- Submission completeness: It takes about four review cycles to approve ANDA.
- Volume of applications
- Other factors. Several factors delay timely consumer access.
FDA has to develop a program or strategy to prevent such harassment. Roadblock could be set but there has to be a resolution that is acceptable to each side. Generics have to be on top of their game to counter such delay tactics. Legislatorial changes might have to be incorporated. In our political system that could be a challenge.
Congressional intervention might be needed. USP or others who have information should be able to share the information. Congress can create a scenario to assure necessary samples are available for the generics. This would be good for their constituents. I believe FDA can intervene also.
If the brand companies are abusing citizen’s petition process, there has to be a counter strategy from the generics. I have not looked at this in detail but I am sure that there are ways and means to counter this challenge.
Generic filers have to develop their strategies. I believe if the approval time is lowered from ten months to 90 days, companies could develop workable measures. Filing company has to have a complete grasp of the situation and strategies.
- Generic Drug User Fee Act Reauthorization (GDUFA II) Accessed March 16, 201
- Testimony of Drs. Woodcock, Marks and Shuren Accessed March 23, 2017
- Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry Accessed March 24, 2017