A: OVERALL, I DON’T SEE REGULATORY ISSUES DRIVING DRUG PRICES, unless you are talking about fundamentally decreasing the overall cost of drug development. Drug pricing is more connected with outcomes, health economics, value-based reimbursement, and contracting power. One idea is that the FDA could provide guidance for acceptable study design (population, inclusion/exclusion, endpoints, etc.), or the agency could provide feedback earlier on specific protocols throughout the drug development process. The FDA also could encourage greater use of enriched trial designs so that if the drug is effective, it is more likely to be readily shown. Companies could also increase their use of modern/novel clinical trial selection strategies (genotype, surrogate markers, etc.) to identify specific populations with higher probability of success. Finally, companies could share study outcomes so others could apply learnings to their future trials.
Mitchell Katz, Ph.D.
Mitchell is head of medical research and drug safety operations at Purdue Pharma, L.P. He has 30 years’ experience in the pharma and biotech industries.