BREAKING NEWS: Grand jury sets sights on compounding pharmacy

By Todd Wallack

| Globe Staff December 01, 2012


A federal grand jury in Boston has begun investigating the Framingham compounding pharmacy that made the tainted steroid injections blamed for at least three dozen deaths in seven states, according to several people familiar with the matter, including one who has been called to testify.
The grand jury has begun issuing subpoenas to people who worked at New England Compounding Center and at least one related company, Medical Sales Management of Framingham, which handled sales and administrative support for the pharmacy, the people said. The grand jury is expected to hear from at least some witnesses in federal court in Boston next week.
The development is the latest sign that federal prosecutors are pursuing potential criminal charges against the companies or people deemed responsible for the outbreak. Criminal investigators from the Food and Drug Administration searched New England Compounding’s offices in October, carting away boxes of documents and other evidence.
“A grand jury has to be convened for a good reason, and usually that means the prosecution is investigating possible crimes or wrongdoing,” said Brad Bailey, a prominent criminal defense lawyer and former prosecutor. “Presumably, the government has some targets in mind.”But Bailey, a lawyer at the Boston law firm Denner Pellegrino, cautioned that the investigation is probably in the early stages of gathering information and evidence, so it may be some time before any indictments are issued, if at all.
One former salesman for Medical Sales Management said he was interviewed by agents from the Federal Bureau of Investigation for an hour on Friday about the sales and production practices at the companies, including allegations that New England Compounding sold drugs without prescriptions in violation of its pharmacy license.
The worker said that the agents delivered a subpoena for him to testify before a grand jury in federal court in Boston on Wednesday morning and that he understands others have received subpoenas. Another former Medical Sales Management employee said former colleagues had told him they have been called to testify Wednesday as well. Both former workers asked not to be identified to protect their careers.
A third person familiar with the situation confirmed that former workers of the companies have begun receiving subpoenas. This person, who was not authorized to talk publicly about the investigation, and the other sources said the companies are arranging lawyers to represent current and former workers called to testify.
The US attorney’s office and the FBI declined to comment on the grand jury proceedings, which are typically held in secret. New England Compounding’s lawyer, Paul Cirel, could not be reached Friday, but he has previously said it was premature, if not irresponsible, to speculate on the possibility of criminal charges.
So far, 36 people have died and more than 500 people have developed fungal meningitis or other serious infections after receiving steroid shots made by New England Compounding in their backs or joints, according to the Centers for Disease Control and Prevention.
State and federal inspectors have found fungal contamination in numerous vials of the steroid methylprednisolone acetate, and evidence that the company performed insufficient testing before shipping the drugs to clinics and hospitals. Regulators have also accused the company of shipping drugs in bulk without individual prescriptions for each patient — acting more like a manufacturer than a pharmacy — in violation of its state license.
The company has a long history of complaints dating back to 1999, just a year after it was founded. And the Globe reported in October that New England Compounding had recently sent customers a “Quality Assurance Report Card” bragging about the cleanliness of its labs, even while its internal tests — later obtained and made public by the FDA — suggested the opposite.
Prosecutors are expected to focus on three potential charges: fraud; selling tainted drugs in violation of the federal Food, Drug, and Cosmetic Act; or defrauding Medicare or Medicaid. Those crimes potentially carry maximum charges of three to 20 years in prison.
Companies charged with these crimes often settle with the government, agreeing to pay monetary penalties to avoid a possible conviction. But defense lawyers have said given the large number of deaths in this case, prosecutors might seek prison sentences for any executives who are convicted.
The outbreak and government investigations have essentially become a death sentence for New England Compounding. It has shut down its operations, recalled its drugs, surrendered its Massachusetts license, laid off most of its employees, and is facing dozens of lawsuits. A related company with shared owners, Ameridose in Westborough, has temporarily agreed to suspend its operations until the end of the year. And two New England Compounding pharmacists, Barry Cadden and Glenn Chin, have agreed to stop practicing temporarily.
Cadden, the company’s main pharmacist and cofounder, was summoned last month to appear before Congress, but declined to answer questions, citing his Fifth Amendment right to avoid incriminating himself. Cadden’s lawyer declined to say Friday whether Cadden has been asked to testify before the grand jury.

Source is the Boston Globe found here

Meningitis Lawsuits: Federal Judge Allows Meningitis Lawsuits Against New England Compounding Center (NECC) to Proceed Read more: http://www.sfgate.com/business/prweb/article/Meningitis-Lawsuits-Federal-Judge-Allows-4081686.php#ixzz2Dm7vf3r4

Published 8:50 p.m., Friday, November 30, 2012

 Bernstein Liebhard LLP continues to investigate meningitis lawsuits on behalf of alleged victims of NECC’s epidural steroid injections.

New York, New York (PRWEB) November 30, 2012

A federal judge in Massachusetts has ruled that meningitis lawsuits filed against the New England Compounding Center (NECC) may proceed, and said evidence in the cases must be preserved, Bernstein Liebhard LLP reports. In a decision announced yesterday, U.S. District Judge Dennis Saylor also said he would consolidate about a dozen meningitis lawsuits currently pending in federal court in Boston that have been filed by alleged victims of NECC epidural steroid injections. NECC had asked Judge Saylor to delay the cases in lieu of a decision next year by the Judicial Panel on Multidistrict Litigation (JPML) on whether all federally-filed meningitis lawsuits pending against the company should be consolidated in a single federal court for pretrial proceeding. (Cole v. New England Compounding Pharmacy, 12- 12066,

Read more: http://www.sfgate.com/business/prweb/article/Meningitis-Lawsuits-Federal-Judge-Allows-4081686.php#ixzz2Dm8Bb48n

December DEA Conference on Preventing Drug Diversion Open to Pharmacy Personnel in Indiana

November 28, 2012 02:17 PM

Topics:

Drug Enforcement Administration (DEA) is offering two regional one-day Pharmacy Diversion Awareness Conferences (PDAC) in Indianapolis, IN, one on Saturday, December 8, 2012, and another on Sunday, December 9, 2012. Each one-day conference is open to pharmacy personnel (pharmacists, pharmacy technicians, or loss prevention personnel) who are employed by pharmacies or hospitals/clinics that are registered with DEA in the state of Indiana. The conference is designed to assist pharmacy personnel in identifying and responding to potential diversion activity. Location details, a conference agenda, and a link to the online registration form are available in a DEA notice. There is no registration fee for these conferences. Upon completion of the one-day conference, pharmacists and pharmacy technicians will receive 6.5 continuing pharmacy education hours (0.65 CEUs).

Source found here

Washington State Department of Health Pharmacy Compounding Standards

Pharmacy Compounding Standards

Standards for Pharmacist/Pharmacies Compounding Drug Products

• Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription for an individual based on past routine prescribing patterns.
• The patient and prescriber must authorize the use of a compounded product if substituted for a commercially available product. The prescriber’s authorization is in addition to signing the substitution permitted side of the written prescription, or advising the substitution when a verbal prescription is issued. The prescriber must document the authorization on the prescription or in the patient’s medication record.
• Drugs/substances used for compounding must meet official compendia requirements.
• The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
• Pharmacists/Pharmacies shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.
• Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.
• Records and Reports related to Compounding Procedures or other records required by Chapter 246-878 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-869-100).
• All records must be readily available at the pharmacy/establishment for authorized inspection during the retention period. As part of the inspection, the records are subject to photocopying or other means of reproduction.
• Compounding records may be kept either in its original format or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. 

Source found here

CA Board of Pharmacy to hold special board meeting RE: legislative proposal for compounding pharmacies on December 13, 2012

Special Board of Pharmacy Meeting Announced
November 21, 2012

November 21, 2012

The Board announces the convening of a special, one-day Board Meeting on December 13, 2012 in Sacramento. Two main elements for this meeting will be a regulation hearing on the adoption of two regulations for e-pedigree implementation, and refinement of a legislative proposal for compounding pharmacies. The agenda for this meeting will be released in early December (before December 3, 2012).

Gov. may seek changes in Mass. pharmacy board

November 28, 2012, 11:24 am

BOSTON (AP) — Gov. Deval Patrick says the state board that oversees pharmacies is too heavily dominated by people who are pharmacists themselves and he might seek a change in the panel's makeup.
The state Board of Pharmacy has come under scrutiny in the aftermath of a national fungal meningitis outbreak that has claimed 36 lives and sickened hundreds of others. The outbreak has been linked to a steroid produced by Framingham-based New England Compounding Center, which is regulated by the board.
Patrick said Wednesday he has become concerned that 10-member board is largely made up of pharmacists and he'd like to see a "different blend of talent."
He told the "Ask the Governor" program on WTKK-FM that he expected to file legislation when state lawmakers return to Beacon Hill in January.

Source found here

The benefits and risks of compounding pharmacies

• Infectious Disease News, November 2012
  Edward A. Bell, PharmD, BCPS

As of the end of October, 28 deaths resulting from the use of poorly prepared compounded medications by a Massachusetts-based compounding pharmacy have been reported. These deaths have focused increased attention on the role and safety of compounded specialized medicines and dosage forms in the United States.

Pharmaceutical compounding is defined as the combining or mixing of pharmaceutical ingredients to create a customized medication product for a specific patient by a prescriber’s order or prescription. Inherent in this definition is the notion that the final product is not tested for safety and efficacy by data that the FDA normally uses to assess a product. Because pharmacy school curriculums include training in the science and art of compounding, pharmacists are generally well trained in how to compound many medicines. More advanced training is also available for post-graduate pharmacists and pharmacy technicians, by organizations such as the Professional Compounding Centers of America. Although most independently owned and chain pharmacies (eg, Walgreens) do not prepare many compounded products, specialized compounding pharmacies are available that do prepare many compounded products.

Continue reading here 

Florida's Mandatory Pharmacy Compounding Survey, FAQ, and Emergency Rule

Mandatory Pharmacy Compounding Survey
FAQs for Pharmacy Compounding Survey - (pdf- 36kb)
Emergency Rule 64B16ER12-1
With the recent nationwide fungal meningitis outbreak caused by contaminated compounded products, the Florida Board of Pharmacy adopted Emergency Rule 64B16ER12-1, Florida Administrative Code This Emergency Rule requires all Florida licensed pharmacy permit holders, including non-residents, to complete a mandatory survey to inform the Board of its compounding activities. The goal of this mandatory survey is to determine the scope of sterile and non-sterile compounding within Florida licensed pharmacies --whether physically located in or out-of-state.

Failure to timely complete the mandatory survey is grounds for disciplinary action; however the goal is not to discipline, only to obtain critical data. Your cooperation in this matter is important to the department’s public protection mission.

Source found here

Maryland: Headline mischaracterized Board of Pharmacy's stance

November 26, 2012

On behalf of the Maryland Board of Pharmacy, we are writing to commend Sun reporter Andrea Walker for a fair and honest reflection of information discussed during her interview with board executive director LaVerne Naesea and board commissioner David Chason about the board's monitoring of sterile compounding pharmacies and addressing potential gaps in oversight. The article's on-line headline, "Maryland pharmacy of board says it can adequately monitor compounding pharmacies — Board beefed up standards in recent years" (Nov. 18), accurately indicated the thrust of the interview.

However, as sometimes happens when a story isn't quite spicy enough, an editor may decide to change the headline to increase sales or perhaps raise controversy. The board suspects something like this may have occurred when the referenced article was published on the front page of The Sun's print edition on Monday, Nov. 19, under the headline, "Maryland board resists U.S. role in regulation of pharmacies."

Source found here

American Society of Health-System Pharmacists-Pharmacy Group to Address Compounding Disaster

By Nancy Walsh, Staff Writer, MedPage Today

Published: November 30, 2012

LAS VEGAS -- Interest is expected to be high at next week's meeting of the American Society of Health-System Pharmacists, where a late-breaking session will address the ongoing meningitis outbreak caused by contaminated products from the New England Compounding Center, highlighting the role of health-system pharmacists in preventing such events in the future.
The session, entitled "A Compounding Tragedy -- A National Response," will feature a speaker from the FDA, a representative of ASHP, and a member of the National Association of Boards of Pharmacy.
"We plan to present the advocacy efforts we have undertaken so far and highlight what still needs to be done," said JoAnn Harris, RPh, who directs the ASHP's educational services division.
Among the measures the society has put in place is the creation of a members' checklist for sterile compounding services, with instructions for reviewing all existing contracts with compounding facilities and assessment of adherence to quality control policies and state and federal requirements for licensure.
The ASHP checklist also calls for members to "work with organizational executives and other departments within the health system to ensure that the pharmacy department is involved in all decisions through the health system in regard to procurement and use of drug products obtained from external compounding facilities."
Another highly anticipated event at the meeting will be a keynote address given by former President Bill Clinton.
In "Embracing our Common Humanity," Clinton will describe the growing challenges of globalization and interdependence, and outline his vision for "a common future based on shared goals and values."
The meeting "will have something for everyone -- students, pharmacy managers, clinical specialists, and front-line pharmacists, and will have all-time record attendance," Harris said.
"ASHP is no longer simply a hospital pharmacy group. We represent all types of ambulatory care pharmacists, including those who work in clinics, accountable care organizations, and long-term care facilities such as nursing homes," she told MedPage Today.
Other important topics that will be featured at the meeting include the role of the pharmacist in reducing hospital readmissions and optimizing medication safety.
Sessions also will be devoted to general pharmacy-related topics such as stroke prevention in patients with atrial fibrillation, the emergence of resistance to gram-negative infections, and the use of neutraceuticals for pain management.
The meeting begins on Monday morning and continues through Thursday.

Compounding pharmacies-NECC and PCCA

By Lisa Brody
News Editor

11/29/2012 - For compounding pharmacies, it's been a bad few months. They have gone from a specialized niche retailer to a feared pariah in the mind of the public, all due to the actions of a large scale compounding pharmacy in Framingham, Massachusetts, the New England Compounding Center (NECC), which is accused of creating a massive outbreak of fungal meningitis through the contamination of medications for epidural steroid injections for back pain.

As of October 9, the Center for Disease Control estimated that as many as 14,000 patients may have been exposed to the tainted drug; to date, 148 patients in Michigan alone have fallen seriously ill with fungal meningitis, and six have died. Others are now being treated for secondary problems at the site of the injections, epidural abscesses, which can develop into meningitis, as well as joint infections, according to the Michigan Department of Community Health.

The outbreak has been a tragedy all around—for those unsuspecting patients in serious pain seeking relief from a steroid injection; for the doctors who unwittingly injected them, trusting that the medicine they used would be safe and sterile; and for compounding pharmacies, which have unfairly received a black eye on their profession for something they have had no hand in.

"My colleagues and I are outraged and sickened by the alleged malfeasance at NECC. They call themselves a compounding pharmacy, but in actuality they were apparently careless manufacturers who needlessly and shamefully endangered the lives of their customers," Mazen Baisa, PharmD, RPh, managing partner and clinical director of BioMed Pharmacy in Southfield said. "It is alleged by regulators that NECC somehow was able to skirt existing state and federal laws and operate its business by shortchanging quality. That is not what a compounding pharmacy does."

"This company (NECC) turned themselves into a large manufacturing company, in violation of every law to keep patients safe, and lost sight of what they were supposed to be doing," asserted product liability attorney Alyson Oliver of the Oliver Law Group in Rochester. "They were already on the radar because they already had had six violations, one of which was on this same drug. Local (compounding) companies shouldn't be tainted by this bad company. I've never seen problems with local pharmacies."

According to the Professional Compounding Centers of America (PCCA), pharmacy compounding is the art and science of preparing customized medications for patients, whose practice dates back to the origins of pharmacy. As a matter of fact, in the 1930s and 1940s, the majority of prescriptions written were compounded. As drug manufacturing by pharmaceutical companies began developing en masse in the 1950s and 1960s, compounding declined as the pharmacist's role as a preparer of medications metamorphosed into someone who dispensed manufactured dosage forms. But, in the process of creating a "one-size-fits-all" approach to dosage, some patients' needs failed to be met.

Continue Reading here

GOP Calls For Bigby’s Resignation In Wake Of Lab, Pharmacy Scandals

November 29, 2012 | 2:09 PM | Rachel Zimmerman

State House News Service reports that Republican lawmakers are charging Dr. JudyAnn Bigby, the Mass. Secretary of Health and Human Services, with lack of adequate oversight following an evidence-tampering scandal at the state drug lab and disclosures of tainted steroids at the The New England Compounding Center linked to more than 30 deaths around the nation. The news service reports that GOP leaders are calling for Bigby’s resignation

House Minority Leader Brad Jones and members of his leadership team sent a letter to Patrick expressing their lack of confidence in Bigby to successfully manage the troubling situations, which both involve the Department of Public Health, an agency under Bigby’s oversight.
Bigby has testified twice this month before lawmakers during oversight hearings looking into the problems at the former Department of Public Health drug lab in Jamaica Plain and pharmacy industry oversight. While she has acknowledged that managers and regulators in both cases missed red flags and opportunities to limit the scope and spread of problems, she has told lawmakers that much of blame falls on the individuals involved in the wrongdoing.
Bigby has also tried to highlight the steps the Patrick administration has taken after the fact to remove managers and impose emergency regulations to improve oversight of the lab and by the Board of Registration in Pharmacy.

Earlier this month, when asked by WBUR’s Deb Becker who is responsible for the public health disasters, Bigby largely blamed the pharmacy and lower level staffers:

I think we need to remember that NECC is responsible for these deaths, and for producing these contaminated medications. There does need to be a stronger system of oversight of these compounding pharmacies, and we will be developing recommendations to build on the emergency regulations that we have already passed here on Nov. 1 to make sure that we have an appropriate system in place so that this will never happen again.
DB: At the same time, there was the state drug lab scandal, which the Department of Public Health was also involved with. Some are suggesting that both of these huge scandals show an agency in trouble…
JB: The drug lab scandal is still under investigation and more information will come to light about that. [Chemist] Annie Dukhan clearly acted in an irresponsible way and that is without question. I do believe that the supervision of the lab and her actions was inadequate, and the people responsible for that lack of supervision have been relieved of their duties.
DB: So in both of these instances, the responsibility really was with lower-level staff members and they and their supervisors have been disciplined, and the state is taking corrective action in both cases. That would that be correct to say?
JB: That is correct.

Source found here

Public Citizen's Letter to FDA

November 29, 2012

Margaret A. Hamburg, M.D.

Commissioner

U.S. Food and Drug Administration

Department of Health and Human Services

WO 2200

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Dear Commissioner Hamburg,

Through publicly available documents, Public Citizen, a consumer advocacy organization representing more than 300,000 members and supporters nationwide, has learned that since 2003, the Food and Drug Administration (FDA) has issued at least 18 warning letters against 16 different pharmacy compounding companies operating in 15 different states. In five of these warning letters, the FDA identified patient injuries or deaths allegedly associated with products distributed by the company. In the other warning letters, the FDA inspections identified manufacturing conditions that posed threats to patients’ safety.

We are contacting you to urge that the FDA either promptly re-inspect each of these facilities or verify that there has been a recent re-inspection documenting that serious safety concerns uncovered in earlier inspections have been corrected. Pursuant to the findings from these inspections, new, urgent regulatory action may be necessary to prevent further deaths and injuries. We also urge you to assess the FDA’s previous enforcement activities against compounding pharmacies and to initiate a systematic program to determine whether other compounding pharmacies are engaged in illegal practices of the kind described in these warning letters.

The 18 warning letters issued to 16 companies since 2003, as identified by Public Citizen, are listed in the enclosed table. These warning letters are a selection taken from the FDA’s official website (http://www.fda.gov) and are not intended to represent a complete list of warning letters issued by the agency to compounding pharmacies over the last 10 years.

For each pharmacy listed in these warning letters, the FDA identified activities that allegedly exceeded the bounds of traditional compounding and constituted alleged violations of the Federal Food, Drug and Cosmetics Act (FDCA), including:

 producing drugs on a large scale or without an individualized, patient-specific prescription;

 producing copies of commercially available, FDA-approved drugs; and

 making drugs out of active ingredients that were not FDA approved.

Each warning letter raised important safety concerns for patients, and, in many cases, FDA inspectors specifically identified alleged violations of good manufacturing practices that could lead to dangerous contamination, mislabeling of products, or potency issues. In five cases, the FDA identified patient injuries or deaths allegedly associated with the pharmacies’ products. These included:

 Five reports of patients exhibiting signs of sepsis (severe infection in response to bacteria or other germs) and one patient death linked to dextrose injections (sugar water injected through an intravenous line [IV]) contaminated with multiple forms of microbial growth. FDA inspectors cited the pharmacy involved for multiple violations of good manufacturing practices.

 An “outbreak investigation” over contaminated samples of Avastin, a cancer drug used off-label to treat macular degeneration through injection into the eye. The pharmacy involved received at least two complaints regarding eye infections, and FDA inspectors found multiple violations of good manufacturing practices, including leaving preservative-free vials of Avastin open for days or weeks before repackaging them into smaller vials for eye injection.

 The death of a 25-year-old woman associated with a compounded topical anesthetic gel after a pharmacy’s printed instructions failed to include appropriate instructions to avoid fatal overdose.

 At least 70 complaints of adverse events associated with an injectable steroid, possibly related to incorrect amounts of preservatives being added to certain lots of these drugs.

Other inspection findings that clearly posed a threat to patient safety, and that warranted FDA warnings, included failure to implement practices to ensure sterility and failure to adequately clean equipment between the manufacture of different drugs. One warning letter reported inappropriately trained staff touching nonsterile items, including a trash can, between repackaging sterile items, without changing gloves. FDA testing in some cases revealed issues with potency, including one company with product strengths averaging 77.6% of the potency declared on the label. Finally, one inspection revealed that vials of sodium tetradecyl sulfate, an injectable drug, had been contaminated with diethylene glycol monoethyl ether, a solvent used in wood stains and industrial cleaners.

The FDA has published very little information on the ways in which it follows up on the violations it has identified. Furthermore, it appears that the FDA’s warning letters were not issued until long after the inspections, signaling to companies that the FDA had little interest in promptly addressing the public safety risks associated with compounding.

Source found here

More lawsuits filed against pharmacy in meningitis outbreak

• By Christine Ferretti
• The Detroit News
• 0 Comments

Detroit — Seven new federal lawsuits were filed Thursday against a Massachusetts-based pharmacy accused of supplying contaminated steroid injections that infected hundreds of patients with fungal meningitis.

The complaints are the latest in a string filed since October — both class-action and individual — against New England Compounding Pharmacy Inc. on behalf of Michigan residents infected with the illness from the tainted injections.

Health officials say roughly 1,900 people statewide were unknowingly exposed to the contaminated steroids when they visited four Michigan medical facilities. More than a dozen people in the state died.

Lawmakers this month have pressed federal medical regulators on how the company was permitted to continue distribution of pharmaceuticals, despite repeated lapses known to government agencies.

Southfield-based attorney Geoffrey Fieger, whose firm filed the newest lawsuits, said the company "had no business" operating and likely doesn't have enough insurance to pay out the claims.

"It was a rogue company. It shows what happens when there's no regulation," said Fieger, who has more than 40 other clients in the matter.

"Here's what happens if you have less regulation; you have a company that puts out contaminated drugs and they have not nearly enough insurance. It's very likely, with a catastrophic claim such is that exists here, there's going to be not nearly enough money."

Contaminated injections from the compounding center are to blame for the deaths of at least 34 people and illnesses of 490 in 19 states.

The Michigan Department of Licensing and Regulatory Affairs' Bureau of Health Care Services has said the agency and other state departments have launched a review of how Michigan regulates compounding pharmacies. .

Compounding pharmacies typically are overseen by pharmacy boards in states in which the companies are based. But larger compounders, like the New England Compounding Center, mass produce and ship vials to many parts of the country.

Also Thursday, a government watchdog group sent a letter to the Federal Drug Administration. The group, Public Citizen, is asking the agency to revisit 16 compounding pharmacies that received warning letters between 2003 and 2009.

Fieger said attorneys for the pharmacy have expressed interest in having the all the Michigan cases consolidated. That hasn't yet occurred.

cferretti@detnews.com

(313) 222-2069

Staff writer Serena Maria Daniels contributed

From The Detroit News: http://www.detroitnews.com/article/20121129/METRO/211290481#ixzz2Dfy5wM9O
From The Detroit News: http://www.detroitnews.com/article/20121129/METRO/211290481#ixzz2DfxXeDTe

Consumer watchdog asks FDA to revisit compounders

The Associated Press

Posted:   11/29/2012 06:26:33 AM PST

Updated:   11/29/2012 07:15:21 AM PST

WASHINGTON—A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded drugs.

Contaminated pain injections from a Massachusetts compounding pharmacy have been blamed for fungal meningitis that has killed 36 people and sickened more than 500, according to federal health officials.

In a letter to the FDA sent Thursday, Public Citizen asks the agency to revisit 16 compounding pharmacies that received warning letters from the agency between 2003 and 2012.

Compounding pharmacies traditionally mix customized medications based on doctors' instructions, turning out a small number of specialized products for patients with unusual medical needs. However, some pharmacies have grown into much larger businesses in recent years.

Congressional investigators recently reported that the FDA inspected the New England Compounding Center three times before the outbreak, and issued the company a warning letter in 2006. The letter cited the company for several violations, including mass-producing drugs without doctors' prescriptions and repackaging FDA-approved drugs into smaller doses.

Public Citizen notes that the agency often does not follow up on warning letters to see if the problems have been corrected.

"By not fully investigating what could potentially be deadly violations of the law,  Continue reading here

Meningitis victims allowed to conduct inspection of compounding lab during wait for jurisdiction decision

By Martine Powers

 |  GLOBE STAFF   

  NOVEMBER 29, 2012

A federal judge ruled Wednesday that attorneys representing patients who contracted fungal meningitis will be allowed to conduct their own inspections of the New England Compounding Center while they await word from a federal judicial panel on where the cases will be heard.

Twelve federal lawsuits have been filed in Massachusetts against the drug compounding facility accused of selling tainted steroids that sparked a nationwide fungal meningitis outbreak, and it will be months before anyone knows whether the cases will be heard in Massachusetts and whether they will be consolidated with other lawsuits filed across the country.

The Judicial Panel on Multi­district Litigation in Washington will hold a hearing Jan. 31 and will issue its decision in February.

In the meantime, US District Judge F. Dennis Saylor IV said Wednesday, attorneys for the plaintiffs will be allowed to begin time-sensitive inspections of the lab’s Framingham facilities.

“We’re either going to do it now, or we’re not going to do it at all,” Saylor said.

‘’

Kim Dougherty, an attorney for one of the 12 plaintiffs who filed federal suits in Massachusetts, said patients should not have to wait until February to start their investigation into the facts of the case. Attorneys want to bring in their own experts to conduct an inspection of the lab. By next year, she said, too much time will have elapsed for their results to be useful.

“Time is of the essence,” Dougherty said. “The further along we go to wait to get the sampling, the further it could be compromised.”

Frederick H. Fern, an attorney for the compounding center, argued that it would be premature for the plaintiffs to conduct inspections before it is determined whether their cases will be consolidated, which could lead to duplicated inspections and conflicting results.

“It is too soon, because it flies in the face of the coordination that this case cries out for,” Fern said.

Fern also questioned whether inspections would be fruitful at all, because of the time that has passed since the steroids were produced and the possible effects of heavy traffic from state and federal investigators inside the lab.

“There is no way that the premises now — in any way, shape, or form — show what things were like back in May, June, or July,” Fern said.

Saylor acknowledged he was also “highly skeptical” that attorneys for the plaintiffs will be able to glean accurate conclusions about the lab’s conditions.

But, he said, they deserved an opportunity to try.

Saylor deferred decisions on guidelines and the timing of the inspections to Magistrate Judge Marianne B. ­Bowler. He called for attorneys to coordinate with state and federal investigators who have been conducting inspections of the lab since October.

“I don’t want counsel showing up and tripping over public health authorities,” Saylor said.

Wednesday’s hearing also examined a slew of other decisions that will have to be made in the complex court cases.

Attorneys will meet again Dec. 10 for a status conference.

Source found here

Michigan Cases Tied To Meningitis Outbreak Hit 181 « CBS Detroit

Michigan Cases Tied To Meningitis Outbreak Hit 181 « CBS Detroit

Judge allows civil suits in meningitis outbreak to proceed

By Scott Malone | Reuters – 11 hrs ago

BOSTON (Reuters) - A federal judge in Boston on Wednesday allowed civil suits against the pharmacy at the heart of the deadly U.S. meningitis outbreak to proceed and noted that any criminal case would have priority in gathering evidence.

U.S. District Judge Dennis Saylor rejected arguments by attorneys for the pharmacy, its owners and an affiliate company to delay the start of civil proceedings until a panel of judges in Washington meets early next year to determine how to handle the roughly 70 suits filed in Massachusetts, Minnesota, Tennessee and Michigan.

"I don't want two or three or four months to go by with nothing happening," said U.S. District Court Judge Dennis Saylor at a hearing in Boston.

The needs of lawyers in the civil cases would fall behind those of federal and state health authorities and any criminal investigators, he added.

"There may be a grand jury investigation, I don't know, but there is certainly a potential criminal investigation overlaid on this," Saylor said.

After federal authorities in October raided the New England Compounding Center's facilities in Framingham, Massachusetts, U.S. Attorney Carmen Ortiz confirmed that her office was investigating the company.

A spokeswoman for Ortiz declined to comment on whether a grand jury had been convened to hear potential criminal charges linked to the outbreak, citing secrecy rules surrounding grand juries.

More than 500 people in 19 states have been infected with meningitis and 36 have died in the outbreak linked to an injectible steroid used to treat back pain produced by the New England Compounding Center, according to the Centers for Disease Control and Prevention.

Saylor said he would consider ordering NECC and its affiliates to preserve all evidence related to the outbreak, but noted that the needs of federal investigators from the Food and Drug Administration and Drug Enforcement Agency and state officials would come first when it came to accessing evidence.

One of NECC's attorneys, Frederick Fern of the New York law firm Harris & Beach, argued it was unnecessary to order the company to preserve its records.

"There has to be a showing of actual risk that evidence is being exfoliated," Fern said in court. "All we have is speculation."

Saylor last week denied a motion in one of the civil suits that had sought to freeze the assets of NECC's owners, though he ordered the company not to make extraordinary cash transfers or to pay dividends or bonuses to its owners.

NECC suspended its operations and recalled all its products after its role in the outbreak became clear. Ameridose, a firm owned by the same people who own NECC, has also shut down temporarily as investigators review its sterility practices.

A report by the U.S. Food and Drug Administration released earlier this month said investigators found bugs and other unsterile conditions when they inspected Ameridose's Westborough, Massachusetts facility.

(Editing by Cynthia Osterman)\

Source found here