Yesterday, CDER Director Dr. Janet Woodcock suggested to the Senate health committee hearing on the Innovation for Healthier Americans Initiative that developing new biomarkers and clinical trial networks, among other strategies, could help improve the drug development process.
“There are other areas in which we hope to work with you as well, including modernizing drug manufacturing, encouraging the development of new antibiotics, and improving the processes for FDA review of drug/device combination products,” said Woodcock in her testimony. She also said drug development could be improved by harnessing evidence from clinical experience, such as through FDA’s Sentinel Initiative, and strengthening patient engagement.
Absent from Woodcock's testimony were controversial measures, included in the first draft of the House Cures bill, that would dramatically revamp current clinical trial design and provide new market exclusivity incentives to a broad swath of drug products. These proposals have been sharply criticized by consumer advocates and some congressional Democrats. “As we say in medicine: First do no harm,” Woodcock said. She also warned lawmakers that giving the agency’s drug center a “large number of unfunded mandates” would cause review performance to suffer.
Woodcock suggested using clinical trial networks and master protocols as a way to reduce clinical trial costs. She said: “First, the cost of clinical trials continues to grow and is the greatest source of cost increases in medical product development. Today, developers of a new medicine spend many millions of dollars planning a clinical trial, developing an elaborate trial infrastructure, finding and enlisting investigators, conducting the trials, and managing the trial data. Each time a new drug is tested, the process is repeated, at great expense, only to dismantle the infrastructure when the study is completed.”
She also advocated improving the science of biomarkers, which are used as indicators of health or disease, or in assessing the response to a therapeutic intervention. Biomarkers have many uses in drug development, according to Woodcock, such as performing safety monitoring, selecting appropriate patients for clinical trials, and selecting therapy for treating specific patients. “However, biomarkers based on new scientific understanding have been slow to come into clinical use, largely because the evidence supporting their validity has been lacking.”
Senate health committee chair Lamar Alexander (R/TN) told Woodcock he welcomed her suggestions. “We would like to invite you to give the bipartisan working group that [Sen. Patty Murray (D/WA)] and I have formed specific suggestions from your agencies about what we can do to enable you to do your job. We don’t want to produce a bill that reduces your productivity, we’d like to increase it,” he said, adding the timing for that feedback would be in the next few months. He also said that funding would be discussed by the Appropriations Committee and to some extent in the health committee.
