On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic Medical Devices Regulation (“IVDR”). The MDR and IVDR will apply from May 2020 and May 2022 respectively. These documents include: Factsheet for
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval inspections. The protocols were developed through the agency’s New Inspection Protocol Project (the “NIPP”), initially launched in 2014. The NIPP is intended to
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law 115-92, which was enacted in 2017. The law gives the DoD new opportunities to advocate to FDA for expedited development,
On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims. In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January
President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on an “International Pricing Index” (IPI), under which U.S. drug prices would be benchmarked against 16 other countries that reportedly have lower drug prices. This
On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling. Under the 24-page decree, a federal court enjoined the defendants,
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would
The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human medical applications or for scientific research purposes. Scope and requirements The biobank legislation
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively. New guidance documents concerning the UDI system are also available on the European Commission website. The rolling plan The rolling plan contains a list
Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug
Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices
In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The documents which are available on the European Commission website include the following practical guides: Factsheet for
In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common rulebook” between the parties in relation to goods. The White Paper discusses what is foreseen as the future relationship between the parties in some detail.
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. If the draft Withdrawal Agreement is finalised by the UK and EU, during the implementation period the UK will no longer be an EU Member
On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and all EU Member States to have an urgent discussion concerning the timelines for the application of the Medical Devices Regulation (MDR) and In Vitro
This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease categories (hemophilia, rare diseases, and retinal disorders), and three of which address manufacturing and clinical study design issues related to gene therapy: chemistry, manufacturing and control (CMC) information in
The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed. The pharmaceutical sector is understood to be under scrutiny in at least one of the current informal investigations, according to a leak in
By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative sanctions imposed by the Ministry of Health on the manufacturer and the editorial director of a TV
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health. The Sunshine Act provides that life sciences companies must publically disclose information concerning all pecuniary advantages or benefits in kind granted, directly or indirectly from Belgium or elsewhere,
At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be overturned. Until now, physicians in Germany were only allowed to offer follow-up treatment by telemedicine (e.g. video consultation) if the patient had already been treated in their practice before.
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product.
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for the following eight international medical device manufacturers under its Medical Device Good Manufacturing Practice.
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by distributors in relation to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).