- FDA seeks suspension of 4,402 illegal prescription drug websites (reuters.com)
The U.S. Food and Drug Administration said...along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers...The move is part of a global effort being led by the INTERPOL...to identify the makers and distributors of illegal prescription drugs...the FDA said it has also issued warning letters to operators of 53 websites that illegally sell unapproved and misbranded prescription drug products to U.S. consumers...Preliminary findings...showed U.S. consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other conditions...
- Florida Stores Help Consumers Buy Imported Drugs Despite Federal Ban (realclearhealth.com)
A hardy market for imported low-cost prescription drugs has taken root in Florida, nourished by older Americans and tolerant regulators...About 15 storefront businesses across Florida claim to help thousands of customers each year place online orders from pharmacies in Canada and overseas for medicines at prices up to 70 percent off what people pay in the U.S...Federal authorities say the practice is illegal and dangerous because the U.S. has not reviewed the safety of some drugs approved for sale in foreign countries or they could be counterfeit. But since the first storefront opened in 2002 in Delray Beach, Florida, the government has never charged shops or their customers, according to operators and researchers who follow the business...The trade’s surprising survival spotlights both seniors’ continuing difficulties with medication expenses, and how far some people will go to save money...the Bush and Obama administrations have let the imported drug stores stay open...If they clamped down on these storefronts, it would be seen as restricting access to affordable drugs and supporting big bad [drug] corporations...The administration is saying that they are against this as a matter of policy, but programmatically [they] are not doing anything about it...At the time, U.S. Customs and Border Protection was routinely seizing mail-order packages of prescription drugs entering the U.S. from Canada...
- India’s Sun Pharma gets U.S. subpoena over generic drugs pricing (finance.yahoo.com)
U.S. Department of Justice has subpoenaed India's largest drugmaker Sun Pharmaceutical Industries Ltd seeking information about the pricing and marketing of the generic drugs it sells in the United States...The DoJ's antitrust division has also asked Sun Pharma's U.S. unit for documents related to employee and corporate records and communications with competitors...They specifically cited doxycycline hyclate 100 milligram, an antibiotic for which the price doubled in the year through June 2014...Other generic drugmakers including India's Dr Reddy's Laboratories Ltd and U.S. firm Allergan Plc also received subpoenas from regulators seeking similar information last year, but they did not disclose the names of the products involved...
- Dr. Robert Rand does not enter plea during Reno federal court appearance (mynews4.com)Reno prescription drug ring case: What we know now (rgj.com)
Dr. Robert Rand did not enter a plea during his appearance in federal court Monday in Reno...Rand has been indicted and charged with taking part in a criminal prescription drug distribution ring...His attorney, John Arrascada, told News 4 that Rand would plead not guilty to all charges...Eight other people have been indicted by a federal grand jury. All eight have pleaded not guilty to the charges they face individually, though only Richard Winston West II remains detained...Doctor Robert Rand will be arraigned...to enter a plea on charges of conspiracy to distribute and possess with intent to distribute controlled substances...
- Troubled Teva plant in Hungary faces an FDA crackdown (statnews.com)
The latest broken link in the pharmaceutical supply chain has appeared in Hungary, where Teva Pharmaceuticals has suspended production at a plant following a crackdown by the US Food and Drug Administration...The drug maker voluntarily halted work at its Godollo facility, which makes sterile injectable medicines, as "a precautionary measure" shortly after FDA inspectors visited last January...The company is "working around the clock to restart manufacturing operations as soon as possible,"...The shutdown only came to light after Hungarian regulators late last week issued a notice in an attempt to address concerns about drug shortages...The disclosure by Hungary’s National Institute of Pharmacy...came several days after the FDA also issued a so-called import alert, which is a notice about products that are banned from entering the United States. The FDA alert cites issues with good manufacturing practices, a regulatory term for minimum standards, but specific problems were not disclosed...the episode underscores the ongoing challenges that even the largest drug makers face in maintaining their plants...
- Synthetic drugs pose alarming U.S. overdose risk: DEA chief (reuters.com)
Synthetic designer drugs, especially synthetic opioids like fentanyl implicated in the death of pop star Prince, pose an "unprecedented" threat for U.S. overdoses and deaths, especially among youth...Drug Enforcement Administration has been cracking down on synthetic drugs since they began gaining popularity in 2010. But because each newly designed drug needs to be separately banned through a "clunky and cumbersome" process, the problem continues to spiral, DEA head Chuck Rosenberg told a U.S. Senate committee...For every one substance we’ve controlled, legislatively or administratively, there are 11 more out there that are uncontrolled...Rosenberg testified that the DEA has seen a particularly alarming rise in illicit use of the fentanyl...More than 11 million people illegally consume prescription painkillers for non-medical purposes each year, and overdoses are likely to increase as fentanyl is introduced to that market...
- Former pharma exec headed to trial on kickback allegations (statnews.com)
- Between 2009 and 2012, W. Carl Reichel allegedly orchestrated a campaign to give doctors money, free meals, and phony speaking fees in exchange for prescribing medicines sold by Warner-Chilcott, where he had been the president of the pharmaceutical division...he goes on trial in what is expected to be a closely watched case in the pharmaceutical industry. That’s because the case marks one of the relatively few instances in which federal prosecutors have sought to hold a high-ranking executive from a drug maker accountable for such activities...drug company executives have faced penalties for illegal activities. Notably, three former executives at Purdue Pharma pleaded guilty in 2007 to misleading the public about the risk of addiction posed by the OxyContin painkiller. They were also banned from any dealings with federal health care programs...such instances are relatively rare...In the Reichel case, the feds allege that he developed and oversaw an illegal strategy to boost prescriptions for several drugs, including the Actonel osteoporosis treatment and the Doryx acne medicine. Among the charges: Reichel provided sales reps with unlimited expense accounts in order to wine and dine doctors, and he suggested targeting doctors who were already frequent prescribers, according to the indictment...He faces no more than five years in prison, three years of supervised release, and a fine of $250,000.
- 5 Things Pharmacists Should Know About Dabbing (pharmacytimes.com)
For some, dabbing is a dance popularized by pro athletes like Cam Newton and LeBron James...For others, it refers to using a potent marijuana extract...Here are 5 things pharmacists should know about the potentially less familiar form of dabbing that is increasingly a public health concern.
- The tetrahydrocannabinol (THC)-concentrated substance is yellow and looks like honey or butter.
- The concentrate can have THC levels anywhere between 40% and 80%.
- The marijuana concentrate is often placed in e-cigarettes or vaporizers.
- The long-term effects of dabbing are unknown.
- One method to manufacture marijuana concentrate can lead to explosions.
- Website Domains of Fake Online Drug Outlets Seized by Federal Authorities (nabp.net)Federal Court Orders Seizure of 67 Website Domains Involved in Smuggling and Selling Misbranded and Counterfeit Prescription Drugs (justice.gov)
Sixty-seven domain names of commercial websites involved in the illegal sale and distribution of counterfeit and prescription drugs had seizure orders executed against them, according to an announcement by the US Department of Justice. The federal government now has custody of the seized domains. When visiting the sites, users will see a seizure banner indicating that the domain name has been seized for violation of federal laws against smuggling and trademark misuse...Individuals who have an interest in the seized domain names have a period of time after the Notice of Seizure to file a petition with a federal court and additional time after the notice to contest the forfeiture.
- Kentucky Anesthesiologist Sentenced to 8+ Years for Unlawful Distribution of Controlled Substances, Health Care Fraud and Money Laundering (dea.gov)
...anesthesiologist Jaime Guerrero, who had practices in Kentucky and Indiana, was sentenced to 100 months in prison...according to...plea agreement, Guerrero agreed to forfeit his license to practice medicine, and to forfeit real property owned by Guerrero Real Estate Investments...Further, Guerrero agreed to pay $827,000 in victim restitution to nine health care benefit programs...pleaded guilty to 31 counts of a 35 count Superseding Indictment...including unlawful distribution or dispensing of controlled substances, health care fraud, conspiracy and money laundering...Guerrero conspired with others to knowingly and intentionally distribute and dispense Schedule II and III controlled substances to patients, without a legitimate medical purpose and beyond the bounds of professional medical practice... Guerrero...fraudulently submitted over 100 claims to various health care benefit programs for office visits at a higher code than the service provided; for office visits that were not medically necessary or within the course of usual medical practice; submitting claims for services that were not sufficiently documented in the patient’s medical record; and making claims for office visits as though a physician saw the patient...