A New England Compounding Center epidemic meningitis that began in September 2012 left more than 800 people sick and resulted in 76 deaths. In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration FDA), began investigating outbreaks of multistata meningitis fungi and other infections among patients who had received contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC is classified as a compounding pharmacy. Such pharmacies are authorized to combine, mix, or alter the ingredients to make specific drug formulations to meet the specific needs of each patient, and only in response to individual prescriptions.
In October 2012, an investigation from NECC revealed that the company had violated the state license for having served as a drug manufacturer, producing medicines for widespread use rather than filling individual recipes. In December 2012, federal prosecutors charged 14 former NECC employees, including president Barry Cadden and pharmacist Glenn Chin, with a number of criminal offenses. It is suspected that from 2006 to 2012, the NECC consciously delivers the wrongly labeled and unclean or contaminated drugs.
In a congressional hearing, the FDA Commissioner was asked why regulators at the FDA and the Massachusetts Board of Pharmacy did not take action on previous pharmacy years. Legislators are told that the agency is obligated to submit to the Massachusetts authorities, who have more direct supervision over the pharmacy. The FDA commissioner also stated, "Given the growing evidence of threats to public health, the government is urging Congress to strengthen standards for non-traditional compounding." The Drug Quality and Safety Act (HPA 3204), a bill to grant the FDA more authority to regulate and monitor the manufacture of compounding drugs, was passed by the Senate on 27 November 2013.
The incident resulted in many lawsuits against NECC. In May 2015, a $ 200 million settlement plan was approved that set aside funds for victims of the plague and their families.
Video New England Compounding Center meningitis outbreak
Outbreak
In September 2012, outbreaks of fungal meningitis are reported in the United States. The US Centers for Disease Control and Prevention traces outbreaks for fungal contamination in three drug lots called methylprednisolone used for epidural steroid injections. The drug was packaged and marketed by the New England Compounding Center (NECC), a joint pharmacy in Framingham, Massachusetts. The dose of these three lots has been distributed to 75 medical facilities in 23 states, and doses have been administered to about 14,000 patients after May 21 and before 24 September 2012. Patients begin to report symptoms by the end of August, but, due to the unusual nature of the infection , doctors do not begin to realize that the case has a common cause until the end of September. Infections other than meningitis are also associated with this outbreak, which extends 19 countries. On March 10, 2013, 48 people have died and 720 are being treated for persistent fungal infections. In November 2012, some patients who recovered from meningitis reported secondary infection at the injection site. Although no reported cases of infection are associated with many other drugs, all of the many drugs distributed by NECC are recalled in a separate action by the NECC and the regulator. Further analysis identifies some contamination in the other lot.
On October 9, 2012, members of the United States Congress asked federal health officials for a briefing on the outbreak as a first step towards possible legislative action to strengthen federal drug safety regulations. On November 14, 2012, congressional committee members investigating the plague accused the Food and Drug Administration (FDA) failed to prevent the crisis by moving too slowly against Massachusetts pharmacies. FDA Commissioner Margret Hamburg testified that the agency's efforts to overcome problems at the compound center have been paralyzed by Congressional intervention, conflicting court decisions regarding FDA jurisdiction, and resilient litigation by the compounding center itself. At the same hearing, the co-owner of NECC chose to invoke the Fifth, refusing to answer all questions. By mid-December, more than 400 lawsuits had been filed against the NECC.
In October 2012, Massachusetts closed two more compounding pharmacies over sterility concerns after they made a surprise inspection. In December, an unexpected inspection of three Massachusetts pharmacies found the problem as well.
On December 21, 2012, the New Compounding Center filed for Chapter 11 bankruptcy protection in the Massachusetts district bankruptcy court.
On September 4, 2014, pharmacist Glenn Adam Chin, 46, was arrested at Logan International Airport, Boston, before boarding a plane to Hong Kong, and was charged with one count of mail fraud. Chin is responsible for overseeing clean rooms at NECC and engaging in the incorporation of contaminated methylprednisolone. The FDA's official statement states that Chin uses sterilizing techniques and incorrect testing, unsafe practices, forged cleaning logs, and instructs pharmaceutical technicians to cheat with false vials. Chin was the first person charged with an ongoing investigation.
On December 17, 2014, 14 former NECC executives and engineers, including co-founder and president Barry Cadden, were indicted on a number of federal charges related to the outbreak. The most serious, Cadden and Chin accused of helping to organize a massive conspiracy that leads directly to 25 deaths.
Maps New England Compounding Center meningitis outbreak
Source of infection agent
The Centers for Disease Control and Prevention (CDC) traces the outbreak to contaminated methylprednisolone (MPA) used for epidural steroid injections. The Food and Drug Administration (FDA) checks foreign ingredients from unopened bottles under a microscope and finds mushroom material. The fungus is found in the cerebrospinal fluid of some patients, which confirm the fungus causing meningitis. The drug was packaged and marketed by the New England Compounding Center (NECC) from Framingham, Massachusetts.
According to the CDC, between May 21 and September 24, 2012, patients in 23 US states received injections from three steroid implications, free preservative methylprednisolone acetate, for back pain, and some of these patients developed symptoms consistent with fungal meningitis.. This form of meningitis can be caused by medications administered epidurally, but is not transmitted through person-to-person contact. On October 9, authorities estimate that as many as 14,000 patients may have been exposed to contaminated drugs.
The NECC said that as soon as it was told about the infection it started voluntarily considering September 26. Subsequently, on October 4, the Massachusetts Department of Public Health issued a recall of all NECC medications, advising hospitals and clinics to remove and separate all lots from their stock inventory. NECC also announced on that day that they suspended all of their operations and voluntarily submitted their licenses to the Massachusetts Department of Health and Human Services, while continuing to cooperate with ongoing investigations by the CDC and FDA.
On October 15, the FDA issued a warning that two more drugs may have been contaminated. Both are from NECC. One is a steroid called triamcinolone acetonide and the other is a product used during heart surgery. If injected, a second steroid can cause fungal meningitis, whereas heart medications can cause different fungal infections.
Although no reported cases of infection are associated with many other drugs, all of the many drugs distributed by NECC are recalled in a separate action by the NECC and the regulator. Further analysis identifies some contamination in the other lot.
Contagious agent
On November 15, the CDC reported that 85 patients had laboratory-confirmed fungal infections. Black print called Exserohilum rostratum was found in 84 cases and Aspergillus fumigatus was found in one case. Another fungus was found in eight cases, but not known to be significant. According to fungal disease specialists, cases of meningitis caused by Aspergillus are rare, but cases caused by black fungus are even worse, making the outbreak finding and recommended treatments almost entirely unremarkable medical grounds.
Aspergillus is a common genus of fungi that humans and animals keep breathing, but that rarely causes problems. However, in patients with suppressed immune systems, or if inserted directly into the spine, the fungus can be deadly. Despite the availability of antifungal agents, aspergillosis in the central nervous system carries a poor prognosis. Although the case triggered a national investigation, on November 4, the CDC said A. fumigatus had been identified in only one patient. Almost all cases in the outbreak involve different fungi, Exserohilum rostratum , other common fungi that rarely cause problems.
Clinical features
On October 12, 2012, the CDC reported that on that date, the patient's average age was 68 years (range: 23-91 years); 48 (69%) were female. At presentation, 57 (81%) had headaches, 24 (34%) had fever, 21 (30%) had nausea, and seven (10%) developed photophobia (intolerance to bright light). Atypical neurological symptoms were observed in a small percentage of patients, mild gait disorders were seen in three (4%), and the history of falls was described in eight (11%). Meningeal signs, including nuchal stiffness (inability to flex the neck forward), Kernig marks, or Brudzinski marks, are uncommon, occurring in 10 (14%) patients. Stroke, either as a sign of presentation, or as an infectious complication, occurs in 12 (17%).
According to the CDC report, for 61 people with symptom onset dates available, the earliest date is August 18th. For 48 patients with injection date and date of symptom onset available for analysis, the mean time from the last steroid injection to onset of symptoms was 15 days (range: 1-42). A total of 25 of 48 patients received single steroid injections; the mean time from injection to symptom onset for patients is 16 days (range: 4-42). People who receive injections are most susceptible to stroke and infection within the first 42 days of injection, but three months may be necessary for symptoms to appear.
Fungal infections associated with non-therapeutic injections are also reported. They are associated with injections in the peripheral joint space, such as knees, shoulders, or ankles. People who are injected in peripheral joints are at risk for joint infection but are not believed to be at risk for meningitis.
On November 4, several people reportedly had been treated for meningitis and were released back to the hospital with abscesses at the injection site. Abscesses differ from meningitis that affects the brain and spinal cord, but it is a local infection that affects the tissues. However, if left untreated, they can cause meningitis. "We do not have a good handle on how many people are returning, we just learn about this and try to assess the best way to deal with these patients." They are very complicated. On 7 December, a spinal abscess was reported in 23 patients receiving injections in Tennessee, and 37 patients in Michigan.
The CDC reports that doctors also report that some people who have been injected with contaminated drugs have arachnoiditis, a nerve inflammation that can cause severe pain, bladder problems, and numbness.
Treatment
Once the infection and its source are identified, due to the rarity of fungal meningitis, some doctors are used to overcoming them. The CDC conducts an expert advisory panel to develop recommended treatment guidelines. Many of the affected patients are elderly and have other existing health problems, making the choice of care more difficult. On October 23, 2012, the CDC issued an "Official Healthcare Guideline Guidance on Management of Asymptomatic Patients Receiving Epidural or Paraspinal Injection with Contaminated Steroid Products". The CDC recommends that healthcare providers monitor patients who receive contaminated injections, but are advised against prophylactic treatment with antifungal drugs for patients who show no signs of infection. They showed that the greatest risk of infection was within the first six weeks after injection. People diagnosed with meningitis can expect to take anti-fungal drugs for at least three months, and perhaps for a year.
Cases
Tennessee is the first state to have cases reported on 21 September 2012. The CDC reports that on January 14, 2013, 678 people in 19 countries have contracted fungal diseases, of which 44 people died. On March 10, 2013, 48 people have died and 720 are being treated for persistent fungal infections. These cases are associated with three many methylprednisolone acetate, a section sent by the NECC to 73 health care facilities in 23 states. This product was also sent to four states where no cases were reported, and no complaints or cases were found in Massachusetts, the only state where NECC has licenses. The latest figures, revealed in May 2015 when litigation is nearing an end, more than 800 people are ill with 64 deaths.
Prescribing steroids for back and joint pain
The frequency of steroid injections to treat back pain in Medicare patients increased 121% from 1997 to 2006. Some doctors believe the efficacy of steroid injections for back and joint pain has not been proven by scientific evidence, and challenges its use in this case altogether.. According to the New England Journal of Medicine, it is important to note that many patients receive sterile injections for back and joint pain, procedures that do not have evidence of high-quality efficacy. can not be placed completely on compound legs when doctors persist in clinical practice despite evidence of weak efficacy. "Doctors in professional societies disagree about treatment guidelines.Although steroid injections for back pain obviously work in some cases, health researchers" almost agree "that" is very widely used ".
A Cochrane review of injection therapy in 2009 for subacute and chronic lower back pain shows no strong evidence for or against the use of any type of injection therapy. A four-year study released in 2013 suggested an epidural steroid injections could actually lead to poor outcomes if the patient subsequently underwent surgery, and no evidence suggests receiving steroid injections helps patients to avoid surgery. Also, in patients who have previously been treated with epidural steroids, evidence suggests surgery is more complicated than in patients who do not.
Compounding pharmacy
NECC is classified as a compounding pharmacy. Such pharmacies are authorized to combine, mix, or alter the ingredients to make specific drug formulations to meet the specific needs of each patient, and only in response to individual prescriptions. Since 1938, the FDA has the sole authority to regulate manufacturing of drugs subject to strict FDA regulations, but in 1998 the Congress excluded the compounding pharmacies from FDA supervision despite strong objections from the then current FDA Commissioner, David Kessler, who made joint responsibility oversight state and federal. agency. Additional pharmacies must be registered with the FDA, but not listed as drug manufacturers, and agencies do not approve their prescriptions prior to being marketed, or automatically receive reports of adverse events. State law generally controls the recording, certification, and licensing of dispensing pharmacies. In 2003, an official from the Food and Drug Administration told the Senate Health, Education, Employment and Pensions Committee that in 2001 the agency had conducted a "limited" survey of drugs from 12 joint pharmacies, including hormones, antibiotics , steroids, and drugs. to treat glaucoma, asthma, and erectile dysfunction, and 10 of 29 drugs failed one or more quality tests. However, grassroots mobilization of combined pharmacists and congress lobbyists action prevents efforts to establish FDA supervisory committees in pharmaceutical compounding.
In response to the NECC meningitis outbreak, health officials and lawmakers said that the compounding pharmacies could "fall into a regulated black hole." Senator Richard Blumenthal (D-CT), who is on the FDA's oversight committee, said that the compounding pharmacies have "relative immunity from safety standards and effectiveness." The state, not the FDA, has oversight of the NECC, although state shipments and the making of large quantities of drugs will make them producers, and under FDA supervision. The pharmaceutical industry of compounding has created safety standards, and in 2004, the United States Pharmacopeia, an industry-backed nonprofit guideline, was established, but the industry is required to follow guidelines in only 17 states. Some compounding pharmacies follow the standards for manufacturers because of their cost. The 1997 legislation would authorize the FDA to regulate all dispensing pharmacies, but the law was partially reversed by the 2002 Supreme Court ruling.
An editorial at The New England Journal of Medicine states that while NECC is clearly violating existing FDA policies, a 2002 Supreme Court ruling may have weakened federal cooperation. The NEJM notes:
- First, traditional compounding is limited to pharmacists or doctors who serve certain patients. Section 503A also permits the incorporation of drugs "in limited quantities before accepting legitimate prescription orders... based on history... receiving legitimate prescription orders." According to an earlier report from the Commonwealth of Massachusetts, NECC far exceeded these limits in preparing and delivering methylprednisolone acetate bottles. Once disconnected from each patient, compounding is increasingly resembling drug manufacturing.
- Secondly, compounding is not necessary if drugs are commercially available from FDA-regulated facilities. Section 503A prohibits the incorporation of "regular or excessive amounts" of any drug that is "essentially a copy of a commercially available drug product." FDA-approved methylprednisolone acetate is sold by Pfizer and two generic companies, but because the NECC version does not contain preservatives, it can avoid this regulatory process - with tragic results.
- Third, Congress acknowledges that the state can effectively regulate traditional compounding pharmacies, but national businesses require federal coordination. Section 503A provides a test to distinguish between the two: it limits interstate shipments to no more than 5% of compound business, unless the country of origin has signed a "memorandum of understanding" with the FDA, strengthening state and federal cooperation. NECC sends large quantities of drugs to many states. If Section 503A has not been destroyed, both the FDA and Massachusetts will be more directly involved in regulating NECC for more than a decade.
Issues in other compounding pharmacies
The FDA reported several previous incidents related to contaminated drugs packaged in dispensing pharmacies. Fungal contamination in relation to sterile drug withdrawal is the second most common form of microbiological contamination. In August 2011, the FDA reported that repeated Avastin (bevacizumab) injection caused serious eye infections in the Miami, Florida area. Pharmacies have repackaged Avastin from disposable bottles into several disposable syringes, distributed them to several eye clinics, and infected at least 12 patients. Some patients lose sight of the left in the eye being treated.
From November 2011 to April 2012, 33 eye ophthalmic patients in seven countries had rare fungal eye infections associated with injectable drug products made by pharmacies in Ocala, Florida. Most patients suffer from partial to severe vision loss.
In October 2012, Massachusetts closed other compounding pharmacies on sterility concerns after they conducted a surprise checkup. The supervisors went to Waltham, Massachusetts, the site of the Rhode Island Infusion Company and found, "a significant problem with the environment in which drugs are mixed". The company manager is a former employee at Ameridose, owned by the same people who run the NECC.
On November 13, manufacturing problems were reportedly found in Ameridose, a Massachusetts company that makes inject drugs. Ameridose and NECC were founded by brother-in-law Barry Cadden and Greg Conigliaro. According to a FDA spokesman, the inspection revealed that the company "failed to test the finished product for potential, failed to investigate complaints for ineffective products, failed to investigate violations of their own environmental sampling plans and failed to retain equipment and facilities used to produce sterile products medicine ". The FDA report also revealed the company had received 33 complaints claiming "lack of effect" and "ineffectiveness" about its medicines. The same problem was found at the plant in 2008, and an FDA spokesman said the FDA was checking to find what, if any, actions were taken in 2008. According to the report, when doctors contacted the company to say problems with the drugs it had. found, complaints are not classified as side effects. These include "incidents when women are given Ameridose oxytocin, a drug used for childbirth, reporting fetal disturbance, severe postpartum hemorrhage, blood thinners, heparin, have complaints that patients have life-threatening side effects. [And when] fentanyl company pain, given to cancer patients and as anesthetic, used, two patients reported to have had respiratory problems. "
The New York Times interviewed eight former NECC and Ameridose employees. Some defend the company, but six say corporate culture pushes a shortcut, even when it endangers safety. At Ameridose, a pharmacist complains to management that quality control workers, who are not trained pharmacists, do work they should not do. He said "almost" wrong doses were captured before being sent. The quality control technician tried to stop the assembly line and was finally fired. An industry bulletin says Ameridose is delivering the drug without waiting for the 14 days needed for sterility test results to return. Joined pharmacies are only allowed to send drugs to certain patients; a former NECC salesman said that NECC sells large amounts without a patient name, and will put names in the file as a drug used, a practice received by some hospitals, but not others.
On December 7, 2012, the Massachusetts regulator has taken action against three compounding pharmacies following a surprise inspection. The Whittier pharmacist, in Haverhill, was ordered to stop sterile compounding after an unspecified offense was discovered, and OncoMed Pharmaceutical Services was ordered to close the Waltham facility after problems with chemotherapy drug storage were found. Pallimed Solutions, based in Woburn, was told to stop production of the sildenafil citrate, which was sold as Viagra, after inspectors found it had been prepared with improper components.
Two compounding pharmacies issued drug breakouts in March 2013. Med Prep Consulting Inc. and Clinical Specialties Compounding Pharmacy both issued a recall after Med Prep found floating particles in five doses of compound solution, and Clinical Specialization heard about five eye infections in patients who had received compounded. eye shots.
Investigation
In October 2012, an investigation from NECC revealed that the company had violated the state license for having served as a drug manufacturer, producing medicines for widespread use, rather than filling individual prescriptions as determined by each doctor in the state. Some doctors and clinics may have turned away from major drug manufacturers and switched to joint pharmacies as producers because they often charge much lower prices than large manufacturers. The Reuters news service reviewed over a dozen emails to NECC and found that they requested bulk orders from doctors and failed to request proof of individual patient prescriptions as required under state regulations. In October, Massachusetts officials launched a NECC criminal investigation and the Massachusetts Registration Agency at Apotek chose to permanently revoke their license to operate in Massachusetts, as well as licenses from three major pharmacists to fill the prescription in Massachusetts.
Initial investigations found unhealthy conditions, including fungi in steroid solutions. The Massachusetts official said that NECC has dispatched orders for contaminated drugs without waiting for the final results of the sterility test. The notes suggest NECC has failed to sterilize the product for "even the minimum amount of time it takes to ensure infertility." The mat used to trap dust and dirt outside the filthy room, the sterile hood is not cleaned properly, and the kettle leaks next to the clean room, according to officials.
US and Massachusetts state health regulators realized in 2002 that steroid treatment from NECC could cause adverse patient reactions. The NECC began receiving complaints in 1999, less than a year after its establishment. Many violations involving the filling of bulk drug orders without individual prescriptions. In 2004, state health officials alleged pharmacies with failure to meet the standards received while mixing methylprednisolone acetate, the same steroids that are the source of the meningitis outbreak of 2012. In 2006, pharmacies agreed to checks and remedial measures and outside investigators were brought in to ensure obedience.
House Energy and Commerce Committee hearing
On November 12, Subcommittee and Investigation of the House Committee on Energy and Commerce Committee released a detailed report on the history of NECC regulations. The congressional report shows that in 2003, the FDA considers the company as a pharmacy, which is significant because after the meningitis outbreak, public health officials have accused NECC of operating more as a producer than a pharmacy. Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies. The report also shows that after an investigation in 2003, FDA officials requested that a compounding pharmacy be "prohibited from production" until improving its operations, but the Massachusetts regulator finally reached an agreement with the pharmacy to resolve concerns about the quality of the prescription drug..
According to documents summarized by the committee, in less than a year of opening of the pharmacy in 1998, they were cited by the state pharmacy council to provide doctors with empty prescription prescriptions with NECC information, which is illegal in Massachusetts - the owner of the pharmacy and director, Barry Cadden, received informal reprimands. Cadden continues to receive other complaints involving unprofessional behavior in the coming years, and in some cases, Cadden refuses to cooperate with investigators and challenges agency authorities over his business. In 2002, the FDA investigated reports that five patients became dizzy and breathless after receiving steroids used to treat joint pain and arthritis that are different from those associated with the current outbreak of meningitis. Initially, Cadden cooperated with the investigation, but during the second day of the inspection, Cadden told officials that he was no longer willing to provide additional records, and the FDA did not continue the investigation. Also in 2002, the FDA received a report that two patients at the Rochester Hospital, N.Y., came with symptoms of bacterial meningitis after receiving a methylprednisolone acetate injection, a similar injection linked to the current outbreak. When officials from the FDA and the Massachusetts Board of Pharmacy questioned Cadden, he said the steroid bottles returned by hospitals had been tested negative for bacterial contamination. When FDA scientists tested samples of drugs collected in New York, they found bacterial contamination in four of the 14 sample bottles.
Speaking to the committee in a statement, the interim commissioner of the Massachusetts Department of Public Health said, "It is clear that NECC consciously ignores sterility tests, prepares drugs in unhealthy conditions, and violates their pharmaceutical licenses.A bad judgment, loss of opportunity, and lack of supervision accordingly enabling NECC to continue on this troubled path. "He announced that" responsible board staff "had been dismissed or replaced.
On November 14, the committee questioned the FDA Commissioner Margaret Hamburg, asking him why the regulators at the FDA and the Massachusetts Board of Pharmacy did not take action on previous pharmacy years. Hamburg responded that the agency was obliged to submit to the Massachusetts authorities, who had more direct supervision over the pharmacy and stated, "Given the growing evidence of threats to public health, the government urges Congress to strengthen standards for non-traditional compounding." Joyce Lovelace, the 78-year-old widow of Eddie C. Lovelace, who was the first victim of the plague, also spoke at the trial. After Lovelace, the committee tried to question Barry Cadden, the owner and director of NECC, but Cadden refused to testify, pleading his Fifth Amendment not to answer questions to avoid self-abuse.
During the second day of the trial, the senator said that the regulator not only failed to move aggressively against NECC, but also against brother company, Ameridose LLC, a large-scale drug composer that supplies drugs to thousands of national hospitals, as well. Although the FDA has repeatedly found reports of adverse events, wrong products, and medication errors in the last decade, no warning letters have ever been issued. In 2002, five patients became ill and two others were hospitalized with symptoms such as meningitis after they were injected with the same steroids involved in the current outbreak, but the country did not take action until 2006. Although the FDA has limited authority over such compounds as NECC, Ameridose is licensed by the FDA as a manufacturer and is clearly subject to its regulatory power.
Litigation and Prosecution
In October 2012, plaintiffs in a federal fungal meningitis lawsuit filed a petition to the US Judicial Panel on Multidistrict Litigation (JPML) for the establishment of joint litigation in a Minnesota federal court. NECC requested that litigation be transferred to federal court in Massachusetts. In December 2012, the company filed for bankruptcy and US District Judge Dennis Saylor ruled that pending lawsuits pending meningitis in Massachusetts federal courts would be consolidated and allowed to move forward. By mid-December, more than 400 lawsuits had been filed against the NECC.
On December 17, federal prosecutors in Boston unveiled a 131-digit federal criminal charge linked to the outbreak. It charged 14 former NECC employees, including president Barry Cadden and pharmacist Glenn Chin, with a number of criminal offenses. It is alleged that from 2006 to 2012, the NECC consciously sent false, unclean, or contaminated drugs - forming the basis for a massive RICO indictment against six people, including Cadden and Chin. RICO counts accuse 68 blatant acts - including 25 second-degree murder cases in seven states against Cadden and Chin. If found guilty, Cadden and Chin face life in prison.
Cadden was eventually convicted of extortion charges but was released from second-degree murder charges in March 2017. He was sentenced to 9 years in prison. In October 2017, Chin was convicted of extortion and letter fraud but was released from second degree murder as well. On December 20, 2016, sales director, Robert A. Ronzio, pleaded guilty to charges of conspiracy unrelated to fraud against the FDA, actions discovered during a joint investigation. Carla Conigliaro, the majority owner of NECC, and her husband, Douglas Conigliaro, plead guilty to withdrawing cash from their bank account in small amounts, after the investigation began, to avoid financial reporting requirements. Carla Conigliaro was sentenced to one year probation and ordered to pay a $ 4,500 fine, and Douglas Conigliaro was sentenced to two years probation and ordered to pay a $ 55,000 fine.
In May 2015, federal bankruptcy judge Henry Boroff approved a $ 200 million settlement plan that would set aside funds for victims of the plague and their families. The settlement plan receives prior approval from an unsecured creditor's official committee in the case of bankruptcy.
Legislation
In September 2013, Michigan State Representative Fred Upton introduced the Drug Quality and Safety Act (H.R. 3204; 113th Congress) in response to the meningitis outbreak. Rep. Upton District has three deaths and 19 total deaths occurred in Michigan. The bill was adopted by the United States House of Representatives on 28 September 2013 by voting and in November the United States Senate began working on a bill that would amend the Federal Food, Drug and Cosmetic Act to grant FDA more authority to regulate and monitor manufacture compounding medicine.. The Drug Quality and Safety Act (H.R. 3204) was adopted by the Senate on November 18, 2013. It was signed into law by President Obama on November 27, 2013.
References
External links
- "Deadly drug associated with meningitis outbreak" CBS Report 60 Minutes (March 2013) [1]
- "Frequently Asked Questions for Physicians: Outbreaks of Multistola Mushroom Meningitis and Other Infections"
- Pettit, A. C.; Kropski, J. A.; Castilho, J. L.; Schmitz, J. E.; Rauch, C. A.; Mobley, B. C.; Wang, X. J.; Spiers, S. S.; Pugh, M. E. (November 2012). "Case Index for Plague of Meningitis Fungus in the United States". The Journal of New England Medicine . 367 (22): 2119-2125. doi: 10.1056/NEJMoa1212292. PMID 23083311.
- Kauffman, C. A.; Pappas, P. G.; Patterson, T. F. (October 2012). "Fungal Infection Linked to Contaminated Methylprednisolone Injections - Initial Report". The Journal of New England Medicine . 368 (26): 2495-2500. doi: 10.1056/NEJMra1212617. PMID 23083312.
- "Vanderbilt team details meningitis TN death" By Brian Haas, The Tennessean , October 22, 2012. Non-technical explanation of the NEJM article .
- Plague of Multistate Fungal Infections Linked to Methylprednisolone Acetate Solution Injection from Single Compounding Pharmaceuticals - USA, Early Release 2012. Monthly Report on Morbidity and Death (MMWR) October 12, 2012/61 (Initial Release)
- "List of Remembered Items Associated with Outbreaks of Meningitis Mushrooms". US Food and Drug Administration.
- "Outbreaks of fungal meningitis and other multistate infections". US Food and Drug Administration.
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