Sunday, February 5, 2012

The FDA and industry has done an excellent job in identifying and reducing Medical Product Shortages. Please update yourself by reading the information on FDA's website under CDER/Drug Shortages. We need to find solutions (not more reasons) for the shortages.

Project one: One of the most important shortages is for sterile injectable oncology drugs (medically necessary drugs) particularly manufactured by generic companies.  In the next few days, I will post thoughts, comments, questions for your input so we can arrive at a faster solution.

Initially, I do not see answers to:

1.  What are the specific quality issues?
2.  A list of FDA guidances that can be used to resolve this situation.
2. Who are the partners that will solve the problem
3.  What is the win-win solution?
4.  Create better incentives (other than saving lives)