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Category Archives: Policy & Regulation
FDA OKs controversial form of Vicodin
The U.S. Food and Drug Administration panel has approved Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. The move comes amid criticism from those who say the FDA should not be approving any additional opioids given the current prescription drug addiction epidemic. An advisory panel last year voted against approving Zohydro, 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.
Hydrocodone is currently the second most-abused medicine in the U.S. behind oxycodone.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, FDA, hydrocodone, Lortab, narcotics, Norco, OP, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Purdue Pharma, Schedule II narcotics, Vicodin, Zogenix, Zohydro
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FDA moves for stricter hydrocodone controls
The U.S. Food and Drug Administration has recommended reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, a move that would bring such medications in line with opioid painkillers such as oxycodone and morphine.
In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. Proponents of the reclassification have noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics have argued that the move would hinder legitimate pain patients from obtaining treatment.
The reclassification must be approved by the Department of Health and Human Services and the Drug Enforcement Administration, which will make a final scheduling decision.
Separately in September, the FDA announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin. The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, Big Pharma, FDA, hydrocodone, morphine, narcotics, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, Percocet, pharmaceutical, prescription drug abuse, prescriptions, reclassification, reschedule, Schedule II narcotics, Schedule III narcotics, Vicodin, Xanax
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Calif. lawmakers OK painkiller legislation
The California Senate has given the green light to two bills aimed at combatting prescription drug abuse and overdose deaths by helping authorities track painkiller prescriptions and enabling enhanced scrutiny of deaths involving such drugs.
The proposed legislation would require coroners to report prescription overdose deaths to the state’s medical board for review, according to the Los Angeles Times, which earlier reported on the nearly 4,000 accidental deaths involving prescription drugs in Southern California and found that in half the cases, drugs that caused or contributed to a death had been prescribed by that person’s physician.
The legislation would also enhance and provide sustained funding for California’s prescription drug monitoring system, known as CURES, which contains detailed data on prescriptions for painkillers, the LA Times said.
The two bills now head to the desk of Gov. Jerry Brown for approval.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, California, CURES, Deaths, doctor shopping, drug monitoring program, legislation, Los Angeles Times, narcotics, opiates, overdoses, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pharmacy, pill mills, pills, politics, prescription drug abuse, prescription drug monitoring program, prescriptions, Schedule II narcotics
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FDA unveils new labeling rules for opioids
Under pressure from activists and other critics, the U.S. Food and Drug Administration on Tuesday announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin.
According to the agency, the changes are aimed at combatting “the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities.”
The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.
The FDA’s move was met with skepticism by some activists who were concerned the changes do not go far enough. Pete Jackson, the president of Advocates for the Reform of Prescription Opioids, said the development could be viewed as either a step in the right direction or as “another smokescreen put out by the FDA to make it look like they are doing something.”
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, ARPO, Big Pharma, Deaths, FDA, hydrocodone, labeling, narcotics, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Vicodin
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Del. becomes 14th state to pass ‘Good Samaritan’ law
The governor of Delaware signed so-called “Good Samaritan” legislation on Tuesday offering protection to anyone seeking medical help in the event of a drug or alcohol overdose, making Delaware the 14th state to pass such a measure. The law gives immunity from prosecution to people reporting an overdose, even if he or she has been involved in drug-related activity.
The bill also grants immunity from prosecution for offenses related to underage drinking.
Lawmakers approved the bill only after exempting higher level drug felonies from its immunity protections, a change that worried some critics who claimed the exemptions weakened the bill and would discourage people from reporting overdoses.
In Delaware, overdose deaths nearly tripled from 50 in 1999 to 137 in 2009, with a majority in recent years involving at least one prescription drug, according to this article.
New Mexico was the first state to pass a Good Samaritan law in 2007, followed by California, Colorado, Connecticut, Florida, Illinois, Massachusetts, New York, Rhode Island, Washington, and the District of Columbia. According to TheFix.com, this year, nearly a dozen more states introduced bills: legislation in North Carolina and New Jersey succeeded, while other bills failed due to partisan bickering (Missouri, Mississippi and North Dakota), were killed in committee (New Hampshire and West Virginia), or ran out of time (Hawaii and Texas); Maine still has a live bill, but it isn’t likely to pass this year.
Posted in Crime, Informational, Policy & Regulation
Tagged addiction, Crime, Deaths, Delaware, Good Samarian, Good Samaritan laws, law, laws, narcotics, opiates, opioid, overdose, overdoses, oxycodone, OxyContin, pain medication, painkillers, pills, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Teen deaths
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FDA shutters rogue Internet pharmacies in massive crackdown
Federal 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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, crackdown, Crime, doctor shopping, FDA, Internet, narcotics, online, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pharmacies, pharmacy, pill mills, pills, prescription drug abuse, prescriptions, Schedule II narcotics
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Rogue online pharmacies still fueling pill sales
Although federal 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.
It is illegal to buy or sell prescription drugs without a prescription.
According to the article:
With an estimated 40,000 to 50,000 rogue Internet pharmacies in operation, law enforcement agencies face an uphill battle shutting down online pharmacies dispensing drugs without a prescription, especially when their operations cross many international jurisdictions.
Buying prescription medicine from fraudulent online pharmacies can be dangerous, or even deadly, according to the FDA. Such pharmacies are likely to be selling counterfeit medicines, which may be less effective or have unexpected side effects; in addition, online pharmacies may intentionally misuse the personal and financial information provided by customers, and sell this information to other illegal websites and Internet scams, the agency says.
Posted in Crime, Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, Crime, doctor shopping, illegal, Internet, narcotics, online pharmacies, opiates, oxycodone, OxyContin, pharmaceutical, pharmacy, pill mills, pills, prescription drug abuse, prescriptions, sales, Schedule II narcotics
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Walgreens to pay $80M over black-market Oxy sales
The 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.
Posted in Crime, Informational, Pharmaceutical Industry, Policy & Regulation
Tagged Big Pharma, Crime, DEA, distribution center, fine, Florida, Jupiter, narcotics, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, penalty, pharmaceutical, pills, prescription drug abuse, prescriptions, Schedule II narcotics, settlement, Walgreens
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Vt. becomes 13th state to pass ‘Good Samaritan’ law
The governor of Vermont signed so-called “Good Samaritan” legislation on Wednesday offering protection to anyone seeking medical help in the event of a drug or alcohol overdose, making Vermont the 13th state to pass such a measure. The law extends both to people seeking assistance for themselves and for others, and seeks to prevent overdose deaths by empowering witnesses to report such episodes quickly without fear of legal repercussions, according to this article.
Drug overdoses were responsible for killing 73 people in Vermont last year, and remain the leading cause of injury death to state residents between the ages of 25 and 64, the article says.
Separately on Wednesday, the governor also gave the stamp of approval to a measure that will increase access to naloxone, a medication used to reverse opiate overdose, the article says. Under that law, doctors who prescribe naloxone to opiate-using patients and bystanders who administer the drug to an overdose victim will no longer be to subject to civil liabilities resulting from rare adverse reactions to the drug, according to the article.
Calif. Senate OKs prescription drug abuse measures
The 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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Assembly, Big Pharma, California, coroners, CURES, Deaths, doctor shopping, drug monitoring program, LA Times, legislation, narcotics, opiates, overdoses, OxyContin, pain medication, painkillers, pills, prescription drug abuse, prescription drug monitoring program, prescriptions, Schedule II narcotics, Senate
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