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PATHWAY TO NEW PRODUCTS. The FDA The Biotechnology Company Life Cycle Adapted in part from FDA Test tube to Patient Regulation of the Product. FDA Regulates the Industry. Traditional Expectations: drugs are effective and safe. high quality. Generic -prices reasonable.
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PATHWAY TO NEW PRODUCTS The FDA The Biotechnology Company Life Cycle Adapted in part from FDA Test tube to Patient Regulation of the Product
FDA Regulates the Industry • Traditional Expectations: • drugs are effective and safe. • high quality. • Generic -prices reasonable. • All advertising informative • Evolving Expectations : • access to investigational drugs. • High-quality information for groups • protect human subjects
Before the FDA • Upton Sinclair “The Jungle” • Published only in magazines (newspapers were worried about advertising revenues MILESTONE: Food Drug and Cosmetic Act (FD&C Act) of 1906 a labeling law! Not safety and efficacy In 1927 Food and Drug Administration (FDA)-enforce food and drug laws. 1938-Safety and studies
Milestone in 1962Kefauver-Harris Drug Amendments to the FDCA • testing in animals before humans • Required clinical trial supervision and informed consent • Required proven EFFICACY • Required reporting of adverse events • Gave FDA authority to regulate advertising
The Regulatory Agencies The USDA (US Dept. of Agriculture regulates plant pests, plants, and veterinary biologics. The EPA (Environmental Protection Agency) regulates microbial and plant pesticides, new uses of existing pesticides and novel organisms. The FDA are responsible for food, feed additives, veterinary drugs, human drugs and medical devices. Recombinant DNA Advisory Committee: Safety of Genetically Manipulated Material
The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective Drug Review Steps • Preclinical (animal) testing. • An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials. • Phase 1 studies (typically involve 20 to 80 people). • Phase 2 studies (typically involve a few dozen to about 300 people). • Phase 3 studies (typically involve several hundred to about 3,000 people). • The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet. • Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. • After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. • If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness. • The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug). • The FDA inspects the facilities where the drug will be manufactured as part of the approval process. • FDA reviewers will approve the application or find it either "approvable" or "not approvable."
NDA Contents • The contents of the NDA include: • Pre-clinical • Clinical • Descriptions of proposed wording for package insert and labeling • Index; • Summary; • Chemistry, manufacturing and control (CMC) information • Samples, Methods Validation Package, and Labeling; • Human Pharmacokinetics and Bioavailability; • Microbiology (for anti-microbial drugs only);
FDA Requires cGMP ManufacturingWhy? To insure what you sell is the same as what you tested (Phase 3)
Man Materials THE PROCESS (something happens here) Machine Output Methods Environment cGMP: Control the Process The process is inextricably linked to the people that use the materials that go into it, the equipment that's involved, the procedures and settings that are defined, and all the attendant environmental conditions that are present during the process.
The Quality Unit cGMPInsure it’s the Same as in Phase 3 • Includes QA and QC • Maintains the records that prove that you • Say what you do =SOPs, • Do What you say=Quality Products Pass Tests • Can Prove it=Document It! • Have Processes to Manage Inevitable Change CAPA (Corrective and Preventative Action)
And How Do They Know its the Same as Phase 3? Audits • Internal audits • Supplier/customer audits • Regulatory audits—FDA, EMEA, etc. FDA cGMP Inspections • Pre-Approval inspection (PAI) • Biennial inspection. • Full inspection: • Abbreviated inspection
To Meet the Federal Regulations21CFR 210 and 211 The Biotech Company must Prove that their Product Safety and Efficacy-Clinical Trials Then there needed to be control on the processes used to make sure the products have ongoing: • Safety • Efficacy • cGMP Good Manufacturing Practices
GMP Simplified! • say what you do • do what you say • document it Or.. If you didn’t write it down… you didn’t do it!
Handy List of Good Documentation Practicesadapted from M. Fino MiraCosta Biotech • Follow directions as written • Document everything thoroughly and completely. Use black or blue ink – follow your company’s procedure. Pencil = not okay • Write clearly and legibly • If you deviate from a documented procedure, write it down and let the supervisor know ASAP • Do not prerecord information • Fill in all the blanks. If necessary, write “NA”, your initials, and the date • To make a correction, draw a line through it once (so you can still read the original remark) clearly write the correction, initial, and date your entry. • Any non-self-explanatory corrections should be explained in a Comments section • Record data upon receiving them. Do not wait until the end of a shift or lunch to record information. • Record data directly onto the approved form, batch record, or log book. • Do not write data on stick notes, scratch paper, etc. • Use the most recent version of a form. Do not stockpile personal copies of SOPs or forms – they will change frequently • Follow your company’s dating preference: • In the US, 6/10/02 is interpreted as June 10, 2002 but in Europe, the same abbreviation is October 6, 2002
Summary: Pathway to Products • Producing a regulated product is risky • You need a sound ‘concept’, a successful ‘trial’, and a good ‘process’. And and good management to get you to the goal without running out of $$. • Consequences of Not Doing So are $$$$$ Adapted in part from FDA Test tube to Patient Intellectual Property to Protect Your Product and Process is also required!
