Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids

How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.

 

By then, the opioid war had claimed 200,000 lives, more than three times the number of U.S. military deaths in the Vietnam War. Overdose deaths continue to rise. There is no end in sight.

 

A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law, undermining efforts to stanch the flow of pain pills, according to an investigation by The Washington Post and “60 Minutes.” The DEA had opposed the effort for years.

 

The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.

 

The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin G. Hatch (R-Utah) negotiated a final version with the DEA.

 

As Rep. Tom Marino’s Pennsylvania district was reeling from the opioid crisis, he sponsored a bill that, current and former Drug Enforcement Administration officials say, undermined the DEA's efforts to stop the flow of pain pills. 

 

For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales.

 

The new law makes it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies, according to internal agency and Justice Department documents and an independent assessment by the DEA’s chief administrative law judge in a soon-to-be-published law review article. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.

 

Political action committees representing the industry contributed at least $1.5 million to the 23 lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $106 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.

 

“The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi, who ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.”

 

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No wonder that Pennsylvania Underestimates Death Due to Opioids by More Than Half!: http://sco.lt/93iR3h 

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The DEA-Pain Pill Pharma Revolving Door

The DEA-Pain Pill Pharma Revolving Door | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharmaceutical companies that manufacture or distribute highly addictive pain pills have hired dozens of officials from the top levels of the Drug Enforcement Administration during the past decade, according to a Washington Post investigation.

 

The hires came after the DEA launched an aggressive campaign to curb a rising opioid epidemic that has resulted in thousands of overdose deaths each year. In 2005, the DEA began to crack down on companies distributing inordinate numbers of pills such as oxycodone to pain-management clinics and pharmacies around the country.

 

Drug Enforcement Agency personnel arrest a suspect in San Diego, Calif. As the agency has expanded enforcement to address the nation's opioid epidemic, drug companies have been hiring away former top-level DEA officials for their expertise.

Drug Enforcement Agency personnel arrest a suspect in San Diego, Calif. As the agency has expanded enforcement to address the nation's opioid epidemic, drug companies have been hiring away former top-level DEA officials for their expertise. Reuters/Mike Blake

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Since then, the pharmaceutical companies and law firms that represent them have hired at least 42 officials from the DEA – 31 of them directly from the division responsible for regulating the industry, according to work histories compiled by The Washington Post and interviews with agency officials.

 

The number of hires has prompted some current and former government officials to question whether the companies raided the division to hire away DEA officials who were architects of the agency’s enforcement campaign or were most responsible for enforcing the laws the firms were accused of violating.

 

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DEA Approves FDA-Approved Insys Synthetic Marijuana

DEA Approves FDA-Approved Insys Synthetic Marijuana | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Insys Therapeutics, a pharmaceutical company that was one of the chief financial backers of the opposition to marijuana legalization in Arizona last year received preliminary approval from the Drug Enforcement Administration this week for Syndros, a synthetic marijuana drug.

 

Insys gave $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona year (read “Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign”; http://sco.lt/4vyNdJ). The donation amounted to roughly 10 percent of all money raised by the group in an ultimately successful campaign against legalization. Insys was the only pharmaceutical company known to be giving money to oppose legalization last year, according to a Washington Post analysis of campaign finance records.

 

Syndros is a synthetic formulation of THC, the main psychoactive component in the cannabis plant. It was approved by the FDA last summer to treat nausea, vomiting and weight loss in cancer and AIDS patients. The DEA approval places Syndros and its generic formulations in Schedule II of the Controlled Substances Act, indicating a "high potential for abuse." Other Schedule II drugs include cocaine, morphine and many prescription painkillers.

 

"It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets," a spokesman for Arizona's marijuana legalization campaign said of Insys last year.

 

Insys is also the subject of numerous state and federal criminal investigations, as well as a shareholder lawsuit, over its aggressive marketing of a product containing the potent and deadly opioid painkiller fentanyl. In December, the FBI arrested the company's former chief executive and five other executives on charges that they "paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression." [See http://sco.lt/5f8yLx]

 

In addition to its synthetic marijuana products, Insys is also developing a drug to treat opioid overdose.

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