European Regulatory Roundup: The EU's Drug Data Scandal (11 December 2014)

Posted 11 December 2014 | By Nick Paul Taylor 

European Regulatory Roundup: The EU's Drug Data Scandal (11 December 2014)

Welcome to our European Regulatory Roundup, a new weekly overview of the top EU regulatory news.

National Regulators Suspend 25 Drugs over Indian Data Anomalies 

The regulatory retaliation against alleged data anomalies at Indian service provider GVK Biosciences has intensified. While the European Medicines Agency (EMA) is holding off on making a recommendation until January 2015, four national regulators have already decided to suspend drugs from manufacturers whose drugs were tested by GVK, including drugs manufactured by Abbott and Mylan.

Regulators in France and Germany have led the investigations into GVK and are among the group that has acted first. The countries, along with regulators in Belgium and Luxembourg, have suspended the marketing authorizations for 25 generic medicines. The scandal could grow bigger still. German regulators are investigating 176 marketing approvals awarded to 28 drugmakers. So far, 16 firms are affected.

GVK is already redoing studies for five clients. Other customers have asked GVK to pay for another service provider to redo the studies or demanded a refund. GVK is willing to accept any of the options. The fallout from the scandal has caused work at GVK’s facility to stop, leading to the loss of around $8 million in orders.

The US Food and Drug Administration (FDA) has reportedly visited the GVK site since French regulators reported their concerns about electrocardiogram data, but found its practices to be satisfactory. GVK said a June 2014 visit by FDA was the last time a regulator came to the site.

Reuters I Economic Times I Regulatory Focus I More

Galderma cut from List of Compliant Marketers After Tangling with UK Watchdog

The Prescription Medicines Code of Practice Authority (PMCPA) has removed Galderma from the list of companies that comply with the United Kingdom’s marketing code. Galderma initially got into trouble over an educational meeting, but the ultimate punishment was handed out after the company refused to let PMCPA audit its procedures.

The trouble began when Galderma made the purchase of two boxes of its dermal filler a requirement for attending one of its educational meetings. A nurse told PMCPA of the stipulation and expressed their disgust. Galderma argued such requirements are “not uncommon,” but the free products it offered to attendees put it on shakier ground with PMCPA.

PMCPA ruled the value of the products, minus the cost of the fillers, was more than £90 ($140). “It could be argued that attendees were paid £90 to listen to talks promoting medicines,” PMCPA wrote in its report. After tallying up all of its concerns with Galderma, PMCPA decided it wanted to audit the company.

Galderma initially agreed to the audit, only to change its mind after hearing why PMCPA felt it was necessary. PMCPA decided the U-turn rendered Galderma noncompliant with its code, prompting it to remove the company from the list of businesses that adhere to its standards.

Pharmalot I PMLiVE I PMCPA Report

EMA Updates Advice on Leaflet Exemptions During Drug Shortages

EMA has updated its labelling recommendations to clarify what happens when a company wants to release a drug with a stripped-down information leaflet to prevent a shortage. The new document features small changes to the initial recommendations EMA released in August 2014 in response to the pharmacovigilance legislation. 

During a shortage and certain other situations — such as when a drug treats a rare disease — EMA will allow manufacturers to release products without some information that is normally mandatory. The recommendations EMA updated this week are intended to help companies navigate the regulatory machinery when faced with such a situation.

When there are severe drug availability problems, the affected member states handle the request to release the product without some label and leaflet information. The member states then tell the marketing authorization holder and Quality Review of Documents (QRD) secretariat of their decision. The broader QRD group is only informed of the decision at the end of the process.

The decision pathway for drugs in short supply cuts out many of the regulatory steps associated with labeling change requests for orphan drugs. Orphan drug-related requests are discussed at QRD plenary sessions, unless the situation is considered urgent. In time-sensitive situations, QRD offers a 28-day written decision-making procedure.

EMA Recommendations 

EC Publishes Recommendations on Blood Adverse Event Reporting

The European Commission (EC) has published recommendations to clear up confusion over which blood-related serious adverse events and reactions (SARE) member states should report.

It took the EC seven years to go from meeting with national blood and blood component experts to the publication of recommendations. Over that period, EC held a series of meetings to close the gap between the data countries collect and what they are legally required to report. For example, the law requires countries to report SARE in recipients of blood, but some nations track events in donors, too.

EC has tried to clear up these and other issues in its 33-page document in an attempt to cut the burden the process places on blood facilities, national authorities and its own operation. The plan is to continue evaluating the recommendations — which are not legally binding — in the coming years.

EC Recommendations

MHRA Warns Fake Ultrasound Transducers were Supplied to UK Hospitals

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned the healthcare system counterfeit Toshiba ultrasound transducers have been supplied to two hospitals. There are no reports of the counterfeits causing harm to patients, but there are also doubts about whether the fake transducers’ performance is comparable to the genuine product. 

MHRA is advising healthcare professionals to check the legitimacy of any ultrasound transducers they purchased from suppliers other than Toshiba Medical Systems UK. The counterfeits were seemingly supplied to the two hospitals by a third-party distributor and slipped past the institutions’ checks. MHRA said a competent user can easily identify a counterfeit transducer.

Toshiba and MHRA are now looking for more counterfeits in the supply chain. MHRA is also asking hospitals to refamiliarize themselves with guidance on the procurement and acceptance testing of equipment.

MHRA Notice

Other News:

Jean-Claude Juncker is under increasing pressure at the start of his term as president of the European Commission. Having mishandled the decision about oversight of DG Sanco, Juncker is now getting bad press for his alleged role in encouraging Amazon to set up operations in Luxembourg. Tiny Luxembourg, where Juncker served as prime minister, is at the center of a tax scandal. Guardian

EMA has released a summary of the comments it received on its draft guidelines for biosimilars. The 223-page overview, which was published last month, outlines the feedback from 24 organizations, including the Biotechnology Industry Organization, Novartis, Pfizer and Teva. EMA lists whether it acknowledged, rejected or partially accepted the comments. EMA Overview

The Novartis flu vaccine at the center of the recent health scare in Italy underwent 35 tests to confirm its safety. Each component of the vaccine goes through a raft of tests for sterility and purity, after which the finished product is also evaluated. BioPharma-Reporter

MHRA has reminded companies they must cancel any authorizations, registrations and licenses by the end of the year if they want to avoid paying the periodic fee. Any licenses that are active as of 1 January will incur a fee for the next financial year. MHRA Notice

The Pharmacovigilance Risk Assessment Committee (PRAC) met at the start of the month but did not commence or conclude any safety investigations. Meeting Highlights


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