18 Representatives Sign on to Compounders' Bill

By Walter F. Roche Jr.

Eighteen more U.S. House members have signed on as co-sponsors of a bill which would make significant changes in a 2013 law passed in the wake of a deadly outbreak caused by contaminated compounded drugs.
The 18, all but two Republicans, join Reps. H. Morgan Griffith, a Virginia Republican, and Henry Cuellar, a Texas Democrat, the original sponsors of the bill backed by the International Academy of Compounding Pharmacists.
The bill, H.R.2871, would eliminate a requirement that pharmacists have a patient specific prescription for each dose of a drug they compound.
Griffith and other backers of the measure contend it will make compounded drugs more readily available for patients who may need them on an emergency basis. They also charge that federal regulators are using the 2013 law to interfere in matters meant to be handled by state pharmacy boards.
Opponents, including Public Citizen, contend it would create a massive loophole that would lead to a repeat of the 2012 fungal meningitis outbreak caused by steroids laden with fungus and shipped to health facilities across the country.
The outbreak took the lives of 76 patients among 778 who were sickened. The former president and owner of the defunct Massachusetts compounding pharmacy blamed for the outbreak is serving a nine year federal prison sentence following his conviction on racketeering and mail fraud charges.
The new cosponsors include several from states that were hard hit in the outbreak including Virginia, New Jersey and Tennessee.
Those signing on to the bill also include some who, like Griffith, have received campaign contributions from the compounding pharmacists political action committee known as COMP PAC.
U.S. Rep Chris Stewart, a Utah Republican, has received $10,000 in contributions from COMP PAC in the past two years. Rep. Earl Carter, R-Georgia, got $5,000  and Rep. Pete Session, R-Texas, got $1,000 in 2016.
Others joining on to the bill include Reps. Chris Collins, R-NY, Ted Poe, R-TX, Frank LoBiondo, R-NJ, David Roe, R-TN, Mac Thornberry, R-TX, Andy Biggs, R-AZ, Cathy McMorris, R-WA, Gregg Harper, R-MS, David Young, R-IA, Paul Gosar, R-AZ, Collin Peterson, D-MN, David Brat, R-VA, Neal Dunn, R-FL, Brian Babin, R-TX and Joyce Beatty, D-OH.
Contact: wfrochejr999@gmail.com.

Prosecutors Seek $13.2 Million Cadden Judgment

By Walter F. Roche Jr.

Federal prosecutors are seeking a $13.2 million judgment against a former drug company president who is now serving a nine year sentence in a federal prison in Pennsylvania.
In papers filed today, the U.S. Attorney in Boston, Mass. said the revised request was in line with guidance issued earlier this week by the U.S. Department of Justice. The guidance was issued as a result of a recent U.S. Supreme Court ruling limiting forfeiture orders.
The $13.2 million is down considerably from the $132.8 million prosecutors originally sought in a forfeiture order against Barry J. Cadden. Cadden, 50,  was convicted in late March on racketeering and mail fraud charges following a 10-week trial. He was acquitted on charges of second degree murder.
In the two-page filing today prosecutors said the $13.2 million represented "the amount of proceeds he (Cadden) obtained directly and indirectly" from the criminal enterprise.
Cadden was the president of the New England Compounding Center, the now defunct drug compounding firm blamed for a deadly 2012 fungal meningitis outbreak.
The government motion notes that a related appeal to the First Circuit Court of Appeals has been stayed clearing the way for the U.S. District Court to rule on the judgment request.
Cadden through his attorneys has argued that any forfeiture or judgment should be limited to a little under $250,000. Prosecutors originally sought a $132.8 million forfeiture order but then revised it downward to $75 million.
In related action, U.S. District Judge Richard G. Stearns has granted a motion by a co-defendant in the case to travel out-of-state while he awaits trial.
Scott M. Connolly was granted permission to travel to Leavittown, N.Y. for two days this month on "a family business matter" and to travel to South Setauket, N.Y. in early October to visit family.
Connolly has been charged with racketeering and conspiracy. He, Cadden and 12 others were indicted in late 2014 following a two-year federal probe of the fungal meningitis outbreak.
Contact: wfrochejr999@gmail.com

2nd Wave of Checks Enroute to Victims

By Walter F. Roche Jr.

A second wave of checks to victims of a deadly meningitis outbreak has begun to arrive and for some, at least, it includes an unexpected bonus.
The checks coming from a more than $150 million settlement fund are going to lawyers representing victims and survivors of the 2012 fungal meningitis outbreak that sickened 778 patients in more than 20 states, killing at least 76 of them.
Interviews with lawyers and victims or survivors of victims show the checks that began arriving late last week are between 17 and 20 percent higher than expected. Previously victims had been told that the second payments would be the same or less than the first payments, which went out earlier this year.
The timing of the payments from the settlement fund are in line with a recent report the administrator had filed with Senior U.S. District Court Judge Rya Zobel. Lynne Riley, the trustee, told the court the second wave of payments would be going out by the end of summer.
The notices being sent also indicate that victims may get yet a third payment, but those checks may not be issued for three to four years. The third payment would come from tax refunds expected by the former owners of the New England Compounding Center, the company blamed for the deadly outbreak.
An attorney representing Riley told Zobel the delay was necessary because the IRS  could reverse itself and recoup the refunds.
The settlement fund was created in the bankruptcy of NECC. It includes payments from the owners of the now defunct company and related parties, including insurance carriers.
The payments from the national settlement fund are separate from payments some victims will or have already received from health care providers who purchased steroids from NECC.  Those include a settlement with the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn.
Second payments from that Tennessee settlement have yet to be made. Initial payments from the fund, estimated at more than $20 million, came last month.
Contact: wfrochejr999@gmail.com

PA Death Prompts Probe

Health Care and Privacy

Friday, August 18, 2017

Hershey Hospital Cited in Death of Six-Year Old

By Walter F. Roche Jr.

A Hershey hospital has been cited by Pennsylvania health officials for failing to report the unexpected death of a six-year-old boy and failure to follow expected standards of care in treating him.
According to a lengthy state inspection report, the Milton S. Hershey Medical Center only notified the Pennsylvania Health Department of the death after an anonymous informant had reported the Jan. 11 death months after it occurred. Under state law and regulations the death should have been reported within 24 hours of its occurrence.
In response to questions about the citation, the medical center issued a statement acknowledging the delay in reporting the incident and also the fact that there was a 10 hour gap in the recording of the patient's temperature.
"The facility failed to meet the emergency needs of a patient with acceptable standards of practice," the inspection report states.
The boy, who was brought to the hospital's emergency room on Jan. 10, was placed in a warming device due to a low temperature. He had a temperature of 107.6 degrees when he was found unresponsive the next day.
"There were no vitals,"the inspection report states, adding that hospital staffers acknowledged the warming device, called a Bair Hugger," had been on high all night.
He was pronounced dead at 5:39 p.m. on Jan. 11.
In addition to the failure to report the death, the hospital was cited for failing to adequately train employees and failing to follow the warming device manufacturer's guidelines calling for temperature checks every 10 to 20 minutes.
In its statement, the medical center said management did not become aware of the incident until notified by the state following the anonymous complaint to the state Patient Safety Authority.
"This situation raised serious issues, and our response has been equally serious" the hospital said in its statement.
Acknowledging that the state found a total of five violations, the medical center
termed the incident an "unacceptable failure" and said corrective action was initiated  as soon as it received notice of the anonymous complaint.
 The state sent inspectors to the hospital on April 12 and they completed their review the next day. Because the inspectors declared a state of "immediate jeopardy," the hospital was required to respond immediately with a corrective action plan. The "immediate jeopardy" was lifted on April 13.
In its statement the hospital said the boy was suffering from "ongoing, complex and life limiting health issues" and "presumed sepsis" when he was brought to the emergency room in January.
After he was found unresponsive the next day, he was taken to the the hospital's pediatric intensive care unit but died later in the day.
The hospital said its own investigation found "an agency nurse was overseeing the child's care during the 10-hour gap in temperature documentation, and no one involved in the child's care reported the incident to our Patient Safety Department."
In its inspection report, the state said that the nurse in question said she knew she took the patient's temperature but forgot to document it.
"I did not have the computer with me. I was probably busy with something else," she told the inspectors.
The state found that although the nurse had been hired a year earlier, there were no evaluations in her file and core competency for use of the warming device "was not completed."
According to the hospital statement, the facility now limits the use of the warming devices to operating rooms "where patients are continuously attended."
Other steps include training for staffers, including those hired through an agency, on the use of such devices and audits to ensure serious incidents are properly reported.
"As an organization that holds itself accountable for providing the highest quality care while protecting the safety of patients, employees and visitors, we recognize this situation was an unacceptable failure," the hospital said in its statement.
Contact: wfrochejr999@gmail.com

Compounded Drug Recall in Progress

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance

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For Immediate Release

August 17, 2017

Contact

Announcement

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy.

Risk Statement: The compounded injectable prescription medications potentially could result in adverse effects.  To date, Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding has not received any reports of adverse events related to this recall.
The compounded injectable prescription is packaged in sterile vials for injection.
Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is notifying its patients by U.S. Mail and is requesting that all unexpired lots of compounded injectable prescription medications be destroyed immediately upon receipt of the notification. Patients that have compounded injectable prescription medications which are being recalled should stop using the compounded injectable prescription medications and discard any remaining unused medication.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Outbreak Victim's Dad Outraged by Congressional Proposal

By Walter F. Roche Jr.

Nearly five years ago a 16 year-old high school football star suffering from back pains went to a Roanoke, Va. clinic where he was injected with a steroid.
About a month later and a week after starring in a game for Cave Spring High School, Zac Foutz was completely incapacitated after being hit with excruciating pain and high sensitivity to light. On Oct. 28, 2012 he was admitted to a local hospital suffering from fungal meningitis.
Hit with  powerful antifungal medications, Foutz remained hospitalized for more than two weeks.
Now Zac has recovered and is listed as a 250 6'4'' tight end at Liberty University.
But that is a small part of the story.
Zac's illness motivated his father, Ben, a medical supply salesman, to become deeply involved in efforts to see that what happened to Zac and more than 750 other victims of the 2012 outbreak never happens again. As Ben Foutz noted, Virginia was particularly hard hit
Federal officials say some 758 patients were sickened and 76 died as a result of being injected with fungus riddled steroids from a Framingham, Mass. drug compounder.
Working with Republican U.S. Rep. Morgan Griffith, who represents a neighboring district, Ben Foutz followed developments in congress, including a 2012 congressional hearing in which Griffith made a specific reference to Zac and his illness.
Eventually a bill tightening regulation of drug compounders like the New England Compounding Center was passed and then signed into law by then President Obama.
Griffith hailed the passage and even took some credit, saying that the final bill was based on a bill he filed.
For that reason Foutz said he was taken aback and angry when he learned last week that Griffith had  just filed "a very flawed" bill that would eliminate a key provision of the 2013 law.
The Griffith bill, strongly backed by a national association of drug compounders, would eliminate a requirement that drug compounders have patient specific prescriptions for each and every drug they compound.
"I will admit my bias," Foutz said in an email, "I am the father of a victim. I am emotionally attached to this issue."
"I want people in our great country to get the medication they need, but I expect those medications to be safe, effective and regulated."
Foutz said that when he spoke to Griffith, the representative told him that he now felt the U.S. Food  and Drug Administration was preventing local drug compounders from providing needed drugs and that regulation of drug compounders should be left to state regulatory boards.
At the 2012 hearing, Griffith was one of several committee members to charge the FDA with failing in its duty to regulate drug compounders.
"Now he feels the FDA has too much authority," Foutz wrote.
He said that when he pushed Griffith for the reason he reversed himself, Griffith said that he didn't have the bill in front of him and would have to get back to him later.
Foutz is still waiting.
Contact: wfrochejr999@gmail.com

Cadden Reports to Western PA Facility

By Walter F. Roche Jr.

Pharmacist Barry J.Cadden has reported to a federal prison in Western Pennsylvania to begin serving a nine year sentence following his conviction on 57 counts of racketeering, conspiracy and mail fraud.
Cadden, the one time president of a now defunct Massachusetts drug compounding firm, was sentenced in June by U.S. District Judge Richard G. Stearns. Federal prosecutors had sought
a 45-year prison term and Cadden had asked for a three year sentence.
Cadden's 10 week trial ended on March 22 when the jury returned a split verdict. While convicting him of racketeering and mail fraud, the jurors acquitted the 50-year-old pharmacist on 25 counts of second degree murder.
FCI Loretto, located near Altoona, Penn., is a low security prison which includes a prison camp. Cadden was assigned to the prison section of the facility not the prison camp.
Cadden was one of 14 employees and owners of the New England Compounding Center who were indicted in late 2014 following a two year federal probe of the deadly 2012 fungal meningitis outbreak. Fungus contaminated drugs from NECC caused the outbreak which sickened 778 patients, killing at least 76 of them.
Cadden had asked to serve his sentence at the federal prison near Ayer, Mass., less than an hour from his Wrentham, Mass. home. Loretto, PA is some 490 miles from Wrentham, Mass.
Cadden has already served notice that he is appealing his conviction.
Codefendant Glenn Chin is scheduled to go on trial in September. Chin, like Cadden was charged with 25 counts of second degree murder, along with racketeering and mail fraud charges.
Other defendants are expected to be tried after the Chin trial has ended.
Stearns has issued orders limiting the length of the Chin trial to a little over a month, in an apparent effort to avert a repeat of the 10-week marathon Cadden trial.
The Loretto federal prison, once the site of a Catholic seminary, has had some well known inmates including John Rowland, a former governor of Connecticut, who was convicted on corruption charges. Others have included a New York assemblyman and a New England mafia boss.

Cadden Prison Assignment Unclear

By Walter F. Roche Jr.

The location of the convicted drug executive due to begin serving a nine-year prison sentence today remains unclear and officials, including his attorneys, did not respond to requests for comment.
Barry J. Cadden, 50, of Wrentham, Mass.,was due to report today to the federal Bureau of Prisons, to begin serving the sentence imposed on June 26 by U.S. District Judge Richard G. Stearns.
Cadden, the former president of the defunct New England Compounding Center, was convicted of 57 counts of racketeering, conspiracy and mail fraud on March 22.
He was cleared on 25 counts of second degree murder.
Cadden was one of 14 indicted by a federal grand jury in late 2014 following a two year probe of a deadly fungal meningitis outbreak caused by drugs shipped from NECC's Framingham, Mass. headquarters.
Cadden, through his attorney, had asked Stearns to recommend that he serve his sentence at Fort Devens, a federal prison about an hour from his home.
The BOP web site lists Cadden as a prospective inmate, but states "Not in BOP Custody"
Cadden has appealed his conviction to the First Circuit Court of Appeals.
Inquiries today to Cadden's attorney, the federal Bureau of Prisons and federal prosecutors went unanswered.
Contact: wfrochejr999@gmail.com

Compounding Bill Could Bring Outbreak Recurrence

By Walter F. Roche Jr.



"Our job is to find out how this happened and then to make sure it doesn't happen again." U.S. Rep. H. Morgan Griffith Sept. 12, 2013



A Virginia congressman who said his district was among the hardest hit in the nation by the 2012 fungal meningitis outbreak, is now seeking to strip a key provision of the law passed to prevent a recurrence  of that deadly public health crisis.
U.S. Rep. H. Morgan Griffith filed a bill recently that would eliminate a requirement that drug compounders obtain a patient specific prescription before compounding even a single dose of a drug.
Dr. Michael Carome of Public Citizen said in an interview this week that passage of the Griffith bill would "clearly guarantee" a recurrence of the 2012 outbreak which sickened 778 patients in 23 states, killing at least 76 of them.
Griffith did not respond to requests for comment.
In the wake of the outbreak Griffith, a Republican whose district is in Southwest Virginia, made a point of stressing how his district was "particularly hard hit."
At a Nov. 14, 2012 congressional hearing on the outbreak he said two deaths already had been reported and as many as 1,415 area residents had been notified they had been injected with contaminated steroids from the same drug compounder, the New England Compounding Center.
He recounted a telephone conversation he had with the father of a 16-year-old, the youngest known victim of the outbreak.
Griffith told those at the hearing that it was unclear whether the teenager would recover despite his youth.
When the current law won final congressional approval, Griffith hailed its passage.
The new Griffith bill was immediately endorsed by the International Academy of Compounding Pharmacists, a group that lobbies in behalf of compounding pharmacists.
The group's political action committee donated $5,000 to Griffith's campaign committee 15 days after he filed the bill.
Carome noted that his organization did not support the 2013 law, because it created a new category of mass drug producers, known as outsourcers, that do not need to meet the same standards as major drug producers.
"We opposed the creation of that new category," he said.
But,  Carome noted, the new law does require the mass compounders to follow standards known as GMP or Good Manufacturing Practices. He said that requirement would not apply to compounders under the Griffith proposal.
"This bill would allow any compounder to mass produce," he said, adding that it was clear that the bill was filed at the behest of the compounders association.
Griffith was a major participant in the Nov. 14, 2012 hearing before the subcommittee on oversight and investigations during which  committee members grilled officials of the U.S. Food and Drug Administration about its failure to prevent the fungal meningitis outbreak.
Contact: wfrochejr999@gmail.com

Proposal Would Loosen Compounding Regulation

By Walter F. Roche Jr.

Fifteen days after filing a bill to loosen federal regulation of drug compounders, a Virginia congressman got $5,000 in contributions from the political action committee formed by drug compounders.
Records at the Federal Election Commission show the $5,000 was donated to the campaign fund of H. Morgan Griffith, a Virginia Republican, on June 27. It wasn't the first contribution by the political action committee for the International Association of Compounding Pharmacists to Morgan. He also got  $5,000 in the previous election cycle.
On June 12, the day the bill was filed the IACP issued a press release praising Morgan and U.S. Rep. Henry Cuellar, a Texas Democrat, for filing the bill entitled "Preserving Patient Access to Compounded Medications.
Charging that the U.S. Food and Drug Administration has been misinterpreting a new law, the Drug Quality and Security Act, passed in 2013, the IACP says the FDA is asserting "regulatory authority over the practice of pharmacy and medicine in a way Congress never intended."
As a result, the IACP says, patients are being deprived of easy access to drugs compounded by local pharmacists.
That new statute was passed in the wake of a deadly fungal meningitis outbreak that sickened 758 patients killing 76 of them. Many of the victims resided in Griffith's district which includes parts of Roanoke County
Dr. Richard Carome of Public Citizen already is warning that passage of the Morgan/Cuellar proposal will likely lead to a repeat of the 2012 outbreak.
That outbreak was caused by a Massachusetts drug compounding firm, the New England Compounding Center in Framingham, Mass.
Next week the former president of NECC is scheduled to begin serving a nine year prison sentence  following his March conviction on racketeering, conspiracy and mail fraud charges.
Carome has charged that the main effect of the IACP proposal is to eliminate a requirement that there be a patient specific prescription before a drug can be compounded by a state licensed pharmacist.
Under the 2013 law congress created a new category of drug producers who can compound drugs without patient specific prescriptions but they must first register with the FDA and meet certain requirements.
Morgan 's proposal would create a loophole negating the effect of that requirement, Carome has charged.
The IACP, which holds an annual fundraiser in Washington, DC, has regularly supported congressional candidates backing their positions. FEC records show the IACP PAC raised $48,825 between Jan. 1 and June 30 of this year.
Contact: wfrochejr999@gmail.com

IACP Applauds the Leadership of Congressmen Griffith and Cuellar in Introducing Bill HR 2871

Wednesday, June 14, 2017   (0 Comments)
Posted by: Dagmar Anderson

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IACP Applauds the Leadership of Congressmen Griffith and Cuellar in Introducing Bill HR 2871

The “Preserving Patient Access to Compounded Medications Act of 2017†is a bipartisan effort to preserve patient access to vital compounded medications.

WASHINGTON – June 13, 2017 - The International Academy of Compounding Pharmacists (IACP) strongly supports new legislation, introduced by U.S. Congressmen Morgan Griffith (VA) and Henry Cuellar (TX), HR 2871 – The Preserving Patient Access to Compounded Medications Act of 2017, formally introduced on June 12, 2017. More than 300 compounding pharmacists traveled to Washington, D.C. on behalf of their patients and physicians to meet with their respective congressional representatives to discuss the Bill’s content, and to urge them to co-sponsor HR 2871.
  
IACP President Baylor Rice, RPh, FIACP, says, “On behalf of the International Academy of Compounding Pharmacists and the patients we serve, thank you, Congressman Griffith and Congressman Cuellar, for your leadership in introducing the bipartisan legislation, HR 2871 - The Preserving Patient Access to Compounded Medications Act.

This important bill will help protect access to medications physicians rely upon for their patients. It will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and better balance public safety and patient access. We applaud your dedication on behalf of patients, physicians, pharmacists, and other healthcare providers who are united in a mission to preserve patient safety and access to needed compounded medications pursuant to state and federal laws and regulations.â€
  
IACP consistently has said that maintaining access to potentially life-saving compounded medications is not only vital for patients; but, is consistent with the legislative intent of the DQSA. While reinforcing Section 503A of the Food, Drug and Cosmetic Act (FDCA) through the passage of the DQSA, Congress came together in a bipartisan and bicameral fashion to make clear that pharmacists’ ability to provide compounded medications for a physician’s administration to or treatment of a patient within their practice should be left to the States.

IACP, working with the DQSA Coalition, has worked with the FDA and Congress on improving the agency’s compounding policies in a way that better balances public safety with patient access to critical medications. Unfortunately, despite these efforts, FDA continues to misinterpret the DQSA and assert regulatory authority over the practice of pharmacy and medicine in a way Congress never intended.  Congress has, in the last two appropriations bills  (FY16 and FY17), included report language directing the FDA to alter their policies on compounding to align with congressional intent and the language of the statute.  FDA has, to date, ignored those congressional directives and continues to substitute their desired regulatory authority over compounding.

As such, it’s vital that Congress support HR 2871 in order to preserve patient access to compounded medications by directing FDA to act within Congressional intent.

About IACP

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. IACP's mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare.  Visit www.iacprx.org to learn more and to find a compounding pharmacist near you.

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