Texas Compounder Approved in Tennessee

By Walter F. Roche Jr.

The Tennessee Pharmacy Board has licensed a Texas pharmacy to issue sterile compounded and other prescription drugs in the state even though the company says it has suspended the production of sterile drugs while its facilities are upgraded.
Records from the state board show Surecare Specialty Pharmacy of El Paso, Texas was issued a pharmacy license in early July. But you won't find Surecare listed among the licensed pharmacies on the board's website. It was removed from the automated listing shortly after a request was submitted for a copy of the application.
Asked why the listing was removed, Shelley Walker, a spokeswoman for the state Health Department, said the action was taken under the state law creating the pharmacy panel. She declined to be more specific.
The unusual handling of the Texas drug compounding firm comes in a state where drug compounding has become controversial. It was a Massachusetts drug firm that compounded fungus laden steroids that took the lives of 15 Tennessee patients in a 2012 outbreak. Dozens more were sickened.
More recently an unnamed out-of-state drug compounder provided the Tennessee Corrections Department with the drug, Midazolam, needed to execute Billy Ray Irick on Aug. 9. Under state law the identity of that compounder has been kept secret.
Repeated calls and emails to Surecare and its majority owner Paul Galbiati went unanswered.
The Surecare web site lists sterile compounding as one of its services, but also states, "We
are currently updating our clean room facilities to meet changes in standards and regulations – at which time we will continue to offer sterile compounding for our patients."
According to the company's application, a predecessor firm, Sun City Compounding, was cited by the Texas Pharmacy Board for failing to disclose the fact that an officer had been convicted of a misdemeanor.
Surecare's Tennessee application lists Alexandra Abbas as the pharmacist in charge.
Abbas was also cited by the Texas board in 2017 for allowing an unlicensed technician to perform technician's duties. She was employed in a different pharmacy at the time.
Though Abbas was listed as the pharmacist-in-charge in the Tennessee application the company web site lists a different pharmacist in that position.
The application lists Galbiati as a 60 percent owner, 4AM Consulting with 30 percent, James A. Lyle at 5 percent and Ed Anderson with 5 percent. Neither Lyle or Anderson responded to requests for comment.
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FDA Proposes Eased Compounding Monitoring

By Walter F. Roche Jr.

The head of the U.S. Food and Drug Administration is proposing an easement in the oversight of drug compounders even as he acknowledges that current inspections have turned up evidence that the practices of some of those in the field "present serious public health risks."
Commissioner Scott Gottlieb, in an announcement issued late last week, said that a revised proposal for compounder regulation sets a higher threshold to trigger closer scrutiny of drug compounders who are shipping their products over state lines. Originally the FDA had proposed in 2015 that drug compounders shipping more than 30 percent of their products over state lines get greater scrutiny. The revised proposal sets a 50 percent threshold.
The new policy would effectively change the definition of an "inordinate amount" from 30 percent to 50 percent.
The new proposal is the FDA's latest effort to implement a 2013 law,the Drug Quality and Security Act. That law was passed in the wake of the 2012 fungal meningitis outbreak which sickened 778 patients across the country, killing 76 of them. The culprit was a Massachusetts drug compounder that was mass producing steroids and other drugs and shipping them across the country. Thousands of vials of methylprednisolone acetate contaminated with deadly fungi were shipped from the New England Compounding Center.
In his statement Gottlieb said the goal of the revision was "to collaborate with the states, so that, working together, we can have the greatest public health impact, while also maximizing our resources."
The new threshold would be included in memorandums of understanding between the FDA and state boards regulating pharmacies.
The original proposal prompted protests from state pharmacy boards and drug compounders who warned that the stricter regulation would lead to a shortage of needed drugs, thus hurting patients.
Traditionally local pharmacists compounded drugs to meet the needs of specific patients,such as a child who was allergic to one of the ingredients in a mass produced drug. As the 2012 outbreak demonstrated some of those local pharmacies had morphed into manufacturers, but were eluding the increased scrutiny required for manufacturers.
In his statement issued Friday, Gottlieb acknowledged that regulators continue to identify "insanitary conditions" at some drug compounding operations "that present a serious health risk." He said those include finding mold growth and animal hair in areas where sterile drugs were being prepared.
"Sometimes," he continued, "these involve situations where the compounders have already been warned to correct violations of law."
"This field is in need of vigilant oversight," Gottlieb said, adding that the goal of the new proposal was to "streamline our operations to expedite enforcement actions."
Gottlieb noted that there were increased risks when compounders ship their products over state lines.
"(I)t can be very difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem," he wrote.
Under the revised proposal state boards signing an MOU would agree to notify the FDA when they find drug compounders who, in any given month, ship more than 50 percent of their compounded prescriptions to out-of-state customers.
"States that enter into the MOU will investigate complaints and advise the FDA when they receive reports of serious adverse drug experiences or serious product quality issues, like drug contamination," Gottlieb said.
Michael Carome of Public Citizen, an advocacy group, noted that the revision still includes a provision requiring states that sign an MOU to notify the FDA within 3 business days of any complaint relating to a drug product compounded by a pharmacist or pharmacist and distributed outside the state involving a serious adverse drug experience or serious product quality issue.
In states where there is no MOU, the threshold for identifying out of state compounders would be 5 percent.
In his statement Gottlieb said his agency will also be issuing new policies relating to insanitary conditions that have been encountered in inspections of drug compounders. He noted that the revisions do not effect a new class of drug compounders who are licensed as mass producers under a provision of the new law.
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NECC Defendants Seek More Challenges

By Walter F. Roche Jr.

Lawyers for the remaining eight defendants in the probe of a deadly outbreak are asking a federal judge to give them three more peremptory challenges of jurors in their upcoming trial.
In a five-page filing today in U.S. District Court in Boston, Mass., lawyers for the defendants asked U.S. District Judge Richard G. Stearns to increase the number of peremptory challenges from 13 to 16.
Stearns last week in a pre-trial order granted prosecutors nine challenges and the eight defendants a combined total of 13.
Citing three factors, the defense attorneys said additional challenges should be allowed because of the unique characteristics of the case and "in the interests of justice."
The eight were among 14 indicted following a two year investigation of the fungal meningitis outbreak which has been described as the worst public health crisis ever to be caused by a prescription drug.
The outbreak sickened some 778 patients in 20 states, killing 76 of them.
All the defendants scheduled to go on trial in October were affiliated with the New England Compounding Center, the company that caused the outbreak by shipping out fungus infested drugs to unsuspecting health providers across the country. None of the eight has been charged with any of the deaths
In the motion the eight defendants cited the highly publicized nature of the case, the fact that charges against the defendants differ widely and the wide demographic disparity among the defendants as justification for additional juror challenges.
In a footnote the defendants also said they oppose a proposed summary of the case offered by Stearns in last week's order.
The charges range from racketeering to conspiracy to mail fraud. Jury selection is set to begin Oct. 2 and opening arguments are set for Oct. 15.
In addition to setting a pre-trial schedule, Stearns order sets limits on the amount of time prosecutors and defense attorneys can spend in presenting their cases. Both sides were allotted 60 hours, with cross examination to be included within those limits. The 60 minutes allocated to the defense must be divided up among the eight attorneys.
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Judge Sets NECC Trial Schedule

By Walter F. Roche Jr.

A federal judge has set a time limit of 60 hours apiece for both defendants and prosecutors in the upcoming criminal trial of the remaining defendants in the racketeering and mail fraud case stemming from a deadly fungal meningitis outbreak.
In a four-page ruling dated Friday, U.S. District Judge Richard G. Stearns also set an Oct. 15 date for opening arguments in his Boston, Mass. courtroom.
The eight remaining defendants were among 14 indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak that sickened some 778 patients in more than 20 states. Though 76 of those patients died, the remaining defendants have not been charged in any of those deaths.
All of the remaining defendants, however, were affiliated with the now defunct New England Compounding Center, the company blamed for the outbreak.
The October trial marks the second time in the case that Stearns has placed time limits on both the prosecution and defendants. He also set limits in the trial of codefendant and NECC supervising pharmacist Glenn Chin.
Stearns order states that jury selection will begin on Oct. 2 and 16 jurors will be selected before opening arguments. The government will be allowed nine challenges while the defendants will be allowed 13.
Stearns also asked both sides to propose a summary of the case to provide to jurors and offered one of his own. Both sides are also required to provide a proposed questionnaire for prospective jurors to fill out.
The order sets a 60 hour limit for the prosecution and 60 hours combined for the defendants. And the limits also apply to cross examination. If Stearns follows his past practice of limiting trial testimony to four hours per day, the trial could be over by the end of November.
The eight going on trial are Gene Svirskiy, Christopher Leary, Joseph Evanosky, Sharon Carter, Alla Stepanets, Gregory Conigliaro, Kathy Chin and Michelle Thomas.
As Stearns noted in his proposed summary six of the defendants were licensed pharmacists. Gregory Conigliaro was an officer and part owner of NECC while Sharon Carter was a pharmacy technician.
The indictment, Stearns summary states, charged the defendants with conspiring to commit fraud by knowingly marketing drugs that had been manufactured in non-sterile conditions.
Chin and NECC president Barry J. Cadden were convicted of racketeering and mail fraud charges in two separate trials. Both are now serving prison sentences. They were cleared of second degree murder charges.
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Mass. AG In Push for Victims

By Walter F. Roche Jr.

The Massachusetts Attorney General's office is planning a final push this fall to reach all victims of the 2012 fungal meningitis outbreak who are eligible for grants of $25,000 to $50,000.
Aides to Maura Healey, the attorney general, say they plan to work with the U.S. Attorney's office in Boston to identify all victims who qualify for grants from a $40 million victims fund allocated from the U.S. Justice Department.
Healey aides said the effort will include obtaining the best available address for any victims who have not yet applied for any of the victim funds.
The allocation to the Healey's office came with the active intervention of U.S. Rep.Mike Bishop, a Michigan Republican whose district was one of the hardest hit in the outbreak. It was caused by fungus riddled steroids shipped to health providers across the country.
The final deadline for applications is Dec. 31 of this year. That deadline has already been extended several times.
The award for most victims will be $25,000 but Healey aides say those who suffered a permanent impairment and the survivors of victims who died as a result of the outbreak can qualify for a second $25,000 grant. The impairment must be verified by a physician.
Stating that outreach will be the priority over the next four months, Healey aides said they were committed to finding every single eligible victim.
The latest round of checks mailed out to victims brought the total distributed to $18 million.
The actual number of victims has never been determined. Nearly 3,000 victims filed for claims in a related bankruptcy.
Federal investigators have stated in court filings that 76 victims died and 778 were sickened in the outbreak caused by contaminated methylprednisolone acetate shipped from the now defunct New England Compounding Center in Framingham, Mass.
In a related criminal case two NECC officials were found guilty of racketeering and mail fraud charges and are now serving prison sentences.
Information on the application process can be found at https://www.mass.gov/mass-necc-program
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NECC Defendants Seek Six Weeks of Testimony

By Walter F. Roche Jr.

Lawyers for the remaining defendants in the fungal meningitis outbreak criminal case say they will need four to six weeks to present their cases when the trial begins in early October.
In a joint filing today in U.S. District Court in Boston, Mass. lawyers for the eight remaining defendants estimated they would need a total of 112 to 161 hours to present jurors with their defenses. Based on the past practices of U.S. District Judge Richard G. Stearns, who is presiding over the case, that could mean more than six weeks of testimony.
Stearns in two previous NECC criminal trials, limited testimony to five hours per day.
Stearns had issued an order requiring prosecutors and defense lawyers to provide an estimate of the time they would need.
An estimate by the U.S. Attorney's office has yet to be filed.
According to the filing the defendants intend to designate a lead attorney for each cross examination and "to divide responsibilities to avoid repetition."
In the three page joint filing, the defense attorneys stated that they had provided more detailed information to Stearns under seal.
Stearns limited testimony in the recent trial of Glenn Chin, who was a supervising pharmacist at the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak. The eight remaining defendants were NECC employees.
Prosecutors already have provided a list of 76 possible witnesses they may call to present their case.
The remaining defendants face racketeering, conspiracy and mail fraud charges. None have been charged in connection with the deaths of outbreak victims.
The eight are Gene Svirskiy, Christopher Leary, Joseph Evanosky, Sharon Carter, Alla Stepanets, Gregory Conigliaro, Kathy Chin and Michelle Thomas.
Chin and NECC president Barry J. Cadden were convicted of racketeering and mail fraud charges in two separate trials. Both are now serving prison sentences. They were cleared of second degree murder charges.
All of the defendants were named in a 2014 indictment following a two year probe of the fungal meningitis outbreak which sickened 780 patients in more than 20 states. Seventy six of them died.
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NECC Defendant Pleads Guilty

By Walter F. Roche Jr.

One of the remaining defendants in the criminal case stemming from the 2012 fungal meningitis outbreak entered a guilty plea today to mail fraud charges.
Scott M. Connolly, who continued to work as a pharmacy technician even after he had surrendered his license, entered the plea before U.S. District Judge Richard G. Stearns in his Boston, Mass. courtroom.
Under a plea agreement with federal prosecutors, racketeering and conspiracy charges were dropped.
Stearns set a Dec. 19 date for sentencing.
Connolly was one of 14 people indicted in late 2014 following a two year probe of a deadly fungal meningitis outbreak that sickened 778 patients, killing 76 of them.
Eight other defendants are scheduled to go on trial in early October.
Three of the 14 have entered guilty pleas.
All of those indicted were employees of the now defunct New England Compounding Center or a sales affiliate. State and federal officials concluded that fungus laden steroids from NECC caused the outbreak.
Connolly worked for NECC for about two years ending 2012 when the company was shutdown in the aftermath of the outbreak. He worked in a room where sterile drugs were prepared. According to the indictment Connolly used co-defendant Barry Cadden's sign on to the company computer system so that there would be no record of his actual role.
Cadden, who was NECC's president and part owner is serving a nine year sentence at a federal prison in Pennsylvania. During Cadden's trial there was extensive testimony about concerns that regulators would discover that Connolly was working as a pharmacy technician even though he had surrendered his license in the midst of an unrelated investigation.
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