- Pacira sues for free speech; FDA pulls off-label warning letter. What gives? (fiercepharmamarketing.com)
On second thought, Pacira Pharmaceuticals, the FDA might just take it back...the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices…the FDA warning letter--now taken down from the agency website--Pacira had claimed that Exparel (bupivacaine), its pain drug and lead product, could work for up to three days at a time, though it's only approved for 24-hour pain relief… It would seem like a good old-fashioned pharma-government tussle over what companies can and cannot say about their products. But the argument has changed significantly, thanks to a series of court rulings that could open the door for drugmakers to market their products in previously unacceptable--even previously illegal--ways...
- Who’s Up Next? More Pharma Companies Expected To Settle Foreign Bribery Cases (forbes.com)
Now that Bristol-Myers Squibb has settled its foreign bribery case with the US government, speculation has turned to which pharma company will be next…Department of Justice will being putting a bigger squeeze on companies…the department is adding to the resources devoted to investigating foreign bribery cases and is focusing on large-value, high-impact matters…Glaxo is a leading example. It paid the largest healthcare fraud settlement ever – $3 billion – to the US in 2012 to resolve criminal and civil allegations of improper marketing practices...Glaxo’s Chinese subsidiary paid nearly $500 million to China after a court found the local subsidiary guilty of bribing healthcare officials. Glaxo is likely to pay millions more to settle bribery charges as both US and UK regulators are investigating the drugmaker’s practices in China, Poland, Jordan and Lebanon.
- Oklahoma may have used the wrong drug to execute an inmate this year (washingtonpost.com)Arkansas judge halts 8 executions as inmates challenge law (news.yahoo.com)
Oklahoma may have used the wrong drug during an execution…After Oklahoma executed Charles Warner…an autopsy report said that his body and containers for lethal-injection drugs were delivered to the state’s Office of the Chief Medical Examiner. Among those containers were empty vials labeled potassium acetate, even though the state’s lethal-injection protocol calls for the use of potassium chloride…potassium acetate and potassium chloride are "medically interchangeable."...The two different types of potassium appear to be equal, said David Gortler, an associate professor of pharmacology…"Potassium is potassium," Gortler said..."The pharmacology isn’t that much different between the different salts."
- Man accused of running unlicensed medical clinic in house; authorities seek patients (reviewjournal.com)Uninsured, immigrants often target of medical scams (reviewjournal.com)
A man police say posed as a doctor and treated people at an east Las Vegas Valley house has been arrested, and authorities are trying to find people who went to him for medical or dental care…Southern Nevada Health District, Las Vegas police and the FBI are requesting information from people who received services…The person who used the building identified himself as Rick Van Thiel or "Dr. Rick," health officials said, but he is not licensed to practice medicine.
- The US FDA has issued an alert warning the public not to take drugs marked as sterile by compounding firm Qualgen. (outsourcing-pharma.com)FDA alerts health care professionals not to use sterile drug products from Qualgen (fda.gov)
During an inspection of Qualgen’s facility in Edmond, Oklahoma, FDA investigators observed "insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced," said the agency…The FDA recommended the company cease sterile operations until it fixed the problems, but Qualgen agreed only to voluntarily recall 67 lots of drugs. The recalled products were compounded before September 1, 2015 and have not yet expired…The Food and Drug Administration said it is not aware of any adverse events associated with Qualgen’s products…
- D.E.A. Effort to Curb Painkiller Abuse Falls Short at Pharmacies (nytimes.com)DEA’S Prescription Drug Take-Back Effort-- A Big Success (dea.gov)
When the Drug Enforcement Administration announced last year that pharmacies nationwide could accept and destroy customers’ unwanted prescription drugs, experts in substance abuse called it a significant step toward easing the painkiller and heroin epidemic…the response has been insignificant…about 1 percent of American pharmacies have set up disposal programs, with none of those belonging to the two largest chains, CVS and Walgreens, which have balked at the cost and security risks… at least eight states, including New York, have laws that forbid pharmacies to take back controlled substances…D.E.A. has held 10 so-called take-back days — with the latest on Sept. 26 — these have collected 2,400 tons of pills, limited research suggests that the vast majority are non-controlled medications…
- Kentucky pharmacy PharMerica agrees to $9.25M settlement (washingtonpost.com)
..Kentucky pharmacy has agreed to pay $9.25 million to settle allegations that it solicited and received kickbacks from a manufacturer in exchange for promoting a drug with nursing home patients,… PharMerica Corp. resolves claims that it received kickbacks from Abbott Laboratories in exchange for recommending that physicians prescribe the Abbott-manufactured drug Depakote. The federal government alleged the kickbacks were disguised as rebates, educational grants and other financial support....
- DEA Requirements for Handling Controlled Substances (pharmacytimes.com)
James Schiffer, RPh, associate at Allegaert Berger & Vogel LLC, discusses some of the DEA's requirements for handling controlled substances.
- Former Georgia Physician Pleads Guilty to Illegally Prescribing Controlled-Substances to Kentucky Residents (dea.gov)
Michael Johnston…former Georgia physician has admitted in federal court that he conspired with the owner of a Georgia pain clinic…to unlawfully distribute thousands of controlled substance prescription pills… further admitted that he ignored the fact that his Kentucky customers were addicts and were likely selling a large percentage of the drugs... Johnston…acknowledged that he had no formal training or experience in prescribing adult pain medication…many of the patients were seen by non-physicians, who then recommended prescriptions, allowing the clinic to increase the number of patients that could be seen in a day…also admitted that he provided little or no physical examination to many of these patients, before providing the prescriptions; he made no referrals for surgery or other medical exams; and he was encouraged to see as many patients, per day, as possible.
- Las Vegas doctor denies sexually assaulting patients (news.yahoo.com)Vegas doctor accused of groping girl was let off after 'impulse control' classes (reviewjournal.com)
Las Vegas physician stood shackled in court and pleaded not guilty Wednesday to drugging and sexually assaulting at least 14 patients, including a 16-year-old girl whose alleged attack was videotaped…An indictment filed last week accuses Bin Minh "Ben" Chung of 24 charges including lewdness, sexual assault, administering a drug in the commission of a felony, and a kidnapping charge that could bring a life sentence if he's convicted.