Originally Published MDDI July 2002

WASHINGTON WRAP-UP

FDA's new warning letters review policy, implemented in March to restore the seriousness of such letters, is working well, according to field personnel.

James G. Dickinson

Abbott Fails FDA Inspection | Device Experiences Database Updated | International Medical Tries to Avoid a Consent Decree

In its first three months, FDA's new warning letters review policy has been a success. It reduced the number of letters by 70%, from 344 to 70, compared with the same three months of 2001.

As reported in this column in February, the new policy was introduced in March through a directive from the deputy secretary of Health and Human Services, Claude Allen, specifically for the purpose of stanching the flow of warning letters—a flow that Allen and others felt devalued the seriousness of such letters.

FDA's new chief counsel, Daniel Troy, said that in implementing the policy he expected to restore that seriousness, eliminating the practice of issuing serial warning letters to the same companies for the same, uncorrected violations. Instead of sending a second or even a third warning letter in such circumstances, he said, FDA would likely move directly to litigation after the first.

An informal survey among FDA field personnel in May by John Scharmann, a former FDA Denver District director, found that from the point of view of FDA personnel, Troy's efforts appeared to be working well, generally. District offices wanting to issue a warning letter soon after completing an inspection reported receiving approval of their drafts within the time frames established by the new policy.

District offices are required to submit their draft letters to Troy's Office of the Chief Counsel within 15 working days of an inspection or a sample analysis. For untitled letters, the submission time frame for a draft is 45 days. In situations where operating center (e.g., CDRH) involvement is necessary, similar time frames apply; but when danger-to-health concerns are involved times are tightened.

Abbott Fails FDA Inspection

Abbott Laboratories has failed to meet a major compliance goal of its 1999 consent decree with FDA. The firm now faces possible daily monetary penalties provided for in that decree.

On May 15, the company said it had been told by FDA that its Lake County, IL, diagnostics manufacturing plant doesn't meet quality system regulation (QSR) requirements. Abbott declined to elaborate until it had received formal notification from FDA.

The consent decree provides that Abbott may have to pay $15,000 per manufacturing process, per day (up to a $10 million cap), for failure to adhere to a QSR compliance schedule established by FDA. Whether the company in fact violated the schedule could not be immediately determined; FDA did not respond to questions about the daily penalties.

FDA has been having problems of its own in adhering to timelines in the Abbott matter. In March, it told Abbott it needed extra time beyond that provided in the consent decree to respond formally to its decree-stipulated inspection of the Lake County facility. That 58-day inspection ended in January and resulted in a 23-page FDA 483.

According to the Dow Jones news service, Abbott had previously warned that it might face additional costs if the Lake County plant were found to be not in conformity with the QSR. Abbott's news release quoted president Richard A. Gonzales as saying, "We are obviously deeply disappointed with the decision [by FDA to find it not in conformance]. We remain committed to ensuring that the quality system meets the agency's expectation, and that the diagnostic products impacted by the consent decree are made available to patients, laboratories, and hospitals as soon as possible."

Device Experiences Database Updated

CDRH has updated its Manufacturer and User Facility Device Experience Database (MAUDE). The database provides information about device-related adverse events, and contains all voluntary, user facility, and manufacturer adverse event reports through March 28.

An on-line search feature allows users to examine the database for specific information on specific medical devices that may have malfunctioned or caused death or injury. The database can be accessed at http://www.fda.gov/cdrh/maude.html.

International Medical Tries to Avoid a Consent Decree

The small device maker International Medical Inc. (Fort Myers, FL) recently met with FDA chief counsel Daniel Troy and Department of Justice attorney Alan Phelps at FDA. The May 8th meeting concerned the company's problems in achieving QSR compliance. "We're trying to resolve the matter without a consent decree," general manager Paul Duddy told this reporter on May 13. He declined to give any specifics about the meeting, but an FDA calendar listing described the subject as "enforcement issues."

A 30-employee maker of urinary and biliary catheters, electric biopsy forceps, and gastroenterology electrosurgical units, International Medical has been experiencing regulatory problems since a 1998 FDA inspection. That inspection led to a warning letter that cited serious regulatory problems with sterile and nonsterile biopsy forceps, laparoscopic devices, and surgical cauterizers.

At the time, FDA noted that the firm failed to establish and maintain design control procedures. The warning letter also said that the inspection found that the firm did not maintain written procedures covering process validation, corrective and preventive action, purchasing controls, or incoming-component testing. Additionally, FDA cited International Medical for failing to report a patient injury under the Medical Device Reporting regulation.

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