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Regulatory Focus™ > News Articles > FDA Rebuffs Attempt to Delay Generic Drugs By Scoring Pills

FDA Rebuffs Attempt to Delay Generic Drugs By Scoring Pills

Posted 10 February 2012 | By Alexander Gaffney, RAC 

Pharmaceutical manufacturer Warner Chilcott's attempt to delay generic competition for its Doryx acne pill has been rebuffed by the US Food and Drug Administration (FDA), according a response letter posted by the agency.

Warner Chilcott had changed the scores on its Doryx tablets from one score to two scores. The scores are used by physicians and patients to properly split the pills. Warner Chilcott's change, it argued, was substantial enough that any generic manufacturers hoping to make a generic copy of the product would need to have the exact same scoring in order to avoid prescribing errors.

Warner Chilcott then filed a citizen petition to request that FDA force Mylan to comply with its pill scoring standard. This would have the effect of delaying its Mylan from competition with Warner Chilcott until its products also contained the correct scores.

FDA denied that citizen petition on 8 February, saying that it does "not agree that approving an ANDA for a generic single-scored 150 mg doxycycline hyclate delayed-release product would raise any new public health concerns, especially if the single-scored [Abbreviated New Drug Application] ANDA product, like your single scored tablet, will be marketed concurrently with the double-scored product only for a finite period of time."

The letter goes on to say that FDA believes there "is very little chance that this marketing" would lead to a safety issue as the patient is unlikely to "have to determine how to use the score for a subsequent unanticipated dosage adjustment."

FDA also addressed Warner Chilcott's assertion that scoring configurations must be the same on the reference-listed drug (RLD) as on the generic. "There is no statutory or regulatory requirement that generic drugs have the same scoring configurations as their RLDs," said FDA, though the agency said it recommends that it be so in guidance provided to manufacturers.

FDA also called Warner Chilcott's argument regarding labeling consistency under 505(j) of the Federal Food, Drug and Cosmetic Act(FD&C Act) "moot", and that it "would be nearly impossible for the ANDA applicant to change its manufacturing practices to transition to a dual-scored tablet and revise its labeling within the 60 days permitted under section 505G)(10)."

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