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...the European Medicines Agency announced that the text for the Seat Agreement between the agency and the Netherlands has been finalized. The agreement describes how EMA will be treated by the Dutch government when EMA relocates to Amsterdam. The agency also announced that the Dutch Council of Ministers had agreed to sign the agreement...The agreement will be signed after the legislative process on the relocation is completed by the European Council, the European Parliament, and the European Commission...According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands...As this transition needs to be supported by EMA staff in the Netherlands, a timely signing of the agreement would make sure that EMA staff and their families have clarity on their treatment and can settle in the Netherlands...

The Centers for Medicare and Medicaid Services has laid out a bevy of initiatives that officials said would reduce drug prices for patients covered by the Medicare Part D prescription drug program—but they have made no decisions yet...That issue is whether the discounts that pharmacy benefit managers negotiate for drugs—the “rebates” that lawmakers have been raising questions about in recent months—as well as other fees, should go toward lowering the price that a patient pays at the pharmacy...“While we are not finalizing any policy in this area at this time, we appreciate the detailed submissions from stakeholders, and we are evaluating these comments as we consider future proposals,” said CMS Administrator Seema Verma...It’s unclear whether lowering the amount of money that the patient pays at the pharmacy would actually lower the total amount of health care spending. According to an analysis by CMS that was part of the proposed rule in November, patients would indeed pay less, but the government would pay more...

Contraceptive Prescriptions

Prescription Readers

What Pharmacists Need to Know About AB 474

National Pharmacy Compliance News

• FDA Requires Labeling Update on Opioid-Containing Cough and Cold Medicines
• Latest NDTA Shows Opioids Pose Significant Impact to Public Health
• FDA Recognizes Eight European Drug Regulatory Authorities Capable of Conducting Inspections
• Incorrect Use of Insulin Pens at Home Can Cause Severe Hyperglycemia
• FDA Advises on Opioid Addiction Medications and Benzodiazepines
• Only About 3% of Pharmacies and Other Entities Voluntarily Maintain a Prescription Drug Disposal Bin, GAO Reports
• One in Five Drivers Uses a Prescription Drug That Can Impair Driving Despite Receiving Warnings
• PTCB CPhT Program Earns Accreditation From the American National Standards Institute

Elizabeth Holmes was an even smoother scamster than anyone thought -- and she's apparently getting to keep her job...The SEC just charged the 34-year-old onetime billionaire with fraud related to claims she made about her blood-testing company, Theranos. To settle the charges, Holmes is giving up 18.9 million Theranos shares, losing voting control of the company, paying a $500,000 fine and will be barred from running a public company for ten years. She will, however, continue as the chief executive of Theranos, which under the fraudulent scheme described by the SEC raised $700 million...What emerges from the SEC's complaint is this: ...that Theranos’ sales were much lower than the company had led outsiders to believe. But the SEC puts a fine point on it: At a time when Theranos claimed it had annual sales of $100 million, sales were just $100,000...SEC says Holmes showed...(Walgreens) executives written evidence that Theranos would be able to run just about any blood test on its machines by the end of that year, using drops of blood taken from finger pricks instead of using needles. The next year, the pharmacy executives raised concerns with Holmes that this device might need to be approved by the FDA. But they missed the scale of her deception...Theranos miniLab was supposed to have been rolled out...the machine wasn't ready at all. That's when, (Sunny Balwani) Balwani and Holmes told their engineers to start using other companies' machines in unapproved ways to analyze finger-prick samples, the complaint says. Theranos allegedly never told the pharmacy executives...

Drugmakers may not be the only ones keeping less-expensive drugs off the market...The Food and Drug Administration has approved nine biosimilars, generic versions of biologic medicines, but only three are available...Manufacturers are using several schemes to "hamstring biosimilar competition," FDA Commissioner Scott Gottlieb said... he worries pharmacy benefit managers have been "complacent participants" in the schemes...PBMs and insurers may stick with branded biologics because they receive discounts from manufacturers on these treatments. That can leave consumers paying for costly treatments when less-expensive ones are available while PBMs make more money on these discounts, known as rebates...Many of these practices persist because high list prices enable lucrative returns across the drug supply chain as the spread between list and net price is carved up and shared among participants...he (Gottlieb) applauded insurers who have recently pledged to pass manufacturer's drug rebates directly on to some of their members...This is a bold action that will help create a fairer, more transparent market...I hope that other insurers, employers, and manufacturers follow their lead. I also hope that your industry will continue to innovate to make it more transparent to pass along these rebates...

The Ohio Department of Insurance said...that pharmacy benefit managers and insurers would have to disclose the lowest price for a prescription drug for Ohio consumers, part of a move to prevent insured consumers potentially paying more than those without insurance...Two of the largest pharmacy benefit managers, Express Scripts Holding Co. and CVS Health Inc said their contracts include clauses by which members receive the lowest cost automatically...The agency said it would ban the practice in which some insurers and pharmacy benefit managers use contractual provisions to prevent pharmacists from discussing with consumers if low-cost options are available for prescriptions, effective immediately...It would also prohibit them from charging customers a higher amount for prescription drugs than what it would otherwise cost without insurance coverage

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."...

The governor’s task force on the opioid crisis met for the second time...to receive a progress report on its efforts to rein in abuse and death resulting from prescription painkillers...Representatives of health care organizations and Nevada officials told members of the Governor’s Opioid State Action Accountability Task Force that progress was being made on four priorities identified by the panel at its first meeting...: prescriber education, treatment options, data collection and criminal justice interventions...Specifics included obtaining federal funding for three new treatment centers; development of informational presentations for schools and law enforcement; distribution of the opioid reversal drug naloxone to law enforcement; and creation of the Opioid Dashboard, a publicly available collection of state data related to the epidemic...At the task force’s third meeting in July, presenters promised to present updates on other task force goals, including identifying ways to compile real-time overdose data...

A new report from the Department of Health and Human Services’ Office of Inspector General found that among a sample of 40 pharmacies, all received at least some of the required drug product tracing information from their supply chain partners, though many said they are not reviewing the information...Under the Drug Supply Chain Security Act, dispensers, including independent, chain and hospital pharmacies, are required to receive complete tracing information before accepting ownership of a drug shipped from a manufacturer or wholesaler...“Although dispensers are generally implementing the requirements for drug product tracing, missing information and a lack of awareness of DSCSA requirements raise concerns that a complete tracing record for a drug product may not always be available to support investigations of suspect and illegitimate drug products in the supply chain,” OIG said...OIG recommends (and FDA concurred) that FDA offer educational outreach to dispensers of drugs to ensure they understand their responsibilities in receiving complete tracing information from supply chain partners before accepting ownership of such pharmaceuticals...

The dividing line between Senate Democrats and Republicans on the 340B drug pricing program was set on Thursday, with Democrats siding with the hospitals, saying the savings from the program is desperately needed for the poorest populations, while Republicans took the side of drugmakers, saying the program is being abused and needs to be reformed...But the hearing also put the spotlight on the lack of transparency from both the pharmaceutical and hospital industries, as neither side could agree to some basic statistics, such as what percent of the total drug spend in the US goes into the 340B program...reform and more oversight may still come...A study published in Health Affairs in 2014 found that 340B hospitals are expanding their base into communities that tend to be affluent and well-insured, which runs counter to the objectives of the program. The Alliance for Integrity and Reform of 340B, backed by the biopharma industry and other groups, also released a report that found in 2015, 61% of participants spent less on charity care compared to both 2014 and 2013 despite additional revenue received...