- Agencies target ‘illegal, unapproved’ products that claim to treat opioid addiction (washingtonpost.com)
Federal regulators said Wednesday that they are cracking down on marketers and distributors selling a dozen products that “illegally” claimed to treat or cure opioid addiction and withdrawal...In letters sent earlier this month, the Food and Drug Administration and the Federal Trade Commission cited products that target people desperate to find relief from their addictions. They include “Opiate Freedom 5-Pack,” “CalmSupport” and “Soothedrawal.” Most of the 12 items are marketed as dietary supplements, while two are homeopathic remedies, the FDA said...The letters are the latest effort to combat what FDA Commissioner Scott Gottlieb called a “proliferation” of unapproved products claiming to treat opioid addiction. In a statement, Gottlieb excoriated “unscrupulous vendors who are trying to capitalize on the epidemic by taking advantage of consumers and selling products with baseless claims.”
- Drug Charity Sues U.S. Over Restrictions on Donor Communications (ptcommunity.com)
DOJ is investigating drug-makers’ financial support of patient-assistance charities...A U.S. charity offering assistance to patients for their out-of-pocket drug costs has sued the federal government over restrictions on its ability to communicate with drug-makers who donate to it...The charity, Patient Services, Inc., filed the lawsuit in federal court in Richmond, Virginia. It comes amid a Justice Department investigation into drug-makers’ financial support of patient-assistance charities...Drug-makers are prohibited from subsidizing copayments for patients enrolled in Medicare, but they may donate to nonprofits providing copay assistance as long as the charities are independent. Amid increased attention to rising drug prices, concern has arisen that drug-makers’ donations to such charities may be contributing to price inflation.
- Kmart to pay $32.3M to settle health care-related whistleblower case (nbcnews.com)
Kmart Corp. has agreed to pay $32.3 million to settle a whistleblower lawsuit alleging its pharmacies overcharged federal health care programs and some private insurers for generic prescription drugs..."Pharmacies that are not fully transparent about drug pricing can cause federal health programs to overpay for prescription drugs," Chad Readler, the acting assistant attorney general of the department's Civil Division, said..."This settlement should put pharmacies on notice that there will be consequences if they attempt to improperly increase payments from taxpayer-funded health programs by masking the true prices that they charge the general public for the same drugs."...The complaint was filed on behalf of former Kmart pharmacist James Garbe. According to the suit, in one case, Kmart had sold a 30-day supply of a generic version of a prescription drug for $5 to customers of its discount program, but then filed for reimbursement from the government for $152 for that same drug for its Medicare customers...Garbe will receive a whistleblower award of $9.3 million, which amounts to 29 percent of the federal government's recovery...
- Apotex founder Barry Sherman and wife, Honey Sherman, found dead in North York home (cbc.ca)Autopsies underway for Canadian billionaires found dead (ottawacitizen.com)
Canadian pharmaceutical giant Apotex has confirmed its founder Barry Sherman and his wife, Honey Sherman, are dead, amid reports that two bodies were found in their Toronto home...Deaths deemed 'suspicious'...investigators are still trying to "determine if there is foul play involved or not. And at this point we cannot say 100 per cent with certainty if there is or there is not...
- Generic-Drug Firms Fall as U.S. Threatens to Sue for Damages (bloomberg.com)
Shares of generic-drug makers including Mylan NV and Teva Pharmaceutical Industries Ltd. fell after the Justice Department’s antitrust division said it might sue them for damages in a price-fixing probe...If taxpayers were overcharged because drugmakers conspired to raise the price of drugs, the Justice Department will consider suing to seek damages, Makan Delrahim, the division’s chief, said...“To the extent that taxpayers have had to pay that bill, I think the taxpayers should recover,” he said. “We will get involved on the civil side and recover damages for the U.S. government.”...Mylan dropped as much as 3.1 percent after the comments and traded down 0.6 percent to $46.25 at 1:37 p.m. in New York. Teva’s U.S. depositary receipts dropped as much as 2.8 percent and were down 1.5 percent to $20.41 and Endo International Plc fell 5.6 percent to $6.92...The three drugmakers are among more than a dozen companies targeted by the Justice Department and state attorneys general in a multi-year investigation into generic drug price-fixing. So far, the probe has led to guilty pleas from two former executives of Heritage Pharmaceuticals...
- Philippines fines Sanofi, suspends clearance for Dengvaxia (reuters.com)Families target Philippine officials and Sanofi executives with request for criminal charges (fiercepharma.com)
The Philippines has fined Sanofi $2,000 and suspended clearance for the French drug maker’s controversial dengue vaccine Dengvaxia, citing violations on product registration and marketing, its health secretary said on Thursday...Concerns over the dengue immunization of nearly 734,000 children aged nine and above resulted in two Philippine congressional inquiries and a criminal investigation as to how the danger to public health came about...The country ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases...The Food and Drugs Administration of Philippines found Sanofi violating post-marketing surveillance requirements...
- Elko cardiologist arrested on opioid and fraud charges (kolotv.com)
An Elko cardiologist has been arrested on 39 charges of unlawful distribution of prescription opioids and Medicare and Medicaid fraud...58-year-old Dr. Devendra I. Patel...is charged with...routinely prescribing fentanyl, hydrocodone, and oxycodone for his patients without a legitimate medical purpose from May 2014 to September 2017, and fraudulently billing Medicare and Medicaid for medical tests he did not perform. The indictment alleges Patel performed EKGs on his patients, so he could then order nuclear stress tests which he did not administer. He allegedly used a poorly-calibrated machine and presented his patients with fraudulent X-rays to deceive his patients into thinking they had coronary issues that needed to be treated by him...
- Barry and Honey Sherman were murdered by multiple killers, private investigators believe: source (cbc.ca)
Private investigators believe that the billionaire Toronto couple found dead at their home in December were murdered by multiple killers, a source with direct knowledge of the parallel probe into their mysterious deaths...The new information contradicts a widely circulated theory that Barry and Honey Sherman died as a result of a murder-suicide — a notion that is regarded as fiction by those who knew the Shermans well...Barry, 75, and Honey, 70, were found dead by a real estate agent in the basement of their Toronto mansion on Dec. 15. The source said their bodies were in an upright seated position on the floor near an indoor pool. Police deemed the deaths "suspicious" but have said little else since their investigation began...The Sherman family has hired a team of experts...Barry Sherman is the founder of Canadian pharmaceutical giant Apotex, and both he and his wife have been recognized internationally for their generous philanthropy.
- The McGill Drug Store museum has been vandalized a second time – Letters to the Editor (elynews.com)
Dear Editor:
This saddens me to write this to you. The McGill Drug Store museum has been vandalized a second time and was discovered by Dan Braddock Saturday morning. Rocks the size of bowling balls have been thrown through the windows. There was also damage to some items in the interior.
Windows are something that are replaceable however damage to some items is irreplaceable. The cost of repairs and insurance increases are something that we are having to pull out of our budget when we have other repairs and projects that are more important.
All of us board members are volunteers and there is only one paid staff. We take time away from our families to help preserve items and information from our past. We ask that everyone be vigilant of your surroundings.
If you have any information on this criminal activity please contact the White Pine County Sheriff’s Office.
Thank you to Kirt Braun for boarding up the windows until the new windows get here.
Anyone who is interested in volunteering for the White Pine Public Museum in Ely or the McGill Drug Store museum please call the White Pine Public Museum at 775.289.4710 or stop by at 2000 Aultman Street.
- Billionaire pharma couple were strangled, case being treated as possible homicide, Toronto police say (cnbc.com)
Toronto Police said billionaire Barry Sherman and his wife, Honey, died of strangulation and they are now treating the case as a possible homicide...Barry Sherman was the founder and chairman of Apotex, a generic pharmaceutical manufacturer...Sherman has been involved in scores of legal disputes over the years, including a decade-old one involving his cousins and Apotex...