EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78710
26 EW CATARACT May 2012 Cataract editor's corner of the world Drug development in the eyes of industry by Faith A. Hayden EyeWorld Staff Writer W hen a physician orders a medication for a patient, the main concerns are drug choice, dosage, side effects, and com- pliance. However, when the patient re- trieves the medication, other issues such as availability, brand versus generic, and cost become apparent. Many of these factors involve the drug manufacturers' interactions with the FDA. To better understand the compli- cated pathway for a drug to become approved, we talked to some represen- tatives from leading pharmaceutical companies. Bonnie An Henderson, M.D., cataract editor Source: Image Source/Getty Images I t's no secret that funneling medical devices and new drugs through the FDA channel can be a frustrating, cryptic process; doctors comment on this fact at meetings and on forums all the time. But opinions from drug companies themselves are a less-fre- quently heard perspective. How do companies feel about the drug path- way? What goes into, for example, the decision for post-approval stud- ies? EyeWorld spoke to Scott Krueger, Ph.D., head of portfolio and project management, Alcon (Fort Worth, Texas), and Andrew Chang, director of product marketing, ISTA Pharmaceuticals (Irvine, Calif.), on their viewpoints. EyeWorld: From start to finish, how long does it take to get a new drug approved in the U.S. and in Europe? Alcon: From identification of the new eyecare drug to its approval, it takes 7-10 years on average in both the U.S. and the E.U. EyeWorld: Can you take us through, step-by-step, a typical path- way from the origin of a new drug idea to having the drug approved? Alcon: Our new product devel- opment process begins with identi- fying the existing unmet needs in the selected research area. This could be, for example, a product that re- quires a lower dosage frequency, re- duces potential side effects, or pro- vides increased efficiacy. Following the research phase, we identify the selected drug and conduct a proof- of-concept to ensure that the drug achieves the desired effect in the tar- geted patient population. If success- ful, this is followed by additional clinical trials with larger populations and, finally, the submission of the dossier to regulatory bodies for ap- proval. EyeWorld: What is the average total cost of getting a new drug ap- proved? Do you expect this amount to peak at some point, or will the total cost continue to rise? If costs continue to rise, what does that mean for the pharmaceutical indus- try and drug innovation? Alcon: Depending on the dis- ease being targeted, new eyecare drug development costs between $70-150 million per product. We expect costs will continue to rise to meet the increasing thresholds of both regulatory and payer require- ments, but we are also making serious efforts to limit the rate of increasing per-patient costs. Rising development costs could have a neg- ative influence on innovation and result in further consolidation in the industry. ISTA: The costs to approval con- tinue to increase and with no guar- antees. Phase III trials can be three times more than similar trials in years prior. There are also special protocol assessments that are needed within each step of Phase I, II, and III, and there are fees associated with almost every step of the process. EyeWorld: Once a drug is ap- proved, are there additional trials? Alcon: Additional R&D trials are conducted primarily in two cases: 1) where a country requires local clini- cal experience for their population; or 2) where reimbursement institu- tions require separate clinical trials to address comparative questions not required for regulatory approval. ISTA: Post-approval studies are based on the needs of our customers and the ophthalmic community and can vary from additional data points or head-to-head [comparison] with a major competitor. EyeWorld: Once a drug is approved, how much control does the pharmaceutical company have over the cost to the patient? Alcon:We work with payers on national levels to get our drugs reim- bursed based on our clinical results. EyeWorld: How often does the FDA need more data on a drug? Is there any way to predict that? Are you typically surprised when the FDA comes back requesting addi- tional studies, or is it sometimes expected?