The FDA’s new policy accelerating the Abbreviated New Drug Application (ANDA), though well intentioned, will have limited influence on an already fiercely competitive space within Pharma. Late last week, the FDA began a push intended to increase competition within the branded drug space, ostensibly by driving manufacturers in the development of generic alternatives. It looks to do this through allowing and encouraging the expedited review of generic drugs applications and a published list of off-patent, off-exclusivity, branded drugs without an approved generic.
By encouraging the introduction of more generic drugs to market, patients who might otherwise not receive affordable treatment can gain increased access. Patient access can be limited in a variety of ways - by participating in a generics only plan or by having their co-pay/co-insurance be at a price point where they cannot reasonably afford to stay on therapy. Pushing alternatives allows patients to benefit from more generic introductions.
The biggest win in all of this is the expedited review policy allowing for expedited review for products with less than three ANDA submissions. Many caveats and exclusions exist including the windows related to patent expiry and 180-day exclusivity, among others. How this plays out and just how much of a true benefit exists is left to be seen. At a minimum, expect to see a race among manufacturers to be one of the three ANDA filings to receive expedited review.
The race will be similar to what is seen now. However, instead of rewarding each successive ANDA filing with a slightly smaller piece of the collective pie, the first three to file will reap a slightly quicker--therefore larger—reward. Those that do not make the cut will have a smaller percentage to recoup.
In the end, this is simply a token attempt at shortening the window to approval. The smoke and mirrors takes shape when you closely examine the decision to provide a list of branded drugs without a generic alternative. The FDA is overtly publicizing something that is already closely watched by generic manufacturers. All branded drugs and their associated patent expiry dates are publically available, including their chemical composition being readily available within the NDA itself. Generic drug manufacturers only need to copy, test, and prove the safety of their products in time to file their ANDAs and coincide with the reference products loss of exclusivity.
For products without generic competition, there is likely a reason that nothing has been put forth – a safety concern, manufacturing limitation, patent infringement suit, or simply too small of a market opportunity to justify the expense of the generic product. On the surface, the publishing of this list appears to be a realistic attempt at closing an unmet need in the market. In the end, this feels like a publicity play – more of an appeal to the generic public, than to the manufacturers themselves. The manufactures know what is out there and are already in fierce competition to win their share of the market.
The devil is always in the details, and it comes down to the execution of these changes. As stated earlier, generic competition is good for the general public and patients themselves. The magnitude of the benefit is not guaranteed, though the impact will be greater in a disease state/indication where this is currently no generic competition compared to one where it is just a single product that has no generic competition.