Tag Archives: Big Pharma

Lawmakers seek reckless prescribing info from Purdue

DRUG BANNEDIn the wake of a Los Angeles Times report describing a decade-long effort by Purdue Pharma to identify potentially problematic prescribers of OxyContin, two state lawmakers are requesting that the company turn over the names of doctors it suspects recklessly prescribed the pills to drug dealers and addicts.

Sen. Richard “Tick” Segerblom (D-Las Vegas) and California state Sen. Ted Lieu (D-Torrance) want Purdue to reveal the names of physicians contained in a database that includes some 1,800 doctors who showed signs of dangerous prescribing, according to the LA Times.

Purdue has taken the stance that the painkiller addiction epidemic was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets, but has admitted that a small number of physicians might account for a “substantial portion” of the nation’s black-market supply of prescription painkillers, the article says.

According to the article:

Beginning in 2002, Purdue trained its sales representatives to report “red flags” in doctors’ offices, such as young patients, long lines, people nodding off in waiting rooms and frequent cash transactions. Purdue attorneys review their reports, and if a doctor’s practice is deemed too risky, the company bars sales representatives from marketing to the physicians. The suspect doctors are removed from the company’s numbered sales territories and assigned to the database, known as “Region Zero.”

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FDA shutters rogue Internet pharmacies in massive crackdown

computerpillsFederal regulators have launched a massive crackdown on Internet pharmacies that are selling unapproved and potentially dangerous prescription medicines that could pose significant public health risks. The U.S. Food and Drug Administration said it has shut down 1,677 websites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards. Regulators have also seized more than $41 million worth of illegal medicines and arrested 58 people, while a number of additional websites have received regulatory warnings, according to the FDA.

Several sites had interfaces and names that could easily be confused with legitimate pharmacy retailers, such as Walgreens-Store.com, which imitated the well-known drugstore chain’s website, which is actually Walgreens.com, the agency said.

The crackdown marks the largest Internet-based action of its kind, the agency said, adding that prescription medicines, including those purchased online, should only be used with a valid prescription and under the supervision of a licensed health care provider.

Although regulators have long had their eye on the online market for prescription pills, it is still disturbingly easy to find a rogue Internet pharmacy that will sell painkillers like codeine and hydrocodone without a prescription, according to this article. Research shows that 97% of Internet pharmacies are not operating legitimately and most of those do not require a prescription at all, the article says. Many of these pharmacies are based overseas, and will provide the medication even if customers are underage, the article says.

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Painkillers over-prescribed to Medicare patients: study

bunchofpillsA new study by the Department of Health and Human Services highlights a variety of problems concerning prescription medication practices among doctors and pharmacies servicing Medicare patients, including over-prescribing, over-billing, and over-medicating.

The review identified more than 2,200 doctors whose records stood out in one of five areas: prescriptions per patient, brand name drugs, painkillers and other addictive drugs or the number of pharmacies that dispensed their orders, according to this article.

More than half of 736 physicians studied wrote prescriptions for extremely high amounts of controlled substances that have the potential for addiction and abuse, the article says.

All told, the drugs ordered by the doctors labeled “extreme outliers” cost Medicare $352 million, according to the study.

In 2008, more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs, according to the CDC.

Nearly three out of four prescription drug overdoses are caused by prescription painkillers. The unprecedented rise in overdose deaths in the U.S. parallels a 300% increase since 1999 in the sale of these medications, which were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, the CDC says.

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13% of Americans take prescription painkillers: study

pill bottlesA new study has found that 7 out of 10 Americans take at least one kind of prescription medication, and more than half take two — and 13% of them take painkillers that can be highly addictive. The study by the Mayo Clinic said that opioids, antidepressants, and antibiotics were the most commonly prescribed type of pills, and that women receive more prescriptions than men across several drug groups, especially antidepressants.

The percentage of people who took at least one prescription drug in the past month increased from 44% in 1999-2000 to 48% in 2007-08, the study found. Spending on prescription drugs reached $250 billion in 2009 the year studied, and accounted for 12% of total personal health care expenditures, and drug-related spending is expected to continue to grow in the coming years, according to the researchers.

In 2008, more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs, according to the CDC.

Nearly three out of four prescription drug overdoses are caused by prescription painkillers. The unprecedented rise in overdose deaths in the U.S. parallels a 300% increase since 1999 in the sale of these medications, which were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, the CDC says.

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Walgreens to pay $80M over black-market Oxy sales

bunchofpillsThe U.S. Drug Enforcement Agency announced Tuesday that Walgreens has agreed to shell out $80 million to settle allegations that it allowed oxycodone and other controlled drugs to be diverted for black market sales from its Jupiter, Fla., distribution center.

The settlement, which is the largest in the DEA’s history, comes after the agency accused Walgreens last year of failing to maintain proper controls to ensure it didn’t dispense drugs to addicts and drug dealers.

According to the DEA, the Jupiter distribution center has been the single largest distributor of oxycodone products in Florida since 2009. In 2011, 16 of the top 25 largest oxycodone purchasers by Walgreens retail pharmacies, including the top six purchasers, were in Florida and supplied by the Jupiter center, the agency said.

Walgreens “committed an unprecedented number of record-keeping and dispensing violations” under the Controlled Substances Act, which is designed to prevent prescription painkillers from ending up on the streets, the DEA said.

In addition to the payout, Walgreens’ Jupiter center is banned from distributing and dispensing similar controlled substances until 2014. The deal also resolves similar investigations nationwide, including in Colorado, Michigan, and New York.

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Calif. Senate OKs prescription drug abuse measures

gavelThe California Senate has given the stamp of approval to a package of bills aimed at reducing prescription drug abuse and overdose deaths, including a measure that would require coroners to report deaths involving prescription drugs to the Medical Board of California. The Los Angeles Times reports that the Senate also signed off on a bill that would upgrade the state’s prescription drug monitoring program, known as CURES. In addition, lawmakers approved a measure that would make it easier for the medical board to investigate physicians suspected of overprescribing and suspend their prescribing privileges, and a bill that would prohibit pharmacies from advertising commonly abused narcotic medications, such as OxyContin and Vicodin, according to the LA Times.

The package of legislation will now move on to the California Assembly for approval.

The CURES bill faced the strongest opposition from the pharmaceutical and biotech industries, the Times says, even though it had the support of a coalition of law enforcement groups, health insurance companies, and business, labor and consumer organizations. That opposition was dropped after the bill’s sponsors removed a provision that called for a tax on drug makers to pay for teams of investigators to crack down on drug-seeking patients and doctors who recklessly prescribe to them, according to the Times.

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Generic Opana to remain on the market: FDA

PillsThe U.S. Food and Drug Administration said Friday it will continue to allow sales of the generic version of the painkiller Opana that does not include an abuse-resistant feature.

Opana’s manufacturer, Endo Pharmaceuticals, had submitted a petition to the agency asking it to ban generic forms of the painkiller, which Endo has reformulated as “Opana ER” to make it harder to abuse. That petition was denied by the FDA, which said Endo’s reformulation was not significantly safer than the original version:

While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.

Endo’s petition came after Purdue Pharma successfully asked the FDA to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make it more difficult to crush, break, or dissolve.

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Painkiller market to reach $8.4B by 2017: WSJ

pill money signPrescription painkiller sales are set to increase by 15% and hit $8.4 billion by 2017, due in part to the U.S. Food and Drug Administration’s recent decision to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse. Experts are predicting a race across the pharmaceutical industry to create a market where all opioids have abuse-deterrent properties, according to the Wall Street Journal.

According to the FDA, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”

OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.

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FDA bans copycat versions of original Oxy amid abuse concerns

DRUG BANNEDThe U.S. Food and Drug Administration said Tuesday it will not approve any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse.

According to the agency, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”

OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.

The FDA’s decision came on the same day that Purdue’s patent on the original OxyContin expired, which normally opens the door for generic drug makers to launch their own cheaper versions of a product. Now, these generic companies will have to develop their own abuse-deterrent designs, preserving Purdue’s monopoly on the OxyContin market for the time being.

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Naloxone’s rising price costing lives

naloxHospira, the sole manufacturer of opiate overdose reverser naloxone, has jacked up the price of the antidote by 1,110% since 2008, threatening the sustainability of overdose prevention programs nationwide, according to this article. Naloxone distribution programs have handed out more than 53,000 naloxone kits and report over 10,000 overdose reversals since 1996, the article notes — but in the past two years alone, almost 10% of the distribution programs have closed their doors, causing overdose deaths to start to bounce back up.

Possible solutions: the FDA could allow temporary importation of naloxone from foreign manufacturers, the federal government could lower prices by enticing new pharmaceutical companies to enter the market through a fast-track approval process, or the FDA could give the green light to naloxone for over-the-counter use so that people who need it can purchase directly from pharmacies, the article says.

Of course, Hospira could also lower the price of naloxone, which is a $20-million-a-year industry: it would cost a mere $100,000 for Hospira to supply every harm reduction program in the country with enough naloxone to meet current capacity, the article points out.

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