Pharmaceutical Regulatory Affairs: Open Access

There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to identify the major areas of focus in medical device regulation according to industry, regulators, and practitioners, and to investigate the feasibility of increased practitioner participation in medical device reporting. The author interviewed 5 industry, 5 regulators, and 6 practitioners. The stakeholders’ views were influenced by their personal distribution on the importance of outcomes such as cost, speed, safety and effectiveness. Industry, regulators and practitioners’ main perspectives were that medical device regulation is inconsistent and unpredictable, and that the US medical device industry is lagging behind Europe. Individual stakeholder goals were not aligned and caused bias resulting in a varied depiction of FDA regulation of medical devices. A practitioner-focused survey on medical device reporting was sent to 1567 practitioners in the University of Pennsylvania Health System. 340 survey responses showed that 46% of practitioners have witnessed a medical device failure, but only 19% have ever filed a medical device report. The survey results revealed that practitioners do not currently have enough experience or knowledge about medical device reporting to participate effectively and positively impact postmarket surveillance.

Biopharmaceutical companies are actively seeking ways to simplify study design complexity and improve protocol feasibility. One new approach adopted by a growing number of companies has been to establish internal facilitation committees charged with evaluating the benefits and costs of various study design elements (e.g. volunteer eligibility criteria and protocol procedures). In late 2012, Tufts CSDD conducted in-depth interviews and compiled and analyzed profiles of internal facilitation committees implemented recently by ten major pharmaceutical. This article discusses common committee characteristics and goals and highlights implementation challenges and early measures of committee impact.

Absence of therapeutic equivalence (TE) of generic antibiotics versus the innovator has been reported, even in case of pharmaceutical equivalence (PE).The pharmaceutically active principle of teicoplanin is mainly represented by the A2 group analogs (A2-1 to A2-2) which exist in given ratios in the innovator.

We studied the evolution of these ratios in humans volunteers receiving 2 dosage regimen (6mg/kg IV every 12 hours, 3 times, and then 6 mg/kg per day for ten days - group1-, and 12 mg/kg IV every 12h, 3 times, followed by 15 mg/kg every other day till D11 - group 2-), by a specific HPLC methodology, after single dose (D1) and at steady state at day 11(D11).

The less lipophilic analogs A2-1, A2-2, and A2-3 percentage decreases respectively were 18%, 11%, and 21% (group 1) and 34%, 14%, and 15% (group 2) between D1 and D11 for trough concentrations. At the same time, the more lipophilic A2-4 and A2-5 analogs ratio increases respectively were 15% and 19% (group 1) and 13% and 30% (group 2). These variations raise the problem of generics having the same global qualitative composition of analogs (PE) but with differing initial ratios. The bactericidal activity of innovator teicoplanin is optimal at its own ratios of the different analogs that act in a synergistic manner. Regarding generics, it would lead to final ratio in blood and tissues that are at risk of a sub optimal bactericidal activity. Thus, concluding in bioequivalence and therapeutic equivalence of these generics with the innovator remains highly questionable.

Introduction: There are different combinations of neoadjuvant chemotherapy (NCT) to treat locally advanced breast cancer (LABC); treatment with cytostatics drugs make it a costly concern, by establishing economic differences in the consumption of health care resources.

Objective: To compare the cost-effectiveness of two NCT strategies.

Patients and method: it was made a cost-effectiveness analysis (CEA) of two treatment schemes (4FE100C vs.6FE100C) in patients with clinical stage III breast cancer, each cohort included 48 patients.

Effectiveness parameter: pathologic complete response (pCR).

Differential cost: incremental cost-effectiveness ratio (ICER) using a Markov’s model. Results are expressed in terms of incremental cost per extra unit of effectiveness. Costs were expressed in Mexican (MXN) pesos ($) as of 2005; these were calculated under the perspective of public health care system (SSP, for its acronym in Spanish) denominated IMSS, with a 3 to 4 years analytical horizon. In order to determine the robustness of the results, a sensitivity analysis was carried out by modifying only the medical direct costs with a 3% discount rate.

Results: The use of 6FE100C offered greater effectiveness compared against 4FE100C; the medical direct cost of only the cytostatic drugs for NCT with 6 FE100C and 4 E100C generated a cost per case of $30,467.00 MXN (€ 2,343.61) and $18,004.00 MXN (€ 1,384.92), respectively. The greatest unit price was given by epirubicin. The CEA demonstrated that the cost-effectiveness (C/E) was greater with 6 FE100C and the incremental cost-effectiveness ratio (ICER) showed that it was necessary to pay $11,765,925.42 MXN (€ 905,071.20) because it tells us how much it is paid additionally for every extra unit of effectiveness (pCR) which assumes 6 FE100C in front of 4 FE100C. The sensitivity analysis performed shows the robustness of the results.

Conclusion: The 6 FE100C scheme is the strategy with better  cost-effectiveness ratio and is the most efficient in the short run for treating LABC.