Industry hopes to piggy-back abbreviated NDAsAnger has turned to action as the PET community struggles to cometo grips with federal initiatives that threaten to hamstring themodality. PET practitioners have launched a major effort to comeinto
Anger has turned to action as the PET community struggles to cometo grips with federal initiatives that threaten to hamstring themodality. PET practitioners have launched a major effort to comeinto compliance with the Food and Drug Administration's new policyto regulate cyclotron-produced PET tracers through new drug applications(NDAs) and good manufacturing practices (GMPs) (SCAN 3/15/95).
"There is no point in being mad about it," said Dr.Steven Larson, president of the Institute for Clinical PET (ICP)and chief of nuclear medicine services at Memorial Sloan-KetteringCancer Center in New York City. "We have to accept (whatthe FDA has done) and go forward with our approach, as well aslegislative options that might provide us with some relief."
Larson and the ICP are advising PET practitioners to startwork on piggy-backing abbreviated NDAs (ANDAs) on the NDA heldby the Downstate Clinical PET Center at Methodist Medical Centerof Illinois in Peoria for its formulation of 18-fluorodeoxyglucose(FDG-18). While Larson believes that the FDA will accept abbreviatedNDAs based on the Peoria submission, the FDA has not indicatedwhat criteria it will use to accept an ANDA.
At the same time, efforts on Capitol Hill are aimed at gettingthe FDA out of regulating PET radiotracers entirely and at winningMedicare reimbursement for selected procedures. Private industry,led by CTI of Knoxville, TN, and organizations including the Societyof Nuclear Medicine, American College of Nuclear Physicians andCouncil on Radionuclides and Radiopharmaceuticals, are behindthe legislative actions.
But success on either point -- regulatory relief or reimbursement-- is considered a long shot by PET pundits. That means the communityhas to deal with the reality of meeting FDA demands by the agency'sdeadline just 18 months away.
The current strategy calls for building on and expanding theNDA held by Downstate while getting other facilities to put inabbreviated NDAs, wherever possible. At present the Peoria NDAcovers only applications of PET regarding epilepsy, a niche areathat Larson hopes to extend to cover other applications.
"Oncology is the one we are going after first becausewe have the greatest amount of information on that," Larsonsaid. "But we will also be trying to develop a parallel approachwith cardiology."
There are difficulties in going the ANDA route, however, becausenot every center uses the same method of producing FDG, accordingto Larson.
Methodist Medical, for example, uses Siemens technology, whichis just one of several product offerings for making FDG. As aresult, Larson and the ICP are encouraging PET centers to submitNDAs on their own.
Congressional action. The NDA burden will be removed from theshoulders of the PET community if the Pharmacy Restoration Actmakes it through Congress. This bill would put state boards ofpharmacy, rather than the FDA, in charge of regulating PET compounds.Another bill, which is in the early stages of development, callsfor general reform of the FDA. PET advocates are trying to includea provision that would limit the regulation of PET radiotracersby the FDA.
There is also legislative activity to get PET reimbursed aspart of the budget reconciliation process. CTI, which has a jointventure with Siemens to make PET scanners, and also makes cyclotronsfor PET radiotracers, is directly lobbying Congress to includePET reimbursement as a means for reducing Medicare expenditures.
"We are trying to convince the Congressional Budget Officeand others that PET can actually reduce Medicare costs as opposedto adding to costs," said Terry Douglass, president of CTI.
Several members of Congress have signed on to the effort, mostnotably Sens. Pete Domenici (R-NM), Ted Stevens (R-AR) and BillFrist (R-TN). In a letter sent April 19 to the director of theCongressional Budget Office (CBO), the senators formally requestedan analysis of PET reimbursement, stating their belief that ifPET were used for breast, colorectal, and lung cancers, as wellas heart disease, approximately $1 billion for Medicare and $5billion for the nation as a whole would be saved annually.
But reimbursement for medical procedures is handled by theHealth Care Financing Administration (HCFA) and is seldom decideddirectly by Congress. The PET community received good news inlate March when HCFA decided to allow Medicare reimbursement formyocardial perfusion studies using rubidium-82 (SCAN 4/12/95).
At present, HCFA's position is that reimbursement for FDG hingeson acceptance of the use of this radiotracer by the FDA. If CTI'sefforts to include reimbursement provisions for FDG fail on thefloor of Congress, the PET community's only recourse will be toget the nod from HCFA, which in turn depends on meeting FDA requirementsfor NDAs and GMPs.
Since the FDA's announcement on PET radioisotopes, the FDACenter for Drug Evaluation and Research has been getting commentsfrom both industry and practitioners. John Levchuk, who has servedas the point man for questions and comments from the communityspecifically on the GMPs, said the comments the agency has receivedare under review.
"We can't predict when the review process will be done,"Levchuk said.
Levchuk refused further comment, as did Dr. Patricia Love,director of the FDA's Division of Medical Imaging, which is chargedwith developing the policy regarding NDAs. But the agency's messagehas come through loud and clear to the PET community.
"The FDA is entrenched in their position and they areshowing no willingness to change," Larson said. "Weare stuck with that for the moment and we will have to make thebest of it."