|IACP Monitors Congressional Drug Pricing Hearing|
On February 4, 2016, the Full House Committee on Oversight and Government Reform held a congressional hearing, "Developments in the Prescription Drug Market: Oversight."
IACP has been monitoring this situation closely, and is pleased to let you know that Congressman Buddy Carter (R-GA) went to bat for pharmacy compounding. Congressman Carter was able to place questions directed to the Food and Drug & Administration (FDA) officially on the record, specifically asking them about compounding and appropriations language.
The FDA acknowledged in this hearing the approved appropriations language, and said that guidance on office-use is coming this year. This represents the first time FDA has admitted the language is binding, and that they're working on the guidance. Please see the excerpt below with Congressman Carter questioning the FDA.
*Rep. Carter: It's my understanding that the FDA can expedite a generic drug approval to help with the shortage problem. Could you address an issue of drug shortage with compounding?
*Dr. Woodcock: we would prefer not to do that.
*Rep Carter: you control the list of ingredients they can compound correct so you could add one to that if there was drug shortage, which you did in 2012 when the FDA waived the enforcement in the compound creation of a hormone cream that lowered the risk of premature birth. This could have helped in this situation.
*Dr. Woodcock: This is enforcement discretion, usually when a new drug is approved other versions should not be marketed.
*Dr. Carter: but to clarify you could do that. Another issue - in the Omnibus spending bill there was language in the bill to direct FDA to come out with guidance on office-use compounding, can you indicate where you are on that?
*Dr. Woodcock: we are working on a set of guidances to implement the recent regulatory changes and I would hope they would come out by the end of this year in draft.
Please click here to view a Summary of the Developments in the Prescription Drug Market: Oversight hearing.
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