A Medical Device Daily
The House Energy and Commerce Committee voted through its version of the FDA reauthorization bill last week and included some changes to the original set of bills that were the objects of dismay from the GOP, FDA and many members of the public (Medical Device Daily, June 13, 2007).
The current iteration of the House bill calls for an overall device user-fee boost of 31% in 2008 and an annual increase of 8.5% each of the four following years, for a total of about $287 million. The 8.5% per year increase mirrors a cap imposed on fee increases in MDUFMA II.
The senate passed its version of an FDA reauthorization bill May 9 by a vote of 93-1, with the sole nay vote coming from Bernie Sanders (D-Vermont).
The House and Senate presumably will hash out any differences in their respective bills by Sept. 30, the expiration date for the previous five-year FDA reauthorization bill.
According to the Congressional Budget Office (CBO), the device user fee program would bring in $48 million in FY08 and $53 million the following fiscal year. The total projected user fees collected for the last year of the five-year agreement, 2012, is projected at $67 million.
As for the agency’s performance goals under the MDUFMA agreement arrived at by industry and the agency, 60% of conventional PMAs and PMA supplements would be decided on within 180 days, with 90% of such filings acted on within 295 days.
For 510(k) filings for low-risk devices, the agency has committed to deciding on 90% within 90 days and 98% within 150 days.
Reaction to the passage of the House bill was predictably mixed.
In a June 22 press release, Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said that the association’s members “are especially pleased that the committee removed a proposal to limit the preemptive effect of FDA’s device-specific actions. Ubl was referring to a proposal that would have allowed lawsuits to proceed in state jurisdictions without regard to the agency’s approval or clearance of a device or the labeled indications.
Ubl said that the pre-emption provision “would have created hundreds of standards for medical technology manufacturers.”
Many members of the committee’s health subcommittee were opposed to an amendment by Jay Inslee (D-Washington) and Joe Pitts (R-Pennsylvania) that would boost the agency’s third-party inspection program, including the subcommittee chair, Frank Pallone (D-New Jersey), but after the June 12 health subcommittee hearing, the Inslee-Pitts amendment made it into the final mix for the full committee. Ubl also thanked the chairman and the ranking member of the full committee, John Dingell (D-Michigan) and Joe Barton (R-Texas), respectively for their help in “preserving the carefully negotiated FDA/industry user fee agreement in this critical package of legislation.”
The Medical Imaging and Technology Alliance (MITA; Rosslyn, Virginia) also chimed in, with VP Andrew Whitman stating in a June 22 press release that MITA favors the bill “because it will increase user fees and provide FDA with stable and predictable funding.” Whitman also said that MITA was likewise “pleased with the legislation which addresses third-party inspection provisions.”
Offering a counterpoint was Andre DiMino, co-CEO of electrotherapy maker Ivivi Technologies (Northvale, New Jersey), who last week argued in an entry in Medical Device Daily Perspectives — MDD’s weekly commentary on med-tech happenings — that the increase in user fees will hamper small firms. DiMino said that “the current fees for submission of a PMA already have forced some companies to withhold submission,” and that additional fees, such as the fees for multiple facility registration, “will stifle innovation and timely patient access to safe and lifesaving medical devices.”
A spokesperson for the Energy and Commerce committee who declined to speak for attribution said that the House Rules committee would have to review the bill prior to introduction on the floor and that the general hope is that the bill will get a vote prior to the August recess.
Baucus: SCHIP funding ‘unacceptable’
The current controversy over funding for the State Children’s Health Insurance Program (SCHIP) between the White House and the Senate Finance Committee chairman, Max Baucus (D-Montana), has drawn substantial ink, with Baucus blasting as “unacceptable” the Bush administration for its proposed increase of $1 billion a year.
In a Feb. 7 press release, Baucus charged that “more than one million children and 600,000 of their parents, caretakers and other low-income adults could lose health coverage” as a result of the 20% boost in the federal government’s contribution (CHIP) under the administration’s 2008 budget proposal.
Baucus has proposed a $50 billion increase for the five-year authorization period, and went on record earlier in the year that he would use his position on the committee as a bully pulpit in favor of a universal healthcare program.
Into the fray comes a report from the Urban Institute (Washington) that claims that the situation is not as dire as Baucus has claimed.
The U.S. Department of Health and Human Services released the results of the Urban Institute report last week, and according to HHS, the report “showed that 689,000 uninsured children are in low-income families that fall below 200% of the federal poverty level” and that consequently, “adding $50 billion in additional funding is not necessary.”
Using the various state guidelines would boost the number of eligible children to 794,000, according to the report. The HHS press release claims that the Census Bureau has under-counted those enrolled in CHIP and Medicaid, and counts illegal immigrants as well as legal immigrants who have not been in the U.S. long enough to qualify.
The Urban Institute report relies on “a comprehensive microsimulation model” that “uses detailed, state-specific rules to determine which children are eligible for Medicaid and/or SCHIP.” According to the HHS press release, two million children from low-income families have been added to the CHIP program over the past six years, and the Congressional Budget Office has estimated that “up to 50% of those newly enrolled in SCHIP were formerly enrolled in private plans.”