|
|
|
|
|
|
|
up the process and at the same time create impediments for the more formative, dynamic, small companies: creating anticompetitive practices in which the FDA is an unwitting ally. |
|
|
|
|
|
|
|
|
I have often heard the statement that the FDA needs to take its time to plow through each data point to protect the public. By never approving a drug, the FDA would be the most protective, since no adversity would ensue from approved drugs. However, the adverse effects of no therapeutic advances would be intolerable. Thus, a compromise in the tension between the regulators charged to protect the public and the public's need for new effective therapies needs to be struck. The use of the information revolution to facilitate drug development needs to be explored. We are at the beginning of this exciting period and the government will evolve slower perhaps than other centers in the development process, but it will indeed evolve. |
|
|
|
|
|
|
|
|
A number of approaches are possible. The use of quality assurance techniques for partial-to-comprehensive data verification on a random basis certainly needs to be validated and then applied. Perhaps data analysis performed by certified groups that are paid for by the company, but at the same time are licensed by the FDA, would eliminate the need for data re-entry and reapplication of analytical techniques. The focusing in on quick review techniques for the critical pivotal studies and ascertaining their veracity needs to be placed at the top of the review list. With the acceptance of efficacy, rapid computerized analysis of toxicity of a product and comparison of the results to those obtained with other agents could permit an estimation of the agent's potential benefits and toxicity. This could facilitate early presentation of the NDA material to an advisory committee that would be able to understand its place in the therapeutic armamentarium and decide whether a more prolonged thorough evaluation is needed or an early release could be considered. Of course an early release might be combined with a more prolonged preliminary period where information is collected on adverse experiences and efficacy and these items then used for continued drug evaluation. |
|
|
|
|
|
|
|
|
The process of approving a drug, getting very little additional information after the approval, and once approved, having it remain on the market forever is really as wrong as a very slow and time-consuming initial development process. The fact that it is so difficult to get a drug off the market and that we have so little postmarketing information validates the regulators' approach of making the initial approval stringent indeed. It would be far better to look to a system such as that in Great Britain where there may be a more provisional stage of approval, where there is a very detailed program of postmarketing surveillance that makes it quite simple for practitionists to participate. We must understand that drugs can be marketed and then knowledge and information developed that changes our initial impression. A drug could be severely limited in its labeling, have warnings issued to physicians who will be using it, |
|
|
|
|
|