California regulators seek to police out-of-state pharmacies

The pharmacy board wants to inspect compounding pharmacies that sell drugs in California after a nationwide meningitis outbreak linked to contaminated drugs.

By Marc Lifsher, Los Angeles Times

January 1, 2013

SACRAMENTO — State regulators are responding to a deadly nationwide meningitis outbreak linked to contaminated drugs by seeking new power to inspect out-of-state pharmacies that sell special-order prescription drugs in California.

In September, the New England Compounding Center in Framingham, Mass., sent three shipments of contaminated injectable steroid solutions to 76 healthcare facilities and pain-control clinics in 23 states, including four in California.

These customized drugs, which were injected into patients' spines and joints, caused 39 deaths among 620 reported cases of fungal meningitis and other infections, according to a Dec. 17 report from the federal Centers for Disease Control and Prevention in Atlanta.

The steroids were recalled by the now-bankrupt firm before they caused any deaths or illnesses in California. But that fortunate outcome hasn't kept the California Board of Pharmacy from being more aggressive about policing sometimes poorly regulated pharmacies that produce and ship large volumes of these medications, known as compounded drugs.

At issue is whether these outfits ought to be regulated by theU.S. Food and Drug Administration. The FDA regulates large drug manufacturers, but its legal authority to oversee the compounding pharmacies has been disputed in the courts. As a result, states are moving to play a bigger role in ensuring the safety of their products.

In one such case in 2012, the now-defunct Franck's Compounding Pharmacy in Ocala, Fla., shipped supposedly sterile products for injecting into the eye that caused infections in 17 California surgery patients.

The state pharmacy board, which oversees and licenses nearly 7,000 drugstores in California, plans to sponsor a bill in the Legislature this year that would give state agents the authority to make unannounced on-site inspections of out-of-state pharmacies that the board licenses to ship sterile medicines, such as injectable steroids, eyedrops and inhaled aerosol drugs, to healthcare providers here.

The California initiative is getting preliminary support from two industry trade groups, the Pharmacy Compounding Accreditation Board and the International Academy of Compounding Pharmacies. The FDA also is supportive of the thrust of the proposed legislation, said Virginia Herold, the state pharmacy board's executive director.

"We're being proactive for the public health because we don't want another incident," she said. "We want to make sure that if the product is coming into California, it meets the requirements of California law."

Increasing amounts of these compounded drugs are flowing into the state. The Board of Pharmacy told a congressional committee in December that it licensed 86 out-of-state compounding pharmacies to make sterile medications for use in California in fiscal year 2011-12, compared with just 17 in 2003-04 and none in 2002-03.

But keeping track of out-of-state, large-volume pharmacies isn't easy, Herold conceded, because both state and federal laws are ambiguous about who is responsible for regulating different types of compounded drugs.

The advantage of traditional compounding, federal and state health officials agree, is that it enables pharmacies to offer prescriptions in individualized formats. That includes producing such drugs as creams, powders or solutions to direct relief to specific parts of the body or supplying drugs as a liquid to make it easier for people who can't swallow pills, for example.

Any state-licensed pharmacist can make these drugs with a doctor's prescription, if the pharmacy also has a state license. In most cases, regulation and inspections are the legal province of state pharmacy boards, not the FDA.

But over the last decade, the definition of what is a compounding pharmacy has been blurred. Some pharmacies have begun manufacturing large volumes of drugs — such as sterile, injectable steroids used to temporarily ease back pain — that are shipped in bulk to hospitals and outpatient surgical centers.

"FDA's ability to take action against compounding … that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions," FDA Commissioner Margaret Hamburg said in congressional testimony Nov. 14.

The House Energy and Commerce subcommittee on oversight and investigations was probing the New England Compounding Center-related deaths.

As part of Hamburg's effort to boost enforcement and protect patients, she met in December with representatives from the boards of pharmacies in all 50 states.

California supports federal and state efforts to figure out a way to avoid more contamination-related illnesses from these drugs, said Amy Gutierrez, a California Board of Pharmacy member and chief pharmacy officer for the Los Angeles County Department of Health Services.

"The problem is really the other states" that might have different or weaker standards or less enforcement resources than California, she said.

"What we're looking for is holding the out-of-state pharmacies that compound sterile products to the same standards as our own state-licensed pharmacies."

marc.lifsher@latimes.com

Source found here

Drug Compounders Regulation Discussed

December 28, 2012 By Anthony Nguyen Leave a Comment

FDA officials met with their public health counterparts from 50 states last week about best measures to strengthen rules that govern compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted product produced by a Massachusetts pharmacy. Patients who were affected received contaminated preservative-free methylprednisolone acetate steroid injections from New England Compounding Center (NECC) used to treat back and joint pain. So far over 600 cases have been attributed to the contamination, with 39 deaths attributed. The meeting was the first public discussion for the agency since FDA Commissioner Hamburg testified before Congress in November regarding what measures could be undertaken to address drug compounding, or tailor-making of medicine for individual patients.

Unlike drug manufacturers, compounding harmacies are primarily regulated under state law via state boards of pharmacy. The public hearing was convened to gather information for the FDA on gaps in the regulatory net and how the states view the role of the agency. Some states have requested that the FDA handle large-scale compounders such as NECC. 

Current law does not require compounders to give the FDA access to their books. Notably, about half of all the court orders the agency obtained over the past decade were for pharmacy compounders, although compounders are only a small part of the agency’s regulatory responsibilities.

At the testimony in November, the FDA stressed that it was unable to effectively monitor the compounding pharmacies and sought more authority for oversight. The FDA’s critics argue that the agency already has all the legal authority to police compounders. Noting that many compounders have been operating as major drug manufacturers, shipping to states across the country, critics have argued that the FDA should be using its jurisdiction over drug manufacturers to regulate those companies’ activities.

The FDA contends it is not as simple as labeling compounding pharmacies as drug manufacturers. Doing so would effectively require compounding pharmacies to file new drug applications for each product made, which could be costly and time-consuming for products that do not need it, such as IV feeding tube bags. In turn, this could affect the supply chain, especially when there are drug shortages. Under consideration is an oversight category for large-scale compounders, apart from the drug manufacturers.

Whether the FDA steps in and adopts a common pathway to address state and industry concerns remains to be seen, as there are requests for changes from compounding pharmacy groups to emergency state regulations following the Massachusetts contamination

Source found here

Dingell Questions FDA On Additional Products Tied To Meningitis Outbreak

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The Regulatory Blame Game

Cary Coglianese | 12/24/12

Have you noticed the pattern? A private company cuts corners on risk control; a terrible disaster occurs; and then politicians and the public blame . . . the U.S. regulatory system. 

The latest example: a Massachusetts drug compounding pharmacy that contaminated vials of steroids and caused hundreds of cases of fungal meningitis, including dozens of deaths. Even while the Food and Drug Administration was still responding to the serious public health threat, the FDA Commissioner had to answer angry questions from members of Congress. Representative Cliff Stearns (R-FL) told Commissioner Margaret Hamburg that the meningitis outbreak “was a complete and utter failure on the part of your agency.”

 

The FDA joins a growing club.  Over the last several years, regulators have been singled out after virtually every major disaster. Federal offshore oil regulators were blamed for not preventing the Deepwater Horizon explosion and the resulting Gulf Coast oil spill. Financial regulators were blamed for failing to prevent the economic devastation wrought by the housing collapse and ensuing failures by major financial firms. Safety regulators have been blamed for mine and pipeline explosions and suspected automobile defects.

 

Alexis de Tocqueville once observed that in America almost every political question eventually turns into a question presented to the courts. If he were writing today, he could properly observe that scarcely a disaster occurs in the United States that does not result in a widespread indictment of its regulatory system.

 

Of course, in some cases regulators really do fall asleep at the switch. And with the benefit of hindsight, it is always possible to say regulators could have done better.  But it is another thing altogether to say that the U.S. regulatory system has fundamentally broken down. In each disaster, we need to ask “what really did break down,” as Representative Fred Upton (R-MI) asked at a recent hearing on the meningitis outbreak.

 

Not surprisingly, the answer often depends on political ideology. At the same legislative hearing, Representative Henry Waxman (D-CA) opined that the FDA commissioner was “being picked on by Republicans because you’re with the Obama administration.”

 

But no matter which party holds the presidency, seldom does investigation lead to the judgment that someonefailed. We do not usually see Petraeus-like resignations for poor judgment by the heads of regulatory agencies implicated in disaster. 

 

Rather, we see politicians ultimately conclude that something failed – the system. With the Deepwater Horizon disaster, for example, the culprit was said to be a government organizational chart that fostered too much conflict of interest, placing drilling safety inspectors in the same agency as collectors of oil excise taxes. In the immediate wake of the meningitis outbreak, the FDA has claimed that the problem lay with “fragmented” and “ambiguous” legal authority over compounding pharmacies.

 

Fortunately, these kinds of structural problems can be fixed. Congress has the ability – and, in the wake of disaster, often the political will – to pass new legislative authority or to break up and reorganize regulatory agencies. But unfortunately, structural change only works when problems truly have structural causes. Sometimes the problem lies with leadership, not laws. 

 

And sometimes the problem can be redressed by neither leadership nor laws. Sometimes the problem is that we simply live in a risky world where accidents do, regrettably, happen.   As much as everyone hopes that reforms can ensure disasters will never occur again, the truth is that short of banning an economic activity outright its risks can never be fully eliminated. We cannot demand gasoline for our cars without understanding that this means some risk of spills or other oil-production accidents. 

 

In addition, regulation always confronts tradeoffs. Oversight and regulatory standards can be tightened – but only at a cost. We might eliminate automobile accident fatalities altogether if drivers were barred from ever exceeding five miles per hour, but surely that would not be an acceptable option for an automobile-dependent society. For much the same reason, a responsible FDA might well face a limit in overseeing drug manufacturing processes. If more stringent oversight means driving some manufacturers out of business or slowing down manufacturing times, then FDA oversight can affect the access to and affordability of valuable medicines – another challenging tradeoff.

 

The existence of tradeoffs and competing goals means that determining what may be truly broken with the U.S. regulatory system is often harder than it first appears. One thing is clear: we need to put aside unrealistic expectations for what regulation can achieve.  Regulation manages risk; it does not eliminate it altogether. It also is hardly realistic to tighten agencies’ budgets while expecting they will have the resources to find and address all risks of harm from the hundreds of thousands of businesses they oversee. 

 

In the end, responsibility does lie with those businesses. Government can play a vital role, but it can only improve its performance in the wake of disaster if members of the public and their elected and appointed servants make clear-headed appraisals of what truly broke down, why, and what might be done to address root causes in the future. 

 

 Cary Coglianese is the Edward B. Shils Professor of Law, Professor of Political Science, and Director of thePenn Program on Regulation at the University of Pennsylvania Law School.  He is the founder of and faculty advisor to RegBlog.  His most recent book is Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation. 
This post originally appeared in The Hill's Congress Blog.