The Food and Drug Administration (FDA) plays a vital role in the search for better drug treatments for Parkinson’s disease. Representatives from this government agency spoke in February at the 14th Annual Parkinson’s Action Network Forum in Washington, D.C., and explained its role in the current search for new Parkinson's disease treatments.
The Food and Drug Administration's role is to:
- Oversee drug development
- Set standards for reviewing drug applications and approving new drugs
- Monitor safety and effectiveness of drugs after they are on market
- Monitor continued drug manufacturing quality
Sinemet, the main drug used to treat Parkinson’s disease, is often called the “gold standard” for treatment. It helps to control symptoms like tremors and rigidity.
However, this drug is 40 years old, and it does not stop or slow the progression of PD. The effectiveness of Sinemet also diminishes when taken for a number of years.
The length of time it takes a drug to get on the market can be as long as 15 years. This is not acceptable, nor is a 40-year-old drug as the main treatment for PD.
Americans are often discouraged by slow progress in the FDA's approval of new drugs and treatments. Furthermore the FDA faces other problems. The FDA points out that its productivity is down, and states:
- The number of new drugs in development is down.
- The rate of failure for drugs in development is increasing.
- The FDA has not responded to demands for more information about the effectiveness and safety of drugs before they are approved.
In response to these negative appraisals, the FDA launched the Critical Path Initiative in 2004 to bring together drug development and basic scientific research.
This initiative has been working to stimulate and facilitate a national effort to modernize the methods for developing FDA-regulated products. The exciting discoveries scientists have made in the last few years and the knowledge they have acquired does no good if it is not translated into practical application. With the FDA and scientists working together, better therapies will abound.
The science must be applied to patients if the FDA is to succeed in bringing new drugs to the consumer, and modernization must occur to shorten the trial process.
No shortcuts need be taken, and the FDA will continue to oversee, set standards, and monitor the drug development process.
Sources:
Parkinson's Action Network 2008 Forum - You can watch the FDA presentation online.
Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Product