FDA Battles against "Regulatory Anarchy." (Food and Drug Administration)

By Farley, Dixie | FDA Consumer, April 1990 | Go to article overview
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FDA Battles against "Regulatory Anarchy." (Food and Drug Administration)


Farley, Dixie, FDA Consumer


A federal district court has banned an unproven, potentially life-threatening dialysis filter.

Without such action, said Judge Charles Schwartz Jr. of the U.S. District Court for the Eastern District of Louisiana, "immediate and irreparable damage or injury" may result to patients and to FDA's ability to protect them.

Despite repeated warnings from FDA that the blood filter, known as the Al/Fe Clark Specific, was illegal and could be hazardous, Clark Research and Development, Inc., of Folsum, La., continued to sell the device, causing the agency to seek a restraining order.

"Loosing a novel ... device intended for life-sustaining purposes ... without solid study data upon which FDA can evaluate its safety and effectiveness is a serious violation of law that threatens the public health," wrote FDA attorney Mark Heller in a court brief dated July 20, 1989. "Were one to follow Clark Research's path," he stated, "regulatory anarchy would occur."

Judge Schwartz issued a temporary restraining order against the firm on July 26, ruling that Clark was marketing the filter illegally and was likely to continue to do so. FDA and Clark agreed to an order of preliminary injunction, which the judge signed on Aug. 1.

The Al/Fe Clark Specific filter is intended to remove excess iron and aluminum from the blood of patients suffering from metal toxicity, as can occur after repeated dialysis or many blood transfusions. It contains deferoxamine mesylate (DFO), a substance that binds the metals. The traditional treatment for this condition is to administer the DFO and then filter the combined DFO-and-metal complex from the blood.

Firms planning to market a medical device must submit information for FDA's review at least 90 days before marketing-the "review clock" starting anew with each submission. The device may be marketed if FDA determines it is substantially equivalent to a Class I or II device or to a Class III device marketed before the Medical Device Amendments of 1976. (Devices are classified on the basis of risk to the patient. Class I devices pose the least risk, and Class III devices pose the greatest.) A post-amendments (or "new") device deemed not to be equivalent is automatically placed in Class HI and requires pre-market approval before distribution. A firm wishing to test a new Class III device must have approval to do so, obtained through an application for an investigational device exemption (IDE). The law does not require FDA to complete its classification of new devices by a certain time, though the agency generally does this within 90 days.

Clark claimed FDA "missed the opportunity to interrupt marketing" because of an allegedly late response to the firm's pre-market notification submission. This is the first time FDA's pre-market notification program has been challenged in court.

In a pre-market notice CDRH received on Nov. 10, 1988, Clark claimed the Al/ Fe Clark Specific was substantially the same as a Clark filter already on the market. But FDA found the submission did not provide enough data to determine whether the new filter was as safe and effective as a pre-amendments device. The agency wrote Clark on Feb. 6, 1989, asking for more information about how the device worked. The firm received FDA's letter on Feb. 13, 96 days after the November submission, but had begun marketing its unapproved filter a week earlier, at the end of the 90-day period.

On Feb. 14, Clark sued FDA and individuals within the agency, charging harrassment-among other allegations-and claiming that FDA had no right to interfere with the marketing of its device. On the same day, Clark sent FDA a letter responding to the agency's request for scientific data.

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