FDA reports that in many cases branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition.
FDA is taking steps to clear a path for more efficient generic development. In doing so, FDA knows that various factors may influence a manufacturer’s decision to develop and market a generic drug. For example, some drugs may not attract a high level of interest if there is a limited market for them.
FDA is working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients. Over the next year, the FDA will advance additional policies to promote generic competition including for complex drugs.
Among other steps, FDA intends to issue additional guidance documents for developing specific complex generic medicines, as well as address categories of complex drugs that are hard to copy because of their complex formulation or mode of delivery. This will include the publication of a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generics. As part of this, FDA will offer draft guidance with recommendations on establishing active ingredient sameness. In addition, they will advance the development of new analytical tools and in vitro tests to provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs. Better tools for proving sameness can open up more complex drugs to generic competition.
FDA has also issued a new pathway for Competitive Generic Therapies (CGTs) is a significant advancement in generic drug competition. Designation of a drug as a CGT can be granted to a company submitting an application for their generic drug when there’s inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. The designation, which was established by Congress when it granted the FDA new authorities in the FDA Reauthorization Act of 2017, provides certain incentives for industry to develop generics for drugs lacking competition that have been designated as CGTs.
Under this pathway, companies may submit requests to designate a drug as a CGT at the time of submitting an abbreviated new drug application (ANDA) or at any time before the original ANDA submission. At the request of the applicant, the FDA may expedite the development and review of an ANDA for a drug that is designated as a CGT. CGT designation can afford companies a number of early benefits, including product development meetings with the FDA to discuss specific scientific issues or questions they may have such as proposed study design or alternative approaches. These early benefits may also help to reduce the number of application review cycles ultimately decreasing the time it takes for the generic drug to receive approval.
If a CGT designation is granted, the application may be eligible for a 180-day period of marketing exclusivity provided the applicant is the first approved ANDA for that CGT and meets other conditions.
