A recent joint investigation by 60 Minutes and the Washington Post has shed light—and quite a bit of heat—on a law that diminished the DEA’s authority in the battle against the opioid crisis.
The outlets reported that the pharmaceutical industry, wholesalers, distributors, and chain drugstores used their influence to lobby Congress to relax regulations on suspiciously large shipments of opioids. This easing of regulatory power may have helped fuel the national opioid crisis by weakening the DEA’s power to freeze suspicious shipments of huge amounts of opioids to pharmacies or pain clinics and to sanction drug makers or distributors who turn a blind eye to them. The report also revealed a revolving door culture that exists between the DEA and the drug industry.
The investigation highlighted a provision in a 2016 law sponsored by Rep. Tom Marino (R-Pa) that makes it easier for drug companies to distribute large quantities of opioids that would have triggered DEA investigations under previous rules. Twenty-three lawmakers sponsored the bill, many of whom accepted large donations from the drug industry. The bill was passed by unanimous consent and signed into law by President Obama.
When the report aired, Marino was President Trump’s nominee to head be drug czar, as director of the Office of National Drug Control Policy. He has since removed his name from consideration.
The 60 Minutes/Post report made national headlines and the pharmacy community responded swiftly. Several members of Congress have issued statements about whether or not they knew that the law took some authority away from the DEA.
“As a pharmacist for 36 years, I have seen the utilization of opioids grow by leaps and bounds. We were always assured by the manufacturers that these products were safe and non-addictive at any dose as long as the patient truly had pain,” said Peter A. Kreckel RPh, a community pharmacist in Altoona, PA. “This 60 Minutes segment will not change the way I dispense, as according to the Controlled Substance Act, we pharmacists have a corresponding responsibility along with the physician.”
Kreckel told Drug Topics that what is really needed is pharmacists embedded in the physicians’ office to help them work with the patients to de-escalate opioid doses and to help monitor therapy. “Because we as bench pharmacists don't have the privilege of being in that examination room, we have to assume the physician is acting in the patients’ best interest to manage pain. The best we can do is to not fill prescriptions for those "unscrupulous" physicians.”
James Schiffer, RPh, Esq., an associate at New York-based Allegaert Berger & Vogel and Adjunct Professor of Pharmacy at the Arnold & Marie Schwartz College of Pharmacy and Health Sciences at Long Island University, told Drug Topics that pharmacists now understand why the wholesalers are requiring their sales data with regard to the dispensing of controlled substances, because some pharmacy owners were unaware of the need for suppliers to monitor alleged suspicious ordering.
Robert Mabee, RPh, JD, said that the information revealed in the investigation appears to exonerate manufacturers and suppliers, or at least “indemnify or insulate” them from prosecution.
“Both investigations, combined with the DEA Seminars and decisions by some chain pharmacies and various PBMs, give the impression that the pharmacist has to spend additional time on insurance claims and potential DEA violations,” said Mabee, adding: “this further limits the pharmacist’s ability to perform his clinical role, leaving the patient bewildered and underserved.”
The NCPA told Drug Topics that community pharmacists are on the front lines of the opioid epidemic. “They must balance their professional judgment in filling legitimate prescriptions while also interacting with patients to identify red flags that may signal abuse,” NCPA said in a statement.
NCPA recently offered congress recommendations for dealing with the opioid crisis. NCPA said that those recommendations require “a multi-stakeholder approach—manufacturers, wholesalers, prescribers, pharmacists and enforcement agencies working together.”
In a statement posted on their website, the Healthcare Distribution Alliance (HDA)—a trade organization representing drug distributors—said that the investigation by The Washington Post presented a “misleading picture about the role of health-care distributors in the pharmaceutical supply chain and the regulation of controlled substances and opioids in the market.”
HDA said the industry has taken steps to prevent diversion of controlled substances. “Pharmaceutical distributors have no mechanism to increase demand or patients’ use of opioids. Our primary role is to coordinate the logistics for the safe and secure distribution of all medications, including controlled substances, from drug manufacturers to DEA-licensed pharmacies and other health-care providers,” the HDA said.
Fallout from the report is ongoing. Sen. Claire McCaskill—who has been investigating the role drug companies may have played in the opioid crisis—has said she will introduce legislation to repeal the law at the center of the controversy.