TREATMENT IND REG's DEFINITION OF "ALTERNATIVE THERAPIES"

TREATMENT IND REG's DEFINITION OF "ALTERNATIVE THERAPIES" needs to be clarified to specify what criteria would be used by FDA in determining whether alternative therapies are available, the National Association of Pharmaceutical Manufacturers (NAPM) suggested in May 1 comments to FDA. The association suggested that FDA could clarify the treatment IND criteria for lack of alternative therapies in a Q&A document to be issued after publication of the final rule. Among the issues FDA should address, NAPM said, are: "Would a decision on acceptable alternatives be based on general presumptions or would FDA consider the particular facts of individual patients?" "What level of documentation will be required if the decision on lack of acceptable alternatives is permitted to be patient selective?" "Will the availability of an investigational drug for treatment purposes be limited only to the manufacturer's intended purposes, or will it be permitted to be used for other purposes as well, depending upon the particular physician's professional judgment?" The association suggested that FDA attempt to persuade the Health Care Financing Administration (HCFA) to issue a policy that would provide for third party reimbursement of investigational drugs. NAPM also said it is concerned that the sale provision of the proposal may be abused. "We are concerned that the profit incentive will interfere with, or even supercede, research interests for drugs which receive an IND treatment protocol," the association said. "Where there is a drug that serves a legitimate treatment need but is very costly to produce, a manufacturer should be allowed to recover costs . . . But FDA must guard against the sale of investigational drugs becoming too widespread. These therapies are unproven and should, with few exceptions, remain within the current system of medical and scientific control," NAPM asserted.