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“Temporary Compounding” To Mitigate Off-Patent Monopolies

 
• By Cole Werble

FDA has two years of experience with self-registering compounding organizations. Is the agency ready to use them to address situations of access constraints from extreme pricing?

Ex-FDA Deputy Commissioner Josh Sharfstein is suggesting that the agency okay “temporary compounding” as a short-term solution to off-patent products in monopoly situations until FDA can encourage submission of ANDA applications from other companies and give those applications thorough but prioritized (head of the queue) reviews.

Call it the Daraprim policy.

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