Pebble Beach, CA FDA Urged To Fast Track More Drugsby Richard Kuehn on 09/27/12
There have been quite a few articles recently which have discussed the potential danger of releasing drugs too early to the market via expedited Food & Drug Administration (FDA) approval. There are good arguments on both sides of this important issue. On the one hand, expediting approval can result in doctors prescribing drugs which are later found out to have unknown side effects. Some of them can be serious, even deadly. But on the other hand, if you have a disease for which there is no treatment which works on the market, you may be perfectly willing to take the risk, particularly if your affliction is potentially life threatening. A White House Advisory Body this week threw in its opinion, making public a plan that would urge the FDA to double the number of new prescription drugs that go on the market each year. They would favor more expedited approvals for high-risk patients. The President's Council of Advisors on Science and Technology is urging the FDA to expand faster approval for drugs in the pipeline for a wide range of diseases using what is being called "special medical use" approvals. Since 1990, the FDA has used accelerated approval to get drugs for AIDS on the market, and more recently cancer. However, it has used this authority extremely sparingly. The council is urging the FDA to be more aggressive with this early approval process. It will be interesting to see how quickly the FDA acts on this recommendation.