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INFUSAID CIVIL PENALTY UNDER REVIEW BY REP. RON WYDEN,

This article was originally published in The Gray Sheet

Executive Summary

INFUSAID CIVIL PENALTY UNDER REVIEW BY REP. RON WYDEN, chairman of the Small Business/Regulation, Business Opportunities and Technology Subcommittee. Concerned that the $290,000 fine recently levied by FDA against Pfizer subsidiary Infusaid ("The Gray Sheet" Nov. 29, p. 4) was not stringent enough to deter "scofflaw" device manufacturers, the Oregon Democrat wrote the agency Nov. 24 requesting a copy of the consent agreement signed between FDA and Pfizer/Infusaid. Infusaid's civil penalty is the first imposed by the agency under authority granted by the Safe Medical Devices Act of 1990. The subcommittee notes that it is interested in reviewing the consent agreement "to assess how FDA has begun to implement [SMDA] and whether the public has been provided an adequate degree of protection against developing medical device manufacturers that seem driven more by a carnival marketing mentality than a conscientious appreciation for the law, public health and quality." The subcommittee voices specific concern that "the use of fines alone simply will become the cost of doing business for some companies, especially for companies that have parent corporations with deep pockets." Certain companies, the letter cautions, "may believe it is cheaper to pay a fine than to pay the cost of going by the book in bringing an FDA product to market. Even worse, the same firm, given a corporate mentality that defies the spirit of the law, may become a repeat offender, and plan on paying for its speeding ticket if caught again by FDA." Wyden maintains that protecting "the public from medical device manufacturers that conduct unbridled experimentation on unknowing human subjects by marketing significantly altered devices demands the full and fair enforcement of the law." The subcommittee chairman notes that the "sound scientific principles" governing FDA's requirements for bringing new products to market are "breached" by the "hit and run practice of market-and-modify" used by certain medical device firms. FDA responded to the subcommittee's request for the FDA/Infusaid consent agreement the week of Nov. 29. After receipt of the three-page document, the subcommittee submitted a second letter to FDA on Dec. 1 requesting further information on the agreement, including internal memos and minutes of FDA/Infusaid meetings. The agency says it intends to compile the necessary documents and submit them to Wyden before the subcommittee's deadline of Jan. 1, 1994.
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