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is a searchable catalog of the US Food and Drug Administration (FDA)
approved drug products, both prescription and over the counter, with
links to documents relating to marketing approval. More information is
available from their FAQ section.
What are FDA drug approval packages?
FDA Drug Approval Packages consist of FDA employees' reviews of new drug
applications (NDAs) submitted by pharmaceutical companies seeking
approval to market their drugs in the US. These NDAs consist primarily of
clinical study reports (CSRs). Some drugs have more than one approval
package, because approval is granted not for a drug per se, but for each
drug-indication combination.
How will OpenTrialsFDA improve access to the FDA data?
The team will scrape the FDA website and extract the relevant information
from the PDFs through a process of OCR (optical character recognition).
Through the new OpenTrialsFDA interface, users will be able to explore and
discover the FDA data. In addition, the information has been integrated into
the OpenTrials database, so that the FDA report can be linked to reports
from other sources, such as ClinicalTrials.gov, EU CTR, HRA, WHO ICTRP, and
PubMed.
How does the FDA review process differ from the peer review process
used for manuscripts submitted to journals?
The key is the before-versus-after-the-trial aspect. Before the sponsor
can begin a trial in the US, it must submit the trial protocol to the
FDA. By means of this "pre-trial" review of the protocol, the FDA learns
(1) that that trial is to be conducted and (2) the nitty-gritty
methodological details. That way, a few years later, when the sponsor
submits its NDA, the reviewer compares the clinical study report (CSR) to
the original protocol to determine (1) whether any studies have been
omitted and (2) whether any outcomes have been switched. By contrast, in
the world of peer-reviewed journal articles, there is no "pre-trial"
review, allowing both (1) and (2) to take place.
Who authors FDA reviews?
The FDA review team is multidisciplinary, yielding different types of
reviews. Medical reviews are usually authored by physicians who summarize
and evaluates the data on drug efficacy and safety. Statistical reviews
are carried out by statisticians who test whether they can replicate the
sponsor's results using the patient-level data submitted electronically.
There are other review disciplines, e.g. chemistry,
pharmacology-toxicology, whose reviews pertain primarily to the
preclinical phase and early clinical (human) phases of drug development.
What is the Open Science Prize?
The Open
Science Prize is a collaboration between the Wellcome Trust, the US
National Institutes of Health (NIH) and the Howard Hughes Medical
Institute. Its goal is to unleash the power of open content and data to
advance biomedical research and its application for health benefit. The
OpenTrialsFDA team is one of the six finalist teams that were selected in May 2016.
All teams will showcase their prototypes at the BD2K Open
Data Science Symposium on 1 December 2016, when public voting will
begin. The public is asked to help select the most promising, innovative
and impactful prototypes from among the six finalists - among which one
will receive the grand prize of $230,000.
Troubleshooting your search
In case you're having difficulty with your search, here are some questions
you can consider.
Was the drug approved before or after 1997?
The FDA started posting reviews (Drug Approval Packages) in 1997. If the
drug in question was approved in 1996 or earlier, you probably will not
find it posted.
Are you sure that the use you're interested in is not off-label, ie.
that the FDA approved it for the indication you're interested in?
Oftentimes drugs are used widely for a certain condition (indication) for
which the FDA has not granted approval (off-label use). If you check the
product label (e.g. at https://dailymed.nlm.nih.gov/dailymed/index.cfm) and
look within the section on "Indications and Usage", you will see a list
of the approved indications.
Are you looking for indication #1 or one of the subsequent ones?
A given drug might be FDA-approved for multiple indications. The FDA is
careful about posting the Drug Approval Package for the first indication
(the one that allowed that drug to enter the market), but for subsequent
indications (#2, #3, etc.), it's more hit-or-miss. If you are motivated,
one way to get such reviews is to file a Freedom of Information request; but be warned—the
FDA might take months or longer to fulfill your request. If you do get such
reviews, we would appreciate you sharing it with
us so we can add to OpenTrialsFDA and make it available to others.
Did you use the generic name or brand name?
If you use the generic name, you will probably get lots of hits: one
for when the molecule was first being introduced to the market plus hits
for subsequent generic versions. The FDA does its review for efficacy and
safety when the molecule is first introduced to the market. Years later,
when the patent expires, generic equivalents get approved, but what the FDA
cares about at this stage is bioequivalence (in terms of blood levels) to
the original brand name version. Thus generics do not have to demonstrate
efficacy and safety all over again, which is why these approval packages
generally contain little or no such data.
Is the review an NDA or an ANDA?
Please see the question and answer immediately above. NDAs (new drug
applications) correspond to brand name versions, while ANDAs (abbreviated
new drug applications) correspond to generic equivalents. They are
abbreviated because less is required of the sponsor (see above). Assuming
you are interested in drug efficacy and/or safety (and not
bioequivalence), you will want to focus on NDAs and ignore ANDAs.
Is this the original or a subsequent formulation of a drug?
This is similar to the issue brand name versions vs. generic versions
(see above). The burden of proof regarding efficacy and safety is highest
when a molecule is first entering the market. A given drug will often
enter the market as an immediate release (IR) formulation, before which
the FDA will do its most comprehensive review of drug efficacy and
safety. Some years later, the sponsor may seek approval for a
sustained-release (SR) formulation, but by that time, millions of
patients have already been exposed to the IR formulation. Because it is
relatively unlikely that the efficacy and/or safety profile will differ a
great deal between the IR and the SR, the SR may have to do fewer
clinical trials compared to its IR version.
