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Compounding the compounding problem: FDA seeks out high-risk pharmacies.

IN A REMARKABLE ABOUT-FACE, the FDA recently began taking concerted action against compounding pharmacies that may pose a public health risk. And the effort goes beyond seeking compounders that operate like large-scale drug manufacturers by producing large quantities of medicines without requiring individual patient prescriptions or shipping to out-of-state customers.

FDA officials say they are deliberately seeking out so-called high-risk operators, such as those that mostly make a lot of injectable sterile medicines and, in some cases, have problematic track records that warrant agency attention. Since January 1, the FDA has inspected nearly 50 compounders and issued more than two dozen 483 inspection reports.

This is a highly surprising turn of events, given that FDA officials have spent months insisting their bureaucratic hands have largely been tied by judicial rulings that prevented tougher action against compounding pharmacies. FDA commissioner Margaret Hamburg testified before Congress last fall that more authority is needed and, more recently, she told the same thing to the CBS program, 60 Minutes.

Of course, the extent to which the FDA can act has become a heated topic in the wake of a nationwide outbreak of fungal meningitis that was traced to the now-infamous New England Compounding Center, which has since filed for bankruptcy. By mid-April, federal health officials had tallied 733 cases of meningitis, including 53 deaths, making this the worst public health crisis in the U.S. in decades.

Yet, the NECC scandal, which erupted last fall, has been characterized by missed opportunities. In particular, the FDA sent a warning letter in 2007 to NECC over concerns about marketing anesthetic creams and potential microbial contamination associated with splitting and repackaging the Avastin cancer medication, which some ophthalmologists use to treat wet age-related macular degeneration.

Why didn't the FDA get more aggressive with NECC? The agency has continually pointed to judicial rulings. In 2002, the U.S. Supreme Court struck down a portion of a law that prohibited compounders from advertising their products under free speech concerns. As a result, the FDA decided to defer to states to oversee compounding pharmacies in most cases.

Then, a 2008 court ruling confused the issue still more, saying the earlier ruling applied only to the advertising portion of the law. This prompted debate over the ability of the FDA to pursue enforcement actions. But the FDA made things still murkier by indicating it would continue to take action in response to safety concerns or when the equivalent of mass production takes place.

Of course, NECC engaged in the sort of activities that should have prompted the agency to get tough years ago. But only now are FDA officials admitting they could have done more. After all, if the FDA can send inspectors these past few months into dozens of compounders and, in some cases, seek warrants in order to do so, then the same tactic could have been used before the meningitis outbreak.

In a recent interview, Howard Sklamberg, who heads the Office of Compliance in the FDA's Center for Drug Evaluation & Research (CDER), begrudgingly acknowledged that the agency had the same capability at any time over the past few years to aggressively inspect potentially wayward compounders. But there was an obvious reluctance to explain why the FDA failed to do so.

Rather than directly address the reasons for regulatory shortcomings in years past, he instead harped on agency hesitancy and uncertainty over the ability to pursue actions against compounders. And Mr. Sklamberg maintained overseeing compounders was relegated to what he called a reactive effort, rather than a cohesive regulatory strategy that could be consistently and easily applied.

"We faced this legal environment where we were arguing over the very basic ground rules and the very basic ability to do the inspections," he told me in an interview that appeared recently on the Pharmalot web site. "We were dealing with a landscape that shifted legally during this period a whole bunch of times. And as we were, in fact, working on those inspections and the oversight of those particular firms, the firms themselves, even aside from warrants, were pushing back on our authority."

Yet so far this year, the FDA has encountered remarkably little pushback from the compounders that have been inspected. In fact, as of early April, just one forced the FDA to go to court for a warrant in order to conduct an inspection. An obvious explanation for that, which Mr. Sklamberg himself cited, is that few compounders want to risk incurring public wrath after the torrid NECC publicity.

But this does not absolve the FDA of failing to more aggressively and pursue compounders before this year. In fact, the agency could have been expected to more forcefully eyeball compounders in the wake of the ongoing shortage of many injectable medicines, which, ironically, some agency critics attribute to overly aggressive inspections of facilities run by generic drugmakers and contract manufacturers.

Another reason that was blamed for the spotty inspection record of the past is agency resources. With some 28,000 compounders operating around the U.S., agency officials say the FDA has limited staff to keep tabs. And the problem is compounded--pun intended--by the fact that the law does not require these compounders to sufficiently report their activities.

"Sure, we could have out and done more inspections like this and battled each one in court," said Janet Woodcock, director of CDER. "But ... we don't know who's who, because they don't send us anything or tell us. So how would you regulate that industry when we go there and have to get a warrant from a judge to walk in the door? You could say we could battle in court and get in the firm, but what about the other 27,999?"

Now, Dr. Woodcock and Mr. Sklamberg maintain they are taking a less reactive approach. By using a high-risk model to identify manufacturing problems--which they say Congress mandated in the FDA Safety and Innovation Act (FDASIA) that became law last summer--they are taking a more comprehensive and useful approach to the issue.

That may be true. But the effort is clearly a belated response to an unfortunate tragedy and ensuing pressure from a variety of directions. While it also true that playing Monday morning quarterback is a wistful exercise, the FDA did have the needed tools to force NECC, for instance, to acquiesce to agency inspectors years ago, even if it meant going to court to get past the front door.

Of course, FDA officials are correct to say Congress must clarify any outstanding uncertainties caused by the various court rulings and also ensure that agency inspectors have the right to demand and obtain paperwork from stubborn compounders, an issue the agency says remains a problematic obstacle.

But at this point, FDA officials are fooling no one when they say that pursuing NECC a year ago or at any time in the past was an uphill battle. NECC may have been more recalcitrant than other compounders when confronted with agency inspectors, but the FDA has clearly proven its regulatory powers are not toothless--and Congress has yet to convey additional authority for this purpose.

There is no turning back the clock, but FDA commissioner Margaret Hamburg is, in part, throwing up a smokescreen by asking Congress to authorize a third class of compounders, as she did at a hearing last November. The idea is to segregate old-fashioned compounders that cater to individuals from larger players that function like large-scale drugmakers.

The idea may have some merit, and if there is justification, then Congress ought to consider the notion. But the excuses trotted out by agency officials over the past weeks and months have worn thin. The FDA could have moved against NECC in the past and simply failed to respnd to the warning lights. What's done is done, as the saying goes. But FDA officials should no longer offer excuses for unfortunate mistakes or oversights. The time has come to simply admit failings and double down on enforcement efforts.

By Ed Silverman

Contributing Editor

Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation's largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor's Business Daily. Ed blogs about the drug industry at Pharmalot, at He can be reached at
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Title Annotation:THE PHARMA BEAT
Author:Silverman, Ed
Publication:Contract Pharma
Date:May 1, 2013
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