FDA budget increase not enough, advocates say

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The Food and Drug Administration will get a 1% funding increase from President Barack Obama's proposed fiscal 2015 budget, a level some say is not enough to cover the agency's new responsibilities and the increasingly global nature of the products it regulates. The budget requests roughly $2.6 billion for the FDA in fiscal 2015, which begins in October. Included is $25 million more to oversee controversial high-risk compounding pharmacies.

“Given that the FDA regulates about 25 cents of every dollar of the gross domestic product, it does not have enough money to fulfill its public health mission,” said Kasey Thompson, vice president of policy, planning and communications for the American Society of Health-System Pharmacists. He is also president and chairman of the Alliance for a Stronger FDA.

The FDA plans to allocate $24 million of its funding to improve food safety oversight, as well as $25 million to conduct routine and follow-up inspections of high-risk compounding pharmacies.

The ASHP welcomes the new funding for the oversight of high-risk compounders, but is waiting for additional information from the upcoming extended analysis of the budget before commenting further, Thompson said.

Such pharmacies have been at the center of a public health crisis that began in 2012 when a Massachusetts compounding pharmacy distributed compounded steroid injections contaminated with fungus to healthcare providers in 23 states.

Sixty-four people died and hundreds more were sickened with meningitis and other types of infections from the compounded injections. The crisis triggered federal and state investigations into high-risk compounding pharmacies that were operating more like drug manufacturers, making large batches of drugs and shipping them across state lines. It also raised questions about the FDA's past oversight of this sector and how common it has become in recent years for hospitals and physicians' offices to buy drugs from these types of pharmacies.

The budget allocation for compounding pharmacies will “put in place new programs and policies to better protect patients who rely on compounded medications,” FDA spokeswoman Karen Riley said.

Last November, President Obama signed the Drug Quality and Security Act. The legislation provides the FDA with increased and clarified authority over so-called high-risk pharmacies. While the DQSA requires registered outsourced facilities to pay user fees that will help fund the agency's regulatory efforts, not all of these facilities are expected to register with the FDA, which is why the agency plans to allocate some funding to boost enforcement of high-risk compounding pharmacies.

The Alliance for a Stronger FDA plans to request more money for the FDA from Congress, according to the alliance's Deputy Executive Director Steven Grossman, who noted that four new laws affecting the FDA, including the compounding legislation, have been enacted since 2010.

“There are a lot of needs, but we also have to temper what we ask for based on the budgetary environment,” Grossman said.

The agency's overall projected budget of $4.7 billion includes existing and proposed user fees which finance FDA operations. The FDA reaches user-fee agreements every five years with the drug and device industries. In exchange for receiving billions of dollars from the industries, the FDA agrees to performance goals. The most recent user-fee reauthorization law was passed in 2012.

Follow Jaimy Lee on Twitter: @MHjlee



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