NEMA analyst predicts new legislation in 1995Health-care reform wasn't the only medical-related legislationthat died when Congress adjourned earlier this month. Severalbills that would have assessed user fees on companies submittingdevice
Health-care reform wasn't the only medical-related legislationthat died when Congress adjourned earlier this month. Severalbills that would have assessed user fees on companies submittingdevice approval applications to the Food and Drug Administrationwere killed when Congress failed to act on the proposals beforethe end of its term.
The demise of user-fee legislation gives device manufacturersa temporary respite from additional fees and paperwork. Thereis little cause for celebration, however. Legislators are almostcertain to take another stab at device user fees, and future legislationmay not be as amenable to industry as were several of the billsthat were under consideration.
One bill, the Medical Device User Fee Act of 1994 (H.R. 4728),was the product of careful negotiations between the National ElectricalManufacturers Association, the Health Industry Manufacturers Association,the FDA and lawmakers. The bill would have assessed fees of $52,000for a premarket approval (PMA) application and $3200 for a 510(k)filing (SCAN 8/10/94 and 6/29/94).
The device industry was successful in bringing down the proposedcost of the fees, which stood at $100,000 for a PMA and $9000for a 510(k) in early versions of the bill. Industry was alsoable to include language committing any device user fee revenueto the FDA's product approval process rather than general deficitreduction. In addition, the bill's proponents secured a commitmentfrom FDA chief David Kessler that the agency would support devicereview performance goals if it received user fee revenue.
Two other device user fee bills were also competing for legislators'attention in the waning hours of the 103rd Congress. One bill,sponsored by Sen. Orrin Hatch (R-UT), was almost a wish list fordevice companies and was never given serious chance of passage.
A more serious threat to H.R. 4728 was language in a SenateAppropriations subcommittee bill for the FDA's 1995 budget thatwould have raised $150 million in device user fees, without specifyingwhere the revenue would be spent. The medical device industryhas historically opposed user fees that are not tied to the productapproval process.
In the end, all three proposals died. NEMA and its legislativeallies tried to push H.R. 4728 through for a floor vote undera procedural rule that would have prevented amendments to thebill, according to Robin Wiley, NEMA's manager of legislativeand regulatory affairs for the diagnostic imaging and therapysystems division. The tactic would have preserved the integrityof the bill and would have allowed it to proceed to the Senatemore quickly.
Several Republican representatives balked at the tactic, however.The bill never made it to the House calendar and died when Congressadjourned on Oct. 7.
Likewise, the Hatch proposal never developed into legislativelanguage and died on the vine. On the positive side, the SenateAppropriations subcommitee's proposal to raise $150 million inundirected user fees was stripped from the budget before it waspassed, Wiley said.
The death of the legislation does not mean that the medicalindustry has seen the last of device user fees. Since 1980 userfees have appeared frequently in proposals for the FDA's budgetand will probably show up again when the 104th Congress drawsup the agency's 1996 budget, Wiley said. NEMA and its allies maynot be as successful then in crafting a compromise palatable toindustry.
"To have the funds targeted to product approvals and tohave a series of performance goals that the agency was supposedto meet was a major victory for the industry," Wiley said."I don't know if we'll be as successful next time around.Buying yourself time is not always the best solution."