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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policies the draft CPG discusses that are not addressed, in detail, in other FDA allergen documents, such as the recent draft guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act.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

Last year, Congress passed and President Biden signed into law the Inflation Reduction Act (IRA), which included provisions to allow Medicare to directly negotiate the price of drugs along with other cost control measures that, taken together, represented the most sweeping and impactful drug pricing policy reform in generations. “We finally beat pharma,” the President declared.

President Biden doubled down in his State of the Union address, repeating the mantra that Americans “pay more for prescription drugs than any major country on earth” – to back up his promise to veto any effort in Congress to repeal the IRA. Given the albeit slim Democratic majority in the Senate, the odds of legislation to repeal the IRA hitting the President’s desk in the next two years are nil. But putting political rhetoric aside, the reality is that the congressional environment for pharma remains threatening on a number of fronts.

Democrats in Congress continue to see drug pricing as a winning issue. Senate Finance Committee Chairman Wyden has essentially already rejected the idea of amending the IRA to put small molecule drugs on the same timeline for negotiation as biologics.  Wyden also recently sent a letter to the Centers for Medicare and Medicaid Services to make certain that the IRA’s inflation rebate provisions are timely and completely implemented. At the same time, as a counter balance, new House Energy and Commerce Chair McMorris Rodgers and others plan to use their oversight authorities to force transparency from Administration regarding the impact of the IRA on drug innovation and other issues.…

Continue Reading Drug Pricing Reform Efforts in DC: A Continuing Pill for the Biopharma Industry

As with its decision to implement a ban on cigarette smoking in public places, Ireland is ahead of the EU curve on the issue of requiring warning labels to be placed on alcohol products.  With 72% of Irish consumers welcoming the initiative and the EU Commission recently giving it a green light, it seems likely that Ireland will press ahead with enforcing the measure.

Some background

Section 12 of Ireland’s Public Health (Alcohol) Act 2018 includes a provision requiring health warning labels to be placed on alcohol products. In June 2022, Ireland took first steps towards implementation of that provision by notifying the draft Public Health (Alcohol) (Labelling) Regulations 2022 (the Draft Regulations) to the European Commission. 

This so-called Technical Regulation Information System (TRIS) notification was required under the Single Market Transparency Directive 2015/1535 (SMTD), which seeks to ensure transparency of technical regulations adopted at a national level and reduce the risk of fragmentation of the single market by creating different marketing standards and requirements at national level.  This is particularly relevant for food labelling, which is harmonized at the EU level, by, amongst others, the Food Information to Consumers Regulation (EU) 1169/2011.  This Regulation requires certain national proposals for technical regulations, such as the Irish labelling proposal, to obtain a TRIS notification to allow Member States to comment on them and if necessary, raise concerns.  There is a three month standstill period following notification during which the notifying country cannot adopt the technical regulation, which is extended by another three months if the Commission or a Member State submits a detailed opinion.  If a detailed opinion is received, the notifying country must inform the Commission of the measures it intends to take to address the issues raised in the opinion.…

Continue Reading Alcohol Labelling in Ireland

On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the redesign “transformative” and believes the…

The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.

On 20 October 2022, the German Parliament has accepted the draft Act for the Financial Stabilization of the German Statutory Health Insurance System („GKV-FinStG“). The new act was subject to month-long controversial discussions within and outside of the Parliament and affected stakeholders. This was due to the fact that the new rules will affect almost all players within the healthcare system, including the health insurers, doctors, hospitals, pharmacies and, especially, the pharmaceutical industry. The new law encompasses significant cost-containment measures as the German healthcare system faces increased costs while, at the same time, the system suffers from a reduced inflow of funds.

According to the explanatory memorandum of the GKV-FinStG, the cost increase is particularly due to the disproportionate increase of expenditures for medicinal products. Correspondingly, a number of new rules specifically target the pricing and reimbursement of pharmaceuticals. Key elements of the GKV-FinStG that apply to the pharmaceutical industry include the following measures:…

Continue Reading Germany significantly tightens Drug Pricing and Reimbursement Laws

The UK government has proposed legislation to open the way for gene‑edited food products in England.  The Genetic Technology (Precision Breeding) Bill (“Precision Breeding Bill”) sets out a new regulatory regime that may provide a faster and easier path to market for certain gene-edited plants, animals and derived products.

Overview of the Precision Breeding Bill

The Precision Breeding Bill applies to “precision bred organisms”.  These are defined in the Precision Breeding Bill as plants and animals that have been genetically modified through the use of “modern biotechnology”, where that genetic modification is of a type that could have been produced using “traditional processes” (i.e. selective breeding, grafting, embryo transfer, spontaneous mutation, etc.).  The definition of “modern biotechnology”, for the purposes of the Precision Breeding Bill, aligns with the set of techniques listed in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443).  Ultimately, the effect of the Precision Breeding Bill is to create a distinction in law between ‘precision bred organisms’ and all other ‘genetically modified organisms’ (“GMOs”) where the genetic modification could only have been produced using genetic modification technologies (e.g. introducing genes from one species into another, entirely unrelated, species).

The Precision Breeding Bill provides that a person wishing to use precision bred organisms for research or for marketing must first notify and register the precision bred organism.  Once notified and registered for research and development, the precision bred organisms can be released i.e. planted, bred or cultivated.  No specific authorisation is required.  Before marketing the precision bred organism, a person must apply for a ‘precision bred confirmation’, which indicates that the Secretary of State is satisfied, on the basis of information provided by the person, and scientific advice, that the organism qualifies as a precision bred organism.  The UK government will maintain a public register of all notified information. …

Continue Reading UK Draft Bill Permits ‘Precision Bred’ Gene-Edited Plants, Animals and Products

From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways for pharmaceutical companies.

First, the…

If Vice President Biden’s election is confirmed, we anticipate a somewhat more assertive regulatory posture in certain areas to develop over time.

As some of you may recall, the Obama Administration was very active on nutrition issues. Participants will recall that First Lady Michelle Obama was very engaged on those issues.

One item that remains…