Drug Approval
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| what authority does the FDA have over drug development and use (4) | 1) requires demonstration of drug efficacy; 2) demonstration of safety; 3) regulate drug testing and manufacture; 4) force withdrawal
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| the FDA has oversight of drug development and usage, with what exceptions (3) | 1) does not regulate non-prescription drug advertising; 2) prescription drug advertising reviewed, but not pre-approved; 3) DEA regulates controlled substances
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| what is the first form to submit for drug approval | IND (investigational new drug)
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| what is required before IND is submitted | chemistry / animal testing
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| what cannot happen before IND is submitted | human testing
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| what is the next form that needs to be submitted | NDA (new drug application)
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| what is needed to support the NDA | clinical studies
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| how many phases of clinical studies are there | three
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| what part of drug approval requires the most time and resources | clinical trials
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| how much can it cost for developing a new molecular entity | one hundred million dollars and more
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| what is a new IND required for (2) with the same drug | 1) each dosage form; 2) each disease target
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| what is the IND approval process like | they are not approved, but are put on a "clinical hold" by the FDA within 30 days - if there is no hold placed, the sponsor may proceed
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| what must the sponsor continually send the FDA, as far as the IND (3 - forms/reports, not general information) | 1) annual IND reports; 2) IND amendments that describe change in trials; 3) safety reports
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| what are three pieces of general information that must be included in the IND application | 1) description of drug (chemical analysis, stability); 2) description of drug product (e.g. tablet); 3) proposed drug labeling to guide IND clinical investigators
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| what is some pharmacologic/toxicology information expected to be included in the IND (3) | 1) MOA/effects in animals; 2) absorption/metabolism/distribution/elimination (pharmacokinetics) studies in vitro and in animals; 3) toxicology
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| what types of toxicology studies are done (2) | 1) acute; 2) chronic
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| what information is necessary for a NDA application (3) | 1) information from IND; 2) new data from animal studies; 3) clinical data from phase 1-3 trials
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| what things are looked at in phase 1 studies (3) | 1) metabolism; 2) drug/food interactions; 3) adverse effects
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| what things are looked at in phase 2 studies (3) | 1) dose-ranging; 2) detailed pharmacokinetics; 3) first efficacy data
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| what things are looked at in phase 3 studies (2) | definitive safety/efficacy studies
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| what % of drugs successfully get through phase 1, 2, and 3 | 70%, 33%, 25-30%
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| when must NDA reports be submitted once a drug is approved, and for how long | every year, as long as the drug is marketed
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| what is post-marketing reporting (NDA annual reports) focused on | drug safety
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| what were two "problem areas" of adverse effects that have led to drug withdrawal | 1) hepatic toxicity; 2) promotion of ventricular arrhythmias
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| how effective is adding "black box" warnings to problem drugs | FDA considers it to be ineffective
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| what are "risk management action plans" | when the FDA approves limited access to high-risk drugs if medically necessary
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| what example was given | thalidomide for leprosy, despite risk of phocomelia
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| what conditions are placed on thalidomide prescription (3) | 1) restricted set of prescribers; 2) patient registry; 3) agree to use two types of birth control
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| what does ANDA stand for | abbreviated new drug application
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| what is ANDA meant for | generic versions of previously approved drugs
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| what is not necessary in an ANDA | repetition of clinical safety/efficacy studies
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| what must the company show in the ANDA application | that drug is identical (chemical analysis, formulation process, pharmacokinetics)
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| what is the purpose of the orphan drug act (what three things are provided, and for what purpose) | provides: 1) research grants; 2) tax credits; 3) and extended exclusive marketing for drugs that treat rare diseases
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| what are examples of drugs (and their uses) that are covered in the orphan drug act (2) | 1) digoxin immune Fab (for digoxin toxicity); 2) imatinib (Gleevac) for CML
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| what constitutes a "rare disease" | <200,000 patients/year
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| what are "treatment INDs" and who do they apply to | allows patients not in clinical trials to use drugs at phase 3 stage - only applies for seroius conditions for which there is no approved alternative treatment
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| what drugs are eligible for accelerated development | those meant for life-threatening and severly debilitating illnesses; drugs may have to address unmet clinical needs
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