Policy to improve access and foster price competition for generics

The FDA commissioner, Scott Gottlieb, has issued a statement to outline a policy to improve access and foster price competition for drugs that face inadequate generic competition.

He stated, ‘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.

‘We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development. In doing so, we know 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. We also know that some drugs may be less desirable to genericise because they are complex drugs, which are more difficult to copy.

‘We’re 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.’

The FDA is currently looking to issue guidance documents as help when developing complex generic medications, and to address categories of complex drugs that are difficult to copy due to their formulation or mode of delivery.

He stated that the ‘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.’

‘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 (Competitive Generic Therapy).’

To date, the FDA has granted over 100 CGT designation requests.