Human Genome, FDA and Product Liability, The
![handle is hein.journals/risk7 and id is 277 raw text is: The Human Genome, FDA
and Product Liability
Jeffrey N. Gibbs*
Introduction
Human genome research will revolutionize our understanding of
human genetics and health. It has already resulted in powerful new
diagnostic tools, and more diagnostics are continually being developed.
In time, this research will almost surely result in successful new
therapeutic products as well. New understanding of the human genome
offers the prospect of large rewards for companies that successfully
commercialize technology based on it. Marketing new diagnostics and
therapeutics, however, will also be accompanied by several risks.
Major areas of risk relate to Food and Drug Administration (FDA)
that pervasively regulates therapeutics and diagnostics. Regulatory risks
take a variety of forms, including judicial sanctions. Also, companies
that commercialize these products face liability risks. Indeed, such risks
arise even before products enter commerce, and liability risks for
therapeutics are increased by FDA regulation.
This paper will summarize some such risks and discuss the
intersection between regulatory violations and liability litigation.
Regulatory Risks
Clinical Investigations
Before a new therapeutic can be marketed in the U.S., it must
undergo clinical testing. Its sponsor must show, through adequate and
well-controlled clinical trials, that it is safe and effective for its intended
use.' Ordinarily, these proceed in three phases.2
* Mr. Gibbs is a partner in Hyman, Phelps & McNamara, P.C., Washington, D.C.
and was formerly Associate Chief Counsel for Enforcement at FDA. He graduated
from Princeton University and New York University School of Law.
1 21 U.S.C. § 355(b)(1).
2 See 21 C.F.R § 312.21.
7 Risk Health, Safety & Environment 267 [Summer 1996]](ViewImageLocal?handle=hein.journals/risk7&div=30&collection=&method=preview&ext=.png&size=3)
What Is HeinOnline?
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most
Human Genome, FDA and Product Liability, The
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most