The Food and Drug Administration was designated last month bythe Department of Health and Human Services as the agency to administerthe Mammography Quality Standards Act. While the FDA strengthenedits position in implementation of this legislation,
The Food and Drug Administration was designated last month bythe Department of Health and Human Services as the agency to administerthe Mammography Quality Standards Act. While the FDA strengthenedits position in implementation of this legislation, questionsremain as to the future role of the American College of Radiologyin the MQSA process (see related story, page 6).
The ACR was helpful to Congress in drafting the act by virtueof its experience managing a six-year voluntary mammography accreditationprogram. The society was confident after passage of the legislationin October that it would be deeply involved in mammography sitecertification.
That confidence has been shaken, however, since the selectionof the FDA to run the program. The ACR is on the outside lookingin--and this has the society worried.
"We're not sure exactly what decisions have been madeor what's going on at the present time," said Gary Price,senior director of government relations for the ACR. "Thereis a lot of work being done behind the scenes."
The college may be out of the loop because of its close tieswith physicians who will be regulated by the program. Ironically,the ACR's voluntary mammography accreditation program has succeededlargely because of the society's close relationship to the medicalimaging community.
Through this voluntary accreditation program, the ACR has approved--oris in the process of reviewing--9000 of the 11,000 mammographysystems operating in the U.S.
The ACR's insider status under the MQSA program may have somegovernment officials spooked. At least one FDA staffer has askedwhether the college would be faced with a conflict of interestif it were immersed too deeply in the program.
"I'm not sure specifically who at the FDA has raised (theconflict-of-interest issue)," Price said, "but I certainlyknow that it has been said."
John McCrohan, acting deputy director of the FDA mammographyquality assurance program, confirmed that the conflict of interestissue has been raised by his staff.
Concern over potential ACR conflict of interest goes beyondthe FDA to include other agencies within the Department of Healthand Human Services, Congress and the White House, according toRichard Gross, who serves as program liaison with radiation controldirectors in state governments.
Both McCrohan and Gross agree that the issue of possible conflictsof interest will not stand in the way of tapping the expertiseof the ACR and radiologists.
"It is a situation where we have to identify what theconflict is and deal with it during the process. But you don'texclude those folks--it would be outrageous to exclude them,"Gross said.
A process will be developed for dealing with conflict of interestissues, McCrohan said. Since that process has yet to be workedout, however, the FDA has not officially tapped the expertiseof the ACR and the radiological community in organizing the program.
FIVE OFFICIALS FROM THE FDA Center for Devices and RadiologicalHealth's Office of Training and Assistance have been hammeringout the general outline of the program and hiring new staff. Tennew positions have been approved to date.
The FDA plans to put together an advisory committee that willassist in implementing the act. A conference to determine standardsfor accreditation will be scheduled for late September or earlyOctober.
The agency is also writing specifications for equipment thatwill be used to run the program, including data processing, calibrationand field testing devices.
The ACR would like to be involved as these first steps aretaken.
"After all, this (mammography quality assurance) wasn'tsomebody else's idea," Price said. "We've gotten verygood at what we do."
The society's experience in mammography quality certificationmay be helpful, if not necessary, to the FDA in meeting deadlinesimposed by the legislation. The new law requires that mammographyfacilities either be certified by October of 1994--or they stopperforming mammograms.
"One would certainly think that if you have a voluntaryprogram that has either accredited or is currently processingaccreditation for between 85% and 90% of all mammography providersin this country, that you would use that program," Pricesaid. "The wheel has already been invented and is rollingdown the road. It seems absurd to reinvent it."
The college is pulling out all the stops to drive that pointhome. Regular meetings are being held with FDA staff, and theACR is generally pleased with the progress made, Price said.
But the ACR has too much at stake not to play all the cardsit can. Meetings are presently going on with the staff of thesecretary of the department of Health and Human Services, a staffthat wields direct power over the decision-making done by theFDA. The college is also meeting often with congressional leaderswho have expressed an interest in the mammography program, especiallythe women's caucus.
Despite the ACR's influence in devising the MQSA in Congress,the legislation calls for the Department of Health and Human Servicesor a designated group, which has become the FDA, to develop andimplement program criteria. Those criteria could end up beingstronger than what is now being used by the ACR, McCrohan said.
The ACR has indicated privately to the FDA that its staff wouldbe happy to strengthen its criteria, if it will keep the establishedprocess on track.
"There have to be ways to effect this mechanism withoutstarting all over again," Price says.
Similarly the FDA has expressed a desire to work with the ACR.
"We will have to follow the (mammography quality standards)law and the ACR will have to follow the law. And we will do ourbest to accommodate each other on that," Gross said.