1. Regulatory Big Brother of Biotechnology

2. Role of FDA FDA was designed to promote and protect the public’s health Food and Drug Cosmetic Act first passed in 1906 to prevent the sale of unacceptable food and drugs How do they know when a drug is safe for use?

3. Role of FDA Minimum requirement for release of a drug is that it has to safe and effective –There are always risks and side effects The FDA has to determine when the benefits out weigh the risks –Vaccines and life threatening diseases –Clinical trials: when is enough enough? Thalidomide incident

4. Center for Drug Evaluation & Research CDER Group which assures the safety and effectiveness of drugs available in the U.S. Monitors for adulterated or contaminated drugs –Adulterated: drug or food produced by methods which do not conform to cGMP

5. Center for Biologics Evaluation and Research CBER Reviews applications for new biologics produced from microbes and viruses –Examples: vaccines, allergens, monoclonal antibodies Regulates all aspects of the process from mfg. to QC, to labeling and advertising

6. Center for Devices & Radiologic Health CDRH Regulates medical devices and some in vitro diagnostic kits Examples of devices: –Pace maker, ultrasonic cleaners for cleaning medical instruments, insulin monitors, thermometers Examples of in vitro diagnostic kits –CK-MB kits

7. Center for Food Safety & Applied Nutrition Protects and promotes health & economic interests by ensuring that foods are safe, nutritious, and honestly labeled Also oversees cosmetics

8. Does the FDA oversee Blood Donations? Yes, they do What testing or procedures do they require? –Donor screening: medical history –Blood testing: for HIV, Hep, Syphilis, etc –QC SOPs for drawing, testing, processing, inventory control and lot traceability

9. FDA Actions Facility Inspections 483: inspector’s note documenting a deficiency –Not following procedure –Incomplete records Warning letter: written letter citing cGMP violations. Requires a written response of corrective actions to be implemented.

10. FDA Actions If a company does not comply with FDA requests the FDA can do any and all of the following: –Take the product(s) off of the market –Sue and or arrest executives –Detain imports / exports FDA cannot do nothing when they know there are issues at a company