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October 17, 2017

'Drug czar' nominee withdraws after report claims he backed law that curbs DEA's opioid authority

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    Congress in 2016 passed and then-President Barack Obama signed into law legislation (PL 114-145) that ultimately hindered the Drug Enforcement Administration's (DEA) efforts to curb the amount of prescription painkillers distributed in the United States, according to an investigation by "60 Minutes" and the Washington Post published Sunday.

    Your top resources for combatting the opioid epidemic in one place

    According to "60 Minutes"/Post, Rep. Tom Marino (R-Pa.), whom President Trump had nominated to head the Office of National Drug Control Policy, first introduced the bill in Congress in 2014. Trump on Tuesday announced Marino has withdrawn from his nomination to serve as the United States' drug czar.

    Background: DEA targets wholesale drug distributors

    DEA's Office of Diversion Control in 2005 launched an effort, called the "Distributor Initiative," to help stem the opioid misuse epidemic. Under the initiative, DEA targets wholesale companies that distribute billions of doses of opioid painkillers to hospitals, nursing homes, pain clinics, and pharmacists.

    DEA under the initiative requires distributors to monitor their drug sales in real time and withhold drug shipments if they find suspicious activity, as well as report such activity to DEA. To ensure compliance, DEA's diversion control office can issue:

    • An "order to show cause," which allows DEA to start the process to stop drug shipments; and
    • An "immediate suspension order," which allows DEA to immediately halt drug shipments from facilities where there is an "imminent threat" to public health.

    In fiscal year 2011, the number of civil cases DEA filed against distributors, manufacturers, pharmacies, and physicians reached 131, and the number of immediate suspension orders DEA issued reached 65.

    Congress passes a new law

    According to the "60 Minutes"/Post investigation published Sunday, the pharmaceutical industry in recent years have recruited former DEA and other federal government officials to help them stave off DEA targets for opioid distribution. In addition, the investigation found that the pharmaceutical industry had lobbied in support of the Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDA). According to the investigation, DEA originally opposed the bill, but after the agency experienced a change in leadership and the bill underwent several revisions, Congress passed the legislation with unanimous consent and former President Barack Obama signed the bill into law in April 2016, with the backing from the Department of Justice's (DOJ) congressional affairs office.

    EPAEDA raised the standard that DEA must meet to obtain an immediate suspension order for opioid distributors. According to the Post, DEA for decades could halt shipments believed to pose "an imminent danger" to the community. But EPAEDA raised that standard so that DEA now must demonstrate that a distributors actions pose "a substantial likelihood of an immediate threat" of drug misuse, bodily harm or death, the Post reports. Under the law, drug companies also are able to submit "corrective action" plans that detail how they will address any problems before DEA can levy sanctions.

    According to the Post, Marino declined various requests to comment on the investigation.

    Pharmaceutical Research and Manufacturers of America in a release contested the investigation's depiction of the industry's involvement and influence, saying, neither the Post nor "60 Minutes" contacted them for comment.

    Industry experts say law has curbed DEA's enforcement ability

    Some observers have said the new threshold severely hinders DEA's ability to target opioid drug distributors, the Post reports. According to internal documents from DEA and DOJ, as well as an independent assessment by DEA's chief administrative law judge, the new law has made it almost impossible for DEA to halt suspicious shipments of opioids from distributors.

    DEA Chief Administrative Law Judge John Mulrooney in a draft article for the Marquette Law Review wrote, "At a time when, by all accounts, opioid [misuse], addiction, and deaths were increasing markedly" EPAEDA "imposed a dramatic diminution of [DEA's] authority." He added that it now is "all but logically impossible" for DEA to suspend a pharmaceutical company's operations over its failure to comply with federal law.

    Joseph Rannazzisi—a strong opponent of the bill who headed DEA's Office of Diversion Control for 10 years before he retired from the agency in 2015, according to the Post—said, "There's no way that we could meet that burden, the determination that those drugs are going to be an immediate threat, because immediate, by definition, means right now."

    According to DEA, the agency so far this year has issued just six immediate suspension orders against pharmacies, drug companies, and physicians so far this year, compared with the 65 orders it had issued in 2011, and not one of the orders issued this year has been against distributors or manufacturers, the Post reports.

    However, John Parker—a spokesperson for the Healthcare Distribution Alliance, which represents drug distributors—said EPAEDA "does not 'decrease' DEA's enforcement against distributors." Instead, he said the law "supports real-time communication between all parties in order to counter the constantly evolving methods of drug diversion."

    Confusion over EPAEDA's effects

    According to the Post, few lawmakers knew how EPAEDA would affect DEA's investigations, and former senior Obama administration officials have said the administration was not aware of the effects EPAEDA would have on efforts to curb illicit opioid distribution.

    Michael Botticelli, who led the White House Office of National Drug Control Policy at the time EPAEDA became law, said neither DEA nor DOJ objected to the legislation at the time of its passage, which led Obama to sign the bill. "We deferred to DEA, as is common practice," Botticelli said.

    A former senior Office of Management and Budget (OMB) official also said neither DEA nor DOJ told OMB the legislation would change DEA policy, the Post reports. According to the Post, former acting DEA Administrator Chuck Rosenberg, who led the agency at the time EPAEDA became law, declined various interview requests.

    Matt Whitlock, a spokesperson for Sen. Orrin Hatch (R-Utah), also said DEA was not opposed to EPAEDA when it became law. "We worked collaboratively with DEA and DOJ … and they contributed significantly to the language of the bill," Whitlock said, adding, "DEA had plenty of opportunities to stop the bill and they did not do so."

    However, Rannazzisi said the bill's passage shows the influence the pharmaceutical industry has over federal policymakers, and reflects the industry's recent recruitment of government officials to work for their companies. "The drug industry, the manufacturers, wholesalers, distributors, and chain drugstores, have an influence over Congress that has never been seen before," he said, adding, "I mean, to get Congress to pass a bill to protect their interests in the height of an opioid [misuse] epidemic just shows me how much influence they have." According to the investigation, DEA stopped opposing the bill around the same time Rannazzisi retired from the agency.

    Marino withdraws from consideration for US drug czar

    On Tuesday, Trump announced via Twitter that Marino had "withdrawn his name from consideration as drug czar."

    The announcement came after several Senate Democrats called on Trump to withdraw Marino's nomination, the Morning Call reports.

    According to the Morning Call, Trump when asked about the investigation on Monday said he was going to "look into" the investigation and "take it very seriously." In addition, Trump said his administration next week would make "a major announcement" regarding the U.S. opioid misuse epidemic.

    Sens. introduce bill to repeal EPAEDA

    Meanwhile, Sen. Claire McCaskill (D-Mo.) on Monday introduced legislation to repeal EPAEDA, The Hill reports.

    McCaskill said she introduced the legislation in response to the "60 Minutes"/Washington Post investigation. "Media reports indicate that this law has significantly affected the government's ability to crack down on opioid distributors that are failing to meet their obligations and endangering our communities," she said (Chappell, "The Two-Way," NPR, 10/17; Higham/Bernstein, Washington Post, 10/15; Conradis, The Hill, 10/15; Baker, "Vitals," Axios, 10/16; Olson, Morning Call, 10/16; AP/PBS Newshour, 10/16; Manchin statement, 10/16; Carney, The Hill, 10/16; Gearan, Washington Post, 10/17; Weixel, The Hill, 10/16).

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