Treatment IND regulations stipulate that under some circumstances a manufacturer may charge for an experimental drug, but solely to recover costs. The proposed policy statement for the parallel track contains a brief reference to the treatment IND ruling but does not explore further the issue of drug costs. The policy of the Pharmaceutical Manufacturers Association is that the drug sponsor should bear the cost of any drug administered before market approval—in clinical trials or through expanded access protocols. So far, only one sponsor of an AIDS drug has sought payment under existing IND regulations.
Previous chapters have emphasized the importance of making sure that expanded access programs do not delay FDA approval of effective drugs by slowing patient accrual in randomized clinical trials. After all, access to a drug is greatest when the drug is on the pharmacist's shelf. Pharmaceutical manufacturers also are concerned about the possible loss of income. In most cases, manufacturers do not begin to make a return on their investment in a drug until the FDA has reviewed all safety and efficacy data and approved the drug for marketing. Thus, the perception that a government agency might request an expanded access protocol for a drug and that such a protocol could delay the time to commercialization might lead a manufacturer to forgo development of that drug.
A spokesman for Bristol-Myers Squibb notes that time and energy invested in the expanded access protocols for ddI have caused delays in market approval for two other drugs, both antibiotics in the late stages of clinical development. He says that the opportunity cost associated with these delays—the nonrecoverable loss of future sales resulting from reductions in useful patent life—might emerge as the largest single cost factor of the expanded access effort.
A brief recounting of Bristol-Myers Squibb's experience with ddI demonstrates the full range of expenses associated with an effective expanded access program. At the request of the FDA, the company submitted a treatment IND application for ddI on August 15, 1989.