Monday on the Senate floor, Senator Orrin Hatch (R-Utah), the senior Republican in the United States Senate, addressed the Washington Post’s recent misleading report about Congress’s ties to the drug industry.
Senator Hatch rebutted the Post’s claims by detailing the history of the Ensuring Patient Access and Effective Drug Enforcement Act and the bill’s intended purposes.
The Washington Post article glosses over much of [the Ensuring Patient Access and Effective Drug Enforcement Act’s] background. The article 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 also does not explain that 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.
On his personal commitment to end the opioid crisis, Senator Hatch pointed to his proven record of fighting drug abuse.
To begin with, Mme. President, I have spent forty years of my life here 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 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’s making a real difference in the fight against opioid and heroin abuse. And currently, I’m 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.
The full speech, as prepared for delivery, is below:
Mme. President, over the weekend the Washington Post ran an article about a piece of legislation I helped negotiate last Congress. The bill 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 today 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 prior 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. Abalance is needed to ensure that individuals who need prescription drugs for treatment receive them but that such drugs are not diverted for improper purposes.
And 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 so doing, 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 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 also does not explain that DEA has otherenforcement 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.
I want to quote from a letter that a coalition of patient and health advocacy groups sent 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.”
This letter was signed by, among others, the American Academy of Pain Management, the Fibromyalgia and Chronic Pain Support Network, and the Drug Free America Foundation. I ask unanimous consent, Mme. President, to enter this letter into the record.
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.
To begin with, Mme. President, I have spent forty years of my life here 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 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’s making a real difference in the fight against opioid and heroin abuse. And currently, I’m 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 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.
Or how about the fact that this bill passed both Houses of Congress by unanimous consent? Did the entire United States 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, and that at the time included both the current Attorney General of the United States andthe current Senate Minority Leader.
Mme. President, are we seriously to believe that Jeff Sessions, the toughest foe of illegal drugs that I have ever known in my entire life, sat on his hands while Congress eviscerated the DEA’s enforcement authority?
No. To merely state these allegations is to make clear how utterly ridiculous they are.
Not one Senator or Member of the House opposed this bill. And do you know why? Because DEA, the very agency that 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: DEA could have stopped this bill. It could have stopped it at any time. In fact, it 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 where 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.
And 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 DEA show a substantial likelihood of an 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 in the bill, and now Congress is the bad guy? I should note here 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, Mme. President, lest we forget, President Obama signed the bill into law on the advice of his own DEA Administrator.
Mme. President, I think we need to be candid about what’s 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 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 that motivated my 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’re 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 not gin up a one-sided narrative based almost entirely on the statements of former agency officials who disagreed with a change in 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 DEA and DOJ. Let’s be clear that 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 of the House of Representatives, agreed to it.
Let’s remember, too, that 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 it. Don’t forget, 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.
Mme. President, 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.