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FDA new policy to improve access and foster price competition for drugs that face inadequate generic competition

 

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In too 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. Instances like these may keep prices high and ultimately hurt American patients.

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 As part of this, we intend to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, we’ll 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 is taking another step to encourage generic entry for drugs that face inadequate competition by laying out new, efficient guidelines for the use of a novel pathway that provides incentives for developing generic versions of drugs that currently face little or no competition.

This 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.

Since being granted these new authorities, the agency has moved quickly in designating drugs as CGTs. To date, the FDA has granted more than 100 CGT designation requests, and in 2018 between August and December, the FDA approved the first five ANDAs for generic drugs designated as CGTs, and when the drugs covered by those ANDAs were commercially marketed those ANDAs qualified for 180-day exclusivity. The successful implementation of these new authorities demonstrates that the competitive generic therapy pathway is efficient and effective at promoting new competition. It’s also a key step in making safe and effective generic drugs available to patients quickly while helping to ensure there’s adequate competition in the market place, so patients have access to the treatments they need.

In addition to taking action to enhance generic competition, the FDA is working to make generic drug development more efficient and predictable. Building on those efforts, the FDA has issued the new draft guidance aptly titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway. This new guidance provides robust information on how drug developers can apply for CGT designation and when they may be eligible for CGT exclusivity. The CGT pathway is intended to incentivize effective development, efficient review, and importantly the timely market entry of generic drugs.

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