Millions of dollars are spent each year researching and testing new medications to treat disease, relieve symptoms, and save lives. In many cases, medical breakthroughs have resulted in effective and important drugs. Manufacturers, physicians, and patients alike want to get these drugs to those in need as soon as possible. The U.S. Food and Drug Administration (FDA) also recognizes the need to get new drugs or drugs with distinct advantages over existing medications into the market as soon as possible. To that end, the group offers some avenues for a drug to gain faster approval. Hundreds of drugs have entered the market in this manner, but recently the Government Accountability Office (GAO) released a report indicating that these expedited drugs should be subject to further, post-market review.
Gaining Faster Approval for Medications
The FDA offers four ways to earn a quick approval and get a drug into the market. These avenues are:
- Fast Track. This expedites the review of drugs used to treat serious conditions or those that can fill an unmet need.
- Breakthrough Therapy. The drugs in this category represent a substantial advantage over the drugs currently available to treat a specific medical condition.
- Accelerated Approval. In this category, drugs must fill an unmet medical need for a serious condition based on a surrogate endpoint. A surrogate endpoint is a measure (such as laboratory results or physical indicators) that is a predictor of a clinical benefit, but not an actual, proven clinical benefit.
- Priority Review. A priority review accelerates the FDA review time goal from the standard 10 months to just 6 months. Drugs must show significant improvement over current market offerings.
Since 2007, the FDA has approved approximately 525 drugs using one of these expedited programs.
Government Calls for Continued Monitoring
Some patient safety advocacy groups and drug researchers have questioned the safety of the expedited programs. They say the programs could cause unsafe, improperly tested drugs to enter the market and cause additional harm to patients who are already fighting a disease or disorder.
The FDA is required to continue to monitor the drugs they approve to ensure the safety of consumers as more people begin to use the drug. Recently, however, the GAO investigated the monitoring practices and determined that changes need to be made.
The report states that the use of these fast approval programs “further increases the importance of the agency’s post market safety oversight.” The report identifies problems with the current post-market review program, including:
- Incomplete, inaccurate, and outdated reporting of post market data.
- Poorly designed software.
- Lack of a clear plan to examine data.
The GAO recommended the FDA correct the problems with the review program and develop a plan to use recorded data to examine the safety and efficacy of the drugs the FDA approves.
There have been many cases in which drugs approved by the FDA have proved harmful to patients. If you or someone you love has suffered injuries or illness due to a defective drug, the experienced legal team at the Tapella & Eberspacher Law Firm may be able to help. Fill out our contact form to have your questions answered today.