4. fda.pptx by dr mugudde nuru pharmaceutics

FDA

1. The American food and drug Authority Dr. NURU MUGIDE

2. FDA The  Food and Drug Administration  ( FDA  or  USFDA ) is a  federal agency  of the  United States Department of Health and Human Services , one of the  United States federal executive departments . The FDA is responsible for protecting and promoting  public health  through the control and supervision of  food safety ,  tobacco  products,  dietary supplements ,  prescription  and  over-the-counter   pharmaceutical drugs  (medications),  vaccines ,  biopharmaceuticals ,  blood transfusions ,  medical devices ,  electromagnetic radiation  emitting devices (ERED), cosmetics,  animal foods & feed [4]  and  veterinary products .

3. Regulatory body that governs testing and marketing of new therapeutic drugs, food, medical devices and procedures Establishes guidelines for how drugs should be tested in animal studies, as well as clinical trials Shares responsibility with clinicians and drug company

4. The FDA also enforces other laws, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household  pets  to  sperm donation  for  assisted reproduction .

5. FDA Mission Foods are safe, wholesome, sanitary and properly labeled Human and veterinary drugs are safe and effective Safety of devices intended for human use Public health and safety are protected from radiation Cosmetics safe and properly labeled

6. History 1906 Food and Drug Act regulates food, drugs and cosmetics ensure proper labeling and product unadulterated NOT DRUG SAFTEY 1927 Establish Food and Drug Administration 1933 FDA sought to revise laws to include safety eyelash dye- caused blindness cream- mercury poisoning weight loss drugs - death 1938 Revised Food, Drug and Cosmetic Act passed included drug safety (animal and clinical studies) and efficacy

7. Sulfanilamide Antibiotic Sold by Massengill Pill solubilized in diethylene glycol ELIXIR 350 poisonings, 100 deaths Pulled from shelves because mislabeled - NOT an elixir Massengill not held responsible for poisoning

8. New drugs receive extensive scrutiny before FDA approval in a process called a  new drug application  (NDA ). Critics , however, argue that the FDA standards are not sufficiently rigorous, allowing unsafe or ineffective drugs to be approved .  A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed".

9. Issues Should drugs be available prior to completion of testing ? HIV Needs of few vs many Cancer How Safe should drug be? Risk assessment Risk vs Reward Short term effects Long-term effects (withdrawal of a drug) Education of patient

10. Where does FDA look for Safety? 1 . During Pre-Clinical Studies lab and animal studies 2 . Clinical Trials 3 . During NDA review 4 . Post-Marketing

11. Orphan Drug Act Two incentives 1) 7- year period of market exclusivity following approval of drug by FDA 2) 50 tax credit for clinical research expenses Orphan diseases affect less than 200,000 patients No cure or treatment Difficult to get patients for clinical trials

12. What does FDA Recognition Mean for Regulatory Boards? The US Food & Drug Administration approves marketing claims , not use Medical devices (CDHR) Dietary supplements (ONPLDS) Also other areas not generally applicable to chiropractic regulatory boards Approving USE of devices & supplements is a regulatory board decision But involves truthful marketing claims

13. What does FDA Recognition Mean for Regulatory Boards? FDA does not actually inspect devices FDA reviews the application materials provided Should the device be allowed to be marketed for the purpose claimed?

14. Dietary Supplements

15. Dietary Supplements Regulated by FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement Health and Education Act of 1994 (DSHEA) Manufacturer is responsible for safety before marketed FDA takes action against unsafe products after they reach the market

16. Dietary Supplements Generally, manufacturers do not need to register products with FDA nor get FDA approval before producing or selling Manufacturers must ensure product label information is truthful and not misleading Not required to report injuries or illnesses that may be related to products

17. Dietary Supplements FDA monitors safety Voluntary dietary supplement adverse event reporting Product information Labeling Claims Package inserts & literature Federal Trade Commission regulates dietary supplement advertising

18. FDA Oversight – via 3 Acts 1990 Nutrition Labeling and Education Act (NLEA) FDA issues regulations after careful review of scientific evidence submitted in health claim petitions 1997 Food and Drug Administration Modernization Act (FDAMA) Health claims based on authoritative statement of scientific body of the U.S. government or National Academy of Sciences Such claims used after submitting notification to FDA 2003 FDA Consumer Health Information for Better Nutrition Initiative Health claims where quality and strength of scientific evidence falls below that required for FDA to issue authorizing regulation

19. What is a Dietary Supplement? Vitamin Mineral Herb or other botanical Amino acid Dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or Concentrate, metabolite, constituent or extract

20. Dietary Supplements There is no list of FDA approved dietary supplements for boards to check Boards should understand the three types of claims that manufacturers can make legally Health Nutrient Content Structure / Function

21. What is a Health Claim? Describes a relationship between dietary supplement ingredient , and reducing risk of a disease or health-related condition

22. What is a Nutrient Content Claim? Describes the level of a nutrient or dietary substance in the product Such as free , high , and low , or Compares the level of a nutrient in a food to that of another food Such as more , reduced , and lite

23. What is a Structure / Function Claim? Describes the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans "calcium builds strong bones" OR Characterizes the means by which it acts to maintain such structure or function "fiber maintains bowel regularity" or "antioxidants maintain cell integrity" OR describes general well-being from consumption of a nutrient or dietary ingredient OR describes a benefit related to a nutrient deficiency disease (like vitamin C and scurvy) Provided the statement also tells how widespread such a disease is in USA

24. Structure / Function Claims Must be accurate and truthful, not misleading Claims are not pre-approved by FDA Must include "disclaimer" that FDA has not evaluated the claim Disclaimer must also state that it is not intended to "diagnose, treat, cure or prevent any disease" because only a drug can legally make such a claim Must notify FDA within 30 days of marketing if making structure / function claims

25. Off-Label Uses

26. Off-Label Uses Botox example 1989: FDA approved for facial neurological movement disorders 2002: FDA approved to combat wrinkles and excessive underarm sweating Currently, FDA approved for both cosmetic and therapeutic uses Until 2002, it wasn’t illegal from FDA to use Botox for wrinkles but it was prohibited to advertise it for wrinkles

27. Off-Label Uses Decisions about Off Label USES are up to licensing boards To support off-label use: boards should look for a substantial body of Evidence; or Tradition; or Authority

28. Over the Counter Drugs

29. Over the Counter Drugs: FDA definition Drugs that do NOT require a doctor's prescription Bought off-the-shelf in stores Regulated by FDA through OTC Drug monographs “Recipe book" covering acceptable ingredients, doses, formulations, and labeling Products conforming to monographs may be marketed without further FDA clearance Non-conforming products must undergo separate review and approval through the "New Drug Approval System"