Category Archives: Pharmaceutical Industry

CVS to stock R.I. Walgreens stores with Narcan

narcan-with-needle3The opiate overdose antidote Narcan will soon be available in all CVS pharmacies in Rhode Island without a prescription. The move comes as the state is seeing a surge in recent deaths due to opiate drug overdoses, which can be reversed by Narcan, also known as naloxone. Narcan can be administered as a nasal spray or an injection, and CVS says it will offer both, following in the footsteps of a similar move by Walgreens last year.

Rhode Island ranks among the highest in the country in illicit drug use, including the non-medical use of prescription painkillers and per capita overdose deaths.
In the first four months of 2014, 90 Rhode Islanders died from accidental drug overdoses, a 23% increase from the 73 drug overdoses reported during the same period last year.

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DEA clamps down on hydrocodone

HydrocodoneHydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.

Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.

Combination hydrocodone products are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.

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FedEx faces drug-trafficking charges

pharmacyFedEx Corp. is facing charges that it delivered prescription painkillers and other controlled substances for illegal Internet pharmacies.

The charges include 15 counts of conspiracy to distribute controlled substances and misbranded drugs and drug trafficking. Prosecutors claim FedEx delivered drugs to Internet pharmacies that supplied pills to customers who filled out online questionnaires without undergoing doctors’ examinations, in violation of federal and state drug laws.

According to the indictment, FedEx knew as early as 2004 that it was delivering drugs to dealers and addicts:

FedEx’s couriers in Kentucky, Tennessee, and Virginia expressed safety concerns that were circulated to FedEx Senior management, including that FedEx trucks were stopped on the road by online pharmacy customers demanding packages of pills, that the delivery address was a parking lot, school, or vacant home where several car loads of people were waiting for the FedEx driver to arrive with their drugs, that customers were jumping on the FedEx trucks and demanding online pharmacy packages, and that FedEx drivers were threatened if they insisted on delivering packages to the addresses instead of giving the packages to customers who demanded them. In response to these concerns, FedEx adopted a procedure whereby Internet pharmacy packages from problematic shippers were held for pick up at specific stations, rather than delivered to the recipient’s address.

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Non-tamper-proof Oxy hitting U.S. from Canada

DRUG BANNEDAn older form of the powerful prescription painkiller OxyContin that has been banned in the United States is still showing up in some areas of the country, possibly making the journey from Canada, where it is still legal, according to this article. In 2013, the FDA banned generic versions of OxyContin, which could easily be crushed, in favor of a tamper-resistant version produced exclusively by Oxy maker Purdue Pharma under a new patent. The Canadian government has so far continued to approve generic, crushable forms of oxycodone that are highly prone to abuse — though it has recently indicated it may soon force all opioid manufacturers to render their products tamper-resistant.

The news came as a study into skyrocketing opioid deaths in Canada found that painkillers are responsible for one in eight deaths among young adults in Ontario, according to this article. Opioid overdoses killed nearly 6,000 people in Ontario between 1991 and 2010, half of them under the age of 42, the study found.

Canada is the world’s second largest per capita consumer of prescription opioids after the United States.

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Del. orders Zohydro prescribing restrictions

RXDelaware has put into place emergency prescribing regulations regarding Zohydro, a powerful new painkiller many critics fear may fuel the epidemic of painkiller abuse. Late last year, Zohydro gained FDA approval despite the fact that after its own advisory committee had voted 11-2 against allowing the drug on the market. Since then, 29 state attorneys general have urged the agency to reconsider its decision, and Massachusetts Gov. Deval Patrick even attempted to ban the drug (a federal judge later blocked that order). Delaware Secretary of State Jeffrey Bullock said the regulations were necessary “to address the imminent peril to the public health, safety and welfare of all Delawareans” caused by Zohydro. According to his statement:

The use of this new and dangerous narcotic painkiller known as Zohydro must be monitored closely because the abuse of it can be deadly. It carries even higher risks of abuse than other short-acting formulations.

Zogenix, the maker of Zohydro, recently reported that about 9,000 prescriptions were filled through June 13 since the drug hit the market in March. The company plans to target about 20,000 prescribers it describes as “high decile [extended-release/long-acting] opioid prescribers” who account for 60% of the market, and envisions Zohydro along the lines of the multibillion-dollar market for OxyContin, according to this article.

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Ca. counties sue Big Pharma over opioid marketing

pill money signTwo California counties have launched a lawsuit accusing five major pharmaceutical companies of obscuring the addictive effects of OxyContin, Percocet and other powerful opioid painkillers while reaping billions of dollars in profits from the drugs. The companies deceived tens of millions of doctors and patients about the “significant dangers and questionable benefits of prescription opioids” for the treatment of long-term non-cancer pain, according to a complaint filed today in California state court. The five opioid manufacturers — Purdue Pharma, Cephalon, Janssen Pharmaceuticals, Endo Health Solutions, and Actavis — concealed the dangerously addictive nature of the medicines while touting benefits that had no scientific support, in order to expand the market for the drugs and boost profits, the lawsuit alleges.

The complaint charges that the pharmaceutical companies marketed opioids as “rarely” addictive, misrepresented the evidence of their efficacy for treating chronic non-cancer pain, trivialized their serious side effects and falsely assured doctors and consumers that opioids were safer than over-the-counter drugs.

According to the suit:

These pharmaceutical companies have a long history of aggressively marketing these dangerous drugs through sophisticated campaigns. These campaigns employ industry-funded professional associations, patient advocacy groups, and physicians to deceive consumers and their doctors about the harms and purported benefits of opioids for treating chronic pain.

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Zohydro backlash intensifies despite FDA’s defense

No-pills-4-1-14Opposition to Zohydro, the powerful new opiate some critics are calling “heroin in a pill,” continues to build, but the U.S. Food and Drug Administration is strongly defending the agency’s approval of the drug, saying its benefits to pain patients outweigh the potential negative consequences.

Since its approval by the FDA last October, Zohydro has come under fire from members of Congress, state attorneys general, doctors and addiction specialists who have worked to block the pill from being sold in the U.S., according to this article. Critics want the agency to rescind its approval of Zohydro, citing the alleged danger of the drug as well as the growing abuse of prescription drugs nationwide, but the FDA says that instead of blocking the sale of Zohydro based on a fear of abuse and addiction, providers should screen patients before they prescribe the drug and while they are on it, the article says.

The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, citing concerns about the danger of addiction posed by the opioid drug class.

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Judge nixes Zohydro ban in Mass.

gavelA federal judge has struck down Massachusetts Gov. Deval Patrick’s ban on the controversial new form of hydrocodone, Zohydro, saying the state lacked the authority to override the FDA’s approval of the painkiller. U.S. District Court Judge Rya W. Zobel noted that the FDA approved Zohydro after a screening process, and said the federal regulatory agency has more power than the state in this case, according to this article. She also said Massachusetts lacked the authority to force Zohydro’s maker, Zogenix, to make an abuse-resistant form of the drug because that formulation has not been approved by the FDA, the article says.

Gov. Patrick issued the Zohydro ban last month, declaring a public health emergency in response to the state’s growing opioid addiction epidemic and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added.

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FDA OKs new overdose antidote treatment

naloxone-hcl-narcanThe U.S. Food and Drug Administration has approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The hand-held device, known as Evzio, rapidly delivers a single dose of the drug naloxone and can be carried in a pocket or stored in a medicine cabinet, according to the agency. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for such situations, but until now it has been available mostly in hospitals and other medical settings.

Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous), the FDA said. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the U.S. Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.

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Zohydro critics fear new wave of addiction

Vicodin-half-life-how-long-does-Vicodin-remain-in-your-body2The U.S. Food and Drug Administration’s approval of Zogenix Inc.’s Zohydro painkiller has come under fire from critics who say the agency should not be approving any additional opioids given the current prescription drug epidemic. Forty-two public health groups are urging the FDA to withdraw its support of the painkiller, according to National Public Radio. Zogenix says it will introduce a non-crushable version of Zohydro in three years and plans to closely monitor prescription abuse, and claims that millions legitimately need the drug, NPR reports. But addiction experts say another high-potent, high-dose, long-acting opioid drug will simply add more fuel to the painkiller addiction epidemic, NPR says.

The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, citing concerns about the danger of addiction posed by the opioid drug class.

Unlike other hydrocodone-containing drugs like Vicodin, Lortab and Norco, Zohydro is not buffered with acetaminophen or some other over-the-counter medication. The drug also lacks an abuse-deterrent feature such as the ones used in new formulations of drugs like OxyContin.

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