O equilibrio no sistema de regulação na federação americana

Prof Farlei Martins, Ucam e doutorando de direito da Puc-rio, envia a noticia abaixo. Já houve postagem de decisão da Corte Suprema em matéria de drogas farmacêuticas favorecendo um equilibrio dos entes da federação americana na regulação dessas matérias.




By Robert A. Schapiro, Professor of Law, Emory Law & Author of Polyphonic
Federalism: Toward the Protection of Fundamental Rights

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It has been a good spring for federalism. In recent years, the doctrine of
preemption has stood as a prime enemy of federalism and an obstacle to state
efforts to promote health, safety and environmental protection. For that
reason, President Barack Obama's May 20 memorandum limiting federal
assertions of preemption comes as welcome news. That memo, along with an
important Supreme Court decision in March, signals a turn away from an
aggressive policy of administrative agency preemption and recognition of the
value of concurrent state and federal regulatory initiatives.

The basic principle of preemption, that state laws cannot interfere with the
operation of the federal government, is an important and uncontroversial
feature of our constitutional system. However, over the past 25 years,
preemption has become a weapon to defeat state regulations aimed at
improving health and safety, as well as state tort suits seeking to
compensate victims of malfeasance. Back in 1992, the United States Supreme
Court issued a fractured opinion in the Cipollone case, holding that federal
regulation of cigarette labeling preempted some state tort actions against
tobacco companies. In the succeeding years, the Supreme Court has found that
law suits relating to seat belts, medical devices and other products must be
tossed out because of federal regulation in the area.

Some assertions of preemption have succeeded. Others have failed. The
judicial doctrine has not been clear. In this confusing area, the position
of the President and his administration has proved significant.

The administration of President George W. Bush frequently urged courts to
find state suits preempted based on the theory that they posed obstacles to
agency regulations. Courts would often listen. In addition to filing legal
briefs, federal agencies added preemption provisions to regulatory
preambles. This practice wrote the preemptive language into the Federal
Register, without the need for the more formal review process normally
associated with the promulgation of regulations. Commentators labeled the
practice, "silent tort reform," as it had the effect of barring various
state law personal injury actions without the need for explicit
congressional legislation.

The new memorandum from the Obama administration should spell the end to
this kind of stealth preemption. The memo declares that regulatory preambles
should not include preemptive statements, unless the underlying regulation
contains a preemption provision. The memo further urges caution in
promulgating regulations with preemptive language. Finally, the memo orders
a review of preemptive statements issued by agencies within the past 10
years. Preemption will remain an essential component of our federal system,
but the memo seeks to ensure that preemption provisions reflect a
transparent and participatory administrative process.

This spring, the Supreme Court also expressed skepticism about preemption by
administrative preamble. Wyeth v. Levine arose out of the tragedy suffered
by Diana Levine. A professional musician, Levine received an injection of
the drug Phenergan. The Phenergan infiltrated her artery, causing gangrene
and the eventual amputation of her arm. She sued the manufacturer, Wyeth,
alleging a failure to provide adequate warnings of the dangers of certain
injection methods. A jury agreed with Levine and awarded her over $6 million
in damages.

On appeal to the United States Supreme Court, Wyeth argued that the Federal
Food and Drug Administration's approval of the drug's label had the effect
of preempting Levine's suit. In support of its assertion, Wyeth pointed to
the preamble to the FDA regulation, which included preemptive language added
in 2006. The Bush Administration filed a brief urging the court to find
Levine's claims preempted.

In a 6-3 decision, the Supreme Court rejected the preemption argument.
Writing for the majority, Justice John Paul Stevens noted the value of
concurrent state and federal approaches to the drug safety problem. In
specific, the Court refused to defer to the regulatory preamble. Noting that
the agency had not promulgated the preemptive language as part of the
regular rulemaking process, the Court declared, "The agency's views on state
law are inherently suspect in light of this procedural failure."

Taken together, the preemption memo and the Wyeth decision recognize the
benefits of overlapping state and federal regulations and the concomitant
peril of preemption. The memo and Wyeth emphasize the importance of
protecting the values of federalism by providing adequate procedural
safeguards. Congress of course retains the power to preempt by express
language, but there are often good reasons not to preempt state law.
Agencies should not rush in where Congress feared to tread.