Medical Device Daily Washington Editor

Congressional interest in the device industry's interaction with physicians has not subsided despite the approaching elections, and a recent letter from two senators to Columbia University and the Cardiovascular Research Foundation (CU and CRF; both New York) makes clear that the issue is not likely to go away anytime soon. However, it does appear that legislators are willing to take up such reviews even in the absence of a specific charge of corruption.

Taking up the matter in reference to their respective committees' jurisdiction over Medicare and the well being of senior citizens, Sens. Herb Kohl (D-Wisconsin) and Chuck Grassley (R-Iowa) penned roughly identical Oct. 16 letters to Lee Bollinger, CU's president and to Gregg Stone, MD, the president of CRF, asking for information on the sources of funding for both organizations. The letters also inquire as to payments made by device makers to a number of physicians associated with one or both of the entities.

The letter to Bollinger asks for details on outside incomes for 22 members of the CU faculty, including Stone and Martin Leon, MD, who founded CRF, as far back as the beginning of 2003. Bollinger's staff will also have to generate data on funding to the university from device makers, including Abbott Laboratories (Abbott Park, Illinois), Medtronic (Minneapolis), Boston Scientific (Natick, Massachusetts), and Johnson & Johnson (New Brunswick, New Jersey), the parent company of Cordis (Miami Lakes, Florida).

Kohl and Grassley also inquired into "the nature of the relationship between Columbia University and the Cardiovascular Research Foundation," asking for a copy of "all pertinent documents" dating back to Jan. 1, 2003.

In the letter to Stone, the senators state that Kohl was interested in the organization's interactions with the American College of Cardiology (ACC; Washington). The letter also states that Douglas Weaver, MD, president of ACC, had written in an editorial in an unidentified publication that industry funding "constitute[s] about 38% of the College's revenues." The senators acknowledge that "such associations do not necessarily exert improper influence upon medical practice," but "serious questions remain."

The letter also cites a statement attributed to Jeffrey Moses, MD, appearing in the New York Times in which Moses is said to have stated that safety "is not the big issue any more" with regard to drug-eluting stents. The letter from Kohl and Grassley argued that "there are divergent scientific opinions concerning such products."

CRF's Oct. 16 statement said that the organization "welcomes the inquiry" and that CRF "intends to comply fully with their requests for information about CRF's research and educational activities and funding sources. The statement also noted that CRF "is committed to maintaining the highest standards of integrity in all its research and educational activities, and ensuring independence, objectivity and scientific rigor in all of its programs."

At press time, calls to the office of Grassley and the Senate Special Committee on Aging, which Kohl chairs, had not been returned.

New guidance on imaging, contrast agents

Pursuant to an agreement FDA hammered out with makers of radiological diagnostics, FDA has published a draft guidance to address the mix-n-match nature of scanning machines and contrast agents that are already on the market. While the draft promises a dose of much-needed clarity, the document also suggests that for at least some new combinations, a PMA will be required.

The draft guidance makes explicit that it addresses only "new contrast indications using an already marketed imaging drug, and the guidance aims to deal with three issues. One is the ability to add contrast agents to the list of allowed agents for a given imaging device "without having modification of labeling for both the device and the drug."

FDA also wants to standardize the scientific and technical information it takes in from industry in pursuit of new combinations "regardless of the type of submission" used for the contrast agent and the imaging equipment, but FDA also acknowledged that the format of the data submitted is also a consideration in hammering out the guidance.

Getting a new combination through FDA might require an application per the device if the new use is consistent with the contrast agent's current approved indications and involves no changes to route of administration, formulation and dose, according to the guidance. In this scenario, the sponsor would be able to add the contrast agent to the list of agents approved for that device without "the need for a conforming change to the imaging drug labeling."

Conversely, if a sponsor wants to make changes to the formulation, dosing, or route of administration for a drug in conjunction with an imaging device that already has a PMA or a 510(k), the holder of the drug or biologics approval will have to submit at least a supplement to FDA. In the case of a tweak to the agent that allows "enhanced biodistribution to a new area but using the same imaging software," the agency may want to see a new drug application.

Any change to the previously mentioned characteristics of the contrast agent that would force a change in the performance characteristics of the imaging equipment or vice versa would likely require a submission of some sort for both components, the guidance states. FDA also indicated that a 510(k) may do the job "if the approved imaging drug and cleared imaging device are already indicated for the same or consistent contrast indication."

In virtually any case, the effort will be neither cheap nor easy. FDA states in the guidance "the safety and effectiveness of the new contrast indication should be established by data collected from appropriately designed clinical trials using both the drug and the device." FDA also indicated that post-market surveillance may be necessary beyond adverse event reporting, but offered no detail.

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