Update: On June 20, 2012, the House of Representatives passed, by
voice vote and under suspension of the rules, S. 3187 (EAH), the
Food and Drug Administration Safety and Innovation Act, as amended.
This bill would reauthorize the FDA prescription drug and medical
device user fee programs (which would otherwise expire on September
30, 2012), create new user fee programs for generic and biosimilar
drug approvals, and make other revisions to other FDA drug and
device approval processes. It reflects bicameral compromise on
earlier versions of the bill (S. 3187 ES], which passed the Senate
on May 24, 2012, and H.R. 5651 EH], which passed the House on May
30, 2012). The following CRS reports provide overview information
on FDA's processes for approval and regulation of drugs: CRS Report
R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness, by Susan Thaul. CRS Report RL33986, FDA's Authority
to Ensure That Drugs Prescribed to Children Are Safe and Effective,
by Susan Thaul. CRS Report R42130, FDA Regulation of Medical
Devices, by Judith A. Johnson. CRS Report R42508, The FDA Medical
Device User Fee Program, by Judith A. Johnson. (Note: The rest of
this report has not been updated since September 1, 2011.) The Food
and Drug Administration (FDA) is a regulatory agency within the
Department of Health and Human Services. A key responsibility is to
regulate the safety and effectiveness of drugs sold in the United
States. FDA divides that responsibility into two phases:
preapproval (premarket) and postapproval (postmarket). FDA reviews
manufacturers' applications to market drugs in the United States; a
drug may not be sold unless it has FDA approval. The agency
continues its oversight of drug safety and effectiveness as long as
the drug is on the market. Beginning with the Food and Drugs Act of
1906, Congress has incrementally refined and expanded FDA's
responsibilities regarding drug approval and regulation. The
progression to drug approval begins before FDA involvement. First,
basic scientists work in the laboratory and with animals; second, a
drug or biotechnology company develops a prototype drug. That
company must seek and receive FDA approval, by way of an
investigational new drug (IND) application, to test the product
with human subjects. Those tests, called clinical trials, are
carried out sequentially in Phase I, II, and III studies, which
involve increasing numbers of subjects. The manufacturer then
compiles the resulting data and analysis in a new drug application
(NDA). FDA reviews the NDA with three major concerns: (1) safety
and effectiveness in the drug's proposed use; (2) appropriateness
of the proposed labeling; and (3) adequacy of manufacturing methods
to assure the drug's identify, strength, quality, and identity. The
Federal Food, Drug, and Cosmetic Act (FFDCA) and associated
regulations detail the requirements at each step. FDA uses a few
special mechanisms to expedite drug development and the review
process when a drug might address an unmet need or a serious
disease or condition. Those mechanisms include accelerated
approval, animal efficacy approval, fast track applications, and
priority review. Once a drug is on the U.S. market (following FDA
approval of the NDA), FDA continues to address drug production,
distribution, and use. Its activities, based on ensuring drug
safety and effectiveness, address product integrity, labeling,
reporting of research and adverse events, surveillance, drug
studies, risk management, information dissemination, off-label use,
and directto- consumer advertising, all topics in which Congress
has traditionally been interested. FDA seeks to ensure product
integrity through product and facility registration; inspections;
chain-of-custody documentation; and technologies to protect against
counterfeit, diverted, subpotent, adulterated, misbranded, and
expired drugs.
General
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