Specialty pharmacy oversight slammed

Tuesday, April 16, 2013

WASHINGTON - Congressional investigators say pharmacy boards in nearly all 50 states lack the information and expertise to oversee specialty pharmacies like the one that triggered a deadly meningitis outbreak last year.

A report released Monday by House Democrats shows that most states do not track or routinely inspect compounding pharmacies. Staff members surveyed state officials about their oversight of pharmacies and then compiled the responses.

The findings come as lawmakers debate how to prevent another outbreak like the one caused by the New England Compounding Center, a Massachusetts compounding pharmacy. Contaminated injections distributed by the company last year have killed more than 50 people and sickened hundreds more.

Compounding pharmacies, which mix customized medications based on doctors’ prescriptions, have traditionally been overseen by state pharmacy boards. But the growth of larger compounding pharmacies such as the New England Compounding Center,which mass-produced and distributed thousands of vials of drugs across the United States, has prompted calls for more federal oversight.

The report from Democrats on the House Energy and Commerce Committee argues that state regulators are not adequately policing the specialty segment, and that the Food and Drug Administration should be given direct authority over the pharmacies.

“In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease and death,” said Rep. Ed Markey, D-Mass, in a prepared statement. Markey represents the congressional district where the New England Compounding Center is located.

John Kirtley, director of the Arkansas Pharmacy Board, took issue with the finding that of the 49 states that responded to the inquiry, only officials from Missouri and Mississippi could provide the exact number of compounding pharmacies in their state and that Missouri and Mississippi were also the only two states that require permits or licenses for pharmacies that perform compounding.

The Arkansas board, in fact, does track compounding pharmacies, he said. There are four major ones, he said: Lee Pharmacy in Fort Smith; Cantrell Drug in Little Rock; Sterile Compounding of America, also in Little Rock; and U.S. Compounding in Conway. There are other small ones, some compounding in a limited sense, such as by adding flavoring to a drug, he said.

The FDA recently cited potential safety problems at Lee Pharmacy and 29 other “specialty pharmacies.”

Kirtley said of the report from the FDA and response from Lee Pharmacy, “I do not know of a pharmacy in the country that could pass the type of inspection or oversight activity that the FDA delivered to pharmacies such as Lee Pharmacy.”

The Arkansas board licenses and regulates compounding pharmacies as retail operations, Kirtley said.

On average, most pharmacy boards have five inspectors responsible for visiting all the pharmacies in the state. Arkansas has three full-time inspectors, Kirtley said.

Investigators found that many states do not keep any inspection records of compounding pharmacies. Twenty-two states, or 44 percent, said they do not keep histories of problems such as contamination, cleanliness and drug potency. Other states said they use a combination of inspection reports, complaints and “staff recollections” to track problematic pharmacies.

Given that picture of laxity, Kirtley said: “I think there ought to be federal standard, even for boards of pharmacy, that they must have oversights in their states, that they must inspect facilities.”

“This report clearly indicates what we’ve known for quite some time - that there is no clear, functioning, or uniform process for all 50 states to manage and oversee compounding pharmacies,” said Rep. John Dingell, DMich., in a prepared statement. Dingell’s office helped conduct the survey.

The findings will likely come into play today, when a House investigative committee holds its second hearing on the meningitis outbreak. Republicans on that committee have argued that the FDA could have shut down the New England Compounding Center using its existing powers. Lobbyists for thecompounding industry generally share that view, and have fought proposals for decades to give the federal government more authority over compounding.

Last week, House Democrats released dozens of documents from the International Academy of Compounding Pharmacists, the industry’s leading trade group. The documents include internal memos to members suggesting how they deal with FDA inspectors, in particular: “when a pharmacist should NOT provide certain information to the FDA,” and “when pharmacists should draw the line and discontinue the visit and call their attorney.”

Democrats on the House Energy and Commerce Committee suggested the chief executive officer of the trade group should testify at today’s hearing. However, Democratic staff members said latelast week that they had not received a response on that request from Republicans, who control the chamber.

FDA Commissioner Margaret Hamburg will testify.

Information for this article was contributed by Matthew Perrone of The Associated Press and by Jack Weatherly of the Arkansas Democrat-Gazette.

Business, Pages 25 on 04/16/2013