Medical Device Daily Washington Editor

The old adage warns to never ask how circumstances can get any worse.

But just when staff members at FDA think things have hit rock bottom, Congress announces that despite its laggardly action on the FDA reauthorization bill, it will take a closer look at the agency’s actions in connection with a device inspection conducted four years ago.

The House Energy and Commerce Committee and one of its subcommittees are commencing with an investigation into the circumstances surrounding a follow-up 2004 warning letter issued to Cordis (Miami Lakes, Florida), maker of the Cypher drug-eluting stent.

The move may strike observers as ironic, given recent criticism of Congress by former associate FDA commissioner William Hubbard, who penned an op-ed column for the Washington Post in May. Hubbard blasted Congress for ignoring warnings from the agency “of threats to the safety of the nation’s food and drugs” while seeking “new resources and tools to deal with those threats,” only to be dismissed by Congress.

Hubbard added that “when [FDA’s] predictions have come true, decision makers of all political stripes rush to bemoan the agency’s failures.”

The chairman of the full committee, John Dingell (D-Michigan), authored both letters, dated Aug. 13, to FDA chief Andrew von Eschenbach, MD, and to William Weldon, CEO of Cordis’s parent company, Johnson & Johnson (J&J; New Brunswick, New Jersey). And the chair of the subcommittee on Oversight and Investigations, Bart Stupak (D-Michigan), also signed the letters.

In the letter to von Eschenbach, the Michigan Democrats say that the inspections of six Cordis facilities conducted in 2003 disclosed “numerous systemic violations resulting in the adulteration of Cypher stents,” and that despite those findings, “Cordis was allowed to continue marketing” the stents.

This is not an uncommon practice, however. Those who read the FDA warning letter page can attest that the FDA usually allows a device or drug maker to continue operations while straightening out regulatory compliance problems.

The letter requests that FDA turn over all records and communications related to the inspections and the writers say, “we have directed the [committee] staff to interview FDA staff” at the Center for Devices and Radiological Health (CDRH) as well as at the Florida, New Jersey and Puerto Rico district offices.

The letter to J&J makes a similar request regarding documentation and notifies the firm that the committee’s staff would also interview J&J personnel.

The April 1, 2004, warning letter, signed by the director of the Office of Compliance at CDRH, Tim Ulatowski, says that the agency is “concerned with the breadth and scope of the specific violations” documented in the inspections, describing them as “symptomatic of serious underlying problems in your firm’s manufacturing and quality systems.”

The first citation of the letter addresses handling and disposition of non-conforming products at three plants. Regarding the San German, Puerto Rico plant, FDA states that a test that indicated an out-of-specification (OOS) outcome for residual solvent analysis was invalidated without documentation of “assignable cause or adequate scientific rationale.” The unspecified number of lots of Cypher stents were said to have been retested and distributed.

FDA also says that the retest was done with new samples from the lot in question, rather than with the originally tested stents.

The letter also states that personnel at the Warren, New Jersey, plant concluded that several OOS outcomes were due to analyst or instrument error and that the company did not document “evaluations of all the possible causes of the OOS results.”

As for the Miami Lakes plant, the warning letter states that documents addressing coating defects “did not include adequate data or justification for using non-conforming product” and that the non-conforming products scored a 1 on a 10-point scale for health hazard. The warning letter stated that 1 was the lowest score on that scale, indicating the least hazard.

Each of those three plants was cited for lack of procedures for corrective and preventive action, whereas a citation covering failure to validate the coating process snared the San German plant as well as plants in Beerse, Belgium, and Roden, the Netherlands.

At press time, staffers with the Oversight and Investigations subcommittee did not return calls for comment for the record, other than to say that the staffers with a working knowledge of the investigation were not in town, and it is not known why Dingell and Stupak opted to investigate this matter.

MDD’s interview on background with a member of the committee staff indicated that the committee views the agency’s ability to conduct effective inspections as dismal, but the staffer would not discuss whether funding for the agency is a factor.

Cordis spokeswoman Mariela Melendez said in a statement that Cordis’ continued manufacturing of the Cypher DES, while addressing FDA’s concerns, is “consistent with typical FDA practice for warning letters related to quality issues” and that the company “will cooperate with the Committee in regard to its requests for information.”

Melendez also said that the Cypher is “the world’s most studied drug-eluting stent.”

CMS scrubs another MA plan

Health plans that do business with the Centers for Medicare & Medicaid Services under Medicare Part C, also known as Medicare Advantage (MA), have been under the gun of late. And MA plans sustained yet another body blow earlier this week as CMS cancelled its contract with a second Florida HMO.

CMS gave the ax to SunCoast Physicians Health Plan (Weston, Florida) because of the plan’s financial struggles after it was ordered into receivership by a Florida court for liquidation of assets.

CMS reported that the SunCoast’s 600 enrollees will be re-enrolled into Humana Gold Plus. The move comes as Congress considers trimming funds for MA plans in order to bolster funding for the Children’s Health Insurance Plan (Medical Device Daily, Aug. 6), which is the subject of controversy and a possible White House veto.

The agency reported last month that it had cancelled its contract with America’s Health Choice (Vero Beach, Florida) due to indications that the plan was unable to service all 12,000 enrollees, as suggested by frustrations that seniors expressed concerning the difficulty in getting appointments.

CMS also alleged that medication errors were observed.

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