The Parkinson's Action Network applauds the recent enactment of the Food and Drug Administration (FDA) Amendments Act of 2007, which will improve patient access to safe and effective therapies in a timely manner. PAN has worked to include vital provisions in this bill that will enhance Critical Path drug development research, provide patients with valuable information about clinical trials and their results, protect patient safety, and maintain speedy review times.
On September 19, 2007, the House of Representatives passed the bill by a vote of 405 to 7 and the Senate passed the bill unanimously the following day. The President signed the bill into law on Thursday, September 27, 2007. PAN commends our congressional champions for drafting and passing this strong, comprehensive legislation.
The Food and Drug Administration (FDA) Amendments Act of 2007 also authorizes the collection of industry user fees that enable FDA to review drug applications in a timely manner. This is the fourth time Congress has considered must-pass legislation known as the Prescription Drug User Fee Act (PDUFA), but it is the first time that patient advocacy organizations have actively participated in the process. PAN, in conjunction with the Alliance for Drug Safety and Access (ADSA), successfully worked to ensure that the bill includes critical provisions that will hasten discovery and access to better therapies for people living with Parkinson's and other diseases.
The following provisions are particularly important for the Parkinson's community:
Creation of the Reagan-Udall Foundation
This legislation creates the Reagan-Udall Foundation for the FDA, which is a public-private partnership charged with advancing the FDA's Critical Path Initiative. The Critical Path Initiative aims to modernize drug development and accelerate discovery of breakthrough, novel therapies by funding research into areas such as biomarkers, animal models, inter-individual variability in drug response, data analysis technology and methodology for use in drug development, and improvements in designing and conducting clinical trials. PAN worked with both the House and Senate to ensure that the Critical Path Initiative's drug development priorities were included in this legislation.
Clinical Trial Databases
The bill establishes a clinical trials registry and a clinical trials results database, which will be publicly available through the Internet. The clinical trials registry will include information on all ongoing Phase II, Phase III, and Phase IV trials. In practical terms, this registry will not be that different from what we already have at clinicaltrials.gov. However, the database will, for the first time, require that after the approval of a drug, results from that drugs earlier trials must be added to the database. This information will include summaries of FDA committee meetings, advisories, assessments, and relevant journal articles and publications. PAN strongly supports the accessibility of this important information.
The bill also requires the Department of Health and Human Services to determine how to include lay-language, unbiased results summaries in the database and if it is feasible to add clinical trial results information for unapproved drugs in the future. Lay-language summaries of trial results would enhance patient assess to and understanding of trial results information. By making results for unapproved drugs public, researchers would have access, for the first time, to critical data on drugs that were deemed safe in Phase I testing but were shelved for other reasons. This could potentially shorten the drug development timeline, and hasten access to future therapies.
Enhancement of Post-Market Surveillance
The bill will also establish a surveillance system to better identify potential adverse effects of drugs that are already on the market. This will be done through enhanced interactions between the FDA and databases maintained by the Department of Veterans Affairs, large insurance provider groups, Medicare programs, and similar large databases. Scientists will routinely analyze data on millions of patients, looking for signals that drugs may pose serious risks. This type of active surveillance will help the FDA continue to gain needed information on products as they are being used by a large, diverse population and provide data that is virtually impossible to collect through pre-market trials.
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