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More than half of Nevada occupational licensing boards aren’t following a 2010 directive to keep their salaries in line with state employees, and another 12 percent are paying salaries above caps set in state law...A report presented...to members of the state’s executive audit committee — composed of the governor, lieutenant governor, attorney general, secretary of state, treasurer and controller — detailed various oversight issues with the state’s nearly three dozen occupational licensing boards on everything from executive compensation to inconsistencies in how boards manage their finances...The audit — and the somewhat testy responses from several licensing boards — underlined a consistent pressure between the semi-autonomous regulatory bodies and the governor’s office, which is nominally in charge of regulating them...The audit reported that at least four of the boards — Pharmacy, Medical, Contractors and Accountancy — paid out salaries above the limit set in state law, which caps most salaries for state employees at 95 percent of the governor’s annual $149,753 salary...The boards presented a variety of reasons for paying their executive directors above the limit set in law. The State Board of Pharmacy wrote in a response to the audit that the salary figure included contributions to the state’s retirement fund and pointed to conflicting language in state law that gave the board the ability to determine the executive director’s salary...The audit suggested that boards were overpaying executive directors between $28,000 and $59,000 on average compared to similar positions for state employees...

A more difficult question is raised if a pharmacist refuses to fill based upon his or her religious beliefs...a University of Wisconsin student requested a refill on her birth control prescription at her local pharmacy. The pharmacist on duty, Neil Noesen, RPh, refused to fill it, citing his religious beliefs. He also would not transfer the prescription or tell her where she could get it filled...The student filed a complaint with the Wisconsin Board of Pharmacy.The board’s administrative law judge restricted Noesen’s license, finding that a pharmacist with a conscientious objection to dispensing a prescription must ensure there is an alternative mechanism for the patient to receive the medication, including informing the patient of their options to obtain their prescription.”...The Court on appeal ruled, “Noesen had a right to refuse to provide birth control pills but not to refuse to transfer a valid prescription to another pharmacy.”...The Trump administration is making it easier for medical providers to object to procedures on religious grounds...an HHS proposed rule...would allow HHS to enforce protections for religious medical providers...Pharmacists must be familiar with their state regulations and new federal guidelines...

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...

Brexit uncertainty is forcing drugmakers in Britain to invest hundreds of millions of pounds to maintain the steady supply of medicines to patients, siphoning off money that could have gone to developing new treatments...Pharmaceutical companies are preparing for potential regulatory and trade hurdles after the U.K. leaves the European Union, expanding testing facilities, moving marketing authorizations and drafting contingency plans. Regulatory alignment between the EU and Britain makes sense to all sides, and if Britain remains part of Europe’s drug-approval system, a lot of the investment may prove to have been unnecessary, said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry...business leaders are urging Prime Minister Theresa May to finalize key Brexit decisions, many are already conducting costly preparations for a rocky break with the EU as the U.K. hurtles toward exiting the bloc in March 2019...The industry is concerned about possible delays in evaluating new drugs when the European Medicines Agency, the bloc’s regulator, moves to Amsterdam from London, he said. The agency is bracing for higher-than-anticipated staff departures due to a host of issues, including the effect of local labor laws on short-term contracts, EMA Executive Director Guido Rasi said in an interview...

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.

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.

...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

The Australian government has endorsed several regulatory activities aimed at reducing the Therapeutic Goods Administration’s oversight on a range of low risk pharmaceuticals and medical devices...The consultation was released as part of the government’s response to TGA’s Review of Medicines and Medical Devices Regulation, identifying ways in which to improve patient access by reducing unnecessary costs associated with entering the Australian market...the government called on TGA to examine whether the regulatory oversight applied to a range of products that represent a very low safety risk too consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products...TGA...also implemented specific criteria last week to aid industry in identifying comparable overseas regulators and a process for work-sharing on drug applications using COR reports.

Online black-market sales of opioid painkillers more than doubled in the United States during the two years after these drugs were “rescheduled,” putting tighter restrictions on legal prescriptions and sales, according to a recent study...In October 2014, hydrocodone combination products...were reclassified from...schedule III to schedule II, imposing stricter controls on prescriptions written by doctors and on patients’ ability to refill them...Almost immediately, the proportion of all drugs illicitly purchased in the U.S. from sellers on the “dark net” that were in the opioid category began rising, reaching 13.7 percent in 2016. Stronger, more dangerous opioids also gained in popularity in these so-called cryptomarkets...cutting off supply leads to people sourcing their drugs from illegal and uncontrolled sources, and they buy products of higher strength - with all the dangers that this type of supply carries...A better approach would be harm reduction, therapeutic intervention, reliable treatment options, dealing with over-prescription early on, and providing information on the danger of opioid use to reduce stigmas...policy measures like up-scheduling, an introduction of abuse-deterrent formulations, prescribing limits, and prosecuting health care providers created a powerful push that precipitated the changes in the overdose dynamics we are contending with today...

A number of AbbVie products coming out of its North Chicago, Illinois, manufacturing facility have been tied to death complaints, including its mammoth blockbuster Humira, and the FDA says the drugmaker has not done enough to investigate those complaints...FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, it didn't go back and compile historical data about death complaints tied to drugs coming from the same lots. It turns out those lots had been tied to another 8 to 11 complaints each...an AbbVie spokeswoman countered the FDA observation, saying the company “investigates all complaints where a death has occurred during the use of our products,” and that “written complaint procedures are in place to investigate, analyze and resolve complaints.”...The FDA also found AbbVie's procedures for handling death complaints for products made at the plant “inadequate.”...no document showed that AbbVie evaluated complaints to see if there were other ones for nearby lot numbers or different strengths, or that it examined the reserve sample...the agency also warned AbbVie for not examining reserve samples at least once a year for evidence of deterioration, and for its failure to investigate drug batches manufactured close to a problematic one.