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Download FDA Legal and Regulatory Strategies for Start-up
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FDA Legal & Regulatory Considerations for Biomedical Startups Tech Coast Angels San Diego, California March 7, 2003 FDACounsel.com Michael A. Swit, Esq. Michael A. Swit, Esq. Law Offices of Michael A. Swit 539 Samuel Ct. Encinitas, CA 92024 760-815-4762; fax: 760-454-2979 [email protected] FDACounsel.com Establish FDA Strategy Early!! Some considerations follow . . . FDACounsel.com FDA's Three Key Development Roles: "Gatekeeper" to the marketplace -the new drug approval process "Cop on the beat" or "Enforcer" -ensuring quality compliance via inspection and enforcement actions (e.g. criminal charges) "Sentinel" of Safety Concerns - during development and post-approval FDACounsel.com The Approval Gate … Preliminary Considerations -Determining the Regulatory Status of the product Is it a "drug", "device" or "biologic"? Drug: FDACounsel.com described in USP or intended (via labeling) to affect the body of man or other animals to be used in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals The Approval Gate … Regulatory Status of the product con'd… Is it a "drug", "device" or "biologic"? Device: defined as involving: "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or "similar or related article including any component, part or accessory." FDACounsel.com in USP/NF or intended to be used in diagnosis … cure, mitigation, treatment or prevention of disease or other conditions intended to affect the body of man The Approval Gate … Regulatory Status of the product con'd… Is it a "drug", "device" or "biologic"? Thus -- device definition can capture products that resemble drugs if they do not achieve their result via being metabolized in the body or via chemical action within or on the body -- regulated by FDA Center for Devices & Radiological Health (CDRH) Examples of "drug-like" devices: FDACounsel.com Ultrasound contrast media Contact lens solutions The Approval Gate … Regulatory Status of the product con'd… Is it a "drug", "device" or "biologic"? Biologic - FDACounsel.com Generally, if derived from human or animal tissue; used to be regulated by FDA Center for Biologics (CBER) using approval standards similar to CDER therapeutic biotech products going to CDER vaccines – remain behind NOTE: "true" biotech products usually are biologics The Approval Gate … Regulatory Status of the product con'd… Is it a "drug", "device" or "biologic"? OR BOTH?? "Combination" or "hybrid" products - FDACounsel.com are regulated per their "primary mode of action" -but this may be difficult to discern -- get clarification very early as will impact FDA Center you deal with can request in writing -- under FDAMA § 416, FDA can't later change its mind w/o your consent or public health reasons exist The Approval Gate … Regulatory Status of the product con'd… What type of submission is needed to get FDA approval or clearance? Drugs: Full New Drug Application (NDA) 505(b)(2) NDA or "Paper NDA" Abbreviated New Drug Application The OTC Drug route -- Abreva (Avanir/SKB) FDACounsel.com NDA OTC Review monograph change The Approval Gate … Regulatory Status of the product con'd… What type of submission is needed to get FDA approval or clearance? Devices: Premarket Approval Application (PMA) -- clinical studies will be needed Premarket Notification under § 510k -- clinical studies MAY be needed (or wanted) FDACounsel.com The Approval Gate … Regulatory Status of the product con'd… What type of submission is needed to get FDA approval or clearance? Biologics FDACounsel.com Biologic License Application (BLA) no generic versions now possible – may change … The Approval Gate … Regulatory Status of the product con'd… What quantity and quality of data will be demanded by FDA to show safety & effectiveness? Will vary -- FDA has extensive discretion here Key task -- try to get clarity as soon as possible in the process -- Ways to do so: FDACounsel.com Pre-IND meeting -- encouraged by FDA prior to start of human clinicals End of Phase 2 Meeting - also encouraged -- here's where you want to "lock" them in The Approval Gate … Regulatory Status of the product con'd… What quantity and quality of data? FDAMA § 119(a) - FDACounsel.com FDA must meet with you on design of studies; and Any agreement on study design must be written and can't be changed later w/o your consent unless a new safety or effectiveness issue arises later The Approval Gate … Regulatory Status of the product con'd… What quantity and quality of data? FDAMA § 115(a) -- data from must one adequate and well-controlled study and confirmatory evidence can be used to show substantial evidence of effectiveness FDACounsel.com The Approval Gate … Regulatory Status of the product con'd… What quantity and quality of data? "Pure" proof of clinical effectiveness may not be needed -- e.g., under “Fast Track,” may be able to use: Surrogate endpoints Clinical endpoints Phase IV study will be needed usually FDACounsel.com The Approval Gate … FDA -- Legal Barriers to entry Orphan Drug Exclusivity -- 7 years for drug for orphan indication can't "remake the wheel" Waxman-Hatch Exclusivity FDACounsel.com 5 years -- New Chemical Entities 3 years -- New uses, dosage forms, etc. of previouslyapproved products The Approval Gate … The FDA Review -- Priority and Speed "Fast Track" -- FDAMA § 112 FDACounsel.com treats a "serious or life threatening condition" shows "potential to address unmet medical needs for such condition" If so, FDA must "facilitate the development and expedite and review" of the drug Request at time of or after IND filing See 1998 Guidance on Fast Track http://www.fda.gov/cder/guidance/2112fnl.pdf The Approval Gate … The FDA Review -- Priority and Speed General NDA classification system FDACounsel.com 1 -- New molecular entity 2 -- New Salt of Previously Approved Drug (not a new molecular entity) 3 -- New Formulation of Previously Approved Drug (not a new salt OR a new molecular entity) 4 -- New Combination of Two or More Drugs 5 -- Already Marketed Drug Product - Duplication (i.e., new manufacturer) The Approval Gate … The FDA Review -- Priority and Speed General NDA classification system 6 -- New Indication (claim) for Already Marketed Drug (includes switch in marketing status from prescription to OTC) 7 -- Already Marketed Drug Product - No Previously Approved NDA (e.g., Unithroid) NDA Review Priority: FDACounsel.com S - Standard -- drugs similar to currently available drugs P - Priority -- significant advances over existing treatments. The Approval Gate … The FDA Review -- Pre-Approval Inspections -- Expect one if NDA is: new chemical or molecular entities; for a narrow therapeutic range drug the first approval for the applicant; or are sponsored by a company with a history of CGMP problems or that has not been inspected for a considerable period. CDER's Compliance Program Guide 7346.832 @ http://www.fda.gov/cder/handbook/insaccep.htm FDACounsel.com The Approval Gate … A few tips to avoid problems in drug development and speed FDA review: If outsourcing, audit aggressively your "vendors": CROs Clinical investigators Contract manufacturers IRBs FDACounsel.com Duke University of Oklahoma Joint venture partners The Approval Gate … Tips to avoid problems & speed review… Make sure R&D and Sales & Marketing are talking early on -- ensure the indication being studied is one you want to sell If planning to get Medicare reimbursement, make sure: FDACounsel.com start the reimbursement qualification process early study your drug in Medicare-age patients The Approval Gate … Tips to avoid problems & speed review… Study and File electronically Respond to FDA deficiency letters during review promptly, fully, and honestly remember -- there are these folks called products liability plaintiffs lawyers and Securities class actions folks waiting for you to make a mistake Don't bury your head to problems -- investigate and disclose promptly FDACounsel.com The Approval Gate … Hopefully, will open for you!! But the odds are long, the cost is high, and the time is lengthy FDACounsel.com Good luck!!
