- 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.”
- This Week in Managed Care: January 26, 2018 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- 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.
- FDA issues warning letter to Australian CMO (fiercepharma.com)
The warning letter was sent late last month to Delta Laboratories of New South Wales, Australia, after the FDA put all of the company’s human and animal drugs and antibiotics on its import alerts list in September...According to the FDA, Delta didn’t fully investigate discrepancies, including signs that might have indicated microbial contamination and didn’t have the processes needed to assure products would remain stable during storage and through the expiration date. It also noted the quality assurance unit didn’t have the necessary authority to make sure those kinds of standards are met...Senior management stated that your firm has struggled with manufacturing this drug product, and that you were still conducting research to gain better product and process understanding. Although you acknowledged a lack of understanding to assure consistent quality, you still commercially distributed drug products to consumers...The agency strongly recommended that Delta hire a consultant if intends to continue to producing products for the U.S.
- Why some US cities are opening safe spaces for injecting heroin (cnbc.com)
Why some US cities are opening safe spaces for injecting heroin...The concept recently gained traction in Philadelphia, where officials announced this week that they intend to open such a space, known as a supervised drug consumption facility or safe injection site...The idea: While in an ideal world no one would use dangerous and potentially deadly drugs, many people do. So it's better to give these drug users a space where they can use with some sort of supervision in case something goes wrong. It's a harm reduction approach...Studies consistently show that supervised consumption facilities work. These kinds of sites have opened in Canada, Australia, and Europe, showing drops in drug overdoses, related emergency care calls, risky behaviors that lead to HIV or hepatitis C transmissions, and general public disorder and nuisance associated with drugs...the facilities remain highly controversial in the U.S...much of America's drug policy is colored by a criminalized, stigmatized approach to addiction — one that demands shunning and shutting down all drug use...Under this view, the idea of giving people a safe space to use drugs seems downright counterintuitive...Philadelphia is now angling to become the first city with a legally sanctioned safe injection site. The city is reportedly hoping to hear from potential operators of a facility. It's not clear when such a site will open...
- Pharmacy Week in Review: January 26, 2018 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Lawmakers weigh measure to fight high drug prices (thehill.com)
Lawmakers are considering adding a measure aimed at fighting high drug prices to an upcoming spending deal, in what would be a rare defeat for the powerful pharmaceutical industry...The measure, known as the Creating and Restoring Equal Access to Equivalent Samples Act, is intended to prevent branded drug companies from using tactics to delay competition from cheaper generic drugs...Pharmaceutical companies are pushing back and lobbying against the measure, arguing it would harm patient safety and open companies up to wasteful lawsuits...But they might not be successful in their effort. Lobbyists and congressional sources say the measure could be added to a long-term government funding bill as a way to help pay for higher budget caps. The measure is estimated to save more than $3 billion...The measure would allow a generic company to develop its own safety protocol for a drug rather than have to develop a shared protocol with the branded company. Supporters of the bill say there would still be rigorous standards in place to ensure safety...The bill would also allow generic drug makers to sue to obtain the samples they need. Powaleny warned the bill would lead to “wasteful litigation between companies.”
- Follow the Money: Democrats see fewer contributions from Big Pharma in 2017 (thenevadaindependent.com)
The pharmaceutical industry largely snubbed Democrats when it came to doling out campaign contributions last year after the Democrat-controlled Legislature passed a bill to increase drug-pricing transparency in June...Only four Democrats — two members of Assembly leadership and the chairs of the Assembly and Senate health committees — received any contributions from the industry last year while 19 received industry contributions in 2016. By contrast, 19 Republican lawmakers and candidates and four Republican PACs or committees received donations from pharmaceutical companies in 2017, roughly comparable to 2016 trends...The $17,000 in pharmaceutical donations Democrats received represented about 1 percent of the more than $1.4 million the industry spent in Nevada in 2017. Republicans received 67 percent of the industry’s contributions, while the remaining 32 percent went toward funding the industry’s opposition, through the Healthy Nevada PAC, to the insulin pricing transparency bill sponsored by Democratic Sen. Yvanna Cancela in 2017.
TOP 10 PHARMA MONEY RECIPIENTS:
- Republican State Leadership Committee: $914,000
- Attorney General candidate Wes Duncan: $8,500
- Assembly Speaker Jason Frierson: $8,250
- Sen. Ben Kieckhefer: $6,500 (including $1,250 to his PAC)
- Sen. Joe Hardy: $6,250 (including $1,250 to his PAC)
- Assemblyman James Oscarson: $5,000
- Gubernatorial candidate and Attorney General Adam Laxalt: $3,500
- Assemblyman Mike Sprinkle, 2017 chair of the Assembly health committee: $3,250
- Assemblyman Chris Edwards: $3,000
- Assembly Minority Leader Jim Wheeler: $2,850
- 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...
- Hospitals eye making generics for 20 drugs that they say are overpriced or in short supply (cnbc.com)
Several hundred hospitals that plan to form their own generic drug company are eyeing making "about 20" pharmaceutical products whose existing versions either cost too much or are in short supply for no good reason...Dr. Marc Harrison, chief of...Intermountain Healthcare, during an interview on CNBC's "Closing Bell," would not identify the existing drugs that the new company wants to replicate on its own, or have done on a contract basis..."We think it will be early '19 before our first drugs come to market."...the group also is hoping to possibly get additional financing from "philanthropists who are sick of this activity" by drug companies that is "creating shortages and driving prices in an irrational fashion."...Intermountain is leading the collaboration with several other large hospital groups, Ascension, SSM Health and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form a not-for-profit drug company. The groups together represent more than 450 U.S. hospitals.