Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
European Commission Starts Formal Investigation into Aspen’s Cancer Drug Pricing
The European Commission has opened a formal investigation into the way Aspen Pharma priced five cancer drugs. Officials began the probe after receiving reports indicating Aspen had imposed “very significant and unjustified price increases” on five off-patent cancer medicines it acquired from GlaxoSmithKline (GSK) in 2009.
Aspen bought chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan from GSK in one of several deals that moved off-patent drugs from the global pharma company to the South African generic player. In 2008, GSK generated sales of £56 million ($73 million) from the five products. To increase sales post-acquisition, Aspen reportedly increased the price it charged for the medicines.
The question now being discussed at the commission is whether Aspen’s actions were an abuse of a dominant market position and, by extension, whether the company breached EU antitrust rules.
“Companies should be rewarded for producing these pharmaceuticals to ensure that they keep making them into the future. But when the price of a drug suddenly goes up by several hundred percent, this is something the commission may look at. More specifically, in this case we will be assessing whether Aspen is breaking EU competition rules by charging excessive prices for a number of medicines,” Margrethe Vestager, European commissioner for competition, said.
Officials outlined some avenues of investigation in a release to announce the start of the probe. The commission plans to assess claims Aspen threatened to withdraw medicines from countries if they refused to pay its newly inflated prices. Officials have reports that suggest Aspen followed through on its threat in certain cases.
The start of the commission probe comes seven months after authorities in Italy fined Aspen €5 million ($5.6 million) for its pricing practices. Italian competition agents accused Aspen of entering into negotiations “with the sole aim to obtain a high increase in prices, even in the absence of any necessary economic justifications.” Aspen’s negotiating tactics allegedly extended to “the credible threat of interrupting the direct supply of the drugs to the Italian market.” The Italian case covered the same drugs as the Commission probe, minus busulfan.
Initiation of the European Economic Area-wide probe marks the first time the Commission has started an investigation into excessive pricing practices by pharmaceutical companies. The absence of commission-led investigations to date has left member states to address pricing excesses alone. Member state investigations led to Italy’s charges against Aspen and the United Kingdom’s £84.2 million ($110 million) fine for Pfizer, but they lack the coordinated clout the commission can bring.
Commission Statement, ICA Statement
EMA Adds Scientific Advice on Safety Studies to Routine Services After Pilot Project
The European Medicines Agency (EMA) is encouraging companies to seek its scientific advice when planning post-authorization safety studies (PASS). EMA decided to make scientific advice for PASS part of its routine regulatory service after running a 12-month pilot project to assess whether its input could improve study designs and shorten protocol review times.
In an update to its post-authorization advice, EMA has set out how, why and when applicants and marketing authorization holders (MAH) should seek its input. The agency is encouraging all MAHs to request scientific advice but it is particularly keen to hear from companies who face “complex or controversial issues” or want to implement “innovative approaches or methodologies.”
EMA is primarily aiming the service at companies running non-imposed PASS. These studies, also known as category 3 PASS, are required by risk management plans to enable EMA and the MAH to investigate a safety concern or assess the effectiveness of a risk-minimization strategy. The agency will also accept requests for scientific advice from companies running category 1 and 2 PASS. These studies are imposed as part of the marketing authorization or other agreement.
Whatever the category of PASS, EMA wants companies seeking scientific advice to email it a letter of intent and briefing document. The request can form part of a broader solicitation for advice. This means companies can simultaneously ask for advice on a pivotal Phase III trial and a PASS, although EMA wants applicants to consider whether enough is known about the status and goals of the safety study before making an early request for regulatory feedback.
EMA will charge companies for scientific advice on PASS protocols in accordance with its regulation on fees.
Post-Authorization Q&A, PASS Q&A
EMA Plans Personalized Medicine-Focused Patient-Healthcare Professional Group
EMA is considering creating a personalized medicine-focused group that brings together existing patient and healthcare professional working parties. The idea is to give patients and healthcare professionals a common platform to discuss the advance of personalized medicines.
Plans for the subgroup emerged at a personalized medicine workshop hosted by EMA in March. At the event, patients, consumers and healthcare professionals met with EMA officials to discuss topics including the role of clinical practice and public participation in regulation of personalized medicines in the European Union. This led to the proposal to create a more permanent forum for patients and healthcare professionals to discuss the topic.
EMA envisages the personalized medicine subgroup working closely with its scientific committees, the Scientific Advice Working Party and the Pharmacogenomics Working Party. This arrangement should ensure EMA’s efforts to involve patients and healthcare professionals in its decisions extends to personalized medicines.
The notable absentee from the structure and the event that spawned the idea is the industry. EMA and the patients and healthcare professionals who gathered at the workshop hope to address this gap at a follow-up event. This planned workshop will feature industry participants. In parallel, EMA plans to define roles for patients, healthcare professionals, industry and regulators in personalized medicine.
French Regulators Suspend AB Science Trials over Pharmacovigilance Failings
French regulators have suspended clinical trials run by AB Science after identifying deviations from pharmacovigilance practices and other aspects of good clinical practices (GCPs). AB Science must await the findings of an independent audit before restarting its clinical studies in France.
The regulatory action follows inspections that questioned the reliability of efficacy data and other aspects of the running of the clinical trial of masitinib in the rare condition mastocytosis. AB Science said the findings predate its implementation of a revised quality system and other trials of the drug are unaffected by the problems. It nonetheless faces a delay in the progress of its clinical program while the matter is resolved.
AB Science’s progress in mastocytosis was affected, too. Within days of the publication of the French regulatory report, the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on AB Science’s submission. The rejection cited concerns about the reliability of the study. These concerns stemmed from the findings of a GCP inspection and decisions to make major changes to the trial after it started.
Management at AB Science plans to ask for a re-examination of the application. The company will argue the GCP findings had no effect on the conclusions of the trial. AB Science also plans to downplay the significance of the study changes, specifically by arguing that the revisions were made years before the database was unmasked and that CHMP deemed two of the amendments acceptable during a scientific advice procedure.
ANSM Report (French), Press Release, More