News in brief from around the world… The UK’s medicines regulator has launched new hard Brexit consultations in the past week and the EMA is at work on revisions to its transparency rules. In the US, the Obama administration’s Health and Human Services deputy general counsel has returned to private practice and the Supreme Court has declined to hear an appeal on clinical trial liability. 


⇒ The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on how its regulatory processes should change in the event of a “no-deal” Brexit.

In a 4 October announcement, the agency said it was seeking feedback on changes to four key statutory instruments that underpin the UK’s pharma law framework to help make processes for medicines, clinical trials and medical devices are “legally coherent” on exit day.

The consultation focuses on the Medicines for Human Use (Clinical Trials) Regulations 2004; the Medical Devices Regulations 2002; the Human Medicines Regulations 2012 (HMRs); and the Medicines (Products for Human Use) (Fees) Regulations 2016.

Should the UK fail to reach an agreement with the EU, the government’s preferred option is for the MHRA to act as a stand-alone medicine regulator, taking on the functions and decisions currently exercised by the European Medicines Agency.

General approaches to the change in legislation include maintaining the UK legislative vehicles that implement EU directives, transposing EU regulations into UK law and then revoking the EU regulations themselves and making provision to prosecute offences which occurred before the UK is officially due to leave the EU on 29 March 2019.

The consultation also proposes a notional “UK mark” to replace or run alongside the European CE mark.

The consultation is available online and will close at 23:45 on 1 November 2018.

⇒ The management board of the European Medicines Agency (EMA) has discussed revisions to its “access to documents” policy, following a public consultation in 2017, as part of its mid-year report.

The policy is linked to Regulation (EC) No 1049/2001, which allows EU citizens to access EU documents.

The amendments to the policy increase its scope to include EMA documents not related to medicinal products.

The board was also updated on the ongoing development of the EU clinical trial portal and database.

The EMA states that the portal and database are in an intensive phase of pre-testing before formal user acceptance testing can begin in early 2019.

This comes after a study published by the British Medical Journal revealed that almost half of European institutions running clinical trials do not report their results.

Courts and cases

⇒ Justices of the US Supreme Court have refused to review a case related to the death of a man during a clinical trial, after a California appellate court found Johnson & Johnson subsidiary Janssen Pharmaceutica was not to blame.

The justices denied the petition for a writ of certiorari submitted by Marion Liu, mother of Augustine Liu, the 25-year-old who died while taking part in Janssen’s clinical trial of its drug risperidone.

Liu’s petition asked the Supreme Court to consider whether a drug company conducting a study has a duty to stop and refer a participant to medical care once aware that they are suffering from a life-threatening medical condition.

In response to the petition, Janssen argued that the ruling of the California Court of Appeals “was based entirely on California substantive law” and that Liu “had no basis for jurisdiction.”

In February 2009, Liu enrolled in Janssen’s clinical trial for risperidone, an anti-psychotic drug, to help his schizophrenia. Despite initial blood tests revealing an “abnormal” heart condition and quantity of liver enzymes, he was still admitted onto the study.

Liu received a one-milligram injection of risperidone, before being transferred from College Hospital Cerritos to an acute-care hospital after researchers observed a sharp decline in his cardiac condition. He died 17 hours later.

The initial lawsuit saw Marion Liu win US$5.6 million in damages for Janssen’s negligence, before the California Court of Appeal reversed the verdict.

It stated that Janssen only “undertook a general duty not to harm Augustine as part of the clinical study. That duty encompassed administration of the test dose.”


⇒ Margaret “Peggy” Dotzel has returned to US law firm Zuckerman Spaeder as a partner after serving as acting general counsel and deputy general counsel at the US Department of Health and Human Services (HHS) during the Obama administration.

Dotzel told PLN that she has been “fortunate to work on many important matters”, including several related to the implementation of the Affordable Care Act, a number of which went to the US Supreme Court.

“We are so happy to have Peggy return to her former home here at Zuckerman Spaeder,” said Dwight Bostwick, chairman of Zuckerman. “She’s a remarkable person and one of the nation’s true experts in the areas of health, food and drug law.”

“Having worked side by side with Peggy in the past, we know how much value she will bring to our clients, to the firm, and to our growing reputation and capacity in the healthcare field,” he added.

A trained pharmacist, Dotzel worked as special counsel at Zuckerman from 2006 to 2011, where she focused on food and drug-related matters, before joining the HHS as deputy general counsel. Earlier in her career she was a senior policy analyst at the Food and Drug Administration, eventually becoming its associate commissioner for policy.

Speaking of her return to Zuckerman, Dotzel told PLN “I knew the culture and quality of the firm meant that I would get to collaborate with incredibly talented lawyers in a collegial atmosphere.”

“I know that Zuckerman is equipped to handle the increasingly complex problems facing the healthcare sector and I look forward to being part of the team that helps our clients navigate these issues,” she added.