Medical Device Daily
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WASHINGTON – Acting FDA Commissioner Andrew von Eschenbach's nomination cleared a significant hurdle this week, with a unanimous vote from the Senate Health, Education, Labor and Pensions (HELP) Committee on Wednesday. But his path to confirmation still faces roadblocks that are also significant.

Two new holds have been placed on the nomination, this time from GOP senators, weeks after two long-standing Democrat holds were lifted. In the latest procedural blocks, Sen. Jim DeMint (R-South Carolina) is holding up the nomination in an attempt to get the FDA to rescind its approval of the abortion drug RU-486, and Sen. David Vitter (R-Louisiana) is using the same tactic to secure drug imports from Canada (Medical Device Daily, Sept. 18, 2006).

Calling the FDA's top spot “a very difficult position for anyone to hold,” committee Chairman Mike Enzi (R-Wyoming) noted that clearing this confirmation process “has to be the toughest thing outside a Supreme Court justice to get passed around here.”

The nature of the position, he continued, has become a Catch-22.

Of note, the FDA has had a confirmed commissioner for only 18 months in the last five-and-a-half years. That's clearly due in part to the myriad of political forces seeking to pull strings at the agency.

Enzi stressed that FDA policies should be based upon science, not politics, a cry that's been heard over and over again during von Eschenbach's nomination and also that of his predecessor, Lester Crawford.

“If we move away from basing this thing on science,” Enzi cautioned, “it just becomes more of a political football than it has been.”

The committee's voice vote in support of von Eschenbach was held in the president's room at the Capitol, just off the Senate floor, where the lawmakers have been gathering en masse to urgently move on various legislative matters. Noting the near-term horizon for this congressional session – both chambers are going on recess after next week in advance of the coming mid-term elections – Enzi indicated that he would push for a full Senate vote “as soon as we have a chance.”

But first the full Senate has a chance to raise objections to von Eschenbach's nomination, now that it's cleared the committee, and this is the point where the holds come into play. A filibuster-like procedure, a hold can be used to stymie a nomination or a bill. In the Senate, 60 votes are required to overcome holds. Traditionally, they are filed anonymously, although that hasn't been the case with this nomination.

DeMint, in voicing his continued opposition, said in a statement that von Eschenbach “has done nothing to publicly discourage the use of” RU-486, a product he linked to eight deaths and more than 1,000 adverse events in recent years. “In the face of mounting scientific evidence, injury, and death, the FDA has done nothing to suspend this drug and prevent it from hurting or killing more women,” which he said calls into question “its ability to protect American consumers.”

Less than a month ago, holds from Sens. Hillary Clinton (D-New York) and Patty Murray (D-Washington) were lifted after the FDA approved over-the-counter sales of the Plan B contraceptive product to women 18 and older.

With the coming break in congressional business, there remains the possibility of a recess appointment for von Eschenbach. But Enzi indicated that such an appointment would put the FDA in a position of weakness, especially relative to negotiating bills to reform the agency, as would von Eschenbach's continued acting status. Sen. Barbara Mikulski (D-Maryland) added that FDA needs “vigorous oversight” to ensure that the agency “stays true” to its mission.

The medical device industry has staunchly stood behind von Eschenbach, who first came to the FDA a year ago following Crawford's abrupt resignation just months after receiving Senate confirmation himself. Previously, von Eschenbach led the National Cancer Institute.

The Advanced Medical Technology Association (AdvaMed; Washington), the most powerful lobby group in the U.S. for medical technology issued a statement backing von Eschenbach

“AdvaMed applauds the Senate HELP Committee's vote today to confirm Dr. von Eschenbach as FDA Commissioner,” said Steve Ubl, association president/CCO. “The medical technology industry and the agency both benefit from having permanent leadership at FDA. I urge the full Senate to confirm Dr. von Eschenbach as quickly as possible.”

“I believe Dr. von Eschenbach will be an outstanding FDA Commissioner,” Ubl added. “As a former Director of the National Cancer Institute and as a urologic surgeon and oncologist, he has a clear understanding of the value that medical technology brings not only to patient care but to the U.S. health care system as a whole. He is well-qualified to lead this vital agency, and AdvaMed looks forward to working with him.”

Ortho Evra patch to get new warning

It appears that Johnson & Johnson's (J&J; New Brunswick, New Jersey) Ortho Evra contraceptive patch will come with a new warning about a study suggesting users could face twice the risks of blood clots compared with birth control pills, the company and U.S. regulators said this week.

The label instructions for Ortho Evra also will carry results from another study that found the chances of blood clots were equal with the patch and a birth control pill.

“Let us be clear: We cannot conclude that in fact there is a greater risk,” said Dr. Daniel Shames, acting deputy director of the FDA office that reviewed Ortho Evra.

Shames said there was enough concern, however, that women and their doctors should consider the information when choosing a birth control method. The patch, which is replaced once a week, is viewed as more convenient than daily pills.

Scientists have known for years that the estrogen used in contraceptives raises the risks of blood clots, which can cause heart attacks or strokes. Women who use Ortho Evra are exposed to about 60% more estrogen than pill users.

The two new studies looked at health insurance records for up to 500,000 women. The FDA asked J&J to monitor the records for possible reports of blood clots, heart attacks or strokes. Shames said both studies are set to continue for another 18 months to two years.

The chances of developing a blood clot while using a hormonal contraceptive remain low, Shames said. For every 10,000 women who use a hormonal contraceptive for a year, about three to five of them will develop a clot, he said.

J&J said it had agreed to continue collecting data and would provide new information to the FDA as well as issue a letter to doctors about the label change.

Gen-Probe responds to assay questions

Gen-Probe (San Diego) said it has submitted responses to the FDA's questions regarding its regulatory application to run the previously approved Procleix WNV (West Nile virus) assay on the investigational, fully-automated Procleix Tigris system. The WNV assay was approved to run on the Procleix enhanced semi-automated instrument system (eSAS) in December (MDD, Dec. 5, 2005).

As previously disclosed, the FDA asked the questions in late July in a “complete review letter” (CRL) on the Biologics License Application (BLA) supplement Gen-Probe originally submitted in April. The questions related primarily to a clinical “migration study” that Gen-Probe conducted to compare Procleix WNV assay results on the eSAS to results on the fully automated Procleix Tigris system. The results of this study were presented by independent and Gen-Probe researchers at last year's annual meeting of the AABB (American Association of Blood Banks; Washington).

Blood centers have used the Tigris system to screen donated blood for WNV under an Investigational New Drug (IND) application since the summer of 2004. The company estimated that more than 4 million units of donated blood have been screened for West Nile virus under this IND. This testing on the Tigris system has intercepted more than 200 units of blood that otherwise would have been transfused into as many as 600 patients, the company said.