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Regulating Drug Compounders: Gottlieb Discusses FDA's Flexible Approach

Posted 30 January 2018 | By Zachary Brennan 

Regulating Drug Compounders: Gottlieb Discusses FDA's Flexible Approach

FDA Commissioner Scott Gottlieb on Tuesday testified before a House Energy & Commerce subcommittee to explain what the agency has done to better regulate drug compounders since the Drug Quality and Security Act (DQSA) was passed in 2013 after a contamination crisis at a Massachusetts-based compounder in 2012 led to dozens of deaths.

Following the unveiling of a plan earlier this month on 2018 priorities for drug compounding regulation, Gottlieb said in written testimony that since the enactment of DQSA, FDA has issued 24 draft and final guidances to provide clarity on compounding compliance policies, four proposed and final regulations addressing products that can or cannot be compounded or used in compounding, and a draft memorandum of understanding (MOU) with states addressing certain distributions of compounded drugs.

"We will be updating that MOU soon, taking into consideration the feedback we received from stakeholders," Gottlieb wrote.

Committee Questions

Rep. John Sarbanes (D-MD) questioned Gottlieb on a section of his written testimony on how the agency has worked with states to conduct about 500 inspections of compounding facilities between the passage of DQSA and the end of fiscal year 2017.

Gottlieb told Sarbanes that a lot of inspections are for-cause, and states need to report effectively on which compounders are not meeting certain standards.

"This won't work unless we're working with state authorities and providers," Gottlieb said.

He also noted that FDA is working to create a flexible standard whereby if a compounding pharmacy is engaging with low-risk products, it will not see the same level of oversight as a compounder working with higher-risk products or those distributing products more frequently.

Rep. Frank Pallone (D-NJ) also questioned Gottlieb on FDA's plans and whether they might weaken patient safety protections because the agency is looking to clarify that a compounder has distributed an "inordinate amount" of drug interstate if the number of prescriptions of compounded drugs distributed interstate during any calendar month is greater than 50%, whereas FDA previously set that threshold as 30%.

Gottlieb said he sees the change "as a strengthening … going from a hard threshold, to a risk-based threshold of 50%," noting that FDA does not "think a fixed standard on volume makes the most sense" because there is such a wide range of compounders.

Rep. Buddy Carter (R-GA) also grilled Gottlieb on FDA's use of guidance documents to regulate compounders, which seems to contradict what the Department of Justice has said recently about not driving enforcement actions because of guidance.

Gottlieb explained that FDA can take enforcement action now and that the guidance is intended to provide for public discussion and is not the basis for the enforcement action.

Rep. Michael Burgess (R-TX) questioned Gottlieb on a recent risk alert put out by the agency on the use of compounded drugs in eye injections.

"We're implementing a framework on an industry that's vast and grew up outside the purview of regulation," Gottlieb said, noting that he thinks it will take time to get the regulations fully implemented and the enforcement practices FDA wants.

Written Testimony and Hearing


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