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FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective (Paperback)
Loot Price: R349
Discovery Miles 3 490
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FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective (Paperback)
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Loot Price R349
Discovery Miles 3 490
Expected to ship within 10 - 15 working days
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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 November 10, 2011.) With the
Best Pharmaceuticals for Children Act (BPCA) and the Pediatric
Research Equity Act (PREA), Congress authorized the Food and Drug
Administration (FDA) to offer drug manufacturers financial and
regulatory incentives to test their products for use in children.
Congress extended both programs with the FDA Amendments of 2007
(FDAAA) and, because of the programs' sunset date, must act before
October 1, 2012, to continue them. This report presents the
historical development of BPCA and PREA, their rationale and
effect, and FDAAA's impact. The report also discusses pediatric
drug issues that remain of concern to some in Congress. Most
prescription drugs have never been the subject of studies
specifically designed to test their effects on children. In these
circumstances, clinicians, therefore, may prescribe drugs for
children that FDA has approved only for adult use; this practice is
known as off-label prescribing. Although some clinicians may
believe that the safety and effectiveness demonstrated with adults
would hold for younger patients, studies show that the
bioavailability of drugs-that is, how much gets into a patient's
system and is available for use-varies in children for reasons that
include a child's maturation and organ development and other
factors. The result of such off-label prescribing may be that some
children receive ineffective drugs or too much or too little of
potentially useful drugs; or that there may be side effects unique
to children, including effects on growth and development. Drug
manufacturers are reluctant to test drugs in children because of
economic, ethical, legal, and other obstacles. Market forces alone
have not provided manufacturers with sufficient incentives to
overcome these obstacles. BPCA and PREA represent attempts by
Congress to address the need for pediatric testing. FDA had tried
unsuccessfully to spur pediatric drug research through
administrative action before 1997. With the FDA Modernization Act
of 1997 (FDAMA, P.L. 105-115), Congress provided an incentive: if a
manufacturer completed pediatric studies that FDA requested, the
agency would extend the company's market exclusivity for that
product for six months, not approving the sale of another
manufacturer's product during that period. In 2002, BPCA (P.L.
107-109) reauthorized this program for five years. In 1998, to
obtain pediatric use information on the drugs that manufacturers
were not studying, FDA published the Pediatric Rule, which required
manufacturers to submit pediatric testing data at the time of all
new drug applications.
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