Meningitis outbreak stirs calls for FDA pharmacy oversight

* Lawmakers call for stronger FDA role

* Critics say existing law provides major loophole

* Supreme Court may have to settle legal questions

By David Morgan and Sharon Begley

WASHINGTON/NEW YORK, Oct 9 (Reuters) - A deadly U.S.meningitis outbreak tied to contaminated steroid shots shouldspur new legislation to regulate how pharmacies mix and dosedrugs, experts said on Monday.

Health officials reported eight deaths and 105 cases offungal meningitis stemming from compounded versions of a steroidinjection used largely to treat back pain. They estimated thatas many as 13,000 people in 23 U.S. states may have been exposedto the drugs.

The source of the tainted drugs, the New England CompoundingCenter Inc in Framingham, Mass., is one of thousands ofpharmacies that repackage or recombine medications on a sizablescale, sometimes for off-label use by thousands of patients.

They operate in a legal limbo created by existing laws andfederal court rulings that have effectively blocked theregulatory powers of the Food and Drug Administration, despiterepeated threats to public health in the last decade.

Democratic lawmakers said the new crisis showed it was timefor Congress to strengthen the FDA's hand in overseeing thisside of the drug industry. There was no immediate comment fromRepublican members of Congress, who tend to favor deregulation.

Pending legal cases may land the issue at the steps of theSupreme Court.

"These compounding pharmacies are operating now on a scalewhere (regulation) should be a priority," said Senator RichardBlumenthal, a member of the Senate Health, Education, Labor andPensions Committee, who is urging hearings and an investigationin prelude to new legislation.

His concerns were echoed by U.S. Representative EdwardMarkey, another Democrat who sent a letter to the FDA askingwhether agency rules ensure that compounded drugs meet the samesafety standards as the products of major drug manufacturers.

While compounding to produce appropriate doses ofmedications for individual patients has long been a feature ofneighborhood drugstores, its prevalence and scale has grown asdoctors and patients seek less expensive ways to fillprescriptions.

Disease outbreaks have been traced to compounding pharmaciesrepeatedly in the last decade, including other cases ofmeningitis and hepatitis C infections.

"If regulation doesn't set a standard that seeks to preventthis, we can expect these outbreaks to keep happening," said Dr.John Santa, director of the Health Ratings Center at theConsumers Union advocacy group.


Of the 56,000 or so free-standing U.S. pharmacies - theWalgreens and Duane Reades of America's Main Streets -more than half perform compounding, says the Houston-basedInternational Academy of Compounding Pharmacists.

IACP estimates that there are 7,500 U.S. pharmaciesspecializing in advanced compounding and that 1 percent to 3percent of prescriptions are compounded.

The FDA's main authority over the safety, efficacy, use andproduction of drugs pertains to manufacturers, not pharmaciesthat are mostly regulated at the state level.

"Congress exempted drugs compounded by pharmacists from theusual safety and efficacy requirements," said Dr. Michael Caromeof the Washington-based public advocacy group Public Citizen."And now it's led to a public health disaster."

The 1997 Food and Drug Administration Modernization Actstates that such requirements don't apply to drugs "compoundedfor an identified individual patient based on the unsolicitedreceipt of a valid prescription order."

That means compounding pharmacists do not have to show thatthe version of a drug that they produce - such as crushing anddissolving a tablet - is still safe or effective.

Critics like Carome say that has provided a loophole nowexploited by pharmacies compounding large lots of a medication.In NECC's case, the company shipped 17,676 vials of the steroidmethylprednisolone acetate to 76 healthcare facilities in 23states from July through September, according to theMassachusetts Health Department.

"This is not traditional compounding we're talking about,"said David Miller, chief executive of the IACP. "It ismulti-state selling and large-scale manufacturing."

Pharmacies have further challenged the law's prohibitionagainst advertising their compounded drugs. The Ninth U.S.Circuit Court of Appeals in San Francisco overturned thatrestriction in 1998 and ruled unconstitutional the entiresection that governs the FDA's authority over compounding.

The case, brought by seven pharmacies, eventually wound upbefore the Supreme Court, which agreed that the prohibitionagainst advertising was unconstitutional but did not addresswhether language allowing FDA regulation should stand on itsown.

In a separate 2008 ruling, the Fifth Circuit Court in NewOrleans said the same section 503A could be used to regulatecompounding drugs. Now a third appellate court, the EleventhCircuit in Atlanta, is set to rule on a Florida case that wentagainst FDA at the district court level.

Richard Samp, chief counsel at the nonprofit WashingtonLegal Foundation, said that if the forthcoming ruling in Atlantaclashes with the decision in New Orleans, "the Supreme Courtcould decide to step in to resolve the conflict."

(Writing by David Morgan; Editing by Michele Gershberg andDavid Brunnstrom)

((david.morgan@thomsonreuters.com)(+1202 898 8326)())