- From the Desk of the Chairman: Dietary Supplement GMP Compliance Includes Application to the Cannabis Industry
- Issue of the Month: FDA 483 Responses – Missing the Mark?
- Who’s Who at EAS
- Meet Issue of the Month Author and New Independent Consultant, Cindy Beehner
- Meet New EAS Consultants
- Standards of Identity: Are Plant-Based Proteins Milking Dairy?
- Drug and Device Corner
- Recent FDA Drug / Medical Device Activity
- What’s New on FDA’s Website
- EAS in Action
- Dietary Supplement GMP Seminar to Take Place in Dallas, TX
- EAS Offers Official FSPCA Preventive Controls for Human Foods and FSVP Seminars
- New Webinar on Environmental Monitoring Added to EAS’ Summer Compliance Line-Up
- EAS Offers Complimentary Webinars on Cannabis, Foreign FDA Inspections, Temporary Marketing Permits and more
- Crane Returns as a Presenter at CHPA’s OTC Academy
- Yablunosky and Knutson to Speak at Upcoming Food Safety Consortium
- EAS Consultants Invited Speakers at Two FDLI Conferences
- EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team
- Useful Publications and Regulatory Tools
Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.
Beth Ann Crozier-Dodson, Ph.D.
Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include teaching and training in microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.
Cindy Beehner has worked as a consultant since 1997, specializing in GMP requirements for food, dietary ingredients, dietary supplements and pharmaceuticals. Ms. Beehner performs due diligence assessments as well as procedures and documentation required for certifications for groups such as Therapeutic Goods Administration (TGA), World Health Organization (WHO), United States Pharmacopeia (USP) and National Food Producers Association (NFPA). She has a Bachelor of Science, Chemistry and Clinical Psychology from Moravian College, Bethlehem, PA.
First, for those whom we had a chance to meet at the recent Institute for Food Technologists Annual Meeting held in Chicago, I am sure you will agree with me that this year’s event was one of the best. With so many changes at FDA with the implementation of FSMA, many timely topics on Food Defense and more, I am sure everyone in attendance returned to their firms with good ideas worth implementing. The two sessions that EAS moderated, PCHF – Successes and Challenges for FDA and the Food Industry and Food Importing: Green Light Strategies for Compliance with Game-Changing FSVP Requirements were both well attended with lively discussions. We’d like to thank the panelists who joined us – JoAnn Givens from FDA, Jeff Acker from DFA who participated in the PCHF session, Bob Brackett from IIT and EAS Independent Consultant, Susan Moyers, who participated in both PCHF and FSVP sessions and Erika Daniel from our Italian partner Almater who participated in our FSVP session.
I am pleased that EAS is presenting the next Dietary Supplement Good Manufacturing Practices seminar in cooperation with the American Herbal Products Association (AHPA). It will include an updated content section on how GMPs have application to the cannabis industry. The early bird rate runs through August 5, 2018, and this rate is extended to members of AHPA for the duration of the registration period. We hope you’ll join us in Dallas, TX on September 26-27, 2018 for this informative and updated seminar!
We welcome new consultant Beth Ann Crozier-Dodson, Ph.D., and re-welcome Tamika Cathey and Cindy Beehner, two consultants who have been a part of the EAS family previously and who are increasingly available to EAS clients. Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements and Cindy Beehner specializes in GMP requirements for food, dietary ingredient, dietary supplements and pharmaceuticals. Cindy is also the author of this month’s issue of the month on how to appropriately respond to FDA 483s.
We hope that you enjoy this edition of EAS-e-News! As always feel free to reach out if you have any questions and thank you for your interest in EAS.
Natural Products Insider
July 31, 2018
Food Safety News
July 28, 2018
By Charles Breen, Independent Advisor for FSMA
Those closely watching FSMA compliance dates will note that July 26, 2018 marks a significant date for FSVP and the Produce Safety Rule. Specifically,
- importers with Small Business Foreign Suppliers will now be required to comply with sprout requirements of Produce Safety Rule;
- importers with Small Business Foreign Suppliers that are farms producing sprouts are eligible for a Qualified Exemption under the Produce Safety Rule; and
- importers with Large Foreign Suppliers are required to comply with Produce Safety Rule;
with an exception for importers of food contact substances who now have an additional two years to comply with the FSVP requirements.
FDA is postponing an enforcement regarding written assurances in certain cases when a manufacturer/processor does not control a hazard requiring a preventive control. Originally, an additional two years to comply with the above specific requirements were to be granted based on written assurances from their customer that they will either manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so. Sellers must notify commercial customers that hazards are not controlled, but sellers do not now need to obtain written assurances from customers as a condition of sale. FDA says in this context, “customer” does not mean “consumer.”
FDA provided a decision tree to assist affected firms in their understanding of the details for enforcement discretion of the written assurances provisions.
What does all this mean for your business? Plenty – particularly in light of the recent food safety outbreaks of Listeria monocytogenes which illustrate that even when preventive controls are applied, food emergencies can still occur. Managing a safe food supply requires serious vigilance at all times. Unfortunately, even the most diligent will likely see, at some point, some type of food safety event requiring immediate action, whether it is an unsanitary method of transportation, storage or production, worker hygiene, use of contaminated water or a large number of additional factors.
As part of the Produce Safety Requirement, you may recall our January 2018 FSMA Perspective which discussed the agricultural water testing and safety requirements. After much industry feedback that the numerical criteria for microbial water quality in the final rule are too complex, FDA issued a proposed rule to extend the compliance dates for the agricultural water requirements for produce other than sprouts. If finalized, the earliest compliance date for most agricultural water provisions would be January 2022 for the largest farms. Once finalized the specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to water testing data history for their own assessments of safety. Of course, prior to finalization, agricultural entities would be wise to begin or continue documented monitoring to gain a complete understanding of water quality used for irrigation and worker hygiene in order to provide FDA required data at the time of an inspection. Even though enforcement of FDA’s agricultural water provisions has been pushed back, they should still be considered a suitable benchmark for testing purposes. Any results found to be out-of-specification (OOS) should be retested followed by an assessment and correction of procedures leading to those OOS results.
Firms should also take a look at their entire organization’s policies and procedures, including the very important, and required by FSMA, training. Employees must understand what is required of them and why, and it is management’s responsibility to ensure that all required training is conducted in a language and manner that employees understand. This may mean conducting various types of training in a variety of languages.
Look closely at operations to assess whether they are meeting the requirements of the Produce Safety Rule. Start thinking: What training do we need? What may we have to adjust in our work processes to meet FDA’s standards?
An audit of all practices is a good idea in order to get an accurate picture of how current operating procedures match FSMA requirements allowing for the identification of needed improvements, planning, and execution. Additionally, some buyers require private audits (which may or may not have the same standards as FSMA requirements) so being able to demonstrate results from internal and/or third-party audits or mock-FDA inspections can only enhance one’s demonstration of efforts to meet or exceed standards.
In short, the compliance date for the Produce Safety Rule is right around the corner for importers with large business foreign suppliers as well as some small. It is always the right time to assess one’s current status and plan for improvements, though as FSMA continues to take shape and enforcement dates move forward, the urgency has never been greater.
Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel programs, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.
EAS offers a wealth of regulatory consulting capabilities in all FDA commodity areas, as well as USDA and some state regulatory services as they pertain to food and dietary supplement products. EAS is creating short clips that discuss our capabilities and is posting them on our website. We invite you to learn more about our Product Development and Labeling services, FSMA, food and dietary supplement labeling as well as food additive services through these videos. We’ll be adding additional so stay tuned.
Karen Dixon discusses critical points for helping tobacco firms prepare for FDA Inspections in this month’s issue of the Tobacco Reporter, including FDA’s inspection authority and how companies should prepare internally, including a having a detailed inspection plan in place. It is important to note that FDA inspections are not always preannounced, so companies in all industries are encouraged to have written and detailed SOPs as well as ready access to critical information that would be pertinent and requested as part of FDA’s inspection.
EAS Independent Consultant Steve DeMuri authored an article in Natural Products Insider on Probiotic health benefits of natural foods and supplements. With many reported health benefits currently being studied, “Probiotics are here to stay and now is the time for companies to conduct new product development to incorporate probiotics into the “tinkering process” that is part of all food technology and product development efforts,” he says.
EAS Independent Advisor Elizabeth “Betty” Campbell and Independent Consultant, April Kates have co-written an article on how to keep “clean label” claims legal for Natural Products Insider. “Marketing a clean label can be a great way to for brands to connect to consumers,” they say, “but they need to ensure their statements don’t run afoul of a legal claim.”
Welcome to EAS-e-News, a monthly newsletter produced by EAS Consulting Group and dedicated to FDA regulated industries.
We have sad news to share on the passing of Bill Ment who was a long-time friend and consultant to EAS. Please refer to the Who’s Who section of this issue for our tribute to Bill.
The Food Industry received a long-awaited answer to the question of how the agency will regulate dietary fiber when, on June 14, two guidance documents on how isolated or synthetic non-digestible carbohydrates relate to dietary fiber declarations were published. As you will read in this month’s Highlights of What’s New at FDA, written by Independent Advisor for Labeling and Claims, Betty Campbell and Independent Consultant and labeling expert, Gisela Leon, for almost two years industry has been in a state of uncertainty regarding at least 26 non-digestible carbohydrates under FDA’s review. Firms are encouraged to determine whether this new guidance affects the dietary fiber declarations of their products and revise labels as needed.
Our Issue of the Month article is written by Independent Consultant Charles Otto and discusses ten major updates in the 12th edition of FDA’s Food Code. This Code is the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world.
We welcome independent consultants Kristen Steel, Philip Scharago, and Beth Ann Crozier-Dodson, Ph.D. Kristen is a regulatory professional with a strong background in compliance and strategic partnerships within healthcare, CPG and foodservice environments. Philip is a pharmaceutical consultant with extensive knowledge of Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. Beth Ann is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Read more in our Who’s Who section.
We have added two new webinars as part of our summer webinar series – Preparing for Foreign FDA Inspections and Opportunities and Pitfalls of Temporary Marketing Permits. We invite you to reserve your seat today!
EAS is excited to be exhibiting and speaking at IFT this month – please stop by our booth S322 if you will be in attendance. In addition, EAS is also an invited speaker at the International Association of Food Protection conference. Read more about what’s happening at EAS in EAS-in-Action.
I hope you enjoy this issue of EAS-e-News. As always, please feel free to reach out to me with any questions and share this newsletter with your colleagues.
Philip Scharago is a pharmaceutical consultant with extensive knowledge of ISO 13485, 14971, QSR GMP 820, ICH, MDD/EU, ICH, CGMP, Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. He has more than twenty-five years working in the Medical Device and Pharmaceutical Industries in the areas of Quality Assurance and Regulatory Affairs and extensive experience developing and improving quality systems to meet FDA requirements and remediation of FDA-483 observations and Warning Letters.
Kristen Steel is a regulatory professional with a strong background in healthcare marketing, compliance and strategic partnerships within healthcare, CPG, and foodservice environments. She works with project and database management, organizational management, FDA/USDA/DSHEA regulatory and labeling requirements, as well as an international framework as it relates to product labeling.
Beth Ann Crozier-Dodson, Ph.D., is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Dr. Crozier-Dodson has spoken in, designed and taught customized microbiology/food safety workshops across the globe. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.
FDA has released an updated version of the downloadable Food Safety Plan Builder tool designed to help owners and operators of food establishments with the development of a food safety plan that identified hazards requiring preventive controls to prevent foodborne illnesses specific to their facilities. All Food Safety Plans must contain those components that are needed to be in compliance with the 21 CFR part 117, or “CGMP & PC for Human Food rule” requirements in Subpart C – Hazard Analysis and Risk-Based Preventive Controls. A Food Safety Plan is a set of written documents that are based on food safety principles and incorporates hazard analysis and preventive controls, including supply-chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions, and verification. Those wishing to use the FSPB as their primary tool may wish to have a qualified third-party, such as EAS, review the plan for adequacy.
By Charles S. Otto, III, Independent Consultant
The FDA Food Code is used as the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world. It is updated every two years through a collaborative process with the Conference for Food Protection where all stakeholders have a voice in what is included in the next edition published by FDA. Allen Sayler, Senior Director for Food Consulting Services, in his March column in the EAS-e-News announced the release of the 2017 edition on February 12, 2018.
This article will focus on the 10 major changes in this 12th edition since the first modern risk- and the science-based code was issued by FDA in 1993. Twelve earlier editions had been published by FDA and the U.S. Public Health Service since 1934 that were more retail segment-specific guidance, i.e. food service, food store or food vending.
FDA Food Code only becomes a regulation when its requirements are adopted by local, state, and federal food programs for their segment of this vast industry. The new provisions also become the de facto standard of prudence for many companies, even before their operations are required by the local regulatory authorities to comply with it.
A summary of the 10 major updates in the 2017 edition of the FDA Food Code is provided below. This release also had many less significant changes and numerous editorial and clarification amendments.
|Chapter 2 Management and Personnel|
|2-102||Certified Food Protection Manager
Required, for the first time, that the Person in Charge of the food establishment be a Certified Food Protection Manager. The program that awards this recognition must be accredited, meaning that it has been evaluated and listed by an accrediting agency, as conforming to national standards for organizations that certify individuals.
|2-103||Monitoring of Food Temperatures
Added a new duty for the Person in Charge, ensuring employees are routinely monitoring food temperatures in hot and cold holding.
|2-201||Salmonella Typhi and nontyphoidal Salmonella distinctions
Expanded on the changes begun in the 2013 Food Code in emphasizing the importance of nontyphoidal Salmonella (NTS), such as S. enterica serotypes, that cause more than one million domestically acquired foodborne illnesses in the United States each year.
|2-401||Bandages, Finger Cots or Finger Stalls
Required the use of a single-use glove to cover a bandage, finger cot or finger stall used on the wrist, hand or finger.
|2-501||Written Vomit and Diarrhea Clean-Up Procedures
Required that a written plan be provided for cleanup of these bodily fluid discharges by employees or customers. A very good detailed explanation for the plan elements is provided in Food Code’s Public Health Reasons Annex.
|Chapter 3 Food|
|3-401||Changed Cooking Times
Raised the cooking temperature dwell time for foods like comminuted meats requiring a cooking temperature of 68°C (155°F) from 15 seconds to 17 seconds. Lowered the cooking temperature dwell time for foods like poultry requiring a cooking temperature of 74°C (165°F) or above to < 1 second (instantaneous).
|3-502||ROP Frozen Fish Labelling
Added criteria for fish that is reduced oxygen packaged at retail to bear a label indicating that it is to be kept frozen until time of use.
|Chapter 8 Compliance and Enforcement|
When a Hazard Analysis and Critical Control Points plan is required by a jurisdiction for variances including those for specialized processing at retail, more detailed information is required to be submitted for the jurisdictions review and approval.
Added requirement for the Regulatory Authority to ensure that authorized representatives, who inspect food establishments or conduct plan reviews for compliance with Food Code, have access to training and continuing education, as needed, to properly identify violations and apply the Food Code. You will see in this month’s FSMA Perspective that employee training is also a requirement of FSMA and documentation of that training should be kept and provided to FDA upon request during an inspection.
|8-404||Utility Interruption Contingency Plan
Allowed the regulatory authority to agree to continue operations during an extended water or electrical outage, if written operational plans have been approved by the regulatory authority.
As mentioned with the changes outlined in Section 2-501, the Public Health Reasons in Annex 3 provide excellent plain English descriptions of the science and other details behind the requirements of the changed, as well as the older sections of FDA Food Code. Additional information can be provided by the adopting regulatory authority or by the FDA National Retail Food Team. Questions of FDA on the Food Code may be directed to RetailFoodProtectionTeam@fda.hhs.govor should you have questions which you would like to direct to EAS, contact Allen Sayler at ASayler@easconsultinggroup.com
Bill Ment who was a long-time friend and consultant to EAS. Bill had a 34-year career at FDA, where in his last agency role he served as the Laboratory Director in Baltimore, MD, with responsibility for a full range of FDA field lab sample analyses and research studies for imported and domestic products. Following FDA retirement in 1999, he began consulting with AAC Consulting Group and Kendle Regulatory Affairs, from which EAS Consulting Group grew. Thanks to Bill’s expertise and outstanding reputation both at FDA and as a consultant, he was quickly asked to join the ranks of EAS Independent Advisors, overseeing GMP Auditing Services. Bill performed many pharmaceutical, laboratory and dietary supplement audits of API and finished product manufacturers, and helped companies improve their laboratory and QC/QA operations. He was also instrumental in the development of the EAS Dietary Supplement Good Manufacturing Practices seminar, which has become an EAS flagship training program. Most importantly, Bill was a great friend to many at EAS where he often mentored new consultants, helping them to make the transition from industry or FDA to the consulting world. He was an easy-going man of great integrity, with an unbelievable work ethic and he will be truly missed. Please keep Bill’s family in your prayers as they go through this difficult time. Should you wish to make a contribution in Bill’s memory, here is a list of charities with meaning to Bill and his family.
By Susan Crane
This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution of OTC drugs and dietary supplements.
Each month EAS chooses one question sent in by a reader of EAS-e-News. To submit your question, use the Contact Us link on our website.
Question: Why is FDA updating the OTC monograph system?
Crane: The current OTC monograph system has been in use since the 1970’s and has proven to be a lengthy and cumbersome rule-making process for finalizing, or making changes to the monographs. Several monographs have been in the “Tentative Final” stage for 40 years, while hundreds of active ingredients still lack FDA determination as to their safety and effectiveness. The FDA simply lacks the resources to manage the system as it currently exists.
To address the problem, the FDA, in consultation with other stakeholders, worked with Congress to draft legislation. The resulting Over-the-Counter Drug Safety, Innovation, and Reform Act is currently moving through the legislative process with bipartisan support so is expected to pass and be signed into law, hopefully before the mid-term elections in November.
The reforms include, but are not limited to:
- replacing the current rule-making process with a more efficient “administrative order” process
- providing FDA with funding through a new user fee program
- providing mechanisms to allow FDA to more quickly address safety issues that arise
- encouraging innovation by offering exclusivity to manufacturers for new active ingredients or conditions for use
EAS is monitoring the legislation and will provide details as they become available.
The U.K.’s departure from the EU sparks uncertainty in future trade agreements with the United States, which may not be finalized until after Brexit occurs, says Heather Fairman in a recent article for Natural Products Insider. “For U.S. supplement companies that currently are actively exporting/importing products to the U.K., a watchful eye should be kept on the Brexit transition.”
Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. has published an article in Tablets and Capsules magazine on the importance of quality agreements for dietary supplement manufacturers. “The dietary supplement industry, like the pharmaceutical and food industries, relies heavily on contractors and subcontractors. However, no matter who does what along the supply chain, the product owner is ultimately responsible for GMP compliance,” she says.
Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations, ingredient sourcing and scalability in mind can help companies succeed, she says.
Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber:  non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact in plants; and  isolated or synthetic non-digestible carbohydrates determined by FDA to have acknowledged beneficial physiological effects. The FDA regulation listed 7 ingredients that had been found to have a beneficial physiological effect.
On June 14th, 2018, a little over 18 months before the compliance date for the new nutrition labeling, FDA issued two guidance documents regarding how isolated or synthetic non-digestible carbohydrates relate to the dietary fiber declaration. These guidance documents resolve nearly two years of uncertainty for at least 26 non-digestible carbohydrates under FDA review for their potential beneficial physiological effect.
FDA stated in one guidance document that the agency had found a beneficial physiological effect for 8 more ingredients and would use enforcement discretion to allow manufacturers to immediately reevaluate their fiber ingredients for inclusion in the dietary fiber declaration. The second document contained the scientific evaluation of data showing a beneficial physiological effect for those 8 ingredients.
The list of FDA-approved isolated or synthetic non-digestible carbohydrates with acknowledged beneficial physiological effects now include the following 15 substances:
- [beta]-glucan soluble fiber (as described in 101.81(c)(2)(ii)(A))
- psyllium husk (as described in 101.81(c)(2)(ii)(B))
- guar gum
- locust bean gum
- mixed plant cell wall fibers
- inulin and inulin-type fructans
- high amylose starch (resistant starch 2)
- resistant maltodextrin/dextrin.
The agency describes “Mixed plant cell wall fibers” as a large group of fibers that include cellulose, pectin, β-glucan, and/or arabinoxylan. FDA listed several examples of ingredients that include these fiber components, including apple fiber, citrus fiber, pea hull fiber and many others.
With the evaluation decisions in the new guidance, the list of 26 non-digestible carbohydrates under FDA evaluation as dietary fiber has now been shortened to 9. The ingredients where no determination has been reached include commonly used fibers such as gum acacia, carboxymethylcellulose, karaya gum, pullulan, xanthan gum and some other starches.
With the publication of these new documents, firms are encouraged to verify whether the updated guidance affects the dietary fiber declaration of their products. Nutrition information in recently created Nutrition Facts and Supplement Facts panels might need to be updated. EAS consultants are available to assist in evaluating ingredients in light of the new guidance and revising labels accordingly.
FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the FD&C Act permitting the exemption of a device from the requirement to submit a 510(k).
[6/21/2018] The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product. After considering public comments that the agency received about the draft guidance, the FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved. Comments submitted to the docket addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation. The FDA believes that in better addressing these issues in the future, the agency can advance principles that can promote a more efficient pathway for the development of biosimilar products.
The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.