December 20, 2012
FDA, State Health Agencies Debate Oversight Of Drug Compounders
Lawrence LeBlond for redOrbit.com - Your Universe Online
Looking to enact tighter governing rules on drug compounders, the US Food & Drug Administration (FDA) sat down for a one-day conference with health delegates from all 50 states on Wednesday. The workshop came on the heels of the national meningitis outbreak caused by contaminated injections produced by Massachusetts compounding facility NECC. State health officials who oversee drug compounders told the workshop that better communication and greater clarity is needed to understand what they are responsible for and what the FDA controls.
In the 3 months since the meningitis outbreak started, the FDA has claimed holes in regulating Framingham, Mass.-based NECC led to the deadly health crisis that has sickened more than 600 patients in 19 states. Those regulation gaps also extended to at least 3 other compounding pharmacies, all discovered to have some level of contamination in the lab. With the growing threat of contaminated drugs being distributed across the country, the FDA quickly enacted shutdowns of the offending pharms.
Historically, compounding pharmacies, which are viewed under a different light than typical drug pharms, have not been regulated by the FDA; for the most part, compounders are overseen by state health officials. To change this, the FDA convened the meeting to find out what is needed to close the gaps between the federal and state level. Some states were in favor of the FDA taking charge over large-scale compounders like NECC.
“The consensus in our group was that there is a role for the FDA to be involved in facilities like NECC,” Cody Wiberg, the executive director of the Minnesota Board of Pharmacy, said at the meeting. “If you´re talking about compounding, most states have the authority and resources to handle that. If you´re talking about nontraditional compounding [like the large-scale compounding at NECC], fewer states may have the resources to do that.”
Large-scale compounding has expanded dramatically since the early 1990s, mainly driven by health care reform, such as the rise of hospital outsourcing.
“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Hamburg said in a telephone interview with Sabrina Tavernise of the New York Times on Tuesday. Hamburg added that laws have not kept pace with these shifts.
“We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems,” Hamburg said.
While the FDA hasn´t had a lot of authority over compounders, some critics argue that it already has all the legal authority it needs to police them. They say that many of these compounders are operating large-scale and shipping drugs all across the country, which should allow the FDA to use its jurisdiction to regulate those companies´ activities.
“There should be one uniform federal standard that is enforced by one agency — the F.D.A.,” said Michael Carome, deputy director of Public Citizen´s Health Research Group, a nonprofit consumer organization, who has been a critic of the agency´s approach. “They have been lax in enforcing that standard.”
Hamburg said that states have different laws and resources and a greater understanding is needed to help improve the oversight of compounding on a federal level. While some states were in favor of FDA oversight, others stopped short of handing over the reins completely. Most said some level of federal intervention was needed, asking the FDA to create a better definition of the compounding pharmacy label, as well as make clear distinctions between compounding and manufacturing.
Currently, there is a very fine line between compounding and manufacturing, and Hamburg contended that the distinction between them is not a simple one. Lumping large compounders in with manufacturers would mean they would have to file new drug applications for every product they make, which would be a costly and time-consuming process. Hamburg suggested creating a new federal oversight category for large-scale compounders, separate from manufacturers.
“What concerns me is the idea that we could assert full authority over some of these facilities as though they were manufacturers, as though there were an on-off, black-white option,” Hamburg said. “That is a heavy-handed way to regulate a set of activities that can make a huge positive difference in providing necessary health care to people.”
State representatives said the central problem is how to define large-scale compounding. Do we measure companies based on how much they produce, whether their products are shipped over state lines, what types of products they produce, or is it a combination of these factors?
“It´s easy to stand at a distance and ask why can´t there be a bright line?” said Jay Campbell, executive director of the North Carolina Board of Pharmacy. “Let´s not let the perfect get in the way of the good. We won´t be able to make a distinction that is razor sharp.”
Large-scale compounders are an important part of the national health care supply chain when they produce high-quality products, said the FDA. They fill gaps during shortages and supply hospitals and other medical facilities with products that can be made more safely and cost-effectively in bulk than by individual hospitals.
The key word here is safe. While officials said it is mandatory to ensure products are safe, they said it is also important not to disrupt supply lines.
Under the current system, individual states are not equipped to regulate large-scale compounders; so it is up to the FDA to find a middle path for regulating these pharms.
But in the end it will come down to one party coming out on top while the other suffers. “Either hospitals are not going to like the solution, or the manufacturers aren´t going to like the fact that these guys get a shorter path,” said Carmen Catizone, head of the National Association of Boards of Pharmacy. “But something´s got to give.”
Meanwhile, the 2012 fungal meningitis outbreak continues to take its toll, so far infecting 620 people and killing 39, according to the CDC. But health officials said it could have been a lot worse.
Previous outbreaks revolving around contaminated injections were far more deadly, “killing as many as 40 to 50 percent of those who had become infected,” according to Dr. Rachel Smith, an epidemic intelligence service officer at the CDC.
“We were certainly concerned we could see that kind of mortality rate in this outbreak,” said Smith, who wrote about the ongoing U.S. outbreak of fungal meningitis and related infections in the New England Journal of Medicine.
In the 2012 outbreak, the death rate link was much smaller, only around 6 percent. Smith attributed this to a quick, coordinated response by federal and state health agencies, as well as hospitals and doctors.
"We think it likely saved lives," Smith said in a telephone interview with Reuters Health.
When the first case of fungal meningitis was seen, in a Tennessee hospital in September, health officials believed it may have been confined to a single ambulatory surgical center. But when a similar case popped up in North Carolina, it became evident that the infections were likely related to the steroid medication methylprednisolone acetate, produced by NECC.
The NECC voluntarily recalled three lots of its steroidal injections on September 26 following a call by the FDA urging them to do so. Those recalls consisted of more than 17,000 vials that had been shipped to 76 facilities in 23 states. However, only 3,000 vials had gone unused, leaving state and local health officials with the daunting task of alerting more than 14,000 patients of the possibility they were administered contaminated drugs.
As of October 19, state and federal health officials had been able to contact 99 percent of those who had received injections from the contaminated lots. But even so, the outbreak continued its rampage, with case counts piling up in more than 15 states at the time. As of today, 19 of the 23 states involved in the NECC recall, had reports of infections due to the contaminated steroidal injections.
And while case counts have now slowed to a trickle, health experts are concerned of a new crisis, after seeing several cases of localized infections at the injection site, which may also lead to recurrence of meningitis in those already treated and released.
"This is still an ongoing outbreak," said Smith, adding that there are now 620 cases. "We do expect these attack rates to go up."