A Medical Device Daily
Congressional Democrats and the White House are known to have different views on financing for the Children’s Health Insurance Program (CHIP) for the next five years, and a member of the administration suggested last week that Democrats could decide to wait out the Bush administration in hopes of getting a better deal with Bush’s successor.
The Capitol Hill periodical Congressional Quarterly reported last week that Leslie Norwalk, acting administrator at the Centers for Medicare & Medicaid Services, told a group of Citigroup (New York) investors that the CHIP reauthorization could be for as short a time as two years, given the White House threat to veto any bill that reaches for more than $6 billion a year (Medical Device Daily , Aug. 6).
According to CQ, Norwalk said that “[w]hether it’s two years or one year or five years, a lot of that will just depend on amounts. I don’t know how they’re going to get to five years.”
Norwalk was also quoted as saying that if Congress passes a bill that is “something shorter, that is less money — the president will have a harder time vetoing it.”
Norwalk also said she would not be surprised if Congress “did something less than full authorization for five years.”
While the Senate version of the CHIP bill relies entirely on tobacco taxes to come up with a budget-neutral piece of legislation, the House version would pull back on funding for Medicare Advantage (MA) plans by roughly $157 billion over a decade, said to amount to about 10% of MA funding. Norwalk said that when she addressed MA funding with Congress, “I suggested that they look at the scalpel approach relative to the axe approach.”
The Senate bill would fund the program at a five-year total of $35 billion, whereas the House bill funds CHIP at $48 billion over five years.
Norwalk is said to have also told the Citigroup audience that the agency is not inclined to further restrict reimbursement for Epogen for dialysis patients even if the upcoming Sept. 11 FDA advisory committee meeting recommends a more restrictive label.
Referring to the 68-31 vote on the Senate CHIP bill, Finance Committee chairman Max Baucus (D-Montana) said in a prepared statement that he expects that the “broad bipartisan support for this agreement will cause the President to rethink his veto threat,” but rumblings from the GOP indicate that the Senate will sustain any veto of a CHIP bill that exceeds the Senate’s proposed funding level. At press time, Baucus’s office had not returned calls for comment.
Grassley: Beef up foreign pharma inspections
The ranking member of the Senate Finance Committee, Chuck Grassley (R-Iowa), recently wrote to FDA commissioner Andrew von Eschenbach to ask what the agency intends to do to beef up its inspections of foreign drug manufacturers.
In the Aug. 8 letter, Grassley said that he was “troubled by a number of recent articles discussing the FDA’s failures in inspecting foreign pharmaceutical manufacturing plants,” and referred to an article that appeared recently in the Washington Post in which former FDA associate commissioner William Hubbard described the situation as “dire and deteriorating.”
Grassley told von Eschenbach that because “nearly 80% of the active pharmaceutical ingredients used in the U.S. are manufactured abroad, this is a significant problem that needs to be addressed immediately.”
On the other hand, Hubbard did not let Congress off the hook, either. His May op-ed in the Post stated that “[t]ime after time in recent years, FDA scientists have warned of threats to the safety of the nation’s food and drugs, sought new resources and tools to deal with those threats, and been duly dismissed.” Hubbard added that “when [FDA’s] predictions have come true, decision makers of all political stripes rush to bemoan the agency’s failures.”
FDA’s ability to conduct routine inspections of domestic companies was known to be deficient in the late 1990s, and some manufacturers of devices and drugs managed to go five years or better between inspections despite the agency’s stated intent to inspect every two years. The rapid turnover of FDA staff and the recent increase in the number of firms setting up shop have left FDA in a pinch.
While S. 1082, the Food and Drug Revitalization Act, calls upon the Secretary of the Department of Health and Human Services to bolster FDA’s inspection of overseas food manufacturing facilities, it does nothing to promote the agency’s capacity for inspections of foreign drug and device manufacturing plants.
House Democrats fought to avoid boosting the agency’s authority to license third-party inspectors (Medical Device Daily , July 13, 2007) in the House version, H.R. 2900.
Pelosi says FDA jobs safe
House speaker Nancy Pelosi (D-California) sought to reassure FDA employees that despite the looming deadline to pass user fee legislation, no one will lose their jobs. The current funding cycle ends Sept. 30, and the two houses have yet to reconcile their versions of the FDA reauthorization act.
Sen. Mike Enzi (R-Wyoming) said last week that House Democrats were stalling on the FDA reauthorization as a strong-arm tactic to get the Senate to go along with the House’s requirement that FDA get its clinical trial database up within one year rather than the two years allowed in the Senate version (Medical Device Daily , Aug. 6, 2007).
FDA commissioner Andrew von Eschenbach warned that the agency is required to post notices for reductions in force 60 days before the end of the funding period for drug and device user fees, which would principally affect product reviewers.
In a letter to von Eschenbach, Pelosi said that Congress “will complete action on this legislation so the dedicated federal employees of the FDA will not face termination notices.”
Senate majority leader Harry Reid promised FDA staffers that Congress “look[s] forward to working over the August recess to finalize a package that will revitalize and improve the FDA.”