World of Drug Information - Volume 8, Issue 3 - September 1997
CURRENT CLINICAL ISSUES
FDA Summary Basis of Approval Now Indexed by IDIS
What is a Summary Basis of Approval?
A new drug's Summary Basis of Approval (SBA) is, in my opinion, a little known, untapped source of valuable drug information. To describe an SBA it is necessary to first review the new drug approval process in the United States. When a new drug's sponsor has acquired enough data to convincingly show that the drug is safe and effective for marketing in the U.S., the sponsor may submit such data and information to the Food and Drug Administration (FDA) as a New Drug Application (NDA).
NDA documents can be massive. In an article discussing new drug development the FDA pictures the NDA for Ortho Cyclen-28 as a 240 volume document. (Anon. 1988) While much of the NDA is not open to the public, 21 Code of Federal Regulation 314.430 contains a provision for public disclosure of information immediately after the FDA has sent an approval letter to the applicant. For a new drug, all safety and effectiveness data previously disclosed to the public and a summary of safety and effectiveness data and information that comprised the basis for the FDA approval of the new drug are available for public disclosure. For an application approved on or after July 1, 1975, the CFR requires a Summary Basis of Approval (SBA) document be available for public disclosure. Section 314.430 further provides for public disclosure of test or study protocols, adverse reaction reports, product experience reports, consumer complaints and other similar data and information, a list of all active ingredients and any inactive ingredients previously disclosed to the public, an assay method or other analytical method, all correspondence and written summaries of oral discussions between the FDA and the applicant relating to the application, and all records showing the testing of an action on a particular lot of a certifiable antibiotic by the FDA.
Who writes the Summary Basis of Approval?
The regulation allows for two preparation routes; either the applicant may draft the SBA and submit it to the FDA for review and revision or the FDA may prepare the SBA. Since 1975 both of these methods have been used along with their combination. In the latter case, the applicant was requested to prepare specific sections of the SBA and the FDA provided other sections that were pulled from the FDA's scientific reviews of the NDA. In the mid-1980's the FDA began providing, in lieu of a newly written SBA and in some cases in addition to the SBA, a collection of scientific reviews from the NDA. This collection of reviews contained the essence of the basis upon which the drug was approved. The assembled document is referred to as a Summary Basis of Approval equivalent. Documents that IDIS has received from the FDA for drugs approved in the last few years have all been Summary Basis of Approval equivalents.
What information is included in an SBA?
The only requirement for content of the SBA is that it contain a summary of the safety and effectiveness data and information evaluated by the FDA during the approval process. Summary Basis of Approval equivalents generally consist of most, but usually not all, of the following sections:
<FDA Form 356h> This form provides basic information about the applicant and the product including the applicant's name and address, the name, dosage forms, indications for the new drug and the date of the approval.
<Letter of Approval> A copy of the FDA's letter to the applicant with notification that the drug is approved for marketing. If the product is approved under the Accelerated Approval Regulations further adequate and well-controlled studies to verify and describe clinical benefit are required and these commitments by the applicant will be outlined. If there are Phase 4 commitments specified in the submission, these will be listed. Other conditions such as submission of promotional materials and labeling may be specified.
<Letter of Acknowledgment> A copy of the FDA's letter to the applicant acknowledging receipt of the applicant's NDA submission.
<Labeling> A copy of either a draft of the labeling or the final approved labeling (package insert).
<Patent Information/Certification> Patents for the new drug that have been submitted are identified.
<Exclusivity Summary> An exclusivity determination is made for all original new drug applications. The summary outlines the decisions made by the FDA in determining the eligibility of the product for exclusivity. Exclusivity prevents the submission or effective approval of an abbreviated new drug application (ANDA) for the same drug during a period of three or five years.
<Drug Studies in Pediatric Patients> At the time a new molecular entity is approved by the FDA a "Drug Studies in Pediatric Patients" form is completed. The form classifies the status of pediatric drug studies into one of five areas: (1) the drug is specific for pediatric illnesses and adequate well-controlled studies in pediatric patients support this claim, (2) the drug labeling contains pediatric dosage information not based on pediatric studies and the sponsor requests a waiver of the requirement for studies in children, (3) pediatric studies should be done after approval as the drug has potential for pediatric use but is not expected to have widespread early pediatric use, (4) the drug has little potential for pediatric use and pediatric studies do not need to be encouraged, or (5) none of the above apply.
<Medical Officer's Review> The Medical Officer's Review (MOR) is perhaps the most clinically useful of all the scientific reviews. It frequently is the largest of the review sections. Introductory information about the drug and the commercial product is usually presented. Each of the controlled and uncontrolled clinical studies presented in the NDA is discussed. The clinical studies may be identified as pivotal or supporting in establishing the drug's safety and effectiveness claim. The objective, design, inclusion/exclusion criteria, treatment regimens, controls, results, and subgroup analyses for each study are discussed. The strengths and weaknesses of the safety and effectiveness evidence presented in the studies are considered. The MOR may summarize the safety and effectiveness data in relation to the drug's labeling and phase 4 commitments. The clinical studies presented in the SBA are frequently not published in the scientific literature.
|NDA Clinical Studies....not published elsewhere|
<Statistical Review & Evaluation> The study endpoints and statistical analysis for each of the controlled studies are described and evaluated. Both safety and efficacy analyses are considered.
<Chemistry, Manufacturing and Controls> Basic information about the drug and the drug product chemistry may be presented. Manufacturing methods and controls are considered trade secrets of the sponsor and are not included in the SBA.
<Center for Drug Evaluation Research Labeling and Nomenclature Committee> Nomenclature facts and recommendations may be included.
<Clinical Pharmacology/Biopharmaceutics> Biopharmaceutics may be discussed within the clinical pharmacology section or separately. Studies addressing human pharmacokinetics including absorption, distribution, excretion and metabolism of the product are discussed. Data from special populations may be presented. Drug interaction study data is reviewed. Analytic methods and dissolution may be included.
<Microbiologist's Review> Included if the drug is an antiinfective or antiviral agent. The biochemical mechanism of action of the compound or metabolites on the infective agent is considered. A description of the drug's antimicrobial spectrum of activity and relevant study data is given. Information on resistance may be known. Clinical laboratory methods needed for appropriate use of the drug are discussed.
<Pharmacokinetics Review> The pharmacokinetics of the new drug may be considered with clinical pharmacology or separately.
<Pharmacology and Toxicology> Nonclinical pharmacology and toxicology is reviewed here. Nonclinical pharmacokinetics, pharmacodynamic safety and toxicology studies are presented.
<Carcinogenicity Assessment> Data and information on the carcinogenicity potential of the compound may be included.
<Environmental Assessment and Findings of No Significant Impact> 1969 U.S. Federal legislation required all Federal agencies to consider the potential impact of their actions on human environmental quality. The environmental impact of the drug's manufacture, use and disposal is assessed. A Material Safety Data Sheet is included as part of this section. IDIS identifies the Material Safety Data Sheet separately so that it is easier to find in the document.
<Correspondence & Record of Telephone Conversations> Not all SBA documents contain this section.
|SBA abstract written by IDIS Pharmacist|
How can I easily use a document this size?
Summary Basis of Approval documents are large. They can approach 400 or 500 pages. IDIS has implemented several processing steps to improve the documents' ease of use. First a pharmacist organizes the document into sections and then constructs an index to each major section (Medical Officer's Review, Statistical Review, Clinical Pharmacology/Biopharmaceutics, Microbiologist's Review, Pharmacology and Toxicology). The index for each section is then combined with an overall Table of Contents for the SBA. The detailed Table of Contents is placed at the beginning of the SBA document. An abstract for the SBA is also written by the pharmacist. The abstract appears in the IDIS SYSTEM index record thus it is also free text searchable in the CD-ROM abstract field. The index abstract is an annotated Table of Contents for the SBA. In addition to outlining the contents of the SBA, the pharmacist also includes brief descriptions of each of the pivotal studies that appear in the SBA. By reviewing the SBA abstract as it appears in the IDIS index, the user can obtain a clear picture of the information contained in the SBA and where to find it. On the article microfiche, the detailed Table of Contents appears first and each section of the SBA is clearly identified with a header page.
Why is some information blocked out of the text, tables and graphs of the SBA?
Documents received from the FDA are now most frequently SBA equivalents a collection of reviews and documents from the FDA sections that reviewed the New Drug Application. These documents and reviews may contain information that is considered privileged or trade secrets by the sponsor. Under these circumstances the information can be censored. IDIS does identify these sections in the document and indicates with a stamp that the document has been redacted.
How do I find Summary Basis of Approvals in IDIS?
IDIS has added a new descriptor, 155 SUMMARY BASIS OF APPROVAL. Enter either 155 or any part of "SUMMARY BASIS OF APPROVAL" text in the Descriptor window of the CD-ROM field search screen. Microfiche subscribers will find the SBA under the drug's name in the drug index.
How often will Summary Basis of Approvals appear in IDIS?
Indexing of SBAs began with new molecular entities approved recently. To date we have received the SBAs for four of the seventeen drugs approved by the end of July. The lead time between approval and our receipt of the SBA has been as short as one month, but is generally three or more months.
Health care professionals will now have access via IDIS not only to data and conclusions from the pivotal and supporting studies for new drugs data that justified the drug's safety and therapeutic efficacy claims contained in studies that frequently are never published elsewhere but additionally to the observations, evaluations, comments and recommendations of the FDA scientific reviewers of the drug's New Drug Application.
Hazel H. Seaba, Director (email@example.com)
Anon. From test tube to patient: new drug development in the United States. An FDA CONSUMER Special Report, January 1988.
(FDA Therapeutic Classification)
|Valid IDIS DrugTerm|
|Valid IDIS Disease Term|
Modified ICD-9-CM Number
Ardeparin Sodium (1S)**|
|Prevention of deep venous thrombosis which may lead to pulmonary embolism following knee replacement surgery||Embolism/Thombosis, Vn NEC|
|Bromfenac Sodium (1S)|
|Indicated for the short-term (generally less than 10 days) management of pain||Pain NEC|
|Cerivastatin Sodium (1S)|
|Adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb)||Hypercholesterolemia, Pure|
|For treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy||Neop, MGN-Female Breast|
Disorder, Menopause/Post NEC
|Mibefradil Dihydrochloride (1S)|
|Hoffmann LaRoche Inc.|
|Treatment of hypertension and chronic stable angina pectoris||Hypertension|
|Pramipexole Dihydrochloride (1S)|
|Pharmacia & Upjohn|
|Treatment of the signs and symptoms of idiopathic Parkinson's Disease||Parkinson's Disease|
|For the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement and topical treatment of patients with facial acne vulgaris of mild to moderate severity||Psoriasis & Pityriasis NEC|
|Toremifene Citrate (1S)|
|Treatment of metastatic breast cancer in postmenopausal women with estrogen receptor-positive or receptor-unknown tumors||Neop, MGN-Female Breast|
Disorder, Menopause/Post NEC
|Urea, C-14 (1P)***|
|Tri Med Specialties Inc.|
CARBON C 14
|For use in the detection of gastric urease as an aid in the diagnosis of helicobacter pylori infection in the human stomach||Diag Test-Digest/BMR|
Infection, Helicobacter Pylori
NEW DRUG SELECTED BIBLIOGRAPHY
This new drug selected bibliography provides a selection of key clinical studies and reviews of new drugs approved by the FDA during May, June, and July, 1997. IDIS SYSTEM/CD-ROM was searched to retrieve key articles relevant to the new drugs and their approved uses.
Heit JA, Berkowitz SD, Bona R et al. Efficacy and safety of low molecular weight heparin (ardeparin sodium) compared to warfarin for the prevention of venous thromboembolism after total knee replacement surgery: a double-blind, dose-ranging study. Thromb Haemost 1997;77: 32-38. (IDIS Article Number 380054). A double-blind, randomized controlled trial in 860 patients that compared the efficacy and safety of three different subcutaneous doses of ardeparin sodium to adjusted-dose warfarin as venous thromboembolism prophylaxis after total knee replacement surgery.
Levine MN, Gent M, Hirsh J et al. Ardeparin (low-molecular-weight heparin) vs graduated compression stockings for the prevention of venous thromboembolism: a randomized trial in patients undergoing knee surgery. Arch Intern Med 1996;156:851-856. (IDIS Article Number 367510). A double-blind, randomized controlled trial that compared the combination of ardeparin and graduated compression stockings with graduated compression stockings alone in 246 patients undergoing major knee surgery.
Johnson GH, Van Wagoner JD, Brown J, Cooper SA. Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain. Clin Ther 1997;19:507-519. (IDIS Article Number 387687). A multicenter double-blind, randomized controlled trial that compared bromfenac (50 or 100mg) with acetaminophen 650mg/oxycodone 10mg, ibuprofen 400mg, and placebo in 238 patients who had pain due to abdominal gynecologic surgery.
Bostrom AAS, Forbes JA, Adolfsson C, et al. Evaluation of bromfenac and ibuprofen for pain after orthopedic surgery. Pharmacotherapy 1994;14:305-313. (IDIS Article Number 332579). A randomized, double-blind trial conducted to determine the relative analgesic potency and adverse effect liability of single dose bromfenac 25, 50, and 100 mg and ibuprofen 200 and 400 mg for postoperative pain after orthopedic surgery in 200 patients.
Carroll D, Frankland T, Nagle C et al. Oral bromfenac 10 and 25 mg compared with sublingual buprenorphine 0.2 and 0.4 mg for postoperative pain relief. Br J Anaesth 1993;71:814-817. (IDIS Article Number 323352). A randomized, double-blind study that compared single dose bromfenac with buprenorphine for the treatment of moderate or severe postoperative pain in 91 patients after general surgical or orthopedic operations.
Forbes JA, Beaver WT, Jones KF et al. Analgesic efficacy of bromfenac, ibuprofen, and aspirin in postoperative oral surgery pain. Clin Pharmacol Ther 1992;51:343-352. (IDIS Article Number 293946). A randomized, double-blind study that compared analgesic efficacy and adverse effect liability of single oral doses of 10, 25, 50, and 100 mg bromfenac with 650 mg aspirin, 400 mg ibuprofen and placebo in 280 patients with postoperative pain after oral surgery.
Mcquay HJ, Carroll D, Frankland T et al. Bromfenac, acetaminophen, and placebo in orthopedic postoperative pain. Clin Pharmacol Ther 1990;47:760-766. (IDIS Article Number 268717). A double-blind, randomized controlled trial that compared oral doses (5, 10, and 25 mg) of bromfenac with 100 mg acetaminophen and placebo for postoperative orthopedic pain in 158 patients.
Lipton A, Demers LM, Harvey HA et al. Letrozole (CGS 20267): a phase I study of a new potent oral aromatase inhibitor of breast cancer (erratum) (mn 355837). Cancer 1995;75: 2132-2138. (IDIS Article Number 345826). A report of a Phase I study of letrozole in 23 heavily pretreated postmenopausal patients with metastatic breast cancer.
Iveson TJ, Smith IE, Ahern J et al. Phase I study of the oral nonsteroidal aromatase inhibitor cgs 20267 in postmenopausal patients with advanced breast cancer. Cancer Res 1993;53:266-270. (IDIS Article Number 308191). A Phase I study of letrozole in 21 postmenopausal patients with advanced breast cancer.
Alpert JS, Kobrin I, Dequattro V et al. Additional antianginal and anti-ischemic efficacy of mibefradil in patients pretreated with a beta blocker for chronic stable angina pectoris. Am J Cardiol 1997;79:1025-1030. (IDIS Article Number 385355). A two week double-blind randomized controlled trial that assessed the safety, tolerability and efficacy of mibefradil when added to beta-blocker monotherapy in 205 patients with chronic stable angina pectoris.
Braun S, Van Der Wall EE, Emanuelsson H et al. Effects of a new calcium antagonist, mibefradil (Ro 40-5967), on silent ischemia in patients with stable chronic angina pectoris: a multicenter placebo-controlled study. J Am Coll Cardiol 1996;27:317-322. (IDIS Article Number 362642). A multicenter, double-blind, randomized, placebo-controlled study conducted to evaluate the effects of mibefradil on the frequency and duration of episodes of asymptomatic ischemia in 126 patients with stable angina pectoris and to determine the most efficient single therapeutic dose of the drug.
Schmitt R, Kleinbloesem CH, Belz GG et al. Hemodynamic and humoral effects of the novel calcium antagonist Ro 40-5967 in patients with hypertension. Clin Pharmacol Ther 1992;52:314-323. (IDIS Article Number 302464). A double-blind, randomized, placebo-controlled study conducted to assess the antihypertensive potential of different doses of mibefradil in 64 hypertensive patients and to investigate its duration of action.
Kieburtz K, Shoulson I, Mcdermott M et al. Safety and efficacy of pramipexole in early Parkinson disease: a randomized dose-ranging study. JAMA 1997;278:125-130. (IDIS Article Number 388331). A multicenter, multidosage, parallel-group, double-blind, placebo controlled, randomized trial that evaluated dose-response relationships for tolerability, safety, and efficacy of pramipexole in 264 patients with early Parkinson's disease who were not requiring or receiving levodopa or other dopamine agonists.
Lieberman A, Ranhosky A, Korts D. Clinical evaluation of pramipexole in advanced Parkinson's disease: results of a double-blind, placebo-controlled, parallel-group study. Neurology 1997;49: 162-168. (IDIS Article Number 388119). A 32 week, double-blind, placebo-controlled, randomized, multicenter study, followed by an open-label extension trial, that compared the efficacy, safety and tolerability of pramipexole with that of placebo in 291 patients with advanced Parkinson's disease.
Weinstein GD. Safety, efficacy and duration of therapeutic effect of tazarotene used in the treatment of plaque psoriasis. Br J Dermatol 1996;135:32-36. (IDIS Article Number 374856). A pivotal multicenter, double-blind, randomized controlled trial that evaluated the efficacy of topical tazarotene in 324 patients with mild-to-moderate plaque psoriasis.
Hayes DF, Van Zyl JA, Hacking A et al. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol 1995;13: 2556-2566. (IDIS Article Number 356136). An international, multicenter, randomized study that compared the efficacy and toxicity of tamoxifen (20mg/d) and two separate doses of toremifene (60 mg/d and 200 mg/d) in 648 postmenopausal patients with hormone receptor-positive or-unknown metastatic breast cancer.
Urea, Carbon C-14
Faigel DO, Childs M, Furth EE et al. New noninvasive tests for helicobacter pylori gastritis: comparison with tissue-based gold standard. Dig Dis Sci 1996;41:740-748. (IDIS Article Number 366174). A study that compared the current gold standard for diagnosing H. Pylori gastritis (antral biopsy for urease test and/or histology) to the new low-dose capsule-based 1 microCi [14C] urea breath test and a rapid serum test for anti-H. pylori antibodies in 50 consecutive patients undergoing upper endoscopy.
Peura DA, Pambianco DJ, Dye KR et al. Microdose 14C-urea breath test offers diagnosis of helicobacter pylori in 10 minutes. Am J Gastroenterol 1996;91:233-238. (IDIS Article Number 364051). In a prospective blinded study, 200 fasted patients were breath-tested before elective outpatient endoscopy to evaluate the microdose 14C-urea breath test capsule in a gastroenterology outpatient setting, to determine the diagnostic ranges of the 14C-urea breath test for H pylori positive and negative patients, and to define the sensitivity and specificity of the test.
Ruth Calloway, R.Ph., M.S.
Renewal materials for the 1998 IDIS database subscription were mailed in early September. We ask that you respond as soon as possible. Your current subscription will expire after the December 1997 Update. To avoid interruption of service your renewal must be received in our office by January 12, 1998. Current microfilm subscribers should note a special conversion offer included with their renewal materials. In the event you misplace or fail to receive a renewal form, please contact our office as soon as possible.
As secondary indexing terms, IDIS descriptors aid searchers by specifically identifying the type of information to be found in an article. Three new clinically relevant and valuable descriptors have been added to the IDIS database. They are as follows:
|155 SUMMARY BASIS OF APPROVAL|
The entire FDA Summary Basis of Approval (SBA) Equivalent document (with redactions) for a new drug is indexed and microfilmed. The abstract on the index record for these documents contains a table of contents of the different sections included in the SBA equivalent. The abstract also includes an overview of the clinical trials performed during the approval process. On the microfiched article, a more complete table of contents precedes each section. For a better understanding of the significance of this information, search with descriptor 155 and view the results for yourself.
|156 PRACTICE GUIDELINE|
We are in the process of reindexing close to 2,000 articles in which this new descriptor is applicable. Until this project is complete, title searches with keywords (e.g. consensus, guidelines etc...) is advised. Previously, many of these articles were indexed with the disease term V84. CLINICAL ALGORITHM. We felt that this topic area would be better classified as a descriptor term than a disease term. Consequently, V84. CLINICAL ALGORITHM is no longer a valid term. The best way to utilize this new descriptor is in combination with a disease term (e.g. 401. HYPERTENSION and 156 PRACTICE GUIDELINE).
|157 PATIENT EDUCATION|
This descriptor was added to retrieve articles in which pharmacist or healthcare provider intervention through patient education influenced therapeutic results. Combining this descriptor with drug and/or disease terms is the most effective way to use this descriptor.
Through our twice monthly Quality Assurance/Quality Improvement meetings, we are continually looking at ways to better provide subscribers with the information they need. If there are topic areas or information you have difficulty finding or have ideas for other descriptors, please contact us. Subscriber feedback and input are always welcomed and encouraged.
Brad Gilchrist, R.Ph.
Georgia World Congress Center
December 7-11, 1997
Journals -- Valid Terms and Journal List
When searching in the journal field of the field search template entering American Journal of Health-System Pharmacy, no records are found. Why?
Searching the journal field in the Field Search template requires valid terms. The reason you found no records is that the complete journal title name is not a valid term. The journals valid terms are modified National Library of Medicine abbreviations. To find the IDIS journal valid terms, press <F3>, select Search and choose the journal list option. The journal search template will appear on the screen. Type in the name of the journal or use the asterisk sign (*) to truncate the term and than press ENTER.
The entry for the journal American Journal of Health-System Pharmacy appears below:
AM J HEALTH-SYST PHARM
American Journal of Health-System Pharmacy (1995-)
Formerly Under: American Journal of Hospital Pharmacy
AM J HOSP PHARM
American Journal of Hospital Pharmacy (1966-1994)
Title Changed to: American Journal of Health-System Pharmacy
The current journal title entry is listed first. The journal valid term (abbreviation) is included on the first line. The second line is the complete name of the journal and the date the journal was added in the parenthesis. Journals that include a dash following the beginning year indicate that the journal is currently indexed in IDIS. Title changes are indicated by Formerly Under. The second journal entry information relates to the previous title. For this example to search articles prior to 1995 you will need to search under the prior valid term which is AM J HOSP PHARM.
How can I find a current list of the IDIS journals?
The current list of journals indexed by IDIS arranged by class is included in the help section. To view the list select <F1> Help. The Table of Contents is already highlighted. Press ENTER to select. Press <Pg Dn> to go to the second page of the Table of Contents that includes the journal list option. Arrow down to the journal list and press ENTER to select.
After you select the journal list menu option, you will find general information on the IDIS journal list and its title searching. The third help screen contains information on IDIS journal citations and includes how supplement issues are cited for searching the bibliographic information. The IDIS journal list is arranged alphabetically by category included on pages 4-30 of the help screens.
The IDIS journal list covers more than 200 journals representing a broad range of pharmacy and medical topics. Approximately 72% of the titles are U.S. publications with the balance from international publishers. The most recent addition to the journal list is the FDA SUMMARY BASIS OF APPROVAL. The journal list is continually being evaluated to broaden our coverage to meet subscriber needs. If you have any journal suggestions or comments please contact IDIS and the suggestions will be reviewed.
Mary Ann Cull, R.Ph.
Wendie Vanette joined DDIS in April of 1997. She offers a support system for the accounting division and to the directors of IDIS and IDIN as well. Some of her duties include processing university purchases, ordering supplies for the division, filing subscriber and non-subscriber contacts and information, and retrieving journal articles from the libraries as requested.
Wendie graduated from Manchester College, North Manchester, Indiana, in May of 1996 with a B.S. in Biology/Chemistry and a minor in Psychology. She came to Iowa City in May of 1996 when she entered the Physician Assistant Program at The University of Iowa, which she was a part of for 7 months. She enjoys working with children and is in charge of the after school program at a local day care. She also enjoys her new addition to the family, Alex The Cat, along with outdoor activities, and watching movies. Wendie and her husband, Jason, travel quite frequently to Indiana to spend time with family and friends.
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