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U.S. FOOD& DRUG ADMINISTRATION FDA FDA Drug Topics: An Update on Transmucosal Buprenorphine and Dental Caries Mark A. Liberatore, PharmD, RAC Commander, United States Public Health Service Deputy Director for Safety Division of Anesthe Addiction Medicine, and Pain Medicine Office of New Drugs, Center for Drug Evaluatio...
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FDA 1. Discuss the national opioid crisis, opioid use disorder, and available treatments 2. Describe cases of dental caries with the use of transmucosal buprenorphine-contaainng products 3. Review FDA's framework for updating product labeling and explain FDA's findings and the resulting regulatory action 4. Summarize h...
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FDA SAFETY SIGNAL
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FDA How it Began... Office of Surveillance and Epidemiology (OSE), Division of Pharmacovigilance ll (DPV II) monitors FDA's Adverse Event Reporting System (FAERS) July 2018: A report was found of patient who experienced dental caries following the use of sublingual product containing buprenorphine/naloxone A disproport...
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FDA Sublingual Buprenorphine Can be used sublingually or buccal (but not per-oral Sublingual Administration Place one film under the tongue, close to the base on the left or right side. If an additional film is necessary to achieve the prescribed dose, place an additional film sublingually on the opposite side form the...
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Key Findings from OSE/DPV-II Search FDA 486 Reports Most common course of treatment of the tooth/teeth was ceatractionspullleerrrvvee which occurred in 71 instances 474 FAERS 12 medical literature Many cases were reported by providers, provided extensive documentation, and demonstrated temporal association 305 Cases Se...
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FDA FAERS Case #1 30-year-old male Buprenorphine/naloxxne SL film 8mg BID for OUD PMH included addiction to oral pain meds, "impeccable teeth," no concomitant medications After 1 year of therapy, experienced severe tooth decay with 15 dental caries Treatment with unspecified dental work Treatment with buprenorphine/nal...
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FDA FAERS Case #2 25-year-old female Buprenorphine/naloxxne SL film for OUD PMH: mother reported daughter's teeth were in "perfect condition" with no dental caries or dental problems After 1.5 years of therapy, experienced rapid deterioration of teeth (some began falling out) After 3 years, all teeth removed
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FDA REVIEW OF SAFETY SIGNAL
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FDA Summary of Case Characteristics Formulation reported: 238 Film only: 143 Tablet only: 48 Tablet and Film: 47 Indication for use: 194 Opioid Dependence: 173 Pain: 28 Time to Diagnosis: 136 Mean: 31.5 months Median: 24.25 months Range: 0.5-182 months 50% female Age: Mean: 41.8 years Median: 36.2 years Range: 18-71 ye...
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FDA FAERS Case #3 53-year-old-male Buprenorphine/naloxxnne SL film for OUD PMH: chronic pain, open heart surgery Denied history of dental caries After initiating SL product, patient experienced 15 dental caries over a time period of ~2 years Patient had regular dental cleanings every 3 months Diagnosed with dental cari...
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FDA FAERS Case #4 Buprenorphine (single ingredient) SL tablet Experienced "deterioration of tooth enamel and significant damage to teeth in the region of [product] dissolution" PMH: previous enrollment in methadone program, denial of continued use of "street" drugs Dental exams every 6 months while on methadone Teeth i...
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FDA Presentation Outline Background Opioid Crisis and Opioid Use Disorder Overview and review of safety signal Description of FDA regulatory framework Action, communication, and reaction Takeaways/Summary Challenge Questions Panel discussion and Q & A References available at the bottom of this slide deck www.fda.gov
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FDA Literature Information for Authors Register About Us Now PCC THE PRIMARY CARE COMPANION FOR CNS DISORDERS Suzuki, J., L. Mittal, and S. B. Woo. 2013. 'Sublingual buprenorphine and dental problems: case series', Prim Care Companion CNS Disord, 15. Mean age 34.4 years, predominantly white (91%), taking buprenorphine ...
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FDA Product-Specific Information DRUG X adheres to the moist buccal mucosa and will completely dissolve after application, usually Median dissolve time of DRUG Y was 5 minutes while the median dissolve time of DRUG Z was 12.5 minutes Mean in vivo dissolution time is 17.6 minutes for 8 mg tablet, 8.13 minutes for 2 mg t...
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FDA Biological Plausibility Dental caries can result from activity of acids on tooth structure The pH Scale Battery Lemon Tomato Milk Blood Stomach Tablets Soap Drain Cleaner Normal pH of saliva is between 6.7 and 7.4 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 When pH drops below 5.5, acid begins to erode enamel Prolonged expo...
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FDA REGULATORY FRAMEWORK
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Food and Drug Administration Amendments Act of 2007 (FDAAA) FDA Signed into law September 27, 2007 Section 901 of the Act adds section 505(0)(4) to the Federal Food, Drug, and Cosmetic Act Authorizes FDA to require safety labeling changes for the following products: Prescription drugs with an approved NDA Biological pr...
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FDA Regulatory Authority 505(0)(4): FDA can require, and if necessary, order labeling changes if FDA becomes aware of New Safety Information that FDA believes should be included in the labeling of a drug. What is "New Safety Information?" 505-1((b defines it as "information derived from a clinical trial, an adverse eve...
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FDA What Can be Changed? DOSAGE FORMS AND STRENGTHS Dosage form(s): strength(s) (3) CONTRAINDICATIONS Text (4) Text (4) WARNINGS AND PRECAUTIONS Text (5.x) Text (5.x) ADVERSE REACTIONS Most common adverse reactions (incidence x%) are text (6.x) To report SUSPECTED ADVERSE REACTIONS, contact name of manufacturer at toll...
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FDA Warnings and Precautions Intended to identify and describe a discrete set of adverse reactions and other potential safety hazards that are serious or are otherwise clinically significant. To include the adverse event in this section there should be reasonable evidence of a causal association, but a causal relations...
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Serious or FDA Otherwise Clinically Significant Serious Otherwise Clinically Significant Death Life-threatening adverse event Inpatient hospitalization or prolongation of existing hospitalization A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions A congenita...
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FDA FAERS Case #5 SL buprenorphine/naloxxne Experienced rapid tooth loss over 14 months while on the product Teeth became soft and brittle, chipped just by brushing or chewing soft foods Had X-rays 14 months before starting SL buprenorphine, "showed none of the insane damages (that) had happened to teeth" Dentist state...
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FDA OPIOID CRISIS AND OPIOID USE DISORDER (OUD)
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| Causal Association? FDA | Causal Association? FDA | | Factors | Findings | | 1. Frequency of Reporting | Hundreds of cases | | 2. Adverse event rate in the drug treatment group exceeds the rate in the placebo and active-control in controlled trials? group | (n/a, clinical trial data found explored this no adverse eve...
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FDA Caused by Related Drugs??? Few cases involving other SL/transmucosal forms of Already labeled (note: different composition) 305 cases of dental caries involving TMB 28 of 305 implicated a brand name SL product indicated for pain Notable as well that the dosing for this product is around 10x less than that of TMB fo...
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FDA Regulatory Decision These cases of dental caries were determined to be serious and otherwise clinically significant The totality of evidence provided reasonable evidence of a causal association between the drug in this dosage form and the adverse event This type of adverse event has implications for prescribing dec...
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FDA REGULATORY ACTION
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FDA New Safety Information (NSI) Section 505(0)(4) requires FDA provide NSI to require changes 71/305 cases resulted in tooth extraction Acknowledged that the presence of substance use disorder may increase major oral health problems 26/305 cases occurred in patients with no prior history of dental problems (well docum...
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Labeling -5 Warnings and Precautions (first paragraph) FDA 5.x Dental Adverse Events Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal ouprenorphine-conttainng products. Reported events include cavities, tooth decay, dental abscesses/infection, ...
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Labeling - 5 Warnings and Precautions (second paragraph) FDA Refer patients to dental care services and encourage them to have regular dental checkups while taking TRADENAME. Educate patients to seek dental care and strategies to maintain or improve oral health while being treated with transmucosal auprenorphine-contta...
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FDA Labeling - 2. Dosage and Administration 2.1 Important Dosage and Administration Information 2.2 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose 2.3 Induction Advise patients to do the following after the product has completely dissolved in the oral mucosa: take a sip of water, swish gently...
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FDA Labeling -17 Information for Patients Advise patients that, after TRADENAME has completely dissolved in the oral mucosa, to take a sip of water, swish it gently around their teeth and gums, and swallow. Advise patients to wait for at least one hour after taking TRADENAME before brushing teeth. Refer patients to den...
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FDA Labeling - Medication Guide Under "How should take TRADENAME?" After TRADENAME is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth. Report any problems with your teeth immediately to your provider and schedule an appointment with a dentist. Tell your de...
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FDA Opioid crisis declared a Public Health Emergency on October 26, 2017 "Crisis" is a broad term covering many aspects of the public health issue: Misuse and Abuse Addiction (Opioid Use Disorder (OUD)) Overdose Death
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FDA COMMUNICATIONS PLAN AND PUBLIC RECEPTION
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FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain FDA Benefits for use outweigh these risks and oral care can help Drug Safety Podcas 1-12-2022 FDA Drug Safety Communication | Drug Safety Communication (PDF 94 KB) | | What safety concern is FDA ann...
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FDA Professional Uptake / Reception ADA THE JOURNAL OF THE AMERICAN DENTAL ASSOCIATION Orally dissolving buprenorphine for opioid use disorder linked to caries Stuart L. Segelnick, DDS, MS 2 Meaa A. Weinberg, DMD, MSD, RPh Medscape American Journal of Nursing The Leading Voice of Nursing Since 1900 News> +Medscape Medi...
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Social Media Reaction FDA ng knew it! I'm glad they acknowledge it finally! So that's why some of my teeth are rotting... my teeth were f ing fine at the beginning of the year, and they jus nose dived over the last 6 months, with me starting subs in April... in knew my teeth issues were from this s Never had any proble...
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FDA New Science Research Letter December 13, 2022 Association Between Sublingual Buprenorphine- Naloxone Exposure and Dental Disease Mahyar Etminan, PharmD, Mscl; Ramin Rezaelanzadeh, BSel; Abbas Kezouh, PhDf; etaal > Author Affiliations Article information This study found an increase in the risk of adverse dental out...
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FDA Summary 1. The U.S. is still in an opioid overdose crisis, but treatments, like transmucosal buprenorphine for opioid use disorder are available 2. FDA detected a signal involving transmucosal buprenorphine and dental caries, reviewed the scientific information 3. FDA's review off the safety signal determined that ...
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FDA Q & A PANEL www.fda.gov
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Q&A Panelists FDA Samantha Cotter, PharmD, BCPS, FISMP Safety Evaluator Division of Pharmacovigilance Office of Surveillance and Epidemiology Monisha Billings, DDS, MPH, PhD Team Lead / Epidemiologist Safety, Policy, Research, and Initiatives Office of New Drugs lmmediate office Zachary Illg, DO Medical Officer Divisio...
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FDA References Haffajee, R. L., and R. G. Frank. 2018. 'Making the Opioid Public Health Emergency Effective', JAMA Psychiatry, 75: 767-68. Ciccarone, D. 2021. 'The rise of illicit fentanyls, stimulants and the fourth wave of the opioid overdose crisis', Curr Opin Psychiatry, 34: 344-50. American Psychiatric Association...
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FDA References Suzuki, J., L. Mittal, and S. B. Woo. 2013. 'Sublingual buprenorphine and dental problems: a case series', Prim Care Companion CNS Disord, 15. Hans, Rinki, Susan Thomas, Bharat Garla, Rushabh J. Dagli, and Manoj Kumar Hans. 2016. 'Effect of Various Sugary Beverages on Salivary pH, Flow Rate, and Oral Cle...
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Figure 1. Age-adjusted rate of drug overdose deaths, by sex: Overdose Deaths 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 ed rate d from s per Deaths per 100 000000 standard population 0 10 20 30 40 2022 50 Male1.2 Female FDA g United States, 2002-2022 Total 107,941 drug overdose deaths occurred in 2022 32.6 ...
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FDA References Etminan, Mahyar, Ramin Rezaeianzadeh, Abbas Kezouh, and Kevin Aminzadeh. 2022. 'Association Between Sublingual Buprenorphine-Naloxxnnn Exposure and Dental Disease', JAMA, 328: 2269-71. Barus, R., F. Montastruc, C. de Canecaude, H. Bagheri, A. Sommet, and M. Lapeyre-Mestre. 2023. 'Sublingual/Bucca bupreno...
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U.S. FOOD& DRUG ADMINISTRATION FDA
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Figure 4. Age-adjusted rate of drug overdose deaths involving Current Landscape of Opioid-involved Deaths 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 Deaths per 100, 00.000 standard population 10 15 20 25 FDA Heroin 2021 2.8/100k opioids, by type of opioid: United States, 2002-2022 2022 = 1.8/100k Natural & ...
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FDA Opioid Use Disorder (DSM-5) t least 2 of the following within a 12-month period: 1 Opioids are often taken in larger amounts or over a longer period of time than intended. Mild = 2-3 2 There is a persistent desire or unsuccessful efforts to cut down or control opioid use. Moderate = 4-5 3 A great deal of time is sp...
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Need for Treatment Buprenorphine Need Availability FDA In 2022, estimated six million people in the US had an opioid use disorder Estimated 3.7% of US adults need OUD treatment Medications for the treatment of opioid use disorder (MOUD) decrease opioid- related mortality and overdose Utility Evidence-based treatment is...
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| FDA Buprenorphine | FDA Buprenorphine | | Brief regulatory history | A New Era of OUD Treatment | | 1982: Original approval for pain | | | 2002: Approval for OUD | The Drug Addiction Treatment Act of 2000 is longer in effect no | | Often found in combination with naloxone | The Drug Addiction Treatment Act of 2000 i...
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2018 FDA Douglas C. Throckmorton MD Deputy Director for Regulatory Programs CDER, FDA American College of Surgeons May 21, 2018
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The opinions and information in this presentation are my own anc do not necessarily reflect the views and policies of the FDA
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FDA Summary and Conclusions FDA working to address opioid epidemic as a part of the larger HHS response One of the FDA's very highest priorities Going forward, FDA is committed to taking decisive actions, grounded in the available science and appropriate public input to address this critical challenge to the US health ...
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Thank You FDA
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Drug Overdose Deaths FDA Drugs Involved in U.S. Overdose Deaths, 2000 to 2016 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 0 5,000 10,000 15,000 20,000 25,000 Heroin, 15,446 Methamphetamine, 7,663 Methadone, 3,314 Synthetic Opioids other than Methadone, 20,145 Natural and se...
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9 9 What does 53,000 people look like?
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Overdose Death Rates 1999 2014 Year 1969 Year 2014 Estimated Age-adjusier Extimated Age aeeeadduuedd Death Ritee par 100,000- Death Rate per 100,000c 62 0.328 214 +20 Posiamedb.. Dessan Destinn V 001 IDOE CRONNO 10 Mattonal 1ilkel Cintiation Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital...
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FDA Response to this Crisis "Unquestionably, our greatest immediate challenge is the problem of opioid abuse. This is a public health crisis of staggering human we have an important role to play in reducing the rate of new abuse and in giving healthcare providers the tools to reduce exposure to opioids to only clearly ...
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Available FDA Tools to Accomplish These Goals FDA Improving the safe use of drugs through careful and appropriate regulatory activities Improving the safe use of drugs through careful and appropriate policy development Improving product develoment through improved science Improving the safe use of drugs through communi...
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Responding to Challenges: Opioids
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The Opioid Crisis: FDA's Priorities & Strategie 1. Decreasing Exposure & Prevent New Addiction Appropriate Dose/Duration Labeling Appropriate Packaging, Storage, and Disposal Health Care Provider 2. Supporting the Treatment of Those With Opioid Use Disorder Naloxone Medication Assisted 3. Fostering the Development of N...
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FDA Priorities align to HHS Strategic Priorities and other National Activities HHS STRATEGIC FDA PRIORITIES OTHER Strengthening public health surveillance President's Opioid Initiative 1. Decreasing Exposure & Prevent New Addiction Office of National Drug Control Policy Recommendations Targeting availability and distri...
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U.S. FOOD& DRUG ADMINISTRATION FDA The Public Health Role of Drug Regulation in the US Douglas C. Throckmorton, M.D. Deputy Director for Regulatory Programs, CDER, FDA March 20, 2017
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FDA Disclosure Statement I have no financial relationships with proprietary entities that produce health care goods and services The opinions and information in this presentation are my own and do not mecessarily reflect the views and policies of the FDA
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Notable Disasters Before 1938 FDA Dinitrophenol weight loss drug, caused thousands of cataracts, enucleations in the 1930's. Elixir sulfanilamide sulfa drug killed over 100 people in 1937, many of them children; diethylene glycol (anti- freeze) was the solvent. No animal testing. A chemist simply smelled and tasted the...
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FDA The Food, Drug and Cosmetic Act of 1938 (FD&C) - Age of Safety Two Reguirements: 1. Pre-market notification 2. Demonstration of safety
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FDA Next Major Turning Point: Thalidomide Thalidomide 1,200U.S. DOCTORS GOT BANNED PILL FOR TESTS Thalidomide, the sleeping pill "hha has caused thou- sands of infant malformations in Europe had been dis- tributed to 1,200 physicians in the United States for investigational use since 1959, before it was banned in the U...
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The Age Effectiveness: FDA The 1962 Kefauver-Harris Amendments Not obvious why thalidomide (a safety problem) led to a requirement for demonstrating effectiveness, but the 1962 Act made at least 3 important changes: 1. FDA had to give positive approval before a drug could be marketed 2. A meaningful requirement to stud...
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Since 1962: The Era of the RCT and the Value of Empiric Testing Growth of the medical product development Growth of the medical product development enterprise Non-clinical models of disease Statistics of trials assessment Placebo- and Active-controls Clinical efficacy and safety assessment Sobering experiences where pr...
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FDA Context: New Realities in the 21st Century threatening illnesses Today many more treatments are available, but patterns of manufacturing, public scrutiny of healthcare, and information available to guide use have shifted dramatically. Patients and clinicians need: New products sooner Accurate, up-to-date and unders...
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FDA's Challenges for the 21st Century FDA Supporting Innovation and Advances in Science and Technolog Better understanding of the mechanisms of disease and human biolog Advances in biomedical engineering Increasingly complex products; challenges for development, as well as assessment of safety, efficacy and quality New...
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FDA The FDA Today: Embracing Science- Driven Regulation and Innovation Maintaining the Balance The task for FDA's scientist is to strike the right regulatory balance between providing fast access to new products the one hand, and preventing harm to public health on the other When done right, regulation can be a pathway...
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FDA Critical Part of FDA Work: Sustaining Medical Product Innovation High failure rates for drug development Rising R & D costs A limited pipeline of potential drugs A lack of basic information about the causes of the disease and the pathways for slowing its progress
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R & D Process PHASE 4: POST MARKETING SURVEILLANCE CEE-DISCOVER Y NDA SUBMITTED TO FDA 3-6 YEARS 6-7 YEARS LARGE SCALE MFG DRUG DISCOVERY PRE CLINICAL FDA REVIEW CLINICAL TRIALS 5,000-10,000 COMPOUNDS 250 ONE FDA- APPROVED DRUG 5 PHASE 1 PHASE 2 PHASE 3 Number of Volunteers 20-100 100-500 1000-5000 0.5-2 YEARS IND SUBM...
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FDA FDA's Regulatory Scope: 20 cents of every GDP dollar 120 80
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FDA Improving Evidence Generation Essential Clinical Expertise Patient Values & Preferences Best Research Evidence EBP
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FDA Changes are Needed to Our National Clinical Research System High percentage of decisions not supported by evidence* * Health outcomes and disparities are not improving Current system is great except: Too slow, too expensive, and not reliable Doesn't answer questions that matter most to patients Unattractive to clin...
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FDA We Need An Efficient Evidence Generation System.... More data available than ever in new forms Much more of clinical practice could be guided by high quality evidence Clinicians and their practice organizations could focus on interpreting the evidence and applying it The role of opinion and expertise would be at le...
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Many Stakeholders in Clinical Trials Enterprise Regulator Academia y Agencies Drug Develop ment Federal Partners Conso rtia Patient Groups, Foundati ons, and Professi onal Societies
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Critical Part of FDA Work: the FL Challenges of Globalization to Product Quality and Development When FDA was established more than a century ago: Our regulated industries were predominantly local The volume of imported produce was low The movement of good across country (and between countries) was minimal www.fda.gov
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FDA The Global Drug Manufacturing Supply Chain Imported Finished Drug Ingredients Ingredients Manufacture of Finished Drug Ingredients Active (API) ingredient (API) made in China and ingredients made in Europe, Japan, or the U.S. These components may shipped to India where the finished drug is manufactured and then imp...
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FDA old Shenzhen (1982)
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FDA New Shenzhen (2013)
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FDA Imports Continue to Increase Food Approximately 49% of fresh fruits and 25% of vegetables are imported - 89% of seafood eaten domestically comes from outside the United States Devices - Based on dollar values, at least 35% of all medical devices used in the United States are imported Drugs /Biologica 80% of Active ...
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The Impact of Globalization on FDA's Mission FDA Foreign production of FDA-regulated goods and materials has exploded over the last decade FDA-regulated products originate from more than: 150 countries - 130,000 importers - 300,000 foreign facilities Number of FDA-regulated shipments at 300 U.S. ports has more than dou...
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FDA FDA Mission FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that radiation.
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FDA Critical Part of FDA Work: Responding to New Challenges Public health challenges need to be addressed promptly and fully as they arise Part of FDA mission 'Protect and Promote' Prescription opiold abuse Complex medical, social, scientific issue Over 15,000 overdose deaths in US last year associated with opioid use
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Overdose Death Rates 1999 2014 Year 1969 Year 2014 Estimated Age- adjusted Estimated Age- adjusted Death Rate per 100,000: Death Rate pet 100,00 100,000: 0-2 0.0-2.0 2.1-4 2.1-4.0 4.1-5 4.1-6.0 6.1-8 6.1-8.0 8:1-10 8:1-10.0 10,1-12 10.1-12.0 12.1-14 12.1-14.0 14.1-16 14.1-16.0 16.1-18 16.1-18.0 18.1-20 16.1-20 >20 >20 ...
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Important: FDA One of Many Stakeholders FDA evaluates benefits/risks for the population Benefits Risks Provider evaluates benefits/risks for a patient PRR BBBB B BBB Risks Benefits Patient evaluates benefits/risks in terms of personal values Benefits Risks
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FDA Organization FDA Office of the Commissioner Office of Regulatory Affairs Center for Veterinary Medicine Center for Food Safety & Applied Nutrition National Center for Toxicological Research Center for Drug Evaluation & Research Center for Biologics Evaluation & Research Center for Devices & Radiological Health Cent...
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FDA FDA's Current Resources Total annual budget $4.39 billion for FY 2014 User Fees $1.83 billion, approximately 42% of tota Appropriated Funds $2.56 billion, about $8 per citizen 15,705 FTEs, 77% with college degrees, 21% with doctorates 223 U.S. offices and 13 laboratories 11 international offices and posts in 8 coun...
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Who Works at FDA? FDA Chemists review the drug substance, product, and manufacturing process Biologists review biological products Toxicologists review the non-clinical studies Pharmacologists review drug pharmacokinetics, exposure-response, drug-drug interactions Statisticians review all types of studies; design and a...
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FDA FDA's Reliance on Industry User Fees Approximately 42% of FDA's funding comes from industry user fees: $1.83 billion Industry user fees provide 64% of the funding for FDA's human drugs program, which itself accounts for approximately 30% of FDA's budget FDA's medical device program accounts for 10% of FDA's overall...
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FDA What is the Role of the Regulator in Responding to Public Health Challenges and Supporting Innovation?
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FDA: First Focused on Core Business Functions Pre-Market Review Product Safety & Compliance Assessment of safety and effectiveness of new medical technology & safety of new food ingredients Inspection of manufacturing facilities and products to assure safety, quality & compliance with FDA regulations Consumer & Patient...
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5 "Moral Imperatives" of Government Regulation GOVT. REGULATIONS Protect the Public from Harm Preserve Maximum Individual Freedom of Choice Guarantee Meaningful Public Participation in the Decision-Making Process Promote Consistent and Dependable Rules that are Equally Applicable to Everyone Provide Prompt Decisions on...
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FDA FDA Mission FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science- based information they need to use medicines and foods to maintain and improve their health. FDA als...
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FDA Role for the FDA Beyond These Core Functions to Aid Innovation We are uniquely situated to contribute to innovation: Legal role in application of regulations Focus on public health mission Regulators in unique position to see needs across disease areas Regulators in unique position to respond to needs Regulators ha...
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Vidore3PharmaceuticalsOCRRetrieval

An MTEB dataset
Massive Text Embedding Benchmark

Retrieve associated pages according to questions. This dataset, Pharmaceutical, is a corpus of slides from the FDA, intended for long-document understanding tasks. Original queries were created in english, then translated to french, german, italian, portuguese and spanish. This variant includes the OCR'ed markdown so allow for comparison across image-text and text-only models. It is currently released as a beta and might be removed at a later stage.

Task category t2it
Domains Medical
Reference https://arxiv.org/abs/2601.08620

Source datasets:

How to evaluate on this task

You can evaluate an embedding model on this dataset using the following code:

import mteb

task = mteb.get_task("Vidore3PharmaceuticalsOCRRetrieval")
evaluator = mteb.MTEB([task])

model = mteb.get_model(YOUR_MODEL)
evaluator.run(model)

To learn more about how to run models on mteb task check out the GitHub repository.

Citation

If you use this dataset, please cite the dataset as well as mteb, as this dataset likely includes additional processing as a part of the MMTEB Contribution.


@article{loison2026vidorev3comprehensiveevaluation,
  archiveprefix = {arXiv},
  author = {António Loison and Quentin Macé and Antoine Edy and Victor Xing and Tom Balough and Gabriel Moreira and Bo Liu and Manuel Faysse and Céline Hudelot and Gautier Viaud},
  eprint = {2601.08620},
  primaryclass = {cs.AI},
  title = {ViDoRe V3: A Comprehensive Evaluation of Retrieval Augmented Generation in Complex Real-World Scenarios},
  url = {https://arxiv.org/abs/2601.08620},
  year = {2026},
}


@article{enevoldsen2025mmtebmassivemultilingualtext,
  title={MMTEB: Massive Multilingual Text Embedding Benchmark},
  author={Kenneth Enevoldsen and Isaac Chung and Imene Kerboua and Márton Kardos and Ashwin Mathur and David Stap and Jay Gala and Wissam Siblini and Dominik Krzemiński and Genta Indra Winata and Saba Sturua and Saiteja Utpala and Mathieu Ciancone and Marion Schaeffer and Gabriel Sequeira and Diganta Misra and Shreeya Dhakal and Jonathan Rystrøm and Roman Solomatin and Ömer Çağatan and Akash Kundu and Martin Bernstorff and Shitao Xiao and Akshita Sukhlecha and Bhavish Pahwa and Rafał Poświata and Kranthi Kiran GV and Shawon Ashraf and Daniel Auras and Björn Plüster and Jan Philipp Harries and Loïc Magne and Isabelle Mohr and Mariya Hendriksen and Dawei Zhu and Hippolyte Gisserot-Boukhlef and Tom Aarsen and Jan Kostkan and Konrad Wojtasik and Taemin Lee and Marek Šuppa and Crystina Zhang and Roberta Rocca and Mohammed Hamdy and Andrianos Michail and John Yang and Manuel Faysse and Aleksei Vatolin and Nandan Thakur and Manan Dey and Dipam Vasani and Pranjal Chitale and Simone Tedeschi and Nguyen Tai and Artem Snegirev and Michael Günther and Mengzhou Xia and Weijia Shi and Xing Han Lù and Jordan Clive and Gayatri Krishnakumar and Anna Maksimova and Silvan Wehrli and Maria Tikhonova and Henil Panchal and Aleksandr Abramov and Malte Ostendorff and Zheng Liu and Simon Clematide and Lester James Miranda and Alena Fenogenova and Guangyu Song and Ruqiya Bin Safi and Wen-Ding Li and Alessia Borghini and Federico Cassano and Hongjin Su and Jimmy Lin and Howard Yen and Lasse Hansen and Sara Hooker and Chenghao Xiao and Vaibhav Adlakha and Orion Weller and Siva Reddy and Niklas Muennighoff},
  publisher = {arXiv},
  journal={arXiv preprint arXiv:2502.13595},
  year={2025},
  url={https://arxiv.org/abs/2502.13595},
  doi = {10.48550/arXiv.2502.13595},
}

@article{muennighoff2022mteb,
  author = {Muennighoff, Niklas and Tazi, Nouamane and Magne, Loïc and Reimers, Nils},
  title = {MTEB: Massive Text Embedding Benchmark},
  publisher = {arXiv},
  journal={arXiv preprint arXiv:2210.07316},
  year = {2022}
  url = {https://arxiv.org/abs/2210.07316},
  doi = {10.48550/ARXIV.2210.07316},
}

Dataset Statistics

Dataset Statistics

The following code contains the descriptive statistics from the task. These can also be obtained using:

import mteb

task = mteb.get_task("Vidore3PharmaceuticalsOCRRetrieval")

desc_stats = task.metadata.descriptive_stats
{}

This dataset card was automatically generated using MTEB

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