Medical Foods Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

Medical Foods Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

August 31, 2013 FDA Attempting to Restrict Medical Foods

by Alliance for Natural Health
Want to manage your diabetes this way? FDA says no. Action Alert! 
“Medical foods,” by federal definition, aren’t simply a diet plan prescribed by a doctor. They are foods that are specifically formulated and processed for a sick patient. They form a separate category from conventional foods and dietary supplements in that they are intended to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. These foods can be consumed orally or through a feeding tube.
Medical foods do not require FDA premarket approval. Manufacturers of such foods can make disease claims, which means they are exempt from the labeling requirement for health claims with its demand for random controlled trials. Medical foods do, however, have to follow current good manufacturing practices (cGMPs), facility registration, and other normal safety requirements.
The FDA has just issued an updated draft guidance on medical foods, and this new version drastically limits the number of medical conditions that medical foods can be used to manage. The guidance now uses “inborn errors of metabolism” (IEMs) to determine which diseases or conditions are included on the list. For example, inherited biochemical disorders in which absence of an enzyme interferes with the metabolism of protein, fats, or carbohydrates would be treatable with medical foods. The guidance excludes diseases resulting from essential nutrient deficiencies like scurvy and pellagra.
Outrageously, the guidance specifically excludes diabetes—both type 1 and type 2, as well as gestational diabetes—because, according to the FDA, diabetes can be controlled by simply managing or tweaking one’s normal diet (along with taking FDA-approved drugs, of course). According to the FDA, type 1 diabetics should use carbohydrate counting or the carbohydrate exchange system to match their insulin dose to their carbohydrate intake. And type 2 diabetes patients should simply restrict calories, eat regularly, increase fiber intake, and limit their intake of refined carbohydrates and saturated fats—in addition to taking prescribed drugs.
This is consistent with the usual FDA stance, which wants there to be as little competition as possible for approved drugs. By contrast, nearly all integrative physicians and even many conventional doctors would argue that diabetes requires very aggressive nutritional intervention, and medical foods can be a vital part of the treatment plan.
Merely tweaking one’s normal diet is not sufficient to provide enough nutrients to correct the condition. Leaving aside our nutrient-depleted soil, there’s the fact that many (or even most) people have extremely poor eating habits. Perhaps it’s because they haven’t been clearly taught about a proper diet for their disease, or perhaps they lack the discipline required to monitor their eating so carefully. Whatever the reason, making a few changes to the standard American diet will almost certainly not be enough to manage conditions like diabetes or nutrient-deficient diseases, whereas medical foods may.
For example, this ingredient list for the medical food for diabetes provides many of the essential nutrients required—including a number of specific vitamins, cinnamon, and plant sterols—all of which are essential toward managing diabetes.
Another problem with the FDA’s guidance is that since medical foods are, by definition, administered under medical supervision, the patient’s physician is fully qualified to decide whether the medical food is required or not. The FDA doesn’t need to override doctors’ judgment and tell them what’s necessary for their patient! Yes, doctors are often remarkably lacking in nutrition knowledge. But if so, the FDA is even more lacking.
Besides, medical foods can be used in addition to an overall treatment plan. We should therefore be encouraging consumer access to as many treatment options as possible. By narrowly limiting the conditions that medical foods can be used for, FDA is reducing patient access to nutritional interventions for disease—something the FDA seems to be doing on a regular basis. Famed health and constitutional law firm Emord & Associates put it this way:
The problem with FDA’s approach is that it eliminates beneficial products from the marketplace, requiring them to either proceed through the drug approval process or be marketed as dietary supplements with limited structure/function claims, thus depriving consumers of valuable information that can improve their health. Although some diseases and conditions that have special nutritional requirements can be managed through diet modifications alone, not all consumers are willing or able to make drastic diet modifications. If FDA’s new position stands, companies could resort to the DSHEA’s health claims provisions to spread information concerning a nutrient’s relationship with certain disease states.
We expect to see some serious pushback from manufacturers on this guidance. Several companies, such as Abbott Labs and Metagenics, are either manufacturing ingredients aimed at medical foods for diabetes, or have complete medical food products already on the market. As one spokesperson put it, “They are drawing a line in the sand which, especially in regard to diabetes, might not be that easy. This is more of a physician question; what if a patient is trying to modify their diet and it’s not working?”
Action Alert! Tell FDA they need to broaden their list of diseases and conditions for which medical foods may be administered, not restrict it! Especially let them know that diabetes patients need this kind of targeted nutrition therapy, and merely tweaking their regular diet is not enough. What we need are better medical foods, not the elimination of them. Another good idea would be to let supplement companies make medical foods, rather than just drug and medical products companies. Please send FDA your comments today!

Sept. 2, 2013 | Vol. 45 No. 34 FDA Warns Florida Compounder About Prescriptions, Contamination The FDA has warned a specialty pharmacy in Florida for compounding drugs without prescriptions, a key point in the agency’s push for more compounding oversight powers.

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How Congress Encourages Shortages Of Cancer Drugs

Source: Forbes, Aug 31 2013, 8:42am CDT

US Secretary of Health and Human Services Kathleen Sebelius (R) speaks alongside Food and Drug Administration (FDA) Commissioner Margaret Hamburg during the Daily Press Briefing in the Brady Briefing Room of the White House (Image credit: AFP/Gett ...
Continue reading on: Forbes

The State of Nebraska State Medicaid had stopped covering compounded medications in January 2011

January 2011

Compounded Prescriptions with APIs and Excipients

An API is a bulk drug substance, which is defined by the FDA as any substance that is represented for use as a drug and that, when used in the manufacturing, processing or packaging of a drug, becomes an active ingredient of the drug product. APIs may be included in extemporaneously compounded prescriptions and may serve as the active drug component in a compounded formulation.
State Medicaid programs have been informed by the Centers for Medicare & Medicaid Services (CMS) that many active pharmaceutical ingredients (APIs) and excipients used in compounding do not meet the definition of a covered outpatient drug as defined in section 1927(k)(2) of the Social Security Act and effective January 1, 2011, are not eligible for coverage as drugs in Medicaid programs. Therefore, Nebraska Medicaid will no longer cover such products for dates of service on and after January 1, 2011.
Lists of APIs and excipients identified in the Medicaid Drug Rebate system are posted on the CMS website at http://www.cms.gov/Reimbursement/02_Spotlight.asp. Please note that these are not definitive lists and additional products will be added as they are identified.
If you are treating a recipient who is currently receiving a prescription containing one of the APIs or excipients to be deleted, you must identify an alternative therapy that meets the definition of a covered outpatient drug and is eligible under the federal drug rebate program. Information regarding products covered by NE Medicaid can be found on the Drug Lookup posted at https://nebraska.fhsc.com.

If you have any questions regarding this bulletin please contact Barbara Mart, R.P., Pharmacy Consultant, at (402) 471-9301 or barbara.mart@nebraska.gov

quoted from here

Important!! WAFDO 2013 Annual Educational Conference Compounding Pharmacies Panel Presentations Are Now Available (Includes Presentations from FDA and on Iowa Inspections)

Compounding Pharmacies Panel Contracting with the National BOP for Audits of Pharmacies that Compound Drugs -- Nancy Tay, Accreditation Director National Association of Boards of Pharmacy FDA Interactions with National BOPs Audits of Compounding Pharmacies -- Dennis Baker, FDA Regional Food and Drug Director, Southwest Region Veterinary Drug Compounding -- Miriam Burbach, FDA Director of Compliance, SEADO

Tay Presentation Baker Presentation Burbach Presentation

Video: When are compounded drugs appropriate? Mar 7, 2013 By: Dawn Merton Boothe, DVM, MS, PhD, DACVIM, DACVCP VETERINARY MEDICINE

view video here

Journal Scan: How reliable are compounded trilostane products?

Oct 8, 2012 By: Jennifer L. Garcia, DVM, DACVIM VETERINARY MEDICINE

What they did
Researchers evaluated 96 batches of compounded trilostane capsules in 15-, 45-, and 100-mg sizes purchased from eight different pharmacies. These were compared with 15-mg capsules made with the licensed product, capsules containing inert materials, and proprietary capsules in 30- and 60-mg sizes. All capsules were analyzed for content and dissolution characteristics and compared with the specifications for the licensed product.
What they found
There was a wide variability in drug content among the compounded trilostane batches—39% to 152.6% of label claim—compared with the variance for the controls, which was 96.1% to 99.6%. The average dissolution rate of the compounded batches was also lower than for the controls—76% vs. 85%, respectively.
Take-home message
The wide variability in content and the dissolution rates of compounded trilostane products may compromise effective management of patients being treated for hyperadrenocorticism. Patients may be overdosed or underdosed when these products are used, which may prompt owners to discontinue therapy and negatively impact patient care. If nonapproved capsule sizes are required, it is important clinicians be aware of the source of the trilostane being used.
Cook AK, Nieuwoudt CD, Longhofer SL. Pharmaceutical evaluation of compounded trilostane products. J Am Anim Hosp Assoc 2012;48(4):228-233.

Linke to abstract: http://www.jaaha.org/content/48/4/228.abstract?sid=573668c4-d209-47fb-bff5-3b8d48d12d39

Journal Scan: One month later... Effects of storage on compounded doxycycline Aug 19, 2013 By: Jennifer L. Garcia, DVM, DACVIM VETERINARY MEDICINE

Why they did it
This study sought to determine whether doxycycline suspension made from doxycycline tablets maintains the appropriate concentration after storage for four weeks.
What they did
The researchers made a suspension by mixing crushed 100-mg film-coated doxycycline hyclate tablets with a 50:50 mixture of syrup and suspension vehicles, which met the compendial requirements of the U.S. Pharmacopeia (USP) National Formulary. Two formulations were prepared (33.3 mg/ml and 166.7 ml/ml), and three batches of each strength were made and stored at either room temperature (71.6 to 78.8 F [22 to 26 C]) or a controlled cold temperature (refrigerated 35.6 to 46.4 F [2 to 8 C]). All preparations were protected from light.
Researchers measured doxycycline concentrations in all formulations at day 0 (date of preparation) and at days 1, 4, 7, 14, 21, and 28. The concentration was compared to a reference standard from the USP.
What they found
While concentrations remained within 90% to 110% of the reference standard for the first week, these levels dropped to < 20% by week 2 and remained at this level throughout (range = 14% to 18%). Storage temperature did not appear to have an effect on the loss of concentration. After seven days of storage, the quality of the formulations also diminished as noted by changes in consistency, visible separation of phases noted in the bottle, and a dark-brown band that appeared near the bottom of the bottle.
Take-home message
Use of compounded doxycycline beyond seven days may not be effective. Veterinarians should be cautious when using compounded medications and be sure to prescribe and dispense these medications in accordance with federal and state regulations.
Papich MG, Davidson GS, Fortier LA. Doxycycline concentration over time after storage in a compounded veterinary preparation. J Am Vet Med Assoc 2013;242(12):1674-1678.
Link to abstract: http://avmajournals.avma.org/doi/abs/10.2460/javma.242.12.1674

IACP List Donors and Amounts --Note on Website Reference Senate Bill 959

Thank you to the following for contributing to IACP:

$50,000 plus
Eric Vidrine  *
$25,000 to $50,000 
David Sparks  *
Ernest Gates  
Charles Leiter  
Chris Schulte  *
Kate James  *
Jerrod Roberts  *
$10,000 to $25,000      
Denise Orwick  
Wade Siefert  *
HeeJoo Park  *
Topi-Click Topical Dosing Applicator   
Denise Burnham  *
Gary McCrory  *
David J. Miller  *
Constance Hegerfeld  
David M. Smith  
Sam Pratt  
Scott Karolchyk  
$5,000 to $10,000      
Larry Curtis  *
Kipp Ladd  *
Georgia Pharmacy Assn - AIP  
Georgia Pharmacy Association  
Eddie Glover  
Dave Hill  *
Kevin Borg  *
Matt Buderer  *
Thomas Marks  
Mark Acker  
Marshall Tobin  
Richard Brisson  
Scott Popyk  
Rakesh Patel  
$2,500 to $5,000    
Dale Coker  *
William Beckman  
Jeffery Bray  *
Jeffrey Alan Barris  *
Kenny Walkup  *
Matthew Martin  *
Steve Pressman  *
Joseph Rossetti  
Alan Martin  
Dana Reed-Kane  *