DENVER – Some of Colorado’s federal lawmakers say they are reviewing the ramifications of a 2016 law, of which two of the state’s congressmen cosponsored early versions, that some say has handcuffed the Drug Enforcement Administration in its fight against drug companies—something that was uncovered in a joint Washington Post-60 Minutes investigation published last week.
The two Republican members of Congress – Rep. Mike Coffman and Sen. Cory Gardner, who was in the House of Representatives when he cosponsored the bills – did not, however, put their names on the bill that contained the final language now being blamed by some for neutering the DEA’s diversion program, which aims to stop the flow of pharmaceuticals and scheduled drugs to non-official sources.
And they and other members of Congress from Colorado, who were present when the bill passed both the Senate and House unanimously, say the law may have created “unintended consequences” for the DEA’s power over the opioid manufacturers that might need to be fixed.
Several legislators have endorsed new bills that would reverse the language written into the law, but those from Colorado have yet to sign on, saying they are reviewing the matter.
Whistle blown on writing of drug bill
The Washington Post-60 Minutes investigation centered on a draft-article by DEA Chief Administrative Law Judge John Mulrooney II set to be published later this year by the Marquette Law Review board, and on dozens of interviews with current and former officials involved in the bill’s crafting.
In the article, Mulrooney writes that the law “imposed a dramatic diminution of the [DEA’s] authority” and made it “all but logically impossible” for the DEA to suspend a company’s drug manufacturing for breaking federal laws.
The bill aimed to clearly define language in the Controlled Substances Act of 1970 that required companies to report unusually-large or suspicious orders by working to define what “imminent danger” meant in the act – something that had been argued over and litigated for some time.
In the several years before 2014, some of the country’s largest drug companies, including Cardinal Health and McKesson, were being fined tens of millions of dollars for failing to report some of the suspicious orders.
But when the language finalizing the “imminent danger” portion of the bill was added to the Senate’s version, saying “a substantial likelihood of an immediate threat” was the new bar, some government agencies say they were not told of that change, which has now caused the apparent issues with penalizing the companies filling unusual orders.
The questionable bill was written behind the scenes by a former DEA lawyer who had gone to work for the drug companies, and who had voiced hopes about clarifying the language in the 1970 act for years beforehand, according to the investigation.
Rep. Tom Marino, R-Pa., had President Trump withdraw his nomination as the country’s next “drug czar” last week after the story published on Oct. 15, which showed he was the primary advocate in Congress for the law, which he pushed for at least two years ahead of its passage. Trump has said he would review the investigative report to determine what further action might need to be taken.
Gardner, Coffman cosponsor original legislation
Marino, a former district attorney and U.S. Attorney appointed by President George W. Bush, introduced his first version of the bill, the Ensuring Patient Access and Effective Drug Enforcement Act, in February 2014 while his hometown area was being crushed by opioid overdoses.
Gardner, who is now a U.S. senator but at the time was in the House, was the second cosponsor of that bill, which he tacked his name to just nine days after the measure was introduced.
Rep. Marsha Blackburn, who is aiming to replace Sen. Bob Corker as Tennessee’s senator in 2018 and is also under fire because of the investigation, was the first cosponsor.
The original bill tried to define a new standard under which the DEA could stop drug shipments. It said the DEA would have to establish “a significant and present risk of death or serious bodily harm that is more likely than not to occur.”
According to the investigation, the DEA immediately moved against the bill, saying it was “fixing a problem that doesn’t need fixing,” per a DEA email. But Marino then recruited U.S. Attorney General Eric Holder to try and get him aboard, something that worried his Justice Department and the DEA, according to The Post. Memos obtained by the paper show agents worried that the bill was “without basis” in case law or congressional findings and that it would hamper the AG’s authority.
At an April 7 health subcommittee hearing in the House Energy and Commerce Committee, Blackburn pitched the bill further, while the DEA agent in charge of regulating the drug industry, Joseph Rannazzisi, also testified as to how his job worked. He and Blackburn got into a testy exchange over his division’s enforcement: “You asked me to tick off what I do: 16,651 people in 2010 died of opiate overdose, OK, opiate-associated overdose. This is not a game. We are not playing a game,” he told the congresswoman.
And in a House oversight and investigations subcommittee meeting on April 29, which both Gardner and Rep. Diana DeGette, D-Colo., attended, Rannazzisi had more to say about his division’s enforcement.
DeGette opened with a statement about the “public health crisis” that heroin and opioids were causing across the country. Later, Rannazzisi detailed how the massive amounts of pills were making their way into communities, saying rogue pharmacists, doctors and companies were “overwhelming” the DEA with numbers.
“If you are talking about 99.5 percent of the prescribers, no, they are not overprescribing, but our focus is in rogue pain clinics and rogue doctors who…are prescribing illegally,” Rannazzisi testified.
Blackburn also gave more details on the bill: A working group that included members from the DEA, FDA, state attorneys general offices, pharmacists and the pharmaceutical industry, among others, would provide recommendations to Congress on how to stem the flow of prescription drugs across America within one year of its formation.
About three weeks after that hearing, on May 22, 2014, Rep. Coffman became the 14th and final cosponsor of the 2013 version of Marino’s bill.
Marino introduces 2nd bill, which Gardner also cosponsors
Meanwhile, Marino and others had been drafting a second bill after the DEA and Justice Department objected to his first, according to memos obtained by The Post.
The second Marino bill, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, was introduced on May 21, 2014 – a day before Coffman cosponsored the initial version.
The bill had some slight tweaks to its language, but its goals were still the same in regards to shoring up the “imminent danger” language.
According to The Post, Justice Department emails that summer from top congressional liaisons noted that the former DEA lawyer who went to work for the drug industry had written the second Marino bill.
Gardner signed on to cosponsor the bill that July 22, several weeks after Rannazzisi blew up on a call with legislative staffers, saying the bill would lead to Congress “protecting criminals,” according to The Post, which also reports that the congressional staffers told Rannazzisi they could no longer work with him.
On July 29, 2014, the House passed the bill unanimously by a voice vote after around 20 minutes of debate and it was sent over to the Senate.
But just two days later, Holder, the attorney general, while announcing plans for federal law enforcement officials to carry the opioid-overdose reversal drug Naloxone, sneaked in rare public opposition from the Justice Department to the bill.
“A recently passed House bill would ‘severely undermine’ a critical component of our efforts to prevent communities and families from falling prey to dangerous drugs,” read a Justice Department press release quoting him.
The bill died after being referred to a Senate committee. But according to The Post and 60 Minutes, Marino continued to be perturbed by Rannazzisi’s statement that Marino’s bill protected criminals. He and Blackburn sent a letter to the inspector general saying Rannazzisi had been trying to “intimidate the United States Congress."
Undeterred, Marino drafts another bill
The Post reports that the attack on Rannazzisi emboldened Marino’s efforts, and led him to introduce the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 in July 2015.
Neither Gardner nor Coffman cosponsored the measure this time around, however.
Gardner’s spokesman, Casey Contres, chalked that up to changes in the bill.
Indeed, the new bill did add language about a registrant “who knows or should know” the obligations of the Controlled Substances Act, language about the “abuse or misuse” of controlled substances, and language that would have added veterinarians to the group of people on which Congress would require a report.
But there were few other changes.
“[Gardner] didn’t drop cosponsorship. A new version was introduced. He did not cosponsor that version with different language,” Gardner’s spokesman, Casey Contres, told Denver7.
Contres did not return a follow-up question about the changes in the bill that caused Gardner not to cosponsor the 2015 version after doing so on the previous two.
Daniel Bucheli, who is Coffman’s spokesman, told Denver7 that Coffman did not cosponsor versions beyond the first because of changes.
“The 2014 legislation is different than the actual one signed into law by President Obama,” Bucheli said. “It included several important provisions to combat opioid abuse such as mandating criminal background checks and drug testing for individuals working where controlled substances are stored.”
The bill moved to the full House floor after a motion by Blackburn on April 21. While on the floor that day, Marino praised the bill as being helpful to the DEA’s authority. It passed a voice vote unanimously and was also sent over to the Senate, as the previous year’s bill had been.
More people left the DEA, Rannazzisi being among them. Loretta Lynch took over as the attorney general, and one of her staffers wrote to Marino that the Justice Department “valued” the chance to work more closely with drug companies, according to The Post and 60 Minutes.
Sen. Hatch, DEA make changes to language; bill signed by Obama
Sen. Orrin Hatch, R-Utah, had taken up sponsorship of the Senate’s version of the Ensuring Patient Access and Effective Drug Enforcement Act in early 2015, and once the House version passed, he got to work again on his version.
Hatch had introduced his version in the Senate before the House had passed Marino’s latest version. But by the time the Senate got to work on finalizing the bill and sending it to the president in February 2016, the bill had changed.
Some of the new faces at the DEA had been working with Hatch to add language that would require DEA agents to show a drug company was posing a “substantial likelihood of an immediate threat” of death, bodily harm or drug abuse before they could try to suspend the company, according to The Post.
The investigation reports that DEA staffers “agreed to the bill with reluctance” once the new language was finalized in November 2015, which added the “immediate threat” language and another portion that would allow companies to try and fix problems before they could be hit by the DEA.
And that new language was contained within the newly-reported Senate bill in February 2016, though it’s unclear how many people knew the language had been changed.
A Senate legislative aide tells Denver7 that it’s typical a committee would review the bill with all parties involved, especially the DEA in this instance, and notify them all of a change similar to the one in Hatch’s version of the bill.
But the bill didn’t get another committee hearing between when the modified version was sent from the Senate Judiciary Committee and when the full Senate passed the measure on St. Patrick’s Day 2016 by unanimous consent.
A month later, the House passed the measure without objection, and the Senate sent it to President Obama’s desk. He signed the measure on April 19, 2016 without much hoopla.
The Post reports the DEA had made concessions with Congress to make the bill something it wouldn’t have to object to, and no one at Justice or in much of the White House pushed back on the bill, saying they had referred to the DEA’s stance.
The White House Office of Management and Budget, however, told The Post that the changes made to the measure were never reviewed by the office, as the DEA and Justice Department never told the office about them.
Marino, meanwhile, lauded his bill’s passage, saying “drug enforcement agencies will have the necessary tools to address the issue of prescription drug abuse.” The pharmaceutical industry was happy as well, saying it would work with the DEA in the future.
But in the upcoming article from Mulrooney, he writes that the DEA’s suspension orders have dropped from 65 in FY2011 to just six in FY2017, citing DEA data.
“If it had been the intent of Congress to completely eliminate the DEA’s ability to ever impose an immediate suspension on distributors or manufacturers, it would be difficult to conceive of a more effective vehicle for achieving that goal,” he writes in the article, according to The Post.
Responses from Colorado’s lawmakers
Several of the people involved in crafting the bill have since taken jobs within the pharmaceutical industries, according to The Post, and many of the lawmakers involved have been scrutinized for campaign contributions coming in from the same companies they’ve now, according to some, left off the hook.
During their times in Congress, both Gardner and Coffman have received upwards of $8,000 from the “big three” pharmaceutical companies: AmerisourceBergen, McKesson and Cardinal Health.
But several others from Colorado, including DeGette and Sen. Michael Bennet (D) have received similar contributions from the same companies.
And most of Colorado’s sitting members of Congress received some sort of contribution from the pharmaceutical industry beyond the three manufacturers as well, according to campaign finance data from the Center for Responsive Politics.
All denied that any campaign contribution would ever affect one of their votes.
Lynne Weil, who is DeGette’s spokeswoman noted that DeGette, as a senior member of the House Energy and Commerce Committee, has been the impetus for several investigations into pharmaceutical companies.
“Contributions have never affected her voting or other actions,” Weil told Denver7.
Denver7 also contacted several Colorado lawmakers who had a part in making the bill law. Most said they are now reviewing its ramifications, and some added they would support legislation that would undo the measure.
“In regards to concerns over the legislation, it looks like there could have been some unintended consequences from the legislation,” Gardner’s spokesman, Contres, told Denver7 Monday. “He will certainly continue to look at any proposals that are introduced to ensure that the DEA has the tools it needs to stop any practices leading to increased problems with opioid addiction.”
Contres added that Gardner has voted in favor of several bills aimed at stemming the crisis, including the Comprehensive Addition and Recovery Act and a bill that included $800 million aimed at prevention, education and treatment, and said the senator would continue to support efforts to fight opioid and heroin addiction.
One of Coffman’s Democratic opponents in the 2018 6th Congressional District race, Jason Crow, slammed Coffman’s early support, and tied in $43,000 received from the pharmaceutical industry over his time in Congress, citing numbers from the Center for Responsive Politics, which lumps in pharmaceutical manufacturers, pharmacies and the pharmaceutical lobby into a large “pharmaceutical donations” category.
“He stood by and did little to protect Coloradans while big Pharma silenced the DEA and its ability to protect our consumers,” Crow said.
But Bucheli said Coffman was committed to taking another look at the law after the investigation raised concerns.
“Rep. Coffman believes Congress should absolutely revisit the bill that was signed into law by President Obama to identify unintended consequences of this bipartisan bill and make changes where necessary,” Bucheli said. “Meanwhile, Rep. Coffman will continue to lead on the issue of opioid abuse and issues impacting veterans in his role as a member of the House Veterans Affairs Committee.”
Bucheli said Coffman would continue working with Republicans and Democrats “to overcome the scourge of addiction and opioid abuse facing our country.”
On Friday, Bennet joined a host of Democrats in writing a letter to the Department of Health and Human Services and the DEA asking for more information on the law’s effect.
“It is critical that we have all the information necessary to ensure the federal government is doing everything it can to help support our states and local communities in our collective fight against this epidemic,” the senators wrote, saying they wanted to be sure the DEA had “all of the tools necessary” to fight the opioid and heroin epidemic, which has led to a large uptick of deaths in Colorado over the past decade.
The letter from the senators also notes that the yearly report due back to Congress that was written in the bill is now six months overdue. “As Congress revisits the Ensuring Patient Access and Effective Drug Enforcement Act and considers whether the DEA has all of the tools it needs to play an effective role in combatting this public health emergency, it is critical that we have the information necessary to evaluate this law,” they wrote.
The letter asks HHS to provide that update and a report on “any challenges in diversion control that may have been exacerbated by the law’s passage” no later than Oct. 30, and a full report as written under the law “as soon as possible.”
The House Energy and Commerce Committee also has a hearing set for this week regarding the country’s opioid crisis, which will include new testimony from the DEA on the matter and is expected to play a role in what the House decides to do moving forward.
The same committee sent a letter Friday asking for more information from the DEA about pill-dumping allegations out of West Virginia, which come in addition to letters sent to the "big three" drug companies earlier this year.
Bills have already been introduced by Democrats in the House and Senate to repeal the “immediate threat” language from the changes made to the Controlled Substances Act of 1970. Rep. Evan Jenkins, R-W.V., has already cosponsored the House bill, making it bipartisan legislation.