FDA Runs Protection Racket For Big Pharma

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The court disagreed and determined that it was to give significant deference to the amicus brief based on the U.S. Supreme Court's decisions in Chevron, Medtronic, and Geier which state that an amicus brief is an appropriate form to express preemptive intent and held that the principles of deference do not permit a court to question the FDA's interpretation of its own regulations.

The plaintiff argued that the preamble which was promulgated in 2006 could not be retroactively applied to the October 2003, death of his wife. However, the Court said that preemption could be applied retroactively because the preamble simply clarified the FDA's "longstanding views on preemption," and characterized the preamble as an "interpretive rule," rendering retroactivity concerns "irrelevant."

The Court went on to say that even if the preamble did not apply retroactively, it would have found preemption anyway based on the views previously expressed in amicus briefs by the FDA.

An appeal is pending on the Colacicco decision, and the case has drawn amicus support from a dozen scientists and doctors who contend that preemption "would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA."

The national non-profit consumer advocacy organization, Public Citizen, the Trial Lawyers for Public Justice, a national public interest law firm, and the Association of Trial Lawyers of America, an international coalition of attorneys, law professors, paralegals, and law students, have together filed an amicus brief supporting Mr Colacicco, stating:

"Products liability lawsuits help to protect patients from drugs with undisclosed risks because the potential for being held liable for harm caused by their products provides a powerful incentive for drug companies to make their products as safe and effective as possible and to revise labels as soon as new risks become apparent.

"Furthermore, because FDA lacks authority to subpoena documents from the companies it regulates, products liability lawsuits help to uncover information that can lead to safer products."

In fact, the group points out, since at least several months before the victim's suicide, the FDA had been reviewing data about a possible link between SSRIs and suicidality, and the agency issued a Public Health Advisory on the topic in October 2003, the same month that Mrs. Colacicco died.

The amicus brief also notes that the FDA's preemption statement lacks the "consistency" needed to warrant any degree of deference because prior to 2002, the FDA's consistent view was that State common law was not preempted by federal drug regulation. "For example," the brief wrote, "in both 1979 and 1998, in preambles accompanying various drug regulations, FDA stated that state tort law did not interfere with federal regulation."

In 1998, when addressing pharmacists' provision of written patient information for "Medication Guides," when issuing the final rule, the FDA rejected calls for the agency to express an intent to preempt State regulation of labeling requirements stating:

"FDA regulations establish minimal standards necessary, but were not intended to preclude states from imposing additional labeling requirements. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling." 63 Fed. Reg. at 66384.

According to the amicus brief, "The authority to regulate drug labeling may carry with it the authority to address state drug labeling regulations, but it does not carry with it authority to determine the preemptive effect of federal regulation on state common-law compensation systems."

It appears that the FDA's own regulations acknowledge that preambles are not statements of law and that they should not be presented as such in legal proceedings.

The amicus group states that the preamble is not part of the regulation, will not appear in the Code of Federal Regulations, and does not have the force of law. "In fact," the brief notes citing FDA regulations, "a longstanding FDA regulation provides that a statement in a regulatory preamble constitutes only an "advisory opinion."

The FDA recognizes that an advisory opinion may be used to "illustrate acceptable . . . procedures or standard, but not as a legal requirement," the brief points out.

"Having made no effort to legislate on the topic of drug-related damages remedies," the brief concludes, "Congress can hardly be said to have authorized FDA to supersede the damages remedies traditionally provided by the states."

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