Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Dutch Regulator Sounds Alarm About Shortage of Antibiotics
The Dutch regulatory agency has raised concerns about a shortage of narrow-spectrum antibiotics. A lack of such targeted therapies is forcing doctors to use broad-spectrum antibiotics that increase the risk of antimicrobial resistance emerging.
Officials at the Dutch Medicines Evaluation Board (MEB) issued a warning about the situation after seeing a rise in the number of companies that are struggling to supply narrow-spectrum products. MEB thinks the situation has worsened over the past few years and the number of alternative drugs available to doctors affected by shortages has shrunk. The result is doctors are prescribing antibiotics that affect a wide range of microorganisms, rather than specifically targeting the cause of an illness.
Dutch doctors are generally cautious about prescribing antibiotics, reflecting wider efforts to curb the use of such drugs in Europe. However, this has reduced the size of the Dutch market for antibiotics, making the sector less economically attractive to pharmaceutical companies. MEB thinks this is one driver of the increase in antibiotic shortages.
The regulator also mentioned raw material shortages as a factor. Days later, MEB issued a statement about an impending shortage of GlaxoSmithKline’s Bactroban, an antibiotic ointment used to treat staphylococcus infections in the nose. Supply is expected to stop from June to September. GSK attributed the constraints to problems in its raw material supply chain.
The Bactroban shortage illustrates some of the concerns raised by MEB. As well as being linked to raw material issues, the shortage validates MEB’s comments about the lack of alternatives available to doctors. With no alternative to Bactroban available, MEB is advising doctors to limit use of the drug to certain groups of patients, such as those who have Methicillin-resistant Staphylococcus aureus (MRSA) or are suffering from an infection prior to particular surgical procedures.
Patients who fall outside these groups may receive oral treatments. This is an imperfect solution, but means patients will be able to access a treatment during the shortage, as is typically the case in the Netherlands. An MEB report found that companies made almost 400 reports about problems with the supply of medicines last year. Alternative treatments were found in all but one case.
, Bactroban Alert
EMA Oversees Insulin Injection Color Change to Prevent Medication Mixups
Novo Nordisk is changing the color of its fast-acting insulin Fiasp pens and cartridges to cut the risk of them being confused with its long-acting product Tresiba. Fiasp was originally branded in a yellow color but this led to people mistaking it for the light green Tresiba and administering the wrong drug.
The products are used by diabetics to control glucose levels. Some patients are prescribed both drugs for use in different circumstances, and as such have Fiasp and Tresiba on hand when they need to act to manage their blood glucose. In poor light, the yellow markings on Fiasp look similar to the light green branding of Tresiba, resulting in patients mistakenly injecting one instead of the other.
Novo has responded to the situation by adopting a bright yellow and red color scheme for Fiasp that is clearly different from that used for Tresiba, regardless of the light levels in which it is seen.
The European Medicines Agency (EMA) is advising doctors to warn their patients of the risk of getting the products confused while the yellow version of Fiasp remains on the market. EMA has also told patients to check the name on their medicines before making an injection and contact their doctor if they administer the wrong drug.
Danish Regulator Plans Scientific Advice Service After Strengthening Staff
The Danish Medicines Agency (DKMA) is set to provide scientific advice to drug developers, hospital researchers and other groups that want to run clinical trials or seek marketing authorizations. DKMA is introducing the new service as part of a government drive to grow the Danish life science sector.
Full details of Denmark’s life science plans emerged earlier this month when a team convened by the government in 2016 issued a report on the future of the sector. The report’s recommendations are intended to establish Denmark as an attractive location for R&D and increase the amount of clinical research that takes place in the country. In parallel, Denmark will work to turn DKMA into a leading regulatory agency and provide more opportunities for startups and innovators.
The DKMA advice initiative touches on each of these areas. DKMA wants the service to cover more than just regulatory and legal compliance. Rather, the agency sees it as an opportunity to participate in early discussions about the development of human and veterinary medicines. DKMA plans to “offer advice aimed at exploiting already obtained research results and at future development programs.”
DKMA laid the groundwork for the start of the service in recent months by taking on extra scientific staff, including people with backgrounds in biostatistics and pharmacometrics. The effect of the hires is reflected in the list of areas in which DKMA has advisory expertise, which features biostatistics and pharmacometrics alongside clinical trial protocols, pharmacovigilance and other areas.
These areas are the first targets of DKMA’s scientific advice program. Over time, the agency plans to expand the program to cover medical devices, precision medicines and good manufacturing practices. As it stands, those topics are beyond the scope of DKMA’s legal obligations.
EMA Starts Review of Omega-3 Fatty Acid Medicines After Study Questions Efficacy
EMA has begun a review of omega-3 fatty acid medicines. The agency initiated the review after the Swedish drug agency drew its attention to a meta-analysis that raised doubts about the effect of the class of medicines on the recurrence of heart disease or stroke.
The 10-study, 78,000-patient analysis found no evidence adding omega-3 fatty acid medicines to the standard treatment regimens of high-risk patients prevents coronary heart disease or other vascular events. That finding called into question the wisdom of guidelines that advocate for patients taking omega-3 supplements to prevent coronary heart disease.
Omega-3 fatty acid medicines won approval in Europe on the basis of data suggesting they have a small, positive effect on the risk of heart attacks, stroke and deaths. With the meta-analysis and another study published in 2012 casting doubt on that assessment, EMA is returning to the data and reconsidering the benefits and risks of supplementation.
EMA will make a recommendation following the review and send it to the European Commission for conversion into a legally binding decision. The publication of the recommendation is pencilled in for June.
The United Kingdom
government has said it has no plans to issue guidance to pharma companies to inform their negotiations with the commercial medicines unit. A politician prompted the response by asking whether the transfer of the unit into NHS England
would trigger the release of guidance. The government said it has not previously issued guidance and does not intend to do so. Government Comment
has issued recommendations on the composition of vaccines for the 2018 to 2019 flu season. The recommendations for the strains manufacturers should include in trivalent and quadrivalent vaccines are based on observations made by the World Health Organization
. EMA Notice