Geographic price disparity between pharmaceutical products exists due to the variation in national economies and the unique ways that each country determines the price of pharmaceuticals. Price disparity still exists even in areas of “free trade” or in a single combined market of multiple countries, such as the European Union. This has led to parallel trade, where products are purchased in countries with lower prices and sold in those with higher prices. The fact that such disparities can develop seems contrary to the concept of a simple, free market, and it raises the question of whether price disparity will ever truly disappear.
The principle of free trade and tariff-free access to economic goods across borders is a founding principle of the EU and other regional trade agreements. Therefore, the continued existence of legal parallel trade combined with international referencing could lead to the end of price disparity, with prices converging to an average regional price. Continue reading
Analytical test methods for vitamin testing in foods have been in existence for decades, including microbiological and high performance liquid chromatography (HPLC) methods. While these methods are still considered the “gold standards” for vitamin testing, a new method, liquid chromatography tandem mass spectrometry (LC-MS/MS), is emerging. LC-MS/MS can offer several advantages over the older methods, including greater sensitivity, precision, simplified sample prep, quantitative dynamic range, and most importantly multiplexing.
This new method is an important solution for our food manufacturer sponsors, as it provides you with faster and more reliable data, as well as potential cost savings if you need a full B-vitamin profile. Continue reading
A new data set has been published that paints a clear picture of who gained insurance coverage during the 2014 open enrollment period, which ended on April 15, 2014. Recently featured in the New York Times, the data come from Enroll America, a non-profit organization focused on enrolling Americans in health insurance plans, and Civis Analytics, a data analysis firm.
This data set provides insight into the 10 million previously uninsured individuals who now have health insurance. Overall, these newly-insured people reduced the national uninsured rate for adults under the age of 65 from 16.3% in 2013 to 11.4% in 2014.
Regulatory strategy hinges on having the end in mind from the outset
“Begin with the end in mind” has become a popular catchphrase, but only because it proves itself to be true time and time again. You can more easily comply with regulatory requirements by expending increased effort into your target product profile. The target product profile is the foundation of your regulatory strategy and sets the stage for future development considerations. It is the second of ten elements of regulatory strategy:
- Summary of guidelines/precedents from multiple agencies
- Target product profile
- Agency interaction plan and timeline
- Identification of regulatory data requirements
- Assessment of registration routes and mechanisms globally
- Consideration of country registration timelines to meet business objectives
- Early market access and reimbursement plan
- Consideration of external influencing
- Lifecycle support and supplemental application plan
- Risk management and post-marketing plans
Considering the current level of extensive international food trade, food safety has become a significant global issue. Many people are increasingly concerned about chemical residues in their foods. Hundreds of pesticides, including herbicides, insecticides and fungicides, are among the most hazardous chemical compounds extensively applied in agriculture to increase food production. They are intended for destroying and controlling pests, weeds or plant diseases. Pesticide application is strictly regulated to protect consumers and the environment. However, the misuse of pesticides, lack of good agricultural management and/or cross-contamination during food processing, storage or transportation may result in unwanted or even illegal pesticide residues in foods. Some compounds, such as polychlorinated pesticides, have been banned for crop use but they are still present in the environment due to their long-term persistence and can bioaccumulate in the food chain. There is evidence that chronic exposure to pesticides can cause health risks to humans even at trace concentrations, for instance having adverse effects on endocrine system or causing behavior modification. Continue reading
As device technology significantly improves and becomes more reliable and user friendly, the range and quality of measurable modalities—from actigraphy (movement or sleep patterns) to respiration—continues to expand. Wearable medical devices are being depended on for gathering and transmitting objective, experiential data in real time. These devices could enable researchers to go from looking at a very small number of data points to analyzing hundreds of readings per second from thousands of patients. Continue reading
The lasting image of the initial health exchange roll out is that of persistent technical problems that plagued the federal government’s insurance exchange website Healthcare.gov. At the start of the 2014 open enrollment period in October 2013, the online marketplace for federally-facilitated insurance exchanges was overwhelmed with a volume of potential customers the website was not designed to handle. A handful of state-based exchanges (e.g., Maryland, Massachusetts and Nevada) also witnessed technical glitches that hampered the enrollment process for countless applicants. It took months to fully correct these technical issues, but at the end of the open enrollment period, an estimated 7.3 million people had enrolled in an exchange nationwide. This final tally, released by Politico, is comprised of the 8 million people who signed up in the regular enrollment period less those who did not pay their premiums in time or dropped out of the exchanges for some reason. An additional 6.7 million people also enrolled in Medicaid during the open enrollment period. Continue reading
The integrity of any Phase I clinical program relies heavily on the production, supply and analysis of quality dose formulations. Historically, drug doses have been formulated, manufactured and analyzed at the contract manufacturer, which typically adds significant time and expense given the small volume and the regulatory expectations at Phase I. One solution that is becoming widely practiced is combining extemporaneous preparations at the clinical research unit with independent dose analysis. It’s a one-two punch that not only saves time and money, it provides an extra assurance of quality.
Pharmacies are nimble
Contract manufacturers are built for the scale and regulatory requirements of a large Phase III clinical trial. Volume is their game. In Phase I, volume is overkill and leads to additional time and cost. Continue reading
Failures of Phase III programs after successful Phase II programs is probably the worst outcome of a clinical development program, as it failed in the most costly way. Nevertheless, these failures occur not infrequently. In psychiatry, highly publicized Phase II success stories ended in discontinuations of development programs, such as the NK1-antagonist program in depression several years ago. More recently, other examples have emerged. Some skip the Phase II process altogether with designs, which are supposed to provide “pivotal” data for regulatory purposes in large Phase III-like studies, which are just labeled as Phase II. These failures do not come out of the blue. Sometimes it is important to go back to basics and consider the purpose of Phase II trials.
What is the purpose of a Phase II trial?
The purpose of Phase II trials, besides gaining insights into the safety of a compound, is broadly exploratory, i.e. to generate data, which help with the design of the pivotal Phase III program. In a therapeutic area, a reasonably performed Phase II study can provide insights into clinical and biological patient characteristics, which match the properties of the drug under study. With an increased interest in personalized medicine, these boundaries between patient populations have to be understood in order to be successful. This approach is in direct contradiction to the urge to generate a “pivotal” Phase II outcome. Continue reading
Treatments that are safe and effective for adults may be ineffective or even dangerous for children. But infants and children are often prescribed medications with “off-label” use, where the treatment’s safety, dosage and efficacy are based solely on adult studies. To address this issue, both drug developers and regulators are working to boost clinical trials in children and include this underserved market in their studies.
Challenges with pediatric trials
A number of factors work against studying pediatric populations. As a highly fragmented and dynamic population, children and infants undergo rapid developmental changes over time, complicating study design and interpretation.
In addition, small sample sizes and potentially low incidence rates can make it difficult to find a treatment group—as well as a suitable control group with an approved active control. Finally, ethical considerations, such as informed consent can be more complex in pediatric trials. Continue reading