Medical Device Daily Washington Editor

WASHINGTON - Thanks to a tremendous amount of confusion over the meaning and implications of the word "recall," the FDA announced that it will look into whether the term creates more problems than it solves.

Still left up in the air is the question of whether the agency can legally do this without help from Congress. However, at least one association and one Capitol Hill staffer feel that any such change can be dealt with via regulations and requires no statutory address.

The issue surfaced again with last week's roll-out of a new set of recommendations by the Heart Rhythm Society (HRS; Washington) concerning the language and methods for reporting heart rhythm device malfunctions (Medical Device Daily, Sept. 28, 2006). Dwight Reynolds, MD, president of HRS, said "recall" carries a pejorative ring and has resulted in the explantation of perfectly serviceable rhythm devices from patients. HRS wants the FDA to eliminate its use of the word in connection with implantable defibrillators altogether and substitute an expression such as "Class I advisory."

By some accounts, the agency has issued alerts and notifications of various kinds for more than 300,000 defibrillators and pacemakers since 1990, but the rate of replacement of pacemakers due to malfunctions has been less than 5 per 1,000 and 21 per 1,000 for defibrillators.

According to the Prudential Equity Group (New York), defibrillator implantations have dropped by about 8% in the past 12 months. However, given that doctors implanted roughly a quarter of a million defibrillators in 2005, the need for a recall by one name or another is unlikely to vanish any time soon, regardless of the approach the agency takes.

Amy Melnick, vice president for health policy at HRS, told MDD, "[w]e had an attorney look at this, and the opinion we received was that FDA can do this without Congressional approval."

To make the change, she said, "there are challenges, but it can be done." Melnick nonetheless noted that Congressional input would help, saying, "It might be appropriate to put this change into MDUFMA," the reauthorization of the Medical Device User Fee Modernization Act of 2002 which Congress must take care of next year.

She added: "FDA is doing their due diligence and have acknowledged privately and publicly that the word has caused unnecessary surgeries," but that HRS is nonetheless of the opinion that "it's imperative that Congress take an interest in this."

HRS's interest in this verbiage is restricted to implantable rhythm devices, and it does not believe that the agency would have to implement a similar change of wording across all the products it regulates.

Melnick said that in HRS's talks with the agency, "they did not raise the issue of other products." She made the case that any fix, regulatory or statutory, "can be written narrowly" to apply to a particular range of products.

When asked if a different terminology for different products and/or classes of products might sow confusion in the public mind, Melnick said that this would not be a problem "from an HRS perspective."

Kevin Schweers, a member of the staff at the House Energy and Commerce Committee told MDD: "At first glance, it seems like FDA has enough flexibility to make these sorts of decisions."

Agency seeks comment on OCP procedures

The FDA has completed its internal review of the way it regulates combination products and sees room for tweaking. But it may opt for an informal fix for some of the drag encountered in assigning jurisdiction for products that use both drugs and biologics.

The agency asks that public comment be submitted on or before Nov. 27.

In a Sept. 28 notice in the Federal Register, the agency stated that the Office of Combination Products (OCP) will continue to assign a product to the center that would review the component that provides the primary mode of action were it a stand-alone product. In the event of uncertainty, OCP defaults to a decision tree that assigns the product to a center based on similarity to previously approved combo products that raised similar questions regarding safety and efficacy. If that analysis leads nowhere, the center with the most expertise gets the job.

Review times at OCP for requests for determination of classification (RFDs) were originally set at a 60-day limit, but the average turn-around has been 37.7 days, with the longest running 59 days as of March 31, 2006. Requests for reconsideration are scheduled to come back to the submitter within 15 days, but the notice does not give information on OCP's response times for these actions.

The notice points out that the inter-center agreements, or ICAs, between the three centers involved are not binding, but that those ICAs have performed in a way that is "generally consistent with the requirements of section 503 (g)."

However, some jurisdictional decisions made since 1991 fly against the expected center assignment "because of the particular product's specific characteristics or use," and some such odd-seeming classifications were stimulated by requests for reclassification. The agency also said that the reassignment of some products from the Center for Biologics Evaluation and Review to the Center for Drug Evaluation and Review has added to the confusion.

The FDA is of the opinion that while the ICAs between the Center for Devices and Radiological Health and the other two centers are working reasonably well, it had considered updating the agreement between CBER and CDER. Such a rewrite would be cumbersome, however, and in any case, "would soon be out of date as well."

Instead, the agency "preliminarily proposes to rescind the CBER-CDER ICA" in favor of informal mechanisms that provide greater transparency in its decision-making process.

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