Food and Drug Law

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here).  Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices already on the Great Britain (“GB”) market.  The proposed updates to the UK MDRs seek to bring it into greater alignment with the EU’s Medical Devices Regulation 2017/745 (“EU MDR”) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (“EU IVDR”), whilst also taking advantage of certain opportunities resulting from the UK’s withdrawal from the EU to build on and diverge from this legislation.

The long-awaited draft PMS SI follows the Government’s response in June 2022 to the MHRA’s 2021 consultation on the future regulation of medical devices in the UK.  In January 2024, the Government published its ‘Roadmap towards the future regulatory framework for medical devices’, which set out the intended timeframe for delivery of the future regulatory framework. 

Since the Government’s response in June 2022, reform of the regulatory framework for medical devices has suffered several delays as a result of various factors, including (i) the extension of the transitional periods under the EU MDR and EU IVDR (see our update here) and knock-on impact on UK strategy, (ii) the UK proposals to adopt a new international recognition procedure for device approvals (see our update here), and (iii) a change of government.

The draft PMS SI represents the new Government’s first step in updating the UK’s legal framework for medical devices.  Subject to the PMS SI’s passage through Parliament, the final version is expected to come into force in the summer of 2025.

What are the Key Changes?

Post-market surveillance (“PMS”) requires manufacturers to monitor the safety of a medical device after it has been released on the market, and, where necessary, take appropriate action to prevent or reduce the risk of an identified safety issue.  The current UK MDRs contain high-level provisions relating to PMS, which are supplemented by MHRA guidance (which is based on European Commission MEDDEV guidance applicable to the now repealed EU Medical Devices Directive 93/42/EEC).

The Government hopes the draft PMS SI will improve patient safety by introducing more stringent and clearer PMS requirements for both CE marked devices and UKCA marked devices that are placed on the market or put into service in GB.  To that end, the draft PMS SI introduces the following:Continue Reading UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

August 21, 2024, Covington Alert

On August 15, 2024, the Food and Drug Administration’s (FDA’s) Center for Food Safety and Nutrition (CFSAN) took another important step in its sodium reduction efforts by issuing a Draft Guidance that contains new voluntary targets for sodium reduction in foods. The Draft Guidance builds on FDA’s October 2021 Final Guidance on Voluntary Sodium Reduction Goals, which established short-term voluntary targets for reducing sodium in commercially processed, packaged and prepared food. The Draft Guidance proposes new three-year sodium reduction targets for 16 overarching food categories and 163 subcategories that are commercially processed and packaged, or prepared in food service establishments such as restaurants. 

Background

Average sodium intake in the United States is currently almost 50% more than the recommended limit.[1]  To help reduce sodium across the food supply, FDA has taken an iterative, step-wise approach that includes establishing voluntary sodium targets for industry, monitoring and evaluating progress, and engaging with stakeholders.

FDA’s sodium reduction efforts began in 2016, when it released draft guidance on the agency’s short-term and long-term goals for sodium reduction in a variety of commercially processed, packaged, or prepared foods. FDA issued final guidance on this topic in October 2021 (Final Guidance), in which it set a goal of reducing average sodium intake from over 3,400 mg/day to 3,000 mg/day. As of 2022, about 40% of the targets set for foods in the Final Guidance had been reached.[2]  FDA has deemed the Final Guidance “Phase I” of its sodium reduction efforts.Continue Reading FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods

Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German Parliament has now accepted a modified version of that bill. The Medical Research Act mainly amends (1) national laws for clinical trials with drugs and medical devices, (2) rules for ATMPs (3) drug pricing and reimbursement laws (AMNOG) and (4) initiates a re-organization of the regulatory agencies and ethics committees.

In this blog, we take a closer look at the much-discussed changes in the German drug pricing and reimbursement area. We will focus on two key elements:

  • The controversial new feature of “confidential reimbursement prices”; and
  • The new link between drug pricing and local clinical trials which offers pricing incentives for companies that can show that a “relevant part”  of the clinical trials for a new medicine were conducted in Germany.

We had noted in an earlier blog that the German rules for pharmaceutical pricing and reimbursement are among the most complicated legal areas in the entire world of life sciences laws. With the now coming new laws, Germany adds some additional complexity to its system.

1. Background

The discussed changes to the German drug pricing and reimbursement laws are part of the German Government’s new National Pharma Strategy that aims to enhance Germany’s attractiveness as a place for pharmaceutical research, development, and manufacturing. The Government presented an underlying strategy paper in December 2023 and the Medical Research Act is the first legislative implementation step of that strategy. For an overview of this new National Pharma Strategy, we invite you to read our previous blog on this topic.

The Medical Research Act was first presented to stakeholders in late January 2024. For a comprehensive overview of this first draft, please see our earlier earlier blog. After an initial consultation, the Government revised the draft and initiated the legislative process at the end of May 2024. Overall, the Government has deployed an unusually fast pace and was successful with its plan to get the bill through Parliament before the summer break.Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to harmonize the regulatory landscape across the continent in order to improve access to quality, safe and efficacious medical products in Africa. Other key organizations who are working to establish and implement the vision set out for AMA include the African Union (AU), comprising of 55 member states in Africa, the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO). Of importance, AMA is expected to play an important role in facilitating intra-regional trade for pharmaceuticals in the context of the Africa Continental Free Trade Area (AfCFTA).

Background to AMA and medicines regulation in Africa

Africa currently has limited harmonization of medicines regulation between jurisdictions. The functionality and regulatory capacity of national medicines regulatory authorities varies significantly. For example, many national regulators lack the technical expertise to independently assess innovative marketing authorization applications and instead adopt “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. Pharmaceutical manufacturers seeking to conduct multinational clinical trials or launch their products across Africa can often face challenges when navigating the divergent requirements for each country (and can face additional delays during each approval process).

Multiple initiatives in the last decade have aimed to increase the harmonization of medicines regulation across Africa with varying degrees of success, such as:Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines Agency

On October 13, 2023, the Food and Drug Administration (FDA) announced that the guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry,” originally released as draft guidance on September 13, 2022, has been made final. FDA received no comments on the draft…

Continue Reading FDA Announces Availability of Final Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health and life sciences.  In the white paper, Senator Cassidy disfavors a one-size-fits-all approach to the regulation of AI and instead calls for a flexible approach that leverages existing frameworks depending on the particular context of use of AI.  “[O]nly if our current frameworks are unable to accommodate . . . AI, should Congress look to create new ones or modernize existing ones.”  The Senator seeks public feedback on the white paper by September 22, 2023.  Health care and life sciences stakeholders should consider providing comments. 

This blog outlines five key takeaways from the white paper from a health care and life sciences perspective. Note that beyond health and life sciences issues, the white paper also addresses considerations for other areas, such as use of AI in educational settings and labor/employment implications created by use of AI.

5 Key Takeaways for AI in Health Care and Life Sciences

The white paper – entitled “Exploring Congress’ Framework for the Future of AI: The Oversight and Legislative Role of Congress Over the Integration of Artificial Intelligence in Health, Education, and Labor” – describes the “enormous good” that AI in health care presents, such as “the potential to help create new cures, improve care, and reduce administrative burdens and overall health care spending.”  At the same time, Senator Cassidy notes that AI presents risks that legal frameworks should seek to minimize.  Five key takeaways from the white paper include:Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

The Ninth Circuit recently affirmed summary judgment in favor of a manufacturer of glucosamine dietary supplements, holding that plaintiffs’ state law claims sought to impose requirements different from those under the federal Food, Drug, and Cosmetic Act (FDCA) and were thus preempted.  Hollins v. Walmart Inc., 67 F.4th 1011…

Continue Reading Federal Law Preempts Plaintiffs’ Challenges to the Label of a Glucosamine Dietary Supplement, Ninth Circuit Holds

On May 16, 2023, FDA released a draft compliance policy guide (“draft CPG”) for major food allergen labeling and cross-contact, which updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. CPGs are intended to advise FDA staff, including investigators, of the agency’s strategy for assessing and enforcing industry compliance. The draft CPG contains FDA’s current policies on major food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. The draft CPG is more comprehensive than the 2005 CPG and is intended to create a uniform standard and minimize the possibility that individual FDA staff will follow differing regulatory approaches.    

The draft CPG details the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act. We do not discuss those requirements here, but instead focus on the policies the draft CPG discusses that are not addressed, in detail, in other FDA allergen documents, such as the recent draft guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act.

I. Allergen Cross-Contact

Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning). While FDA acknowledges these factors, the agency states that cross-contact may occur due to practices such as the failure to clean shared equipment adequately or segregate allergens properly, improper rework addition, or improper production scheduling. The draft CPG does not explicitly acknowledge that even with adequate CGMPs, sanitation, and preventive controls, cross-contact can still occur.

The draft CPG also confirms FDA’s position that “[m]ajor food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.”Continue Reading FDA Issues Draft Compliance Policy Guide for Major Food Allergen Labeling and Cross-Contact

Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.”  The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations.  However, it remains to be seen whether in practice the TEMA process will provide a faster procedure than existing routes for early and expedited approval of medicinal products, such as conditional marketing authorizations (“CMAs”) or Member State procedures for temporary approval.

Reason to Introduce the TEMA

The EU took a coordinated approach to approval and procurement of vaccines during the COVID-19 pandemic.  In the EU, COVID-19 vaccines were approved using the CMA procedure combined with a rolling expedited review.  According to the European Medicines Agency (“EMA”), CMAs were the “the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.”  Vaccines approved with a CMA included Comirnaty, Nuvaxovid and Spikevax (amongst others).

However, the approval of COVID-19 vaccines in the EU was slower than in other jurisdictions.  For example, the UK MHRA granted Comirnaty a temporary authorization on December 2, 2020.  The US FDA gave the vaccine an Emergency Use Authorization on December 11, 2020.  Whereas, the Commission did not grant a CMA for the vaccine until December 21, 2020.Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“theProposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages.  In particular, there are new obligations for Marketing Authorization Holders (“MAH”) and competent authorities are given more power to better monitor and control the availability of medicines on the market.

As we have discussed previously, these measures aim to tackle the broader problem of security and robustness of pharmaceutical supply chains, which became especially prominent during the COVID-19 pandemic.  In this blog, we briefly explore some of the changes introduced by the Proposal.

Preventing Supply Disruptions and Shortages

Critical Medicinal Products

The Proposal expands the monitoring of “critical medicinal products” beyond emergency situations.  Now, medicinal products “for which insufficient supply results in serious harm or risk of serious harm to patients” will be included in the “Union list of critical medicinal products” (“Union list”), and the Commission will have the power to implement measures such as stockpiling of active pharmaceutical ingredients or finished dosage forms.  Continue Reading EU Pharma Legislation Review Series: Supply Security and Shortages Control