- House Ways and Means Committee approves bill to improve OTC access, savings (drugstorenews.com)
House of Representatives’ Ways and Means Committee on Thursday approved the Restoring Access to Medication Act of 2015…bill would essentially reverse a provision in the Affordable Care Act that significantly inhibited the use of health savings accounts or flexible spending accounts for the purchase of over-the-counter medicines…bill restores over-the-counter medications to full tax-preferred status, allowing consumers to use their HSAs or FSAs to pay for these products without first obtaining a prescription.
- Female Libido Pill Caused Dissent in FDA Ranks, Memo Shows (bloomberg.com)CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022526Orig1s000, SUMMARY REVIEW (accessdata.fda.gov)The Female Libido Pill and Five Other Drugs That Can Be Defeated by Their Own Side Effects (bloomberg.com)
At least three reviewers recommended against Addyi (flibanserin) approval..They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarized the analysis within the U.S. regulatory agency… One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men… FDA had rejected the drug,…in 2010 and 2013 before approving it in August...
- RGJ files lawsuit against Sparks over redacted medical pot business licenses (rgj.com)
Reno Gazette-Journal filed a lawsuit Friday against the city of Sparks in an effort to compel them to release the names of medical marijuana business licensees...RGJ believes transparency in this matter is in the public’s interest…legal challenge is based on the belief that transparency in government…should prevail…lawsuit comes after an RGJ reporter filed a public records request with the city of Sparks for the business licenses related to medical marijuana facilities…The documents returned to the RGJ, however, included redacted names associated with the business licensees...Sparks'...assistant city attorney argued he was upholding state confidentiality laws protecting people involved with the marijuana industry.
- India may classify vitamin supplements as drugs rather than foods if the manufacturers of such products claim they can treat or prevent disease. (in-pharmatechnologist.com)
The proposal was put forward by the Central Drugs Standard Control Organization…vitamins should be reclassified if there is a claim for treatment, mitigation or prevention of any diseases or disorder… also concluded that supplements containing vitamins already found in schedule V products should be labelled as drugs even if the ingredient is below recommended daily allowance limits...Drugs Controller General of India, Dr GN Singh, has requested industry feedback on the proposed reclassification...
- Mayo Clinic’s Farrugia on the future of precision medicine: Patients are ready to engage (medcitynews.com)
Gianrico Farrugia, CEO of Mayo Clinic…laid out his vision of the immediate future of precision medicine at this week’s Individualizing Medicine Conference…He discussed the issues around patient engagement, reimbursement, data security and salience of President Obama’s Precision Medicine Initiative. In terms of immediate potential,…there are five fields worth watching:
- Pharmacogenomics
- Liquid biopsy
- Non-invasive prenatal testing
- Whole genome sequencing
- Microbiome
- Pharmacists Reduce HIV Drug Interactions (pharmacytimes.com)
Thanks to the introduction of antiretroviral therapy, HIV-infected individuals are living longer than ever before,…this advancement means those with HIV are living long enough to experience aging’s comorbidities. They are also at higher risk for medication errors…as ART is associated with greater polypharmacy and drug-drug interactions…medication errors can increase viral resistance by decreasing ART levels, or increase risk of toxicity by elevating concentrations. Because of this, pharmacists are critical for preventing drug-drug interactions and other medical errors in HIV-infected hospital patients..
- Cloaked Nanoparticles Pave Way For Targeted Drug Delivery (forbes.com)Nanoparticle biointerfacing by platelet membrane cloaking (req sub) (nature.com)Nanotechnology: Platelet mimicry (req sub) (nature.com)
A study from the University of California,…Jacobs School of Engineering shows how nanoparticles can be an effective delivery system for drugs in the treatment of cardiovascular disease and systemic bacterial infections…engineers disguised nanoparticles as human platelets to see if they could increase the healing power of drug treatments by delivering those drugs to targeted areas in the body or organs…By using the natural biology of our bodies with the nanoparticle technology, the researchers have taken advantage of the unique natural properties of human platelet membranes for a new form of drug delivery.
- Who Falls Into the Medicare Donut Hole? (fool.com)
Medicare donut hole forces participants to face an expensive gap in coverage in their Part D prescription drug plans… the costs of prescription drugs covered by a plan get split up in various ways, depending on your total prescription costs for a given year… donut hole simply forced participants to pay these additional drug costs entirely on their own, causing huge financial stress… Affordable Care Act,…started to fill in the donut hole… Over time,..discounts will gradually rise…by 2020, participants will pay only 25% of the net cost of brand-name and generic prescription drugs.
- FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines (fda.gov)Clozapine Dispensing Requirements Changed (pharmacytimes.com)
Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about…severe neutropenia…There are two parts to the changes in the requirements for treating patients with clozapine. First, we have clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, we approved a new, shared risk evaluation and mitigation strategy called the Clozapine REMS Program…
- Australia’s new PM looks to biotech for a boom as mining-led growth wanes, WSJ says (fiercepharmaasia.com)
R&D tax incentives combined with a former investment banker as the country's new prime minister could see steady growth in biotech in Australia gain momentum,…Australia was ranked fourth globally for biotechnology innovation last year,..lags top player in biotech the U.S. by a wide margin…former Goldman Sachs banker Malcolm Turnbull as premier…portends a new push in the sector…I can see biotech and medical tech really transforming Australia..






