FDLI MONOGRAPH SERIES

August 23, 2019 posted by

The Forum welcomes articles on cutting-edge state, national and international policy issues related to food and drug law. Initial signals from FDA suggest that a concern over effective pharmacovigilance looms large and that the agency is considering requiring distinct nonproprietary names. She has published articles and given speeches on the Biologics Price Competition and Innovation Act of and was involved in various types of advocacy leading up to the passage of the act. This caution could lead to regulatory action with respect to the whole class, possibly denying patients access to life-saving medicines that are in fact unaffected by the issue in question. She speaks and publishes regularly on these topics. His practice spans the full range of pharmaceutical and medical device regulation.

Seek public comment on the multitude of issues that could be addressed in the labeling of biosimilars, with the goal of creating rules that will result in clear communication to healthcare professionals regarding the attributes of biosimilars and the basis for approval of each biosimilar product. He has litigated a variety of cases in the life sciences area, has general trial and appellate experience and works actively on legislative matters. Whether the USAN Council or FDA is ultimately responsible for selecting nonproprietary names for biosimilars, FDA should work with other stakeholders to promote a consistent approach to the naming of biosimilars. Lietzan, Partner, Michael S. Add this document to saved. This could result in unwarranted caution about an entire class of related products when, for example, the adverse event actually resulted from an isolated manufacturing change implemented by one sponsor. In addition to the Forum, FDLI publishes the quarterly, peer-reviewed Food and Drug Law Journal presenting in-depth scholarly analysis of food and drug law developments; Update magazine, which provides members with concise analytical articles on cutting-edge food and drug issues; the FDLI Monograph Series, an annual six-publication set of practical guides on contemporary food and drug law topics, and numerous comprehensive new books each year. The concern over inadvertent substitution may be less relevant if a biosimilar has been deemed interchangeable.

These pieces of information will undoubtedly aid in pharmacovigilance, but adverse event reports rarely include details like NDC, as one FDA official suggested at the November hearing.

A name can identify the class to which the product belongs e. FDA therefore faces a number of important decisions regarding how the approved labeling of biosimilars should be used to communicate information about these products to healthcare professionals.

She provides regulatory advice and strategic guidance to pharmaceutical, biotechnology and medical device companies, as well as related trade organizations, on applicable ,onograph, state and local law.

See you at the Annual Conference in April. Most of you know that FDLI is a member-driven organization that holds conferences and publishes books for the food and drug law community.

Individual issues of the Forum are also available for separate purchase. For example, USP has thus far issued very few monographs for biologics, but as this changes, FDA may want to work with USP in order to ensure that the monographs do not inadvertently frustrate attempts by the agency to address its pharmacovigilance and inadvertent substitution concerns through naming conventions for biosimilars.

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There are no clinical trials conducted with Omnitrope in adult [growth hormone deficiency GHD ] patients. Because the approved package insert sets the parameters for permissible advertising mongoraph promotion of biosimilars, and because unlike generic drugs biosimilars may be actively promoted to healthcare professionals, patients and payers, the decisions that FDA makes now about its general approach to biosimilar labeling could have a significant impact on the biologics marketplace.

Specifically, the background rate of a given adverse event for a product and product class can typically be estimated by analyzing past data, including premarket data. Seriex are very lucky to have such great talent join FDLI. This publication is digital-only, peer-reviewed and smartphone enabled.

It may therefore be beneficial to distinguish between the products over the long term, regardless of an interchangeability determination. Each issue of the Forum presents an important policy topic in the form of a question, provides background information and detailed discussion of the issues involved in the policy question, relevant research, pertinent sources and policy recommendations. In addition to the Forum, Monogtaph publishes the quarterly, peer-reviewed Food and Drug Law Journal presenting in-depth scholarly analysis of food and drug law developments; Update magazine, which provides members with concise analytical articles on cutting-edge food and drug issues; the FDLI Monograph Series, an annual six-publication set of practical guides on contemporary food and drug law topics, and numerous comprehensive new books each year.

Naming At the most basic level, the nonproprietary name of a drug or biologic serves to identify the specific pharmaceutical product. Four in this department are attorneys.

Erika Lietzan Archives – Faculty Archive – Faculty

Two overarching public health considerations will be particularly relevant to this decision: Bio – Michael A. It should be recognised that, by definition, similar biological medicinal products are not generic medicinal products, since it could be expected that there may be subtle differences between similar biological medicinal products from different manufacturers or compared with reference products, which may not frli fully apparent until greater experience in their use has been established.

He has litigated a variety of cases in the life serles area, has general trial and appellate experience and works actively on legislative matters. Changing the nonproprietary name after the product fdlj been on the market could create confusion for healthcare professionals and patients. Some interchangeable biosimilars may ultimately be subject to automatic substitution an outcome that will be determined by state law, rather than FDA action, given that states have authority over substitution lawsbut interchangeability ratings may come only after the biosimilar has been on the market for some time, if at all in order to allow the sponsor to gather a ,onograph amount of postmarket data.

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If FDA decides that biosimilars should have distinct nonproprietary names, the question then becomes how the agency can accomplish this goal.

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The other members have not yet publicly expressed their opinions. Will there be any expectation that the biosimilar applicant seek to prove, or extrapolate proof of, indications added to the reference product package insert following initial approval of the biosimilar? At this time, she focuses on, among other things, the regulation of biosimilars and biologics in the United States and foreign jurisdictions, including issues related to data exclusivity, naming and labeling.

The views, opinions and statements expressed in this article are those of the author s. FDA should consider using its role on the Council to advocate for a particular naming convention for biosimilars. Among other things, she provides compliance and strategic advice including with respect to proposed corporate transactions ; frli in regulatory, legislative and policy advocacy in the U.

FDLI SmartBrief

The situation could become particularly complicated if the reference monograh gains approval for a new indication and the biosimilar sponsor has not yet shown interchangeability for that indication. FDA has said very little on this question publicly, but the aeries not entirely analogous—precedents from the FDCA context suggest the approved labeling will be different.

Her areas of special focus at this time include biosimilars; the Hatch-Waxman amendments and BPCIA; data and market exclusivities; WHO initiatives relating to drugs and biologics; comparative effectiveness and health outcomes research; supply chain issues e. A bill introduced by Representative Eshoo in Marchfor example, would have required FDA to ensure that the labeling and packaging of each biological product licensed under this subsection bears a name that uniquely identifies the biological product and distinguishes it from the reference product and any other biological products licensed … following evaluation against such reference product.

For those organizations that have been granted a photocopy license by CCC, a separate system of payment has been arranged. These monogdaph should be vetted through a transparent process that includes an opportunity for meaningful serids comment.

Erika Lietzan Publications

When a patient experiences an adverse event, it will be critical to know which product the patient was taking and because some immunogenic reactions can have a long latency period whether the patient was switched at any time in the past from a related product.

Disclaimer The Food and Drug Law Institute, founded inis a non-profit organization that provides a marketplace for discussing mongoraph and drug law issues through conferences, publications and member interaction. As it implements its biosimilar authority, FDA may be poised to play a key role in this coordination process.

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