Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Frequency of Marketing Code Breaches Raises Doubts About Self-Regulation
An analysis of the frequency with which biopharma companies breached drug promotion codes in Sweden and the United Kingdom has raised doubts about the effectiveness of self-regulation. Academics found the countries averaged more than one breach a week from 2004 to 2012.
The authors of the paper in PLOS Medicine found Swedish and UK authorities ruled against biopharma companies 536 and 597 times respectively over the nine-year period. Nearly 20% of the breaches were classed as serious, and seven companies made such major violations 10 or more times across the two countries.
While the ability of a self-regulated system to catch and punish violators could be seen as evidence of its effectiveness, the authors view it as confirmation the system has failed. More pre-vetting of marketing materials, intensified active monitoring, heftier fines and greater use of name and shame tactics are proposed to improve the situation.
Sponsored Post: What do Regulatory Pros Need to Know About Upcoming Device Regulation Changes?
The proposed revision of the EU Medical Devices Regulation is nearing completion, but there are still a number of fundamental points of political disagreement that prevent the project from being finalized. The proposal on the table will bring about sweeping changes in EU regulation of medical devices if it is adopted in its current draft. Find out what you need to know about these policy developments in this upcoming RAPS webcast, to be held on 11 March 2015. [Read More...]
EMA Updates Q&A to Reflect Evolution of Pharmacovigilance
The European Medicines Agency (EMA) has updated the pharmacovigilance section of its Q&A document on the post-authorization process. EMA has revised several existing answers to reflect the formalization of its approach to the topic and added a question about the deputy Qualified Person for Pharmacovigilance (QPPV).
Legislation requires each marketing authorization holder to have a QPPV who is responsible for pharmacovigilance in Europe, plus backup procedures in case the lead person is unavailable. However, there is no need for companies to include information on their deputy QPPVs in summaries of their pharmacovigilance systems, a point EMA clarifies in its new Q&A document.
Instead, EMA wants to see general details of the backup process in pharmacovigilance summary master files. Companies can therefore change the deputy QPPV without filing a variation with EMA. The clarification is one of several made by EMA to the Q&A document this month in light of the advance of the pharmacovigilance agenda.
Heart Risks Prompt PRAC to Call for Changes to use of Hydroxyzine
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new precautions to ensure the safe use of medicines containing hydroxyzine. PRAC linked the first-generation antihistamine to a “small but definite” risk of QT interval prolongation.
Pfizer began selling hydroxyzine as a relaxant in 1956. In recent years, researchers have linked the active ingredient — which is still used to relieve anxiety — to QT prolongation. The research prompted Hungarian regulators to ask EMA to review the safety of medicines containing hydroxyzine and eventually to PRAC’s recommendation.
PRAC has said EMA should update the product information for hydroxyzine-containing drugs to reflect the risk of administering such products to patients with heart rhythm problems and the elderly. In all circumstances, the dose and duration should be minimized. The committee has also called for further research and ongoing monitoring to confirm the new advice is effective.
MHRA Reconsidering Position on HRT After Lancet Makes Ovarian Cancer Link
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) is reconsidering its position on hormone replacement therapy (HRT) in light of new research. A meta-analysis covering 21,488 women linked using HRT for a few years to a 40% increase in the risk of ovarian cancer.
Dr. Sarah Branch, deputy director of MHRA’s Vigilance and Risk Management of Medicines Division, responded to the publication of the paper in The Lancet by promising to review the findings. The review could lead to a revision of the HRT product information. MHRA already recommends HRT be used at the lowest effective dose for the shortest possible time.
Ovarian cancer was only thought to be a risk for long-term users of HRT, and many health guidelines make no mention of the danger. However, the meta-analysis suggests there is a definite risk of ovarian cancer among women who take HRT for fewer than five years.
Press Release I MHRA Statement
Patient and Industry Pressure Driving Europe’s Regulatory Rethink
Regulators overseeing the European Union and United Kingdom have outlined the thinking behind their moves toward conditional approvals of development-stage drugs. The changes are designed to benefit two groups: drug developers and patients.
Both groups have called for regulators to help cut time to market. “Patients are saying: ‘Why do we have to wait years for this treatment? I’m expected to die next year; I don’t care what drugs will come to market in five years’ time,’” Hans-Georg Eichler, senior medical officer at EMA, told The Financial Times.
The willingness of EMA and MHRA to accommodate such concerns has developed in parallel to the recognition that the demonstration of safety and efficacy is more of a continual process than a binary event. Increased use of post-marketing requirements was the first consequence of such thinking and conditional, fast-tracked approvals are the next step.
The Financial Times
MHRA Posts Guidance on Electronic Instructions for Medical Devices
MHRA has released guidance on how manufacturers of medical devices can supply instructions in an electronic format, an option that became available to companies when Europe introduced legislation in 2012.
The guidance outlines the types of device that can have electronic instructions — in vitro diagnostics are outside its scope — and the circumstances in which the format is acceptable. Paper instructions must be provided if patients are to use the device.
Risk assessments must be performed, too. The assessment should cover safeguards to prevent people from tampering with the instructions, emergency situations in which paper forms may be needed and the knowledge and experience of the target users.
Mendor Gets CE Mark for Device at Center of Sanofi-Backed Virtual Trial
Mendor has received a CE Mark for the 3G wireless blood glucose meter that is being tested in a Sanofi-backed virtual trial. The device manufacturer broke news of the CE Mark days after its partners revealed an ethical committee in Finland has greenlit its use in a virtual study of diabetes monitoring.
Sanofi, Mendor, eClinicalHealth and Langland are collaborating on the study — the first in Europe to use fully electronic informed consent — to gauge the effectiveness of the blood glucose meter. The device automatically uploads glucose readings to a cloud-based database. Individuals could use the device to keep tabs on their health, and the research and healthcare uses have attracted Sanofi.
The French pharma company is partially funding the trial, which is also assessing how well eClinicalHealth’s virtual trial-enabling software works. Pfizer encountered difficulties when pioneering the model — which eliminates the use of trial sites — in 2012, but the industry retains an interest and regulators on both sides of the Atlantic are willing to consider its use.
Press Release I MobiHealthNews
The National Institute for Health and Care Excellence (NICE) has recommended doctors keep an eye on their peers’ antibiotic prescribing habits. NICE made the recommendation in new draft guidelines intended to curb the inappropriate use of antibiotics. The watchdog also asked doctors not to bow to patient requests for antibiotics in instances where such treatments are unsuitable. BBC News
MHRA has released its February safety update. The notice covers the risk of cardiac side effects when delivering tiotropium via Respimat or Handihaler, changes to the acceptable drug concentration limits for drivers and best practices for administering nitric oxide. The nitric oxide reminder was prompted by the ongoing investigation into a possible defect affecting INOmax. MHRA Alert