The backlog of device applications at the Food and Drug Administrationhas become so severe that device manufacturers are ready to talkturkey about the unmentionable: device user fees. An indication of the change in industry opinion came last month,when
The backlog of device applications at the Food and Drug Administrationhas become so severe that device manufacturers are ready to talkturkey about the unmentionable: device user fees.
An indication of the change in industry opinion came last month,when the Health Industry Manufacturers Association forwarded aletter to the FDA indicating that the group is willing to discussuser fees with the agency. The overture indicates that HIMA hasrelaxed its prior position of vehement opposition to user fees.
Prescription drug manufacturers agreed last year to a planto assess user fees as a means of speeding the drug evaluationprocess (SCAN 9/16/92). The FDA initially planned to bring devicesunder the user-fee umbrella as well, but dropped the idea in theface of staunch industry opposition led by HIMA.
Device user fees resurfaced earlier this year as part of PresidentClinton's budget (SCAN 3/10/93). This plan called for user feesto contribute $220 million to the FDA's budget by 1995, but didnot specify how much of the amount would be collected from devicemanufacturers.
The budget request was rejected by the House of RepresentativesAppropriations Committee, however, which said that assessing userfees would be a significant policy change that should be authorizedby the appropriate congressional committees.
Clinton's move--and the willingness of members of Congressto consider user fees--has led HIMA to rethink its categoricalopposition. It will do so to avoid being frozen out of the devicereview reform process, according to a letter sent to HIMA members.
"(The HIMA board) feels it is imperative that our associationhave a seat at the table to ensure that any fees satisfy conditionsthat will protect the continued vitality of our industry,"said Alan H. Magazine, HIMA president.
HIMA's conditions for supporting device user fees are similarto those agreed upon by the pharmaceutical industry; namely, thatthey be tied to improvements in the product review process atthe FDA.
HIMA specifically asked that the agency implement the recommendationsof a report on product review issued in May by Rep. John D. Dingell'ssubcommittee on oversight and investigations. Dingell (D-MI) hasbeen a consistent critic of the FDA's device review process (SCAN9/23/92).
Ironically, HIMA has found strong support for device user feesamong its members. The organization reported that 85% of memberssurveyed in a recent poll indicated they would favor user feesif there were assurances that fees would result in a more efficientdevice review system.
Such assurances are the key to any device user fee system,according to Benjamin L. Holmes, vice president and general managerof Hewlett-Packard Medical Products Group of Andover, MA. Holmesis a member of HIMA's board of directors.
"We could throw a bunch of money at (the FDA), but unlessthey get their internal act together, it's just throwing moneydown a rathole," Holmes said.
It's still too early to tell whether pharmaceutical user feeshave improved the drug approval process, Holmes said.
In addition to the HIMA letter, device user fees won a voteof confidence from the world's largest manufacturer of therapeuticmedical devices, Medtronic of Minneapolis. In May, Medtronic sentthe FDA its own plan for device review reform, which includeda user fee proposal.
Such payments should be balanced to take into account companysize and the type of product submission, according to the Medtronicblueprint. Industry payments should be plowed back into the productreview process and should augment, and not replace, appropriationsfrom general funds for device review.
Medtronic's position is similar to that of HIMA's, accordingto spokesperson Dick Reid.
"We support user fees as long as those fees are dedicatedto improving the device review process," Reid said. "Moreand more companies are realizing that an expeditious approvalprocess would be good for the industry and good for medicine."