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SCT decides 8-1: FDA regulated medical devices products; FDA's new Risk Communication Advisory Committee

Following up on Supra Paul's post about the spring medical device conference,
the news reported today on the 8-1 S Ct decision in Riegal v Medtronic 06-179
(Feb 20, 2008). See the opinion linked below via the SCOTUS blog for an interesting opinion and some perspectives about the role of the FDA .
The decision held that the pre-emption clause enacted in the Medical Device Amendments of 1976 bars common-law claims challenging the safety and effectiveness of a medical device marketed in a form that received premarket approval by the FDA.
The decision states that the common law claims are pre-empted because they are based on New York "requirements" that are "different from or in addition to" the federal ones and that relate to safety and effectiveness. (page 2). Justice Scalia, delivering the opinion of the Court continued,

Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments. Absent other indication, reference to a State's 'requirements' includes its common-law duties (common -law negligence and strict -liability claims.)
p. 2, 11.
Also citing Justice Breyer from the referenced Lohr case (p 12)
...it is implausible that the MDA was meant to 'grant greater power (to set state standards -different from or in addition to-federal standards) to a single state jury than to state officials acting through state administrative or legislative making processes.'
He notes, however, that a State may provide a damages remedy for claims premised on a violation of FDA regulations (thus the state duties in such a case are "parallel" to federal requirements).

Justice Stevens concurring in part and concurring in judgment in this case writes that

The significance of the pre-emption provisions in the MDA of 1976 was not fully appreciated until many years after it was enacted. It is an example of a statute whose text and general objective cover territory not actually envisioned by its authors. In such cases we have frequently concluded that 'it is ultimately the provisions of our laws rather than the principal concerns of our legislators by which we are governed.
In this part of the opinion, he agreed with Justice Ginsburg's dissent providing a description of the actual history and principal purpose of the pre-emption provision at issue in this case -- there is nothing in preenactment history of the MDA suggesting that state tort remedies had impeded the development of medical devices.
Justice Ginsburg in her dissent points out that
...until 1976, the federal government did not engage in premarket regulation of medical devices. Some States acted to fill the void by adopting their own regulatory systems......
" thus reasoning to her conclusion that
state premarket regulation of medical devices , not any design to suppress tort suits , accounts for Congress' inclusion of a preemption clause in the MDA, no such clause figures in earlier federal laws regulating drugs and additives, for States had not installed comparable control regimes in those areas.

The Court's opinion also states that "...Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review-it is federal safety review." (1)

One related important and current event in FDA's federal safety review:

The first meeting of the FDA's new Risk Communication Advisory Committee will meet for the first time on Feb 28/ 29, 2008. The new advisory committee (see FDA's June 4 2007 press release) is designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

The Risk Communication Advisory Committee will;

--help FDA better understand the communication needs and priorities of the general public;
---advise FDA on the development of strategic plans to communicate product risks and benefits; and
--make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

Randall Lutter, Ph.D., FDA’s acting deputy commissioner for policy indicates that:

Communicating the risks and benefits associated with FDA-regulated products is essential to help consumers and health care professionals make informed decisions....The Risk Communication Advisory Committee will bring together a broad range of experts and views to help improve FDA’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions.

(1) http://www.scotusblog.com/wp/wp-content/uploads/2008/02/06-179.pdf
(2) http://www.fda.gov/OHRMS/DOCKETS/98fr/08-588.pdf

Establishment of the new Risk Communication Advisory Committee stems from the IOM 2006 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. The report recommended that Congress enact legislation establishing a new advisory committee to address how FDA communicates information about the efficacy, safety and use of drugs and other FDA-regulated medical products. FDA agreed with the value of such a committee and acted promptly to establish it through more speedy administrative procedures. FDA also expanded the scope of the committee to cover communication of risks and benefits of all products regulated by the agency.

The advisory committee will be made up of 15 voting members that include experts and public members who are not affiliated with the FDA. Experts will include authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Public members will include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health professionals.

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This page contains a single entry from the blog posted on February 20, 2008 3:52 PM.

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