EU Regulatory Roundup: EMA’s PRAC Calls for Withdrawal of Fenspiride Cough Medicines, Temporary Restrictions on Xeljanz

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
PRAC Calls for Withdrawal of Fenspiride Cough Medicines, Temporary Restrictions on Xeljanz
 
The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of cough medicines containing fenspiride from the European market. PRAC made the recommendation at a meeting at which it also placed temporary restrictions on the use of Pfizer’s Xeljanz.
 
PRAC, the pharmacovigilance committee of the European Medicine Agency (EMA), previously called for the suspension of fenspiride cough medicines while it reviewed evidence of their effect on heart rhythm. The review was triggered by a small number of cases but, given the the feared side effects are serious and fenspiride is only used for symptom relief in non-serious coughs, that was enough for PRAC to recommend a suspension.
 
Now, PRAC has completed its review, cementing its concerns about the safety of fenspiride cough medicines. PRAC found evidence that serious heart rhythm problems including QT prolongation can occur suddenly, and that it is not feasible to identify patients who are likely to suffer from these side effects in advance.
 
After factoring in the limited benefits provided by fenspiride, PRAC concluded the side effects are enough of a problem to justify withdrawing the products from the market. The action comes months after authorities in France, which requested the PRAC review, suspended the marketing authorization of Servier’s fenspiride product, Pneumorel.
 
At the meeting to reveal its decision about fenspiride, PRAC also initiated a review into the safety of Pfizer’s anti-inflammatory drug Xeljanz. EMA issued a warning about the potential for fatal blood clots to develop in patients taking Xeljanz in March, and PRAC went a step further late last week by telling physicians not to prescribe 10 mg, twice-daily doses to people at high risk of blood clots. In the EU, the 10 mg dose is only approved in the treatment of ulcerative colitis.
 
PRAC issued the recommendation to protect patients while it reviews the evidence on Xeljanz, which has been subject to regulatory scrutiny since Pfizer identified a safety risk in a post-marketing study. The committee is aiming to complete the review in September.
 
PRAC Statement
 
EU Report Highlights Challenges of Regulating AI and Robotics in Healthcare
 
A European Union report has raised concerns about the regulation of artificial intelligence and robotics in healthcare settings. The report expands on an earlier warning that the system for approving medical devices may be ill-suited to the assessment and clearance of AI technologies.
 
In recent months, multiple parts of the EU political system have strived to come to grips with AI and robots, leading to the publication of the aforementioned warning and the holding of a workshop on the technologies’ potential impacts on healthcare. To add to these efforts, the European Parliament's Committee on Environment, Public Health and Food Safety commissioned an analysis.
 
The analysis summarizes and adds context to the presentations and discussions that took place at the AI in healthcare workshop. Multiple speakers at the event discussed the legal, regulatory and ethical challenges that could arise if AI and robotics advance at the speed foreseen by some observers.  
 
Alojz Peterle, a European politician, articulated some of the concerns by posing “the question of who will be responsible if the robots make a mistake in surgery,” according to the writeup. That question feeds into doubts about whether today’s framework “is fit to address current or future challenges such as regulating the liability of all players involved in the design and deployment of AI and robotics applications.” The framework will need to cover doctors, health centers and other groups.
 
The EU’s stated goal is to have a framework that incentivizes innovation while addressing “potential risks and uncertainties” that could undermine public acceptance of AI and robotics. However, there are divergent opinions about what that will mean in practice. Some people are calling for training in robotic surgery to be held to higher standards than education about conventional procedures.
 
IPOL Report
 
Dutch MEB Floats Packaging Changes After Survey Identifies Scope to Improve Trust
 
The Dutch Medicines Evaluation Board (MEB) has outlined plans to provide information about medicines in a more compact, visual form. MEB outlined the plans after conducting a survey that found there is scope to improve the trust people have in medicines sold in the Netherlands.
 
Overall, the survey found fairly high levels of trust in medicines, the information included in package leaflets and the research performed to assess the safety and efficacy of therapeutics. However, a minority of the Dutch public lacks confidence in these things, and people generally have less trust in generic medicines than their branded equivalents.
 
Dutch officials think they can do more to foster trust in medicines and the system covering them, for example by helping to clear up confusion about generics. With that in mind, MEB sketched out its work on a new form of product information communication in its statement about the survey data.
 
The project, which began before the release of the survey data, has resulted in a prototype of a more compact, visual format for communicating information about medicines. MEB envisions the format complementing the package leaflet, which would continue to play a key role in the dissemination of more comprehensive information in a text-heavy format. Further development of the idea is planned.
 
MEB released the findings days before its Finnish counterpart shared results from a separate survey that identified barriers to the uptake of off-patent medicines in Finland. The Finnish Medicines Agency (Fimea) survey polled physicians who prescribe biologics to gauge their views on biosimilars.
 
The survey found physicians hold largely positive views of biosimilars, but this is failing to translate into widespread use of the off-patent biologics. Fimea found independent information for healthcare professionals and patients is needed to promote greater uptake.
 
MEB Statement (Dutch), Fimea Notice
 
Ireland Removes Reference to Compliance With ISO Sterilization Standards From Guidelines
 
Ireland’s Health Products Regulatory Authority (HPRA) has deleted advice permitting the sterilization of packaging by service providers that lack good manufacturing practice (GMP) certification.
 
In the contract manufacturing section of HPRA’s previous guide to new applications and variations to manufacturer’s authorizations, the agency outlined how companies could work with service providers that had not undergone inspection by an EU authority. HPRA permitted the use of such providers in the sterilization of packaging materials provided they followed certain ISO standards.
 
HPRA has deleted the paragraph outlining the use of non-GMP certified sterilization service providers from the latest guide. The change is one of the few substantial revisions to the text. Elsewhere, HPRA has deleted a section permitting non-GMP sterilization of Class I medical devices.
 
HPRA Guidelines
 
Other News:
 
The Swiss Agency for Therapeutic Products (Swissmedic) has published a form to facilitate the reporting of illegal trading in human and veterinary medicinal products. Swissmedic created the form to help organizations that make, sell or distribute medicines comply with a law requiring them to file reports if they suspect illegal trade in these products. The law came into force at the start of the year. Swissmedic Notice
 
The Finnish Ministry of Social Affairs and Health is seeking feedback on the planned transfer of oversight of healthcare equipment to Fimea. Last month, Fimea said it is on track to complete the transfer of responsibilities by the end of the year, but the government is still collecting feedback on the proposal. Fimea Notice