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Focus on Regulation

New drug marketing applications: how do EMA and FDA compare?

1.            Introduction

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the differing outcomes of individual applications at the Agencies in terms of marketing approval, type of approval, and approved indication, including reasons underlying differences.

2.            High concordance

The study found a high level of concordance between the EMA and the FDA in decisions concerning authorisations. High concordance (91%) was found in the Agencies’ initial decisions on marketing approval. Concordance increased to 98% following review of resubmitted or reexamined applications. Concordant outcomes were found as the Agencies often reached the same regulatory results regarding the applications

3.            Similarities and differences

Both Agencies are committed to global alignment of sound regulatory standards in drug development. Both participate in and have adopted guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Similarly, both Agencies have established clusters as areas for information sharing and collaboration around many aspects of medicinal drug product development and regulation.

The study did, however, find several differences between the Agencies and their decision-making process. First, regarding regulatory authority, the study referred to EMA’s approval under exceptional circumstances, an option which does not exist at the FDA. The study also showed other differences in approach to efficacy and safety conclusion and in clinical data submitted in support of an application for authorisation. Other differences were found in approach to indication and descriptions of diagnostic criteria to describe the recommended patient population. Finally, divergent conclusions were reached by the Agencies regarding certain aspects of data integrity in the application, the quality of the drug substance or product, acceptability of the manufacturing process, or applicant compliance with good manufacturing practices.

These findings should however be considered within the scope limitations of the study. The cohort covered a short period of time and focused on new chemical entities and therapeutic biologics. Important categories of biologics were not considered and the cohort reflected prevalent therapeutic areas such as oncology.

The results of this study do, however, show the positive impacts of engagement and collaboration in drug development and approval.

Publication of rules on designation of expert panels under the Medical Devices Regulations

1.            Introduction

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision) laying down rules on designation of expert panels in the field of medical devices. These expert panels are to be designated to provide scientific, technical and clinical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States, notified bodies and manufacturers under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These expert panels will also be consulted by notified bodies as part of the conformity assessment of high-risk medical devices. Continue Reading

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

1.            Introduction

On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for ATMP imported into the European Union from a third country. It provides guidance concerning grant of the exemption, data to be submitted in order to justify such exemption and obligations of the qualified person for batch control. Continue Reading

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade Agreements Act (“TAA”) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (“DLA”) and the Department of Veterans Affairs (“VA”) that were made in China and Malaysia.  The TAA restricts the Federal government’s purchase of “end products” to only those (1) manufactured in the United States or wholly manufactured in a “designated country,” or (2) ‘‘substantially transformed’’ in the United States or a designated country.  China and Malaysia are not designated countries.

According to the DoJ press release, Ambu executives certified that its products came from TAA compliant countries despite allegedly knowing that most of the products were manufactured in noncompliant locations.  Between December 2011 and March 2015, more than 80% of the product sold by Ambu to the Federal government came from noncompliant countries.

FCA settlements are not new to the healthcare industry.  Nearly 90% of recoveries during 2017 and 2018 under the FCA came from the healthcare industry, according to an analysis by Bloomberg Law.  The TAA focus of the allegations, however, is notable. Continue Reading

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices.

The Draft is to implement the requirements of Article 17(3) of the Medical Devices Regulation 2017/943 (hereafter “MDR”). Article 17 MDR provides that under certain conditions, health institutions can reprocess single-use medical devices.

One of the requirements is that the European Commission adopts “Common Specifications” (hereafter “CS”). The Draft provides for the CS.

The European Commission has published the Draft and intends to collect input from stakeholders as part of a public consultation running until 20 August 2019. Continue Reading

FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs.  In addition to outlining the tools currently available to manufacturers seeking expedited approval of breakthrough therapies, the report recognizes the need for further regulatory innovation to advance emerging scientific knowledge and support timely access to new medicines without compromising established quality and manufacturing standards.

To obtain marketing approval for breakthrough therapies, sponsors face challenges to obtain clinical, non-clinical, and manufacturing information that meets the standards for regulatory approval on compressed timelines.  FDA/EMA recognize this, and on November 26, 2018 held a workshop on FDA’s Breakthrough Therapy Designation (BTD) and EMA’s Priority Medicines (PRIME) programs.  The aim of the workshop was to facilitate discussion with industry stakeholders on challenges associated with quality, manufacturing, and data requirements during early development, and possible scientific and regulatory approaches to address them.

With regard to challenges related to quality and manufacturing data, the report provides FDA/EMA’s perspectives and outlines follow-up initiatives being considered for process validation and control strategy, current good manufacturing practices (cGMP) compliance, comparability and stability data, and regulatory tools to support early access.  The key takeaways relating to quality and manufacturing data are provided below:

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European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving medical devices.

The Medical Devices Vigilance System aims at reducing the likelihood of occurrence and reoccurrence of an incident elsewhere. This is done by the implementation of FSCA across the EU Member States where the device is in use, in contrast to actions taken on an individual EU Member State basis.

The European Commission has published new Additional Guidance  (the ‘Guidance’) complementing the 2013 MEDDEV 2.12-1 rev 8 guidelines on the Medical Devices Vigilance System. The Guidance clarifies certain sections of the initial guidelines and introduces new notions.

The Additional Guidance provides for: Continue Reading

UN Working Group publishes revised draft of business and human rights treaty: commentary on scope, prevention and legal liability

On 16 July, a UN working group published a revised draft of its business and human rights treaty (following the “Zero” Draft published in July last year). Our post looks at some of the key developments, with a particular focus on its scope and the provisions on prevention and legal liability. We conclude by asking what happens next and providing some practical guidance to business. Continue Reading

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential importation of drugs that are (1) off-patent; (2) have no exclusivity remaining; (3) face no generic competition; and (4) can be imported with adequate assurances of safety and effectiveness. Scott Gottlieb’s statement further narrowed the scope of the working group’s task to: “Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories.”

Although there has been little visible sign of the working group’s activity, now the HHS Secretary is facing pressure to approve State drug importation plans that will likely be much broader than the original scope of drug importation that the working group had been asked to consider. These State drug importation plans are likely to be contrary to longstanding HHS and FDA positions opposing such programs based on safety concerns and inadequate cost savings. Moreover, HHS certification of the State plans would need to overcome certain legal barriers that exist under current Federal law. Continue Reading

Ill-Suited: Private Rights of Action and Privacy Claims

“For years, the plaintiffs’ bar has conjured multibillion-dollar class action lawsuits out of largely intangible privacy harms. This wave of litigation is increasingly driven by federal and state statutes that include private rights of action and allow for excessive statutory damages. Given the willingness of some courts to let cases proceed despite a lack of allegations or evidence of concrete harm, this litigation trend shows no sign of abating.”

The U.S. Chamber of Commerce Institute for Legal Reform has published “Ill-Suited: Private Rights of Action and Privacy Claims,” a white paper authored by Hogan Lovells’ Mark W. Brennan, Alicia Paller, Adam Cooke, and Joseph Cavanaugh explaining why private litigation is a poor enforcement tool for privacy laws.  As detailed in the paper, when it comes to privacy interests, “harms” are largely inchoate and intangible, and the wrongdoers are often unknown or unidentifiable. Even where class members may have suffered a concrete injury, the data indicates that they are unlikely to receive material compensatory or injunctive relief through private litigation. Meanwhile, plaintiffs’ counsel often walks away with millions of dollars, court dockets are unduly cluttered, and companies are forced to expend resources on baseless litigation.

Whereas a stream of harmful consequences flow from private rights of action for privacy laws, agency enforcement provides the right balance between protection, penalties, deterrence, and progress.

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