Compounding Study Draws Heat

By Walter F. Roche Jr.

The association representing pharmacy drug compounders is challenging one of the key conclusions of a new study of the ongoing efforts of state pharmacy boards to regulate drug compounding.
In a statement released this week, officials of the International Association of Compounding Pharmacists took issue with the study's conclusion that many state boards are failing to comply with a new federal law as it applies to drug compounding in physicians' offices. The statement was issued in a response to a report by the Pew Charitable Trusts.
"We have identified a primary point of concern which we believe warrants additional clarification and study," the association statement reads.
The group disputed the study's conclusion that the new federal law bars physicians from preparing compounded drugs in their offices without a patient-specific prescription.
Citing six statements of support from members of Congress, the statement also points to language in an appropriations bill supporting their position.
The association said it did agree with some of the Pew findings, including the need for use of a national standard on sterile compounding practices as set by the U.S. Pharmacopia.
The Pew study concluded that many state pharmacy boards were allowing the preparation of sterile compounded drugs in physicians' office without a prescription in apparent violation of the Drug Quality and Security Act of 2013.
The new law was passed in response to the 2012 nationwide fungal meningitis outbreak which took the lives of 76 patients and sickened hundreds more.
The outbreak was traced to a rogue Massachusetts firm mass producing compounded drugs.When regulators began pressing the New England Compounding Center for failure to have patient specific prescriptions, firm  salesmen encouraged clinics to come up with lists.
Clinics purchasing NECC drugs obliged by submitting lists with names including Flash Gordon,  Big Baby Jesus and Mickey Mouse.
Contact: wfrochejr999@gmail.com

Study: States Ignore New Federal Compounding Law

By Walter F. Roche Jr.

A study by led by a non-profit agency has found that the majority of state pharmacy boards are allowing sterile drugs to be compounded without a patient-specific prescription in apparent violation of a 2013 federal law.
The study issued by the Pew Charitable Trusts found that 28 of 43 states that responded to a survey were allowing sterile drugs to be compounded without prescriptions for a specific patient. According to the study, 21 of those states did place some limits on the numbers of nameless prescriptions that could be issued, while seven had no limits.
The study findings, which also cited the virtual lack of any state regulation of drugs compounded in physicians' offices, comes nearly four years after a Massachusetts drug compounding firm triggered a nationwide fungal meningitis outbreak sickening 778 patients, 76 fatally.
The outbreak, caused by thousands of fungus loaded vials of a spinal steroid, led to the new law and a federal probe resulting in the indictment of 14 people on charges ranging from mail fraud to second degree murder. All have entered not guilty pleas and face a September trial in Boston, Mass.
The Pew study focused on the actions of state pharmacy boards in the wake of the outbreak and the passage of the Drug Quality and Security Act of 2013. The federal statute created a new category of licenses for manufacturers producing large quantities of compounded drugs subject to new federal controls.
The study describes drug compounding as a "longstanding practice"under which a pharmacist prepares a drug tailored to a patient's specific needs."
"State policies permitting compounding without a prescription for human use conflict with recently clarified federal law," the report states.
The Pew study focused on drug compounding not subject to the new federal law but still under state regulation.
The study relied on information posted on state and the District of Columbia pharmacy board web sites and the responses to a detailed questionnaire. Eight states including Alabama, Delaware, Florida, Georgia  and Ohio never bothered to respond.
"State policies vary significantly in their policies for sterile drug compounding," the report states, adding, "it appears that states have not moved quickly to synchronize their regulations to the federal policy."
In addition to the widespread failure to require patient specific prescriptions, the report cites the apparent lack of any regulation over drug compounding in physicians' offices.
According to the report only Idaho directly oversees compounding activities in physicians' offices.
"There is little to no clarity on which quality standards apply to sterile compounding in physicians' offices," the report states, "and often no mechanisms exist to track adverse events in these settings.
Among the overall findings were: less than half of the 43 states reported using the U.S. Pharmacopeia standard for compounding sterile drugs; 26 of the 43 don't require the reporting of adverse events, 24 boards track the number of drug compounders, nine require separate licenses for drug compounders.
Contact:wfrochejr999@gmail.com

Victims Angered, Disappointed at HHS Refusal

By Walter F. Roche Jr.

What might seem to some to be an expected bureaucratic decision is proving to be anything but for some victims of the 2012 fungal meningitis outbreak.
The decision triggering an angry reaction came from U.S. Health and Human Services Secretary Sylvia Burwell, who flatly rejected a request from four U.S. Senators that she waive millions of dollars in Medicare liens being levied against victims of the fatal outbreak.
Such a waiver, she concluded, would not be consistent with agency policy. Federal officials contend they are legally obligated to try to recoup monies paid under the Medicare program for the treatment of beneficiaries who were victims of the outbreak.
In comments and postings on social media, the victims have expressed special outrage that the federal government is seeking to extract its share of a $200 million trust fund, when many believe it was the failure of federal and state agencies that allowed the outbreak to occur.
The 2012 outbreak has been blamed on a now defunct Massachusetts drug compounding that managed to operate for years on the outer edges of the regulatory radar. In 2012 the New England Compounding Center shipped thousands of fungus riddled vials of an injectable steroid to health facilities across the country.
Dennis O'Brien, a Tennessee victim, said he gets the policy part, "But 778 people were affected and 76 died. My life will be forever changed by this fungal meningitis. The amount of money we are going to get is so small in comparison to our physical and emotional injuries and needs."
Others put it more bluntly.
"Over 60 people murdered by NECC over three years ago and not one dime paid to the victims or their families," one victim wrote on this blog site.
"I want to scream and curse right now," wrote another.
"Just another knife in our back," yet another victim added.
With Burwell's decision rejecting a blanket waiver, negotiations between the U.S. Justice Department and attorneys for the victims led by Boston attorney Thomas Sobel will continue. If that fails, each case will probably have to be negotiated separately and lengthy delays have been predicted.
Brenda Bansale, a Michigan victim, said it was "a disappointment to know that the very people who need the financial help the most are the very ones who will be affected the most by this decision.
"The lack of governmental oversight on the compounding industry is what helped cause this mess in the first place and now they have their hands in the cookie jar. It's not right."
Another victim cited the years of deficient regulatory oversight.

With out being involved in the legal field on a daily basis, it is very hard to understand.  I can't see how any outcome will be "fair and reasonable" in the eyes of the victims and their families."
O'Brien said while he was disappointed in Burwell's decision, he wasn't surprised.
"Now a large part of some very needed money is gone. And now the money will be tied up negotiating with insurance companies.  It's been 3 1/2 years. Hasn't it been long enough," he asked.

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HHS Secretary Rejects Lien Waiver Request

By Walter F. Roche Jr.

The U.S. Secretary of Human Services has turned down a request by four members of Congress to waive millions of dollars in Medicare liens placed against awards to victims of a 2012 deadly fungal meningitis outbreak.
In a letter to U.S. Sen. Lamar Alexander HHS Secretary Sylvia Burwell wrote that granting such a waiver "would not be consistent" with agency policy.
That means victims of the outbreak sharing in $200 million trust fund will have to rely on ongoing negotiations between lawyers for the victims and the U.S. Justice Department, which is representing the U.S. Center for Medicare and Medicaid Services in the discussions.
While rejecting the request for a blanket waiver Burwell said she was offering her "deepest sympathies" to any of your constituents who may have suffered because of this matter."
Alexander and three other U.S. Senate members had written to Burwell seeking the blanket waiver noting that such a waiver was granted to the 9/11 terrorists attack.
Burwell also disclosed that she had previously received  similar requests regarding the fungal meningitis outbreak and had turned them down also.
The outbreak, caused by a defunct Massachusetts drug compounding firm, sickened 778 patients across the country, killing 76 of them. Tennessee was one of the hardest hit states.
"Through DOJ, CMS is actively engaged in discussions to reach a potential resolution that will minimize any procedural burden on Medicare beneficiaries involved in this matter," Burwell continued.
Lawyers for victims have stated that if the negotiations for a global settlement fail, each victim will be forced to negotiate a personal settlement, a process that is likely to result in considerable delays.
Signing the late December letter along with Alexander, a Republican, were Democrats Al Franken of  Minnesota and Elizabeth Warren of Massachusetts and Republican Pat Roberts of Kansas.
 Contact: wfrochejr999@gmail.com

Judge Rejects Appeal on Meningitis Records

By Walter F. Roche Jr.

A federal judge has soundly rejected the appeal of defendants in the criminal fungal meningitis case who were seeking a review of thousands of records to find potentially exculpatory or favorable evidence.
U.S. District Judge Richard G. Stearns upheld a Dec. 4 ruling by Magistrate Judge Jennifer Boal who had ruled federal prosecutors did not have to search through the  evidence for possible exculpatory evidence that would have assisted the defendant's claims of innocence.
"The government represents that it has provided the defendants with all memoranda of interview and agent notes in its possession, and defendants have offered no reason to believe
otherwise." Stearns wrote in the decision filed last week.
He concluded "the demand that the government identify and designate all known Brady (exculpatory) material amidst the millions of documents thus far produced," was unwarranted.
 The ruling comes in the case of 14 owners and former employees of the New England Compounding Center, who have been hit with charges ranging from mail and wire fraud to second degree murder. The charges stem from an investigation into a deadly fungal meningitis outbreak that sickened 778 patients, killing 76.
NECC shipped thousands of vials of fungus riddled steroids that were injected into the spines and joints of unsuspecting patients in 2012.
The trial of those defendants was recently delayed by Stearns for five months until Sept. 8.
Noting that an earlier ruling found the defendants' request for additional discovery a "make-work order of no particular benefit," Stearns added that he was baffled by the claim that the mishandling of small pox vials by a federal agency "has any connection to this case."
He said other issues raised in the appeal would be more properly considered during consideration of the defendants pending motion for dismissal of the charges.
He also concluded that Boal was correct in denying the defendants' request for access to the minutes of the grand jury that handed up the indictments.
Contact: wfrochejr999@gmail.com

TN Attorney General Backs Clinic's Motion In Meningitis Case

By Walter F. Roche Jr.

The Tennessee Attorney General has stepped in to ongoing litigation stemming from a deadly fungal meningitis outbreak by backing a move by health care providers to privately interview two doctors who treated a Tennessee victim.
In an 11-page filing Friday in U.S. District Court in Boston, Attorney General Herbert Slatery said lawyers for the Saint Thomas Outpatient Neurosurgical Center should be allowed to hold closed door interviews with physicians who treated a Robertson County woman, one of the victims of the 2012 outbreak.
Citing a Tennessee law, Slatery joined with lawyers for the Nashville clinic in contending that a federal law, the Health Insurance Portability and Accountability Act, does not trump the right of defendants to conduct ex parte interviews of Jane Wray's physicians.
Clinic lawyers have asked U.S. District Court Judge Rya Zobel to issue an order allowing the private interviews of Robert Ledford and Lanny Turkewitz, the physicians who treated Wray, then 66, when she suffered a stroke, just weeks after three injections of a fungus tainted spinal steroid.
Clinic lawyers want to interview the doctors prior to a scheduled deposition.
Wray's lawyers immediately filed an objection charging that "the defendants are seeking intrusive and secret meetings to gain an unfair advantage in the discovery process."
Wray's lawyers further charged that the private meetings were "an opportunity to influence the physicians' testimony" and that any needed information could be obtained under the normal discovery process.
In requesting permission to conduct the interviews, clinic lawyers argued that the Tennessee law "allows for the disclosure of protected information in the course of judicial proceedings, while also protecting a patient's privacy."
"The statute unambiguously states that a defendant has a right to conduct ex parte interviews," the motion states.
Slatery argued that the state law "is not contrary to HIPAA" and "disclosure is allowed."
The Wray case is just one of hundreds filed in the wake of the outbreak which sickened 778 victims across the country, killing 76 of them.
Wray's case is one of seven being proposed as so-called bellwethers, which will be heard before the hundreds of others which have been merged in Zobel's court.

List of Proposed Initial Outbreak Trials Narrowed

By Walter F. Roche Jr.
 
A list of seven proposed initial or bellwether cases (see list below) in the long awaited trials stemming from the fatal 2012 fungal meningitis outbreak has been prepared by the opposing sides and is due to be submitted to a federal judge Friday.
The list includes cases proposed by the attorneys for the Nashville clinic where most of the Tennessee victims were treated and the lawyers representing victims.
U.S. District Judge Rya Zobel will finally decide which of those cases will be heard first in her Boston, Mass. courtroom. In a 30 minute hearing today she gave both sides until Tuesday to present written arguments for their respective cases
The list has been shortened considerably from when it was first proposed in October of 2015. Among the names dropped are Diane Reed, a Nashville, Tenn. woman who died leaving her husband, who is suffering from Lou Gehrig's disease, without a caretaker.
Also dropped was Thomas Rybinski, a Smyrna, Tenn autoworker, one of the first to die in the outbreak caused by injected steroids laden with fungus.
Still on the list is U.S. Army Major Adam Ziegler, who was on active duty when he was stricken with an infection from an injection of methylprednisolone acetate from the New England Compounding Center, the defunct company blamed for the outbreak which sickened 778 patients across the country.
During the hearing yesterday Edward Notargiacomo told Zobel that her assistance may be needed to allow the first of the approved payments to be sent out to victims from a $200 million trust fund established in a related bankruptcy case.
Notargiacomo said that while most of the claims are being held up by liens filed by the federal government and health insurance carriers, some victims don't face that obstacle.
"We would like to be able to send checks out," he said, adding that privacy and related issues could present a roadblock.
Zobel indicated she would consider a request to clear any obstacles.
Notargiacomo told Zobel that negotiations were ongoing with officials of the U.S. Centers for Medicare and Medicaid services and major insurance carriers in an attempt to reach a global settlement for all victims.
Asked about those negotiations, CMS officials issued a statement this week in which they contend they are bound by federal law to recoup payments.
"If Medicare has paid for medical care associated with the settlement, it is required under the (Social Security Act) to recover the payments it made from the settlement. CMS is unable to provide specific on the amount of money it will seek to recover from any particular Medicare beneficiaries settlement," CMS officials said in the statement.
Four member of Congress, meanwhile have called on U.S. Health and Human Services Secretary Sylvia Burwell to simply waive any Medicare claims on victims of the outbreak. So far there has been no response.

Proposed Tennessee Bellwether Cases

Adam Ziegler-localized infection

Basil McElwee-fungal meningitis

Jane Wray-fungal meningitis

Reba Temple-death

Denis Brock-fungal meningitis and local infection

Mae Parman-local infection

Reba Skelton-meningitis

Contact:wfrochejr999@gmail.com

FDA Announces Recall of Compounding Drug

Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert - Microbial Contamination with Yeast

AUDIENCE: Pharmacy, Risk Manager, Health Professional, Pediatrics
ISSUE:  The U.S. Food and Drug Administration is alerting compounding pharmacies of the voluntary recall of certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in compounding of various oral liquid drug products, due to the presence of yeast (Candida galli).
The SyrSpend SF lots are:

• 15I21-U01-026920
• 15J26-U05-027457
• 15J26-U05-027473
• 15I21-U01-027370
• 15J19-U05-027406

The SyrSpend SF Grape lots are:

• 15G29-U03-025975
• 15A05-U03-022765
• 15A05-U06-023277

BACKGROUND: If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary. FDA is not aware of adverse events reports with patients who may have used the suspending agents.
RECOMMENDATION: FDA recommends that compounders not use the referenced lots of contaminated Syrspend SF and Syrspend SF Grape in compounding drug products for patients.  Compounding pharmacies who have received the referenced lots of Syrspend SF and Syrspend SF Grape flavor should immediately discontinue use, quarantine the products, and return the products to Fagron, Inc.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the FDA drug alert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm485897.htm

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Judge Sets New Criminal Trial Date in Meningitis Case

By Walter F. Roche Jr.

A federal judge has issued an order setting a Sept. 8 trial date for the defendants charged in the aftermath of the 2012 fungal meningitis outbreak.
The new date moves the trial back by five months and comes following a dispute between prosecutors and defense attorneys over the review of emails seized from the computers of the New England Compounding Center, the Framingham, Mass. firm blamed for the fatal outbreak.
A federal grand jury last years charged 14 owners and employees of the firm with charges ranging from mail and wire fraud to second degree murder.
NECC shipped thousands of vials of fungus infested steroids to health facilities across the country in 2012 triggering the fungal meningitis outbreak.
Court records show some 778 patients were stricken and 76 of them died.
The new date comes as some of the victims are beginning to receive notice that they will get a share of a $200 million trust fund established in the separate NECC bankruptcy case.
Some 1,350 notices were mailed last week to victims or their lawyers whose claims have been approved. Additional notices to those whose claims are being partially approved are set to go out shortly, followed by those whose claims are being rejected.
Those whose claims have been reduced or rejected can appeal.