`
`The Drug Development and Approval Process: FDAReview.org
`
`PDAkReview.org
`
`a project of the Independent Institute
`
`The Drug Development and Approval Process
`
`vy
`
`Drug Development
`
`The Drug Development and Approval Process
`
`The processof getting a drug to market, from first testing to final FDA approval, is summarized in figure
`1 and describedat greater length below.
`
`Figure 1
`
`An Overview of the Drug Development Process
`
`
`
`
`
`Toxicology|Investigational Phase I Phase II PhaseIII New Drug PhaseIV /
`
`New Drug Application|Postmarket
`
`Application
`surveillance
`
`Preclinical
`
`Clinical
`
`Approval
`
`safety
`efficacy
`side effects
`
`Time
`
`21.6
`months
`
`25.7
`months
`
`30.5 months
`
`Search
`
`| to 6 years
`
`6 to 11 years
`
`0.6 to 2
`years
`ealpabivoteees
`Overall probability of success
`[COCee
`Contomipawaipetaces
`Conditional probability of success
`Cmomlmlm[omld
`SaosinTenonoSources: Dimasi, Hansen, and Grabowski (2003).
`Notes: The line marked “Overall probability of success” is the unconditional probability of reaching a
`given stage. For example, 30 percent of drugs make it to phase I testing. The line marked
`“Conditional probability of success” showsthe probability of advancing to the next stage of the
`process conditional on reaching a given stage. For example, the probability of advancing to PhaseIII
`testing conditional on starting Phase II testing is 48 percent.
`
`11 to 14 years
`
`Drug companies continuously analyze thousands of compounds, seeking ones of therapeutic value.
`During the six to seven yearsofpreclinical testing, the manufacturer completes synthesis and
`purification of the drug and conductslimited animaltesting. Of five thousand compoundstested,
`approximately five will appear promising enough to induce the companytofile an Investigational New
`Drug Application (IND).If the IND is approved by the FDA andbyanInstitutional Review Board, the
`manufacturer may beginthe first phase of development.
`
`The IND stage consists of three phases. In phaseI, clinical trials using healthy individuals are conducted
`to determine the drug’s basic properties and safety profile in humans. Typically the drug remains in this
`stage for one to two years. In phaseII, efficacy trials begin as the drug is administered to volunteers of
`the target population. At the end of phaseII, the manufacturer meets with FDA officials to discuss the
`developmentprocess, continued humantesting, any concerns the FDA mayhave,and the protocols for
`phaseIII, which is usually the most extensive and most expensive part of drug development. During the
`
`http:/Avww.fdareview.org/03_drug_development.php
`
`1/2
`
`1
`
`ALL 2030
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01131
`
`1
`
`ALL 2030
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01131
`
`
`
`3/16/2017
`
`The Drug Development and Approval Process: FDAReview.org
`
`phasesof the IND, the manufacturer can obtain accelerated development/review ofthe drug. Other
`accommodations for usage prior to approval include treatment IND andparallel tracking.
`
`Once phaseIII is complete, the manufacturer files an NDA. Review of the NDAtypically lasts one to
`two years, bringing total drug development and approval(that is, the IND and NDAstages) to
`approximately nine years. During the NDAstage, the FDA consults advisory committees made of
`experts to obtain a broader range of advice on drugsafety, effectiveness, and labeling. Once approved,
`the drug may be marketed with FDA regulated labeling. The FDA also gathers safety information as the
`drug is used and adverse events are reported, andit will occasionally request changesin a labeling or
`will submit press releases as new contraindicationsarise. If adverse events appear to be systematic and
`serious, the FDA may withdraw a product from the market.
`
`Overtime there has been a clear tendency for FDA regulations and requirements to expand and multiply.
`In 1980,the typical drug underwentthirty clinical trials involving about fifteen hundred patients. By the
`mid-1990s, the typical drug had to undergo morethansixty clinical trials involving nearly five thousand
`patients.
`
`Public Agenda Online has some useful background information on medical and drug research in the
`form of easy-to-read charts.
`
`© 2016 IndependentInstitute
`
`http:/Avww.fdareview.org/03_drug_development.php
`
`2/2
`
`2
`
`