Medical Device Daily Washington Editor

Congress had a few too many items on its plate as it careened toward the August recess last week, and thus, despite reassurances from the chair of a House committee, some members of the FDA staff could get their pink slips as a consequence.

The Senate passed its FDA reauthorization bill, S. 1082, on May 9 in a 93-1 landslide, and the House followed suit, passing its bill, H.R. 2900, by a margin of 403-16 on July 11 (Medical Device Daily , July 13).

However, the progress stalled last week in what one member of the Senate GOP said was a deliberate effort by House Democrats to force some of its provisions on the Senate before conference.

According to Congressional Quarterly, a spokesman for Sen. Mike Enzi (R-Wyoming) said that House Democrats stalled on going to conference so as to raise the risk of shutting down the agency, that strategy seen as a way to prod the Senate into going along with the more stringent drug safety requirements in H.R. 2900.

CQ also quotes Enzi, the ranking minority member of the Senate Health, Education Labor and Pensions (HELP) Committee, as alleging that Democrats had stalled on the FDA reauthorization to push through the Children's Health Insurance Program (CHIP) reauthorization, which the House passed last week (Medical Device Daily , August 3).

H.R. 2900 would impose a mandatory review of drug safety at seven years post-market and would require FDA to review any direct-to-consumer drug advertising prior to distribution. Both bills call for a clinical trial database for public access, but the House bill would require that the web site go live within a year of the bill's passage while S. 1082 would give FDA two years to set up the site.

The House bill would also limit the number of advisory committee members requiring a waiver of conflict of interest to one per panel whereas the Senate bill imposes no such restrictions. The Senate bill has a provision for generic biologics, which the House bill omits.

According to CQ, Enzi had objected Thursday "to a unanimous consent request by Majority Leader Harry Reid, (D-Nevada), to call up the House bill, substitute the Senate text, pass the bill and request a conference with the House." Enzi had asked Reid a week earlier to move ahead with efforts to get the bills to conference, but Enzi said that had he known "that this was what the House Democrats wanted a few days before, I would not have hand-delivered that letter to the majority leader and the minority leader" to urge quick action.

FDA is required to hand out reduction-in-force notices 60 days prior to the end of the fiscal year if a budget is not passed. Since the fiscal year ends Sept. 30, that 60-day requirement fell onto Aug. 1.

However, Henry Waxman (D-California), who chairs the House Oversight and Government Reform Committee —and whom Enzi blamed for the clinical trials database impasse — said that layoff notices are unnecessary.

Of the FDA bills, Waxman said "we'll get to it when we come back." He also said that he wanted differences hashed out prior to conference, which is purportedly the intent of going to conference.

FDA commissioner Andrew von Eschenbach, MD, said last week that the agency "can get through the next few months with reserves," but that he had informed Congress on several occasions over the past few months that the lack of user fee revenue puts jobs at risk, he said.

The FDA is making use of "carryover funds" from previous years' user fees, but the delay is having an effect on employee morale.

Von Eschenbach also noted that about 30% of the agency's staff is eligible for retirement or is in a position to do so regardless of age-based eligibility.

Senate passes CHIP bill

In a late session last Thursday, the Senate passed its version of the CHIP reauthorization, which, like the FDA reauthorization, has to be completed by Sept. 30 and has to go through a House-Senate conference before a final bill can be sent to the White House.

However, unlike the FDA bill, this one faces an almost certain White House veto.

The House CHIP bill passed last Wednesday by a fairly slim margin of 225-204, largely a party-line vote, and would boost the five-year total of CHIP funding to $48 billion, or close to $10 billion a year (Medical Device Daily , August 3).

The so-called Children's Health and Medicare Protection Act of 2007 relies partly on tobacco taxes and partly on cuts to Medicare Advantage (MA) plans, the latter of which has been the target of controversy on Capitol Hill, while the Senate bill would finance the entirety of its five-year, $35 billion proposal on tobacco taxes. However, questions remain as to whether such taxes would not damp demand for cigarettes, hence driving down projected tax revenues.

The White House has proposed adding $1 billion a year to the current level of $5 billion for a five-year total of $30 billion, but President Bush has indicated that he is no longer in favor of the use of CHIP monies to insure adults. By some accounts, Senate GOP members are of the opinion that the party can sustain a veto for any amount that comes out of conference above the Senate figure.

In a statement, Max Baucus (D-Montana), chairs of the Senate Finance Committee, said "I would hope that the broad bipartisan support for this agreement will cause the President to rethink his veto threat, so that more uninsured kids can realize the promise of the Children's Health Insurance Program."

The ranking member of the Senate Finance Committee, Chuck Grassley (R-Iowa) said that the bill returns CHIP "to its core mission, and that is to provide healthcare coverage to low-income uninsured children."

Grassley also said that "[t]oo many states have gotten waivers and opened enrollment to adults, draining resources from the neediest and most vulnerable children."