Advocates say a recently enacted law that gives pharmaceutical companies more leeway if they fail to report suspicious orders of controlled substances offers a proper balance between fighting misuse of prescription drugs and ensuring access for those who need them.
The law allows pharmaceutical companies to submit a correction plan to the Drug Enforcement Agency as a way to possibly avoid license suspension. It also prevents the agency from suspending licenses unless a failure to implement proper controls has created “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 of the registration.”
Earlier this year, the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 quickly and unceremoniously sailed through the Senate and House and was signed by President Barack Obama.
It is a stark contrast to legislation the president signed last week that supports resources and programs aimed at combating prescription drug abuse. The Comprehensive Addiction and Recovery Act has been frequently touted as groundbreaking in the fight against misuse of opioids.
Deaths from such misuse have quadrupled since 1999 and the epidemic killed more than 28,000 Americans in 2014, according to the Centers for Disease Control and Prevention.
One of the bill's sponsors, Sen. Orrin Hatch (R-Utah), said in a statement that the abuse of prescription drugs by some should not prevent patients who need the medication from obtaining it.
“This bill takes a balanced approach to the problem of prescription drug abuse by clarifying penalties for manufacturing or dispensing outside approved procedures while helping to ensure that supply chains to legitimate users remain intact,” he said. “It will encourage companies to notify law enforcement proactively when they discover potential diversion and to work with officials to help keep these drugs in the right hands.”
Steven Anderson, President and CEO of the National Association of Chain Drug Stores, said the law makes it easier to apprehend those who misuse the drugs while protecting legitimate patients.
“This legislation would require consultation with patient and provider groups, including pharmacies, among other stakeholders,” he said in a statement. “We appreciate the recognition of pharmacies as critical stakeholders in efforts to prevent prescription drug diversion and abuse.”
But the former director of the DEA's office of diversion control, Joseph Rannazzisi strongly opposed the bill and has said it was influenced by the industry. In 2014, two members of Congress said he told them they were “supporting criminals” by pushing for passage.
Sixteen organizations registered to lobby on the bill, including CVS Health, Rite Aid Corp. NACDS and Pharmaceutical Research and Manufacturers of America, one of the most powerful lobbyist in Washington.
The percentage of opioid painkillers diverted from the legitimate market is less than 1% yet it represents more than 10 million pills, according to the 2015 National Drug Threat Assessment Summary produced by the DEA.
“Rogue pain management clinics, commonly referred to as 'pill mills,' have contributed greatly to the extensive ability of illicit (controlled prescription drugs) in the United States,” the report reads.