dailycaller
Ethan Barton Investigative Reporter
5:50 PM 03/01/2018
West Virginia Attorney General Patrick Morrisey sued the Drug Enforcement Agency in December
Morrisey hopes for three crucial changes to the DEA’s quota determination
More than 200,000 Americans across the nation died from prescription opioid overdoses between 1999 and 2016
Attorney General Jeff Sessions ordered the Drug Enforcement Agency (DEA) to review how it determines the number of opioid pills allowed on the market in response to a lawsuit West Virginia filed against in the agency, the state’s attorney general announced Thursday.
West Virginia Attorney General Patrick Morrisey sued the DEA in December to compel the agency to change how it determines drug quotas, particularly to push the agency to decrease its reliance on pharmaceutical companies’ sales estimates.
“I direct the DEA to evaluate and consider whether or not to amend its regulations governing the aggregate production quota where appropriate as expeditiously as practicable, including through a potential interim final rule,” Sessions said in a statement Thursday.
Morrisey, a Republican, hopes for three crucial changes to the DEA’s quota determination: reducing the reliance on market demand estimates and instead seeking input from states, the Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services (HHS); taking into account the amount of medications diverted to the black market when considering quotas; and giving state governments the ability to hold hearings to provide evidence of excess opioid supplies.
“Today, we believe we will begin seeing a major change to the failed drug supply system and federal government policies that have fueled the opioid epidemic and helped lead to the death of hundreds of thousands of Americans nationwide,” Morrisey said in a statement.
“For far too long, going back over the past decade and longer, the DEA maintained drug quota regulations that were fatal and dangerously flawed,” he continued.
West Virginia is among the hardest hit in the opioid epidemic, with 52.5 deaths per 100,000 people – more than any other state, according to Morrisey.
Additionally, pharmaceutical distributors flooded one West Virginia town with a population of less than 3,000 with nearly 21 million opioid pills.
More than 200,000 Americans across the nation died from prescription opioid overdoses between 1999 and 2016, according to the Centers for Disease Control and Prevention. Meanwhile, 80 percent of heroin users began their addiction with prescription opioids, a recent study shows.
The DEA’s quota system relies on the pharmaceutical industry’s estimates of how many drugs can be sold, rather than legitimate demands and need, to determine how many medications are allowed on the market, according to Morrisey.
“The DEA quota program is completely broken because it confuses market demand for dangerous narcotics with the amount of legitimate medical need,” Morrisey said. “The DEA effectively helps determine how many drugs can be manufactured based upon how many drugs pharmaceutical companies can sell.”
“This quota process resulted in the unconstrained, unvalidated, and deadly increases each year for the past decade that helped fuel the drug epidemic and helped cause senseless death,” he continued, calling the DEA’s actions “beyond reprehensible” and “deadly.”
Morrisey began trying to alter the quota system during former President Barack Obama’s presidency, but his efforts “were originally stymied, as the Obama-era DEA was clearly asleep at the switch and unwilling to recognize the fatal nature of this failed system,” the attorney general said.
He also asked the D.C. Circuit Court of Appeals – where his case was filed – to put his suit on hold while the DEA finalizes any rule changes.
Follow Ethan on Twitter. Send tips to ethan@dailycallernewsfoundation.org.
Thank You Mr Barton and the DC.
Showing posts with label West Virginia. Show all posts
Showing posts with label West Virginia. Show all posts
Thursday, March 1, 2018
Friday, March 25, 2011
Internal J&J E-Mails Detail Ugly Mismarketing Of Antipsychotics
BNET has;
by Jim Edwards
One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”
Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded atCourtroomView Network.)
In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk (click to enlarge):
When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:
The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”
Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J … [and] no competent person would have let [the 'dear doctor letter'] go out”:
J&J faces up to $36 million in fines as a result.
And make sure you read Mr. Edwards Related Reports.
Related:
- J&J Drug Is a Wash for Schizophrenia but Worked Wonders on Taxpayers
- J&J May Be Liable for Antipsychotic Kickback Scheme Despite “Legal” Contract
- Dumbest PowerPoint Ever? J&J’s P&L Slideshow of Alleged Kickback Scheme
And Don't try telling us that the pill pushers down at consultation cubicle level don't/didn't know Exactly what Risperdal, or any Other antipsychotic drug is.
Check the AIMS form. It's from 1976.
Tardive Dyskinesia is Risperdals' 9th most often FDA reported adverse Reaction, out of 1,935 distinct Adverse Reactions.
Who the Hell do you think has been filling out those forms, since 1976? It wasn't Bill Weldon or J&J's Board of Directors. And just in case any More of our State Attorney Generals are interested, Neuroleptic Malignant Syndrome was even More frequently reported than TD, occupying the number 7 spot.
Tuesday, May 19, 2009
Judge Imposes $4.5 Million Fine On Johnson & Johnson
West Virginia Record has:WELLSBURG - Circuit Judge Martin Gaughan has imposed a penalty of nearly $4.5 million on drug maker Johnson & Johnson for false and misleading promotion of antipsychotic drug Risperdal and painkiller Duragesic.
Gaughan found 4,450 separate violations of West Virginia consumer fraud law.
He imposed the maximum $5,000 penalty on 400 Risperdal sales calls and 100 Duragesic sales calls. He imposed $500 penalties on 3,900 Risperdal sales letters and 50 Duragesic file cards. That totals $4,475,000.
Johnson & Johnson might have celebrated, for Attorney General Darrell McGraw originally sought more than $20 million.
Instead the company served notice that it would appeal.
McGraw sued Johnson & Johnson in 2004 in Brooke County, claiming it didn't tell customers that Risperdal increased the risk of diabetes.
Chief Deputy AG Fran Hughes signed the complaint. She appointed then-law partners Teresa Toriseva and Barry Hill of Wheeling as special assistants.
Hill amended the complaint to add a claim that Johnson & Johnson concealed the addiction risk of Duragesic.
Rebecca Betts of Charleston answered for Johnson & Johnson that contingency fees for Toriseva and Hill would violate due process.
Hughes replied that Johnson & Johnson would suffer no harm from the fee arrangement and lacked standing to challenge it.
Last year Gaughan set the stage for trial by denying summary judgment to Johnson & Johnson and finding its promotions false and misleading.
At trial in September, Johnson & Johnson proposed to count the Risperdal letters as a single violation.
The company continued to deny that it misled anyone, but Gaughan had made up his mind and didn't appreciate the argument.
In a Feb. 25 order, he wrote that Johnson & Johnson still didn't accept that their promotions were false and misleading.
He rejected its claim that it wasn't conscious of wrongdoing.
"A mass marketing campaign should not be counted as merely one violation as the deterrent effect of a $5,000 civil penalty is minimal," he wrote. "Defendants directly disobeyed a direct Food and Drug Administration mandate to include diabetes warning language within its Risperdal promotional materials."
Hill represented the state at trial. He and Toriseva no longer work together.
Toriseva sent a letter to Gaughan on March 2, claiming a portion of the fees.
Gaughan can't do anything about it, for on March 30 he granted a joint motion to stay post trial proceedings pending appeal to the West Virginia Supreme Court of Appeals.
Johnson & Johnson's insurer, Federal Insurance, posted a $5,414,750 appeal bond.
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