- Legislation looks to limit length of opioid prescriptions (biopharmadive.com)
Senate Health Committee Chairman Lamar Alexander...is offering drafts of two pieces of legislation aimed at addressing the opioid crisis...One measure would attempt to limit overprescribing by allowing the Food and Drug Administration to require drug manufacturers to package certain opioids in blister packs, which would allow for a set dose, such as a seven-day supply...Rather than restrict the number of days on opioid prescriptions, James Madara, CEO of the American Medical Association, wrote a letter...suggesting further research "that specifically identifies best practices in settings ranging from surgical to the emergency department."...Alexander's other proposal involves improved coordination between the FDA and Customs Border Protection. The bill would look to improve the ability to find and seize illegal drugs, such as fentanyl, at the border. It would seek to ensure the two agencies have the technology, facilities and staffing needed...
- Governor Sandoval Announces Second Meeting of Opioid Task Force (ktvn.com)‘This is an issue of rural prosperity’: Nevada roundtable spotlights opioid epidemic in small communities (lasvegassun.com)
Governor Brian Sandoval announced...that the second meeting of his Opioid State Action Accountability Task Force will take place April 18th in Carson City...The 1 p.m. meeting will be held in the Old Assembly Chambers at the state Capitol Building...the Task Force will hear a status report of crosscutting initiatives and status reports on track one – prescriber education and guidelines; track two – treatment options and third-party payers; track three – data collection and intelligence sharing; and track four – criminal justice investigations...“This Task Force has the specific task of reviewing the policies and programs that have been put into place to address the opioid epidemic in our state,” Sandoval added. “I am looking forward to hearing reports on the progress being made to combat this epidemic.”...
- Britain’s use of copycat biotech drugs takes off while US lags (reuters.com)
Cut-price copies of an expensive Roche biotech drug for blood cancer have taken 80 percent of the British market since launching last year, saving the healthcare system $113 million a year...The rapid adoption of two so-called biosimilar forms of rituximab from Celltrion and Novartis has been accompanied by discounts of 50 to 60 percent as the National Health Service has used tenders to bring down costs...The situation contrasts sharply with the United States, where regulators have lagged Europe in approving biosimilars while a complex system of rebates offered to insurers by original-brand drugmakers has created barriers to use...The U.S. logjam prompted Food and Drug Administration Commissioner Scott Gottlieb to complain of "rebating mischief" and a "rigged payment scheme"...
- Green Crack, Blue Dream, Gorilla Glue: The problem of pricing pot (reuters.com)
While a smoker may know the going retail price for “Strawberry Diesel” or “Buddha’s Sister”, the sector’s wholesale tier still operates much like a black market because of ongoing federal prohibition, despite legalizations in 30 U.S. states and Washington D.C...The problem spawned a different investment: The founding of New Leaf Data Services LLC, a...wholesale price data service that fields reporters to take on the steep challenge of cataloguing going rates...New Leaf now publishes weekly benchmark spot prices and forecasts on wholesale indoor-, outdoor-, and greenhouse-grown marijuana for 17 regions with legalization laws...New Leaf makes money from about 350 pot proprietors and other subscribers who buy reports and custom analytics. It has raised money from investors who want exposure to the cannabis sector without the risk of breaking federal law...New Leaf’s experience stalking prices sheds light on the murky trade of what might be the fastest-growing U.S. commodity, sold legally and illegally...prices and available products vary widely in different regions based on whether a state has both medical and recreational markets and the number of licensed dispensaries and producers...The data New Leaf collects is still fairly rough, and the marijuana market has nothing like national benchmark prices or futures contracts common to other legal commodities trades...The retail market is somewhat more transparent, and a pricing service called BDS Analytics runs an online database of more than 140,000 types of pot and pot products. BDS sells pricing and popularity data to retail shop owners...Roy Bingham...collects point-of-sale data from retailers and lists the details for products such as “Blue Dream” and “Green Crack”...When vendors come in and say they have x, y, z products, I can go back and look at whatever the going rate is for that product...
- Aetna will pass drug discounts along to some members at the pharmacy counter (marketwatch.com)
Aetna Inc. will automatically pass along drug rebates to a portion of its members starting in 2019....The policy will be applied to Aetna’s employer-sponsored group health plans, benefiting an estimated three million individuals. The population makes up a minority share of Aetna’s 22.2 million medical members...UnitedHealth Group Inc. made a similar move earlier this month, in what appears to be the first such instance. UnitedHealth’s decision was also geared towards health plans that UnitedHealth insures on behalf of employers...Aetna had previously passed “the majority of rebates” to plan sponsors and their employees through lower premiums, but is making the change in the hope that “additional transparency will encourage [drug] companies to rationalize their prices and end the practice of annual double-digit price increases...
- FDA issues draft guidance on compounding at outsourcing facilities (biopharmadive.com)
The FDA released a draft version of guidance covering compounding, called "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry," directed primarily at outsourcing facilities, addressing the use and qualification of bulk substances in compounding...The proposed rules are an extension of The Drug Quality and Security Act...which identified outsourcing facilities as its own category, separate from traditional compounders...Active pharmaceutical ingredients must be accompanied by a monograph from an appropriate governing party (if a monograph exists), must be made in a facility that has prior approval, and must come with a certificate of analysis (to prove they been characterized)...The agency proposes two specific ways to tell if a compounded drug at an outsourcing facility is safe: whether attributes of the approved drug may make it unsuitable to treat certain patients for particular conditions (including whether the compounded drug is intended to address that attribute), and second, if certain factors for each substance being proposed for use in a compounded drug product – specifically, "its physical and chemical characterization, possible or known safety issues, evidence or lack of thereof of effectiveness, and historical use" — would preclude its use by a third-party facility...The agency says the plan will "clarify and appropriately tailor the policies for traditional compounding pharmacies and the outsourcing facilities that may supply a broader market."...
- Blockchain for pharma: DHL, Imperial and Authentag embrace ledger tech (in-pharmatechnologist.com)
Three contract services firms have launched separate Blockchain-based initiatives, in a bid to increase pharmaceutical supply chain security...Blockchain – a digital ledger technology which records data in a secure, chronological way – has attracted attention in the pharmaceutical industry, as US and European serialisation deadlines approach...logistics firm DHL announced a collaboration with technology provider Accenture, to team serialization services with product verification, using a Blockchain ledger platform...The firms have created a ‘prototype simulation’ service, in order to track and trace pharmaceutical products throughout the entire supply chain...By sharing databases between multiple parties, Blockchain essentially removes the need for intermediaries who were previously required to act as trusted third parties to verify, record and coordinate transactions...Authentag announced its Blockchain-based Distributed Ledger Technology project...Our latest platforms will provide an open source architecture to allow members of the pharmaceutical community to develop their own solutions, improving the safety and security of pharmaceutical products...
- FDA to study how drug promotion affects doctors’ decisions (biopharmadive.com)
The Food and Drug Administration is planning to survey 2,000 healthcare professionals to better understand how prescription drug promotion affects the decisions they make...Promotional activities include meetings with pharmaceutical sales representatives, presentations given at industry-sponsored events, and journal or direct mail advertisements. In 2012, drugmakers spent north of $24 billion marketing their products to physicians, according to data cited by the FDA..."Although HCPs (healthcare professionals) are learned intermediaries, like most people, they may rely on heuristics in making decisions and may have cognitive biases in the type of information they attend to at any given time. They may be persuaded by strong statements and may not have the time to ascertain accuracy of such information," the FDA wrote in a notice posted on the Federal Register on March 15..."There is little qualitative research on people’s attitudes to promotion, and this is a major gap," the organization said. "In order to understand people’s perspectives and values more clearly, in‐depth interviews are needed...
- Israel to launch Big Data health project (reuters.com)
Israel will invest nearly 1 billion shekels ($287 million) in a project to make data about the state of health of its population available to researchers and private companies, Prime Minister Benjamin Netanyahu said...Almost all of Israel’s nine million citizens belong to four health maintenance organizations who keep members’ records digitally, thus comprising a huge medical database...This is a major asset and we want to make it accessible to researchers and developers in order to achieve two things: one is preventive medicine, and the second is personal medicine tailored to each individual...Nadav Davidovitch, head of the Public Health School at Ben Gurion University in southern Israel, said the country’s push to harness big data for healthcare had huge potential, but also held risks in terms of privacy and medical confidentiality...private companies would profit by using a publicly-funded database while continuing to make some medication unaffordable to many patients...mechanisms would be put in place to keep information anonymous while protecting privacy, information security and restricting access as part of the government project...Patients will be able to refuse the use of their information for research...
- Feds charge 5 doctors over role in alleged Insys bribery scheme (fiercepharma.com)
The case of Insys Therapeutics has played out for several years as suspicions first cropped up in 2014 that the company aggressively marketed its powerful opioid painkiller Subsys, often for off-label uses. Now, the feds have charged five...physicians for taking bribes from the drugmaker in exchange for writing more scripts...In addition to the new complaint, authorities announced that two former Insys employees have taken guilty pleas and are cooperating with the government...doctors Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea face up to 20 years in prison for their alleged participation in the scheme...Allegations against Insys and its former management have been piling up in recent years, and in October, authorities made their way to the company's billionaire founder John Kapoor, charging him with racketeering and other felonies... Prosecutors say the company set up a "speakers bureau" to recruit doctors to write more Subsys scripts, holding "sham" speaking events... the company used the events to funnel money to doctors in exchange for more Subsys scripts, even though many of the prescriptions were outside of the drug's FDA label...