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Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

Posted 04 March 2013 | By Alexander Gaffney, RAC

Pharmaceutical compounding and global supply chain issues are the two largest regulatory areas of upcoming focus for the US Food and Drug Administration (FDA), Commissioner Margaret Hamburg said in a 2 March 2013 interview with Yale University's The Politic.

Compounding Issues Remain

In the wide-ranging interview, Hamburg talked about the issues associated with pharmaceutical compounding and a recent outbreak of meningitis several times. In response to a question regarding FDA's role in the outbreak, Hamburg argued that FDA's authority to regulate compounders is fragmented.

"Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern," she said. "I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one."

Hamburg also noted that "more and more healthcare systems are relying on sort of hybrid compounding pharmacy manufacturers in order to produce products they need," and that these facilities operate in a sort of legal and regulatory "gray area."

"[We] need new legislation that recognizes and responds the current state of the health care system and that addresses the fact that there are ambiguities in the law," she added.

A Tough Road to Reform

Hamburg's previous calls for that authority have thus far fallen on unsympathetic ears in Congress. In November 2012, she testified before the House and Senate on pharmaceutical compounding, and in both prepared and stated remarks asked for a coherent framework with which to go after compounding pharmacies.

"FDA would like to explore with Congress other authorities that would be important to support this new regulatory paradigm," said Hamburg, who added the agency would stand to benefit from "clear, full authority to collect and test samples of compounded drugs" and production records from compounding facilities. Those facilities engaged in non-traditional compounding should also be required to register with FDA under her proposed plan, she said. Other requirements, such as special labeling and adverse event reporting requirements, would be welcome as well, she added.

More on Hamburg's plan may be found here.

Her plan, however, seemed to get a cold reception in Congress, with many legislators arguing FDA already had the authority it needed to regulate these compounders, and had simply failed to use it. They also noted-repeatedly-that FDA had failed to turn over many documents requested by its committee, which prevented it from determining how FDA has handled the pharmaceutical compounding issue.

But regardless of the ambiguities and nuances of the current system, the current system "doesn't serve anyone well," Hamburg said in her interview with The Politic.

"To my mind, this is really a critical moment for us to step up to the plate and recognize that we have a situation that does not serve the public well. We need to put in place the kind of regulatory framework, based in statute, that can enable us to do a better job for the American people."

"I am very eager to see legislation concerning the compounding pharmacy issues," she added, responding to a follow-up question regarding what area she would like to "regulate or focus on next."

Global Focus

Hamburg also said she would like to continue to focus on global issues, including the increasingly global nature of the US supply chain and the safety of imported products.

"[W]e can no longer behave as a domestic agency, yet many of our laws were initially defined in the context of an agency that was regulating products made and used in the United States," she said, noting that 80% of active pharmaceutical ingredients used in the US come from outside the US, and that the agency now oversees 300,000 facilities in 150 countries and products coming into the US through 300 ports.

"It's a whole new landscape, and we have to rethink how we work from a legal regulatory perspective-with other countries and foreign regulatory authorities and industries-along with how we can stretch our already-limited work force to create this global footprint," she continued. "That's an area where we need new thinking, new laws, and new partnerships to enable us to have this global safety net. This net will ultimately be vital in protecting the wellbeing of our citizens, and it will also benefit people around the world."

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