Mass. gov: Drug firm may have misled regulators

This photo pro­vided Oct. 9, 2012, by the Min­nesota Depart­ment of Health shows shows vials of the injectable steroid prod­uct made by New Eng­land Com­pound­ing Cen­ter impli­cated in a fun­gal menin­gi­tis out­break that were being shipped to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion in Atlanta from Min­neapo­lis. About 17,700 single-dose vials of the steroid sent to 23 states have been recalled. The out­break involves 10 states, includ­ing Min­nesota. (AP Photo/Minnesota Depart­ment of Health)

JAY LINDSAY

Asso­ci­ated Press

BOSTON — The spe­cialty phar­macy linked to a deadly menin­gi­tis out­break may have mis­led reg­u­la­tors and done work beyond the scope of its state license, Mass­a­chu­setts Gov. Deval Patrick said Wednesday.

Mean­while, a sec­ond phar­macy con­nected to the New Eng­land Com­pound­ing Cen­ter in Fram­ing­ham has shut down for state and fed­eral inspection.

The New Eng­land Com­pound­ing Cen­ter made a steroid that was used in injec­tions for back pain that were later found con­t­a­m­i­nated. More than 130 peo­ple in 11 states have been sick­ened. Twelve have died.

On Wednes­day, Patrick told reporters that state and fed­eral agen­cies “may have been mis­led by some of the infor­ma­tion we were given” by the New Eng­land Com­pound­ing Center.

The com­pany was licensed to fill spe­cific pre­scrip­tions for spe­cific patients but exceeded that, he said.

“What they were doing instead is mak­ing big batches and sell­ing them out of state as a man­u­fac­turer would, and that is cer­tainly out­side of their state license,” he said.

Mass­a­chu­setts U.S. Rep. Ed Markey seized on Patrick’s state­ment, and sent a let­ter to the U.S. Food and Drug Admin­is­tra­tion, ask­ing if it believes it was mis­led by the company.

“This com­pany may have dis­re­garded fed­eral guide­lines, and we need to know from the FDA whether the com­pany mis­led reg­u­la­tory author­i­ties and if sanc­tions against the com­pany are avail­able or war­ranted,” Markey said.

A com­pany spokesman declined com­ment beyond a state­ment that com­pany offi­cials are focused on coop­er­at­ing with the inves­ti­ga­tion. The com­pany has shut down oper­a­tions, recalled the fungus-contaminated steroid and is coop­er­at­ing with investigators.

On Wednes­day after­noon, the state announced that the phar­macy Ameri­dose has agreed to tem­porar­ily shut down, pend­ing inspec­tion by state and fed­eral reg­u­la­tors. Ameri­dose was founded in 2006 by Greg Conigliaro and Barry Cad­den, who opened the New Eng­land Com­pound­ing Cen­ter eight years earlier.

Ameri­dose said in a state­ment that its shut­down ends Oct. 22, though the agree­ment with the state allows the shut­down to be extended or short­ened. The com­pany said that as part of the agree­ment, Cad­den has resigned all cor­po­rate posi­tions with the com­pany, where he has not had a day-to-day role.

Ameri­dose com­pounds drugs at one of its two facil­i­ties in West­bor­ough, but also pro­vides med­ica­tion in pre­filled oral syringes to hos­pi­tals nationwide.

Dr. Madeleine Bion­do­lillo, direc­tor of the state’s Bureau of Health­care Safety, said there’s no evi­dence of prob­lems at Ameri­dose and the state hasn’t requested a recall of any Ameri­dose products.

A phar­macy man­ager at Ameri­dose, Sophia Pasedis, has been a mem­ber of the reg­u­la­tory body, the Mass­a­chu­setts Board of Reg­is­tra­tion in Phar­macy, since 2004. But the state said she has recused her­self from all mat­ters related to Ameri­dose and the New Eng­land Com­pound­ing Center.

Com­pound­ing phar­ma­cies sup­ply prod­ucts that aren’t com­mer­cially avail­able, based on an indi­vid­ual doctor’s pre­scrip­tion. Some have grown into larger busi­nesses, oper­at­ing across state lines and sup­ply­ing drugs to thou­sands of hos­pi­tals, clin­ics and physicians.

Bion­do­lillo said the state has reminded Mass­a­chu­setts phar­ma­cies that com­pound­ing can be done only in response to a patient-specific pre­scrip­tion. She said the state is now requir­ing all com­pound­ing phar­ma­cies to sign an affi­davit that they are fol­low­ing all regulations.

The state has 1,100 phar­ma­cies that can com­pound drugs.

Mass­a­chu­setts last inspected the New Eng­land Com­pound­ing Cen­ter in March in response to a pend­ing com­plaint unre­lated to the out­break, offi­cials have said. It also inspected the phar­macy in 2011 when it moved oper­a­tions, and found no problems.

Asked if the state had tried to deter­mine if the com­pany was mak­ing large batches of drugs, a pos­si­ble sig­nal it was oper­at­ing out­side the bounds of its license, Bion­do­lillo said, “Each time we go out and inspect, we’re look­ing at all aspects of the operation.”

She didn’t give specifics about what the inspec­tors found in the most recent visit.

In Ohio, the state’s board of phar­macy on Wednes­day sus­pended the company’s license to dis­trib­ute in the state, cit­ing evi­dence that the company’s prac­tices pre­sented a dan­ger of seri­ous and imme­di­ate harm to others.

As many as 13,000 peo­ple received steroid shots from the New Eng­land Com­pound­ing Cen­ter, accord­ing to the fed­eral Cen­ters for Dis­ease Con­trol and Prevention.

Com­pounded drugs have never been reviewed for safety and effec­tive­ness by the FDA. The out­break has led to calls from law­mak­ers, includ­ing Markey and Con­necti­cut Rep. Rosa DeLauro, to strengthen the agency’s over­sight over the drugs.

Posted by AP News on Oct 10 2012. You can follow any responses to this entry through the RSS Feed. Comments can be made below.