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As FDA ignores pressure from appropriators on DQSA . . .

Lawmakers Push FDA To Withdraw Guidance On Compounding, Issue Rule Allowing Practice

May 24, 2017

A bipartisan coalition of 65 lawmakers is demanding FDA rescind a controversial guidance prohibiting pharmacies overseen by states from compounding without, or in anticipation of, an individual prescription, and instead issue a proposed rule allowing office-use compounding where authorized by state law. The push from lawmakers came the same day the agency ignored calls from appropriators for FDA to issue guidance allowing office-use compounding. While both groups of lawmakers allege FDA is acting against congressional intent, the agency appears to be sticking to its view that its policy adheres to the letter of the law and protects public health. The agency also says it has worked with stakeholders to clarify its regulation of compounding since the Drug Quality and Security Act (DQSA) was signed into law.

Reps. Buddy Carter (R-GA) and Chris Stewart (R-UT) and 63 other lawmakers argued in a bipartisan letter to FDA Commissioner Scott Gottlieb Tuesday (May 23) that FDA's compounding policy goes against congressional intent. At issue is a final guidance released in December, “Prescription Requirement under 503A of the Food, Drug and Cosmetic Act,” that requires that compounders only compound a drug for an individual patient with a prescription, or when a history of prescriptions and an established relationship allows a pharmacist to anticipate receiving a prescription.

“The policies finalized in this [guidance] are contrary to the plain language of Section 503A as amended by the Drug Quality and Security Act (DQSA) and ignore clear, bipartisan, bicameral congressional intent expressed during passage of the bill,” the letter states. “The FDA has unfortunately chosen to ignore broad and diverse stakeholder input, multiple congressional letters from both chambers, and clear directives in the House Report accompanying the FY2016 FDA appropriations legislation … More importantly, the FDA’s misinterpretation of the law and related enforcement actions against pharmacies are jeopardizing patients’ access to critical compounded medications.”

The lawmakers also slam the agency for allegedly adding new language to the final guidance, which redefined the terms “distribute” and “dispense.”

“It is astonishing that the agency would try to redefine these terms, which have commonly-accepted definitions both in existing law and in pharmacy practice, in a guidance document. This is a clear attempt by the FDA to assert unprecedented regulatory authority over the dispensing of medications and the traditional practice of pharmacy in a way that Congress never intended when passing the FDCA or its amendments in the DQSA. This regulatory overreach by the FDA and enforcement of the DQSA using guidance documents that don't conform to the law is unacceptable and must stop,” the letter states.

The lawmakers urge Gottlieb to withdraw the final guidance and issue a proposed rule allowing office-use compounding where allowed by state law. “[W]e respectfully request that FDA immediately rescind this [guidance] and issue a proposed rule, with notice and stakeholder input as required by the Administrative Procedure Act, that is consistent with the DQSA and that allows for office-use compounding by state-licensed pharmacies where authorized by state pharmacy laws,” the letter states.

House appropriations have also urged FDA to change course on compounding. Fiscal 2017 report language directed FDA to issue a new final guidance that allows office-use compounding in “appropriate circumstances as well as including drugs compounded in anticipation of a prescription for an identified individual patient.” Appropriators also argued that office-use compounding “is authorized in the vast majority of states and was intended to be allowable under DQSA.” Appropriators made a similar demand in the fiscal 2016 report language.

But in response, FDA maintained that its guidance adheres to statute and is critical to public health. “Compounding for office stock by 503A facilities would undermine the incentive for compounders to become outsourcing facilities, a critical measure that Congress put in place in the DQSA to prevent another outbreak on the scale of the 2012 fungal meningitis outbreak, which resulted in over 60 deaths and 750 cases of infection,” FDA wrote Tuesday (May 23) in its fiscal 2018 budget justification.

FDA emphasized that compounding under section 503A can only occur for a patient-specific prescription or in limited quantities prior to receiving a prescription for an individual. “Section 503A does not provide for the distribution of a compounded drug without the compounder first receiving a prescription for an identified individual patient (e.g., for office-use). In contrast, entities that are registered with FDA as outsourcing facilities under section 503B of the FD&C Act can distribute compounded drugs for office-use without receiving patient-specific prescriptions,” FDA wrote. “FDA is not aware of specific drug products needed for office-use that are not supplied by outsourcing facilities.”

The agency added that compounded drugs posed a higher risk to patients than drugs that have gone through FDA review for safety, effectiveness and safety, and noted that 503A pharmacies are not subject to current good manufacturing practice requirements.

“Because such compounders generally do not register their compounding facilities with FDA and are not under routine FDA surveillance, FDA is often not aware of potential problems with their compounded drug products or compounding practices unless it receives a complaint such as a report of a serious adverse event or visible contamination. When FDA has conducted inspections of state-licensed pharmacies because of serious adverse events or contamination, we have observed serious deficiencies in drug production practices and conditions that could put patients at risk,” FDA wrote.

Carter believes FDA's latest justification of its policies doesn't follow the letter of the law. “As I review the budget and the supporting documents, it appears the FDA is continuing to misinterpret the law,” Carter told Inside Health Policy in a statement.

The International Academy of Compounding Pharmacists also blasted FDA's response to the appropriators. “Congress stated the practice of a pharmacist providing compounded medications to a physician, hospital or health system, for administration to patients (often called office-use compounding) was to be allowed where state law allowed such practice,” IACP told IHP in a statement. “Despite clear Congressional intent and stakeholders expressing concerns that FDA’s implementation contrary to Congressional intent would impact patient access to vital compounded medication, FDA moved forward with guidance prohibiting all office-use compounding, even in states that allow such practice.”

FDA maintains that it has made progress working with states since DQSA was signed into law. FDA has held four intergovernmental meetings with states, “numerous one-on-one meetings and interactions,” and has invited state regulators to join FDA inspectors during inspections, according to the budget justification. FDA also conducted 135 domestic inspections of compounders in fiscal 2016, which includes both those registered as outsourcing facilities with FDA and those that are not.

In fiscal 2018, FDA plans to conduct 130 domestic inspections of compounders -- the same number as last year. Since the DQSA became law, FDA has conducted 350 inspections. The agency says the majority of these inspections have been in response to compliance issues.

“Many of these inspections have been for-cause, generally based on reports of serious adverse events or product quality issues. Following these inspections, FDA has issued more than 130 warning letters describing significant violations of the law that could put patients at risk and more than 30 letters referring inspectional findings to state regulatory agencies. FDA also has overseen about 100 recalls involving compounded drugs. In addition, FDA has worked with the Department of Justice on civil and criminal enforcement actions,” the budget justification states.

The agency also points to its attempts to explain its positions to industry. FDA noted Tuesday that it has published 21 draft guidances, of which 11 have been finalized, and proposed three rules, of which one was finalized, on how the agency views the compounding provisions of the DQSA was made law. FDA also notes it rebooted the Pharmacy Compounding Advisory Committee, which has held six meetings.

FDA also says it is on track to implement its electronic interoperable system to track certain prescription drugs by 2023. “The new system will continuously evolve toward an ultimate goal of identification of each individual prescription drug package, enabling better methods for verification of product legitimacy, detection and notification of illegitimate products in the supply chain, and facilitation of recalls,” the budget justification states. -- David Lim (dlim@iwpnews.com)