- Pharmaceutical sales reps gave monetary compensation to two in five Nevada doctors they lobbied, report finds (thenevadaindependent.com)Senate Bill 539 Report: Compensation and Samples Distributed by Pharmaceutical Sales Representatives in Nevada (dhhs.nv.gov)
Two in five Nevada physicians lobbied by pharmaceutical sales representatives in the last three months of 2017 received monetary compensation, according to a report released earlier this month by the Department of Health and Human Services...The department found that 42 percent of doctors, or 396 physicians, identified in reports made to the state received some amount of monetary compensation from pharmaceutical reps between October and December, while 58 percent only received samples. But the report is also telling in what it is unable to say, with only about half of the states’ 2,572 active pharmaceutical reps detailing their doctor lobbying activities and only 13 percent of submitted reports containing enough information to tie the data back to licensed Nevada physicians...Of the small percentage of data it was able to collect and analyze, the state identified a total of 954 doctors that either received direct compensation, samples or both from pharmaceutical sales representatives, with 396 of them receiving direct compensation. (Nevada had a little under 6,000 active physicians as of March 2018.)...The report is the first formal product released as a result of Nevada’s new drug pricing transparency law. The state will be required to compile another report after it receives certain data related to the costs and profits associated with manufacturing and selling so-called essential diabetes drugs from drug manufacturers and pharmacy benefit managers, who are the middlemen in the drug pricing process...The drug lobby is continuing to challenge the constitutionality of those reporting requirements in U.S. District Court after final regulations were approved last month.
- Canada Intends to Further Restrict Promotion of Opioids (raps.org)Notice of Intent to Restrict the Marketing and Advertising of Opioids (canada.ca)
Health Canada this week said it intends to restrict the marketing and advertising of opioid drugs...Evidence suggests that the marketing and advertising of opioids has contributed to increased prescription sales and availability of opioids...From presentations sponsored by opioid manufacturers at conferences to advertisements published in medical journals, these practices “can take many forms of direct and indirect activities and incentives.”...Manufacturers of opioids with a presence in the Canadian market are “strictly prohibited” from advertising to the public, but not to healthcare professionals...Health Canada...set forth additional authority for the Minister of Health to require implemented risk management plans from opioid manufacturers. These plans must include the preclearance of all materials related to opioids and provided to healthcare professionals to safeguard the compliance of their marketing clearances.
- Kentucky sues Walgreens for its alleged role in the opioid crisis (cnbc.com)
Kentucky has sued Walgreens for its role in the state's opioid epidemic...Attorney General Andy Beshear filed the suit against Walgreens for its dual role as a distributor and a pharmacy, saying it allegedly failed to monitor its own operations and shipped and dispensed large amounts of opioids...The lawsuit alleges "unfair, misleading and deceptive business practices by Walgreens for excessively distributing and dispensing opioids in Kentucky and for failing to legally report to state and federal authorities the suspiciously large orders it received for prescription opioids."...This is the sixth opioid-related suit Beshear has filed. He's sued three drug distributors, AmerisourceBergen, which Walgreens Boots Alliance owns a roughly 26 percent stake in, McKesson and Cardinal Health. He's also sued pharmaceutical manufacturers, including Johnson & Johnson.
- A serious new hurdle for CRISPR: Edited cells might cause cancer, two studies find (statnews.com)CRISPR stocks tank after research shows edited cells might cause cancer (cnbc.com)
Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies...scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs...The CEO of CRISPR Therapeutics, Sam Kulkarni, told STAT the results are “plausible.” Although they likely apply to only one of the ways that CRISPR edits genomes (replacing disease-causing DNA with healthy versions) and not the other (just excising DNA), he said, “it’s something we need to pay attention to...We need to do the work and make sure edited cells returned to patients don’t become cancerous.”...Standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called p53, which either mends the DNA break or makes the cell self-destruct...The flip side of p53 repairing CRISPR edits, or killing cells that accept the edits, is that cells that survive with the edits do so precisely because they have a dysfunctional p53 and therefore lack this fix-it-or-kill-it mechanism...The reason why that could be a problem is that p53 dysfunction can cause cancer...P53 mutations are responsible for nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers...
- Walgreens to move 1,800 jobs into new Chicago office (cnbc.com)
The company plans to open a 200,000-square-foot space in Chicago's Old Post Office Building...Walgreens expects about 1,300 employees will relocate from its Deerfield, Illinois, headquarters...Walgreens is the latest of a slew of companies shifting operations out of the suburbs and into the city. Some companies, including food giants McDonald's and Kraft Heinz, have even relocated their headquarters to Chicago...It's one way to attract employees, particularly millennials, in a competitive labor market. In announcing the move, Walgreens said it will help the company "meet the needs of its current and future workforce while continuing to attract and retain the best talent."
- 340B audits target hospitals more than pharma, sparking lawmaker criticism (biopharmadive.com)
The 340B Drug Pricing Program took center stage at the Senate's HELP panel for the third time in several months...this time turning the focus to audits of hospitals and drug manufacturers conducted by the Health Resources and Services Administration...HRSA Director Krista Pedley said that, in the past five years, 12 of 600 program manufacturers faced audits compared to 981 of 12,700 of hospitals...No findings of wrongdoing were discovered in any of the 12 audits of manufacturers, she noted, whereas 60% of the audits of covered entities resulted in repayment to manufacturers...
- Pfizer wins appeal against CMA fine over epilepsy drug price (pharmaceutical-technology.com)
...Pfizer has won its appeal in the UK’s Competition Appeals Tribunal against a £84.2m ($111.6m) fine imposed by the Competition and Markets Authority for dramatically increasing the price of its epilepsy drug, Epanutin...Following a three year investigation, the CMA ruled in 2016 Pfizer and its distributor Flynn Pharma had abused their dominant market position by raising the price of Epanutin from £2.83 per pack of capsules to £67.50, which represents more than a 2,000% increase. Annual NHS spending on the drug increased from £2m in 2012 to £50m in 2013...Philip Marsden, the CMA’s chairman...said the companies had “deliberately exploited” the generic product loophole that allowed the price increase...“Businesses are generally free to set prices as they see fit but those holding a dominant position should not abuse this situation and set prices that are excessive and unfair. There is no justification for such rises when phenytoin sodium capsules are a very old drug for which there has been no recent innovation or significant investment.”...The CTA declared that...CMA had not applied the correct legal tests to assess whether the price rise was excessive and had failed to consider the correct price for the product and take into account other comparable products
- CBER Launches new Program for Early Interaction With Biologics Developers (raps.org)
The US Food and Drug Administration's Center for Biologics Evaluation and Research...announced it is launching a new program for early meetings with biologics developers...The new program, called INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER ProducTs), replaces CBER's existing pre-investigational new drug meeting program...We know that academic investigators, small and medium enterprises, and sometimes even large companies can have questions regarding the path from preclinical to clinical development for biological products—particularly those that raise new regulatory questions," said CBER Director Peter Marks...the new program will be better tailored to providing input to biologics developers at early stages of development and will help sponsors plan their development programs to gather evidence needed for FDA approval more effectively.
- FDA suggests new reimbursement idea for antimicrobial drugs (pharmaceutical-technology.com)
The Food and Drug Administration has published a statement from its commissioner Scott Gottlieb proposing a new reimbursement model for antibiotics and antimicrobials, which it believes will help achieve associated public health goals and overcome investment challenges...The FDA’s idea is that instead of hospitals being reimbursed for antimicrobials on a per-use, which it claims is hindering research and development in the field, they will be reimbursed for licences for certain antimicrobials drugs that target multi-drug resistant infections...The FDA believes this model will help to achieve public health goals because it would ‘create a natural market for drugs that meet certain public health criteria, by providing a predictable return on investment and revenue stream through more foreseeable licensing fees’ and ‘it would put the institutions fully in charge of stewardship of these important medicines. Once they purchase the ability to access a drug, they would be stewards of its use up to a certain number of annual doses’...the proposal would address investment challenges faced by producers of antimicrobials that target multi-drug resistant organisms because it may offer a ‘pull incentive’ that can create a predictable market for antimicrobials with a narrow set of public health applications. In addition, it could disconnect return on investment on these drugs from the volume of the drug that is used...
- NIH Targets $500 Million At Opioid Crisis (forbes.com)NIH leadership outlines interdisciplinary FY2018 research plan for HEAL Initiative (nih.gov)
The National Institutes of Health is explaining how it will spend $500 million in research funds Congress appropriated to address the current opioid crisis...The list of objectives, published...in the Journal of the American Medical Association, includes: developing new medications to treat opioid addiction; tinkering with existing medications so they can be taken less often; improving medicines that reverse overdoses; developing new models of caring for people with opioid addiction in the healthcare and criminal justice systems; determining the best way to care for newborns in opioid withdrawal; discovering and validating new targets for non-addictive pain drugs and devices, and partnering with pharmaceutical companies to accelerate new pain and addiction medications. The $500 million will be distributed as research grants after a call for proposals later this summer.