FDA FDA to levy substantial fees for certain applications


Food and Drug Administration (FDA) is a federal agency of the United States
Department of Health and Human Services The FDA’s organisation consists of the
Office of the Commissioner, the Office of Operations the Office of Foods and
Veterinary Medicine, the Office of Foods and Veterinary Medicine, and the Office
of Medical Products and Tobacco.

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The FDA is largely funded
by Prescription Drug User Fee Act (PDUFA), this Act enables the FDA to levy
substantial fees for certain applications for the review of human drug and
biological products, and prescription drug program fees. The base revenue
amount for the 2018 fiscal year is $878,590,000, fee amounts are to be
established each year so that revenues from application fees provide 20 percent
of the total revenue, and prescription drug program fees provide 80 percent of
the total revenue.i
In 2018 a drug application that requires clinical data will cost $2,421,495.ii

Centre for Drug Evaluation and Research (CDER) is the main division of the FDA
that is responsible for monitoring and approving drugs. The CDER regulates
over-the-counter and prescription drugs, including biological therapeutics and
generic drugs. Before a pharmaceutical companies can market a drug with in the
United States, whether brand name or generic they must first go throw a lengthy
approval process to ensure the safety and effectiveness of the drug. The process
of drug development, from the initial discovery through to final market approval
by the FDA requires 10 years on average, and the overall cost of this process
is estimated to range between $868 million to $1,241 million.iii

CDER has three main classifications of drug product types: new drugs, generic
drugs, and over-the-counter drugs. The approval process for new drugs is
typically the most lengthy and rigorous and begins with the submission of an
investigational new drug application (IND).

 The IND application must contain information
in three areas

Animal Pharmacology and Toxicology

Manufacturing Information

Clinical Protocols and Investigator Information

    Animal Pharmacology and Toxicology Studies
consists of preclinical data to permit an assessment as to whether the product
is reasonably safe for initial testing in humans. Manufacturing Information is
typically information pertaining to the composition, manufacturer, stability,
and controls used for manufacturing the drug substance and the drug product. Clinical
Protocols are detailed protocols for proposed clinical studies to assess
whether the initial-phase trials will expose subjects to unnecessary risks and
Investigator Information is information on the qualifications of clinical
investigators who oversee the administration of the experimental compound to
assess whether they are qualified to fulfil their clinical trial duties.iv

i https://www.federalregister.gov/documents/2017/09/14/2017-19494/prescription-drug-user-fee-rates-for-fiscal-year-2018

ii https://www.federalregister.gov/documents/2017/09/14/2017-19494/prescription-drug-user-fee-rates-for-fiscal-year-2018

iii “How Drugs are Developed and Approved by the
FDA: Current Process and Future Directions” Ciociola, Arthur A; Cohen, Lawrence
B; Kulkarni, Prasad. The American Journal
of Gastroenterology; Cambridge Vol. 109, Iss. 5  (May 2014): 620-623.