In my previous article "Should the design and conduct of clinical trials be simplified? ", I discussed several FDA guidance that suggested that in several areas, the dada collections may be reduced and the clinical trial monitoring may need to switch to the risk-based approach instead of the current frequent on-site visits and 100% source data verification.
Coincidently, yesterday, Sens. Richard Burr and Tom Coburn introduced a new plan to reform the FDA - The "PATIENTS' FDA" Act . The patient' FDA act (if approved) will force FDA to be further transparent and to be mindful in requesting too much data from the pharmaceutical companies. For last several years, after several high-profile drug withdrawals (Vioxx, Avandia for example), FDA has swung to another extreme and become very conservative, which subsequently made the clinical trials more difficult to execute and drug development more costly. Perhaps, it is really not the FDA's intension, however, many of its staff/reviewers become too conservative. Instead of working with the industry to bring the new medications to the patients with the reduced cost and within the reasonable timeframe, some reviewers request the sponsors to collect data with no real justification and ask the sponsors to implement something that may just be for reviewer's own interest or opinion.
Forbes published a good article as a companion to this bill. Here are some of the paragraphs from this article.
More accountability for meeting drug-review deadlines. The FDA has been increasingly failing to meet its PDUFA-mandated deadlines for giving companies approval decisions on new drug applications. The PATIENTS’ FDA Act would require the FDA to “report [to Congress] on a deeper level detail with respect to the performance goals agreed to in the prescription drug, generic drug, and biosimilar user fee agreements,” and hold individual reviewers accountable for their speed in reviewing applications.
stop forcing companies to do unnecessary and expensive busywork. The bill’s summary notes that “some FDA reviewers request reams of additional information about a drug or device that is beyond the scope of data needed to meet the FDA’s approval standard.” The FDA will be required, under the bill, to “document the scientific and regulatory rationale” for such decisions, and review within one year “the costs and adoption of the least burdensome approaches to regulation.” The bill would also codify the FDA’s “commitment to improve on patient risk-benefit considerations…to ensure accountability for fulfilling…the user fee agreements.”
Take more advantage of clinical trials in other countries. The bill would require FDA to work with “other specific regulatory authorities of similar standing” to encourage uniform standards for clinical trials. (The Geneva-based International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, performs many of these functions.) FDA will also be instructed to help sponsors “minimize the need for duplication of clinical studies, preclinical studies or non-clinical studies.”