and Chronic Pain Network. Tell that to the American
Academy of Pain Management. Tell that to the Drug Free America
Foundation.
If we are going to make this bill a political football and try to use
it to sink Representative Marino's nomination, let's tell the full
story. Let's be fair. Let's at least be honest. Let's not gin up a one-
sided narrative based entirely on the statements of former Agency
officials who disagreed with the change of leadership.
No matter how you try to spin it, this is not the latest episode of
``House of Cards.'' Rather, let's be clear that Members of this body
negotiated this bill in good faith with the DEA and the Department of
Justice. Let's be clear--the DEA and DOJ themselves generated the
language that critics now claim is so problematic. Let's remember that
this bill passed by unanimous consent and that every single Member of
this body and the House of Representatives agreed to it. Let's
remember, too, that the DEA and DOJ could have stopped this bill at any
time if they had wanted to but instead chose to allow it to proceed.
After all, they stopped an earlier version in 2014 that had different
language. They could have stopped it again. And even after the bill
passed Congress, they could have advised President Obama not to sign
on. Don't forget that the bill bears his signature. Let's not pretend
that DEA, both Houses of Congress, and the Obama White House all
somehow wilted under Representative Marino's nefarious influences.
Provocative headlines and clever framing may drive page hits, but
this body's decisions should be based on the full story. It should be
based on all the facts. A single news article that tells only one side
of the story should not derail a nominee who has a long history of
fighting illegal drug use and of helping individuals with chronic
conditions obtain treatment. Let's not ignore the full story here in
the rush toward easy politics.
Madam President, I yield the floor.
The PRESIDING OFFICER. The Senator from Florida.