An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once approved, the Sponsor may manufacture and market the generic drug product, and as a result of the Sponsor’s efforts, the public has access to a safe, effective, lower-cost alternative to the brand-name drug that is referenced in the ANDA.
Getting through the process of compiling an ANDA and submitting it for approval is challenging. The application is termed “abbreviated” because applicants are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Still, applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug, and they must do this while complying with a host of statutory and regulatory requirements, policies, and procedures.
There are so many moving parts to deal with—and so much at stake—that it makes sense to seek the assistance of a third party that has existing knowledge and experience to shepherd the applicant through the ANDA process. This is why many applicants choose to work with an FDA consulting firm like The Weinberg Group, a ProPharma Group company. By working with a consultant, applicants can expect an improvement in the cost efficiency, speed, and completeness of their generic drug application.
Building out a comprehensive compliance team capable of overseeing all of the moving parts associated with an ANDA can be cost prohibitive for an applicant. Imagine the difficulty a start-up or small organization will have assembling a knowledgeable team and paying their salaries. Simply finding individuals with requisite knowledge of the applicable FDA regulations can be an intimidating challenge.
Instead, it makes sense to work with a consultant. Ideally, the consultant can bring a small team to the table that has the knowledge necessary to complete the required work both effectively and efficiently. The right consultant will be mindful of the Sponsor’s budget and will keep costs as low as possible.
A consultant understands the delicate balance required to develop an ANDA filing plan which takes into consideration risk, speed to approval, and cost. Without the assistance of a consultant, the ANDA process itself may be cost prohibitive.
When dealing with generic applications, speed is always of the essence. That’s because the first generic drug that makes it to market has significant economic advantages over its future competitors.
One of the most significant barriers to speed is the learning curve associated with the ANDA process. If a Sponsor has never gone through the process before, there is a lot to learn. If a Sponsor has gone through the process and had their application denied, they must figure out how to learn from their mistakes.
Another barrier to speed is the decision-making process. The longer it takes to make a decision regarding the development of the drug and the ANDA submission, the longer it takes the drug to get approved.
The benefit of working with a consultant is that both these barriers are removed. The right consultant is up to speed on the latest FDA guidance documents and has interacted enough with regulators to know how the FDA thinks. There is no learning curve. Additionally, the right consultant won't have a huge bureaucracy that prevents them from making smart decisions quickly.
When it comes to the completeness of an ANDA, experience matters. Small organizations or first-time applicants don’t always know what they don’t know. It takes an experienced consultant to point out gaps in the application and know how to correct them. This experience comes from countless hours attending approval meetings, studying FDA guidance documents, and staying abreast of the Agency’s current thinking.
Here at The Weinberg Group, our team is made up of individuals from small pharma, big pharma, and the FDA. We have the in-depth visibility that comes from consulting on a large number of ANDAs; and as a result, our breadth of knowledge and experience enables us to provide our clients with professional advice and assistance that improves cost efficiency, speed, and completeness of their generic application.
To learn more about how The Weinberg Group can help you prepare and file an ANDA submission with the FDA, contact us today.
July 14, 2020
ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
July 14, 2020
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...
July 14, 2020
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...