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What’s in a name?..A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits…At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine…

In a previous post—now almost one and a half years ago—I described "the coming storm" I anticipated would develop around the 340B drug discount program. After a brief tornado hit the House Energy and Commerce Committee when they considered including 340B reforms in their 21st Century Cures initiative, a slower, hurricane-style churn over the Administration’s proposed guidance on the topic has settled in…With the October 27 comment window steadily approaching, let’s take a look at what the rule says and what it could mean for interested stakeholders.

• A Brief History Of 340B
• What Happened At The Energy And Commerce Committee?
• What’s In The HRSA Guidance?

Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority…These products, that combine drugs, devices, and/or biological product ("constituent parts") with one another… Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas….we’re taking a number of steps to clarify regulatory requirements and improve our internal processes and IT systems.

• Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors);
• Enhancing and simplifying data access and sharing for internal staff;
• Making it easier for staff to request and monitor inter-center consults;
• Updating and maintaining our internal contact directory for experts to review a combination product; and
• Improving our internal standard operating procedures for premarket reviews and compliance activities.

Summer was a busy season for FDA drug warnings...Now that fall is in full gear, pharmacists should get familiarized with the drug safety communications sent out this past summer...Here are the FDA’s medication safety alerts since June, starting with the most recent:

1. Ceftazidime and avibactam (Avycaz) - drug strength
2. Tramadol (Ultram, Ultram ER, Conzip) – pediatric use
3. Clozapine (Clozaril) – neutropenia management , REMS Program
4. Ingenol mebutate (Picato) - adverse reactions
5. Dipeptidyl peptidase-4 (DPP-4) inhibitors - joint pain warning
6. Fingolimod (Gilenya) - progressive multifocal leukoencephalopathy
7. Gadolinium-based contrast agents for magnetic resonance imaging - brain deposits
8. Vortioxetine (Brintellix) and ticagrelor (Brilinta) – name confusion
9. Codeine-containing cough-and-cold medications – pediatric use, respiratory conditions
10. Methylphenidate transdermal system (Daytrana patch) - permanent skin discoloration

Michigan health professionals said… the state's recommendations for curbing prescription drug abuse are on the right track, particularly the call for overhauling or replacing the current prescription monitoring program…The…Michigan Prescription Drug and Opioid Abuse Task Force…released a report with about three dozen recommendations. They included a revamped, stricter prescription monitoring program, more training for physicians and an increase in the number of drug addiction treatment specialists in the state…CEO of the Michigan Pharmacists Association…said it was important to develop regulations around the state's automated prescription service, called MAPS. The system is currently not mandated and has had technical issues in the past…Recommendations for updating or replacing the system as well as requiring all licensed prescribers to register were key…

…most influential source for U.S. oncology treatment guidelines…unveiled ratings aimed at helping doctors and patients assess the costs versus benefits of current therapies for two types of blood cancer…National Comprehensive Cancer Network…its new "Evidence Blocks" for multiple myeloma and chronic myelogenous leukemia are the first in a series that by the end of next year will encompass all oncology therapies, other than surgery or radiation… These are crafted to provide a little bit more information about cost, effectiveness, safety - all those things that the NCCN guidelines in the past haven't provided...The blocks give each therapy a score of between one and five in five categories: efficacy, safety, quality and consistency of evidence and affordability.

Indian regulators are privately pressuring major drug firms to better police how they sell popular codeine-based cough syrups to tackle smuggling and addiction, a move that is reducing supplies of a medicine doctors say is an effective treatment…India's Cipla stopped making the product last year owing to regulatory demands, and Abbott Laboratories and Pfizer have had to reduce batch sizes...Regulators want to make it easier for law enforcement agencies to track cough syrup abuse in the country and bottles smuggled to neighboring Bangladesh...Abuse is... common in Bangladesh. At a treatment center…tales abound of ruined careers and family struggles. A 40-year-old former banker at the Bangladesh Rehabilitation and Assistance Center for Addicts said his addiction was so bad he felt he loved cough syrup more than his four-year-old son.

two steps…the president detailed in a memo all federal departments and agencies…providing prescriber training among federal health care professionals, a move that addresses concerns raised recently by the Center for Disease Control and Prevention, which noted that prescribing behavior was one of the biggest contributors to opioid abuse…need for patients to have access to treatments…Obama has directed federal agencies and departments to…facilitate easy access to health benefits and to find barriers to treatment for those with opioid uses issues.

NHS 111 and GP out-of-hours services are to be brought much closer together under a fundamental redesign of urgent care delivery throughout the National Health Service…NHS England said the new "front door" will offer patients simpler and better access to urgent care through a novel 24/7 clinical assessment, advice and treatment service via the 111 number, streamlining provision around the country… reshaping urgent care stem from NHS England’s ongoing Urgent and Emergency Care Review, and come as local health services are responding to the highest ever number of ambulance calls, A&E attendances and emergency admissions in NHS history, with even more demand expected through the coming winter months…Last winter several hospitals in England were forced to declare a ‘major incident’ and close their doors as they struggled to cope with the influx of patients, and A&E waiting times were the worst in a decade, underscoring the need for a new system.

The…practice at pharmacies and outsourcing facilities of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is actually an unapproved use of these medical devices…"FDA has not cleared or approved any syringes for stand-alone use as ‘closed container systems,’"…Syringe maker Becton, Dickinson and Company…stated that it does not test the performance of its general purpose syringes as storage containers for compounded pharmaceuticals….pharmacies that want to store their own compounded or repackaged sterile preparations in general purpose syringes have two choices:

1. "Test every drug at every concentration that you use and in every size syringe that you use" or
2. rely on the results of published stability studies "if you have the exact same syringe, the exact same concentration, and the exact same drug and you…handle it and store it just like the drug in the study was stored."