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Posted 23 December 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The Committee for Medicinal Products for Human Use (CHMP) has begun a review of drugs tested at two Micro Therapeutic Research Labs’ sites in India. National regulatory agencies asked CHMP to run a review after Austrian and Dutch authorities found fault with the sites during a good clinical practice (GCP) inspection.
Officials visiting the Micro Therapeutic sites in February reported concerns about study data used to support marketing authorization applications in the European Union. That prompted 18 national regulatory agencies to ask the European Medicines Agency (EMA) to look into whether the findings of the GCP inspectors affected its position on the risks and benefits of drugs tested at the sites. CHMP also plans to check whether data generated at the sites are being used to support active applications and, if so, assess whether the provenance of the results should influence its evaluation.
The review covers one centrally authorized medicine, a generic copy of Eli Lilly’s erectile dysfunction drug Cialis sold by Mylan. EMA approved the drug two years ago on the strength of data showing it is bioequivalent to the reference product. The review will also assess the risks and benefits of drugs approved by national regulatory agencies in light of the questions about data generated at the sites in the Indian cities of Chennai and Coimbatore.
Precedent suggests EMA will act forcefully against any drug found to have won approval on the basis of data generated improperly. When EMA found evidence of electrocardiogram data manipulation at GVK Biosciences, it recommended the suspension of 700 products that relied on studies run by the Indian contract research organization to win approval. More recently, the agency suspended dozens of drugs, including many sold by Novartis and Teva Pharmaceuticals, after finding fault with the way Semler Research Centre performed bioequivalence studies.
Politicians have criticized the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) over its handling of transvaginal mesh implants. The Scottish government asked the National Health Service (NHS) to stop using the devices in 2014, but with the products remaining on the market, more than 400 women are reported to have to have received the implants since then.
Scottish politicians discussed the implants after BBC News reported about the ongoing use of the devices. Shona Robison, of the ruling Scottish National Party, spent the debate defining the powers, or lack of, possessed by the government and MHRA and told other politicians a report due to be published early next year will contain answers to their questions. Yet, with one politician arguing the implants cause “organ damage, loss of a kidney, bladder removal, constant and excruciating chronic pain” and other side effects, Robison’s argument failed to appease all of the other speakers.
“Because of the issues that we are discussing, we have tended to speak about the subject in the most careful tones. However, last month in the Australian Parliament, Senator Derryn Hinch gave an absolutely blistering speech in which he lambasted medical watchdogs and manufacturers for once again letting down women, and compared the scandal of mesh implants to that of thalidomide,” Scottish Conservative Party politician Jackson Carlaw said. “I include the MHRA in my criticisms.”
MHRA reviewed evidence of the risks and benefits of the implants in 2014 after groups representing patients affected by the devices approached it. The regulator concluded “that, for the majority of women, the use of vaginal mesh implants is safe and effective.” Other regulators have reached similar conclusions. In January, the United States Food and Drug Administration (FDA) reclassified mesh implants used to repair pelvic organ prolapse (POP) as higher risk devices, but left products used to treat stress urinary incontinence (SUI) in Class II.
FDA’s stance broadly aligns with that of MHRA, which was more unequivocal in its support for the use of mesh in SUI than POP. Despite this, and a requirement that all patients give informed consent before proceeding with a mesh implant, the topic remains politically charged in Scotland.
Debate Transcript, BBC News, MHRA Report
MHRA has begun investigating the diversion of prescription-only drugs into criminal supply chains. The regulator initiated the probe after enforcement authorities in Scotland and the Republic of Ireland told it about “significant diversion” of benzodiazepines and other hypnotics and anxiolytics.
After receiving the reports, MHRA ran an initial investigation to assess the scale of the problem. This led the agency to conclude there is an “extensive network of criminality” made up of wholesale dealers including “a small number of registered pharmacies.” The initial assessment of the extent of the network has prompted MHRA to take further action.
“Evidence shows extensive criminality involving a number of businesses. As a matter of priority we are working with our regulatory and law enforcement colleagues to identify and prosecute those involved in this activity and to implement preventative measures to make sure this illegal industry is shut down,” Alastair Jeffrey, head of enforcement at MHRA, said.
To date, police have arrested two pharmacists in the English county of Yorkshire in relation to the investigation. The charges against the pharmacists include possession with intent to supply a controlled drug. MHRA claims the pharmacists bought 200,000 packs of benzodiazepines, a class of psychoactive drug prescribed for short-term relief of severe anxiety that is widely misused. The pharmacists allegedly dispensed a “very small” proportion of the packs through legal channels.
MHRA has found no evidence the diversion affected the availability of benzodiazepines at registered pharmacies.
The Committee for Medicinal Products for Veterinary Use (CVMP) has begun updating two guidance documents that were last revised in 1992. CVMP wants to rework the texts in light of changes to animal testing practices and accumulation of regulatory experience since they were first released.
One of the guidelines covers veterinary medicinal products for fluid therapy in case of diarrhea. The current guideline was published before EMA established the replacement, reduction and refinement best practices for animal testing. As such, the guideline’s recommended use of an untreated control group may no longer comply with animal welfare practices. CVMP also plans to use the update process to expand the scope of the guideline.
The other guideline up for review addresses veterinary medicinal products for zootechnical purposes, a term that covers products applied to healthy animals for nontherapeutic reasons. CVMP thinks the recommendations made in the 1992 guideline are still relevant, but wants to provide more details on running studies that comply with current good quality practices. The update will also look at the guideline’s position on animal welfare and safety, topics that are particularly important given zootechnical products’ lack of therapeutic benefits.
CVMP outlined its position on the need to update the guidelines in two draft concept papers. Both papers are open for comment until 31 March. After that, CVMP’s Efficacy Working Party will work to have revised drafts of both guidelines ready for consultation in the second half of 2018.
Draft Paper, More
Tags: European Regulatory Roundup, CHMP, GCP