Monday, September 29, 2014

Clinigen Group plc Receives FDA’s First Ever Drug Shortage Assistance Award

URTON-ON-TRENT, England, Sep 29, 2014 (BUSINESS WIRE) -- Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM:CLIN) the global specialty pharmaceutical company, today announces that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration (FDA)in recognition of its contribution in addressing a US shortage of Foscavir® (foscarnet sodium) injection.
Clinigen’s efforts related to the US shortage included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. These actions by Clinigen resolved a critical drug shortage affecting patients.
This award also recognizes companies for their commitment to public health, as well as to quality manufacturing and is the first time the award has been made by the FDA.
Peter George, Chief Executive Officer, Clinigen Group, said: “To be the recipient of this new award from the FDA is a great honor and absolutely reflects Clinigen’s mission to ensure that the right drug reaches the right patient at the right time. Since acquiring Foscavir® from AstraZeneca in 2010, we have worked hard to expand the indications and markets for the drug to increase the number of patients who can benefit. It is a real compliment that the FDA is committed to working with companies, like Clinigen, to prevent and mitigate drug shortages.”
Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013. There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.

FDA: Eye drops recalled over flawed production

THE Food and Drug Administration (FDA) announced Thursday the voluntary recall of a particular batch of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) owing to its supposed failure to meet Good Manufacturing Practice (GMP).
According to FDA Advisory No. 2014-071, Novartis Healthcare Philippines Inc. ordered the recall of the product's Batch No. 420548 with Registration No. DR-X473.
This, it said, is in response to the statement of non-compliance with GMP that was issued by the Italian Medicines Agency (AIFA) to Societa ltaliana Medicinali Scandicci, srl. (SIMS), which is the manufacturer of the active pharmaceutical ingredient, Tetryzoline Hydrochloride.

Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) Ophthalmic Solution (Drops) is being used for the treatment of irritant conjunctivitis, allergic inflammatory conditions of the conjunctiva particularly hay fever conjunctivitis and vernal conjunctivitis.Hydrochloride was used in the manufacture of the specific batch of Spersallerg Ophthalmic Solution (Drops)," said the FDA.
Failing to meet the GMP, the FDA said, may pose threats to consumers, thus making a recall order necessary.
"The affected product presents safety risk and potential adverse health consequences," said the FDA.
With the recall order, all distributors, retailers. hospitals, pharmacies, or clinics that have the affected batches of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) are instructed to discontinue further distribution, sale and use.
Similarly, all field FDA Regulation Officers have been ordered to monitor the availability of the product batches in the market.
The product, the FDA noted, is packed in a LDPE Transparent Bottle containing l0 ml solution (box of 1's).

Wednesday, September 24, 2014

Tuesday, September 23, 2014

Are Generic Drugs Dangerous?

Generic drugs have long been pushed on American consumers as cost-effective alternatives to brand-name prescription medicines. But widespread manufacturing irregularities at drug factories overseas are raising troubling new questions about the safety of generics and whether they are putting Americans’ health at risk. 

A new analysis by the U.S. National Bureau of Economic Research reveals extensive problems with the quality of generics produced by Indian pharmaceutical companies, which supply about 40 percent of the generic drugs sold in the U.S. Bureau investigators examined nearly 1,500 India-made drug samples collected from 22 cities and found that up to 10 percent of some medications contained insufficient levels of the key active ingredients — concentrations so low, in fact, that they would not be effective against the diseases they’re designed to treat.
This new research adds to a growing body of evidence that the generic drug industry, which supplies 85 percent of the drugs sold in the U.S., routinely violates basic quality control standards and ships sub-par medicines to the U.S. and other countries. 
What that means is that many patients prescribed generic drugs are not only getting ripped off, but may not be at risk because their medications are not treating the conditions they have, says renowned cardiologist Chauncey Crandall, M.D.

Read Latest Breaking News from
Alert: What Is Your Risk for a Heart Attack? Find Out Now

Knoxville-area clinics say they aren't affected by injectable warning from state health department

CLEVELAND (WATE) - State health regulators are telling people not to use certain injectable medications produced by a Chattanooga-area compounding pharmacy. The state says two clinics in the Knoxville area received drugs from the pharmacy, but those clinics say the drugs they use are not the ones that have inspectors worried.
The pharmacy at the center of this is the Wellness Store Compounding Pharmacy in Cleveland, Tennessee.
A state investigation found violations like out-of-date ingredients, unsupervised production of sterile products and falsification of records.
The products in question include prescription eye drops, steroids, vitamin B12, amino acids and hormones.
The state sent out a list of clinics known to have received injectable medications from the Wellness Store, including East Tennessee Vein Clinic of Knoxville and Premier Weight Management of LaFollette.
6 News spoke with both of them Monday. Both told us that they do not use the sort of medications listed by the state in the notice.
East Tennessee Vein Clinic of Knoxville said:"Our patients were not affected by any of the injectable medications in question."
Melissa Justice, owner of Premier Weight Management, told 6 News: "Everything we do is to the letter of the law and the highest standards of health care. We do not use that company anymore."
The state health department says the warning was issued out of an abundance of caution, and that it is not aware of any patients harmed by those medications.
Affected clinics, according to the Tennessee Department of Health:
  • Associates in Spine and Joint Medicine, Cleveland, Tenn.
  • Cleveland Medical Associates, Cleveland, Tenn.
  • East Tennessee Vein Clinic, Knoxville, Tenn.
  • Hollywood Body Spa, Athens, Tenn.
  • Internal Medicine Group, Cleveland, Tenn.
  • Kennedy Clinic, Ooltewah, Tenn.
  • Lynn Garden Weight Loss, Kingsport, Tenn.
  • Premier Weight Management, LaFollete, Tenn.
  • Voytik Center for Orthopedics, Cleveland, Tenn

Study shows inconsistent dosages of widely used eye disease drug

Custom-made versions of a widely prescribed, low-cost drug used to prevent a leading cause of blindness in the elderly vary widely in their dosages, Weill Cornell Medical College scientists found in analyses of the eye injections. Investigators saw no evidence of impurities or contamination but found that many of the samples, which were prepared by pharmacists through a process called compounding, contained less medication than doses of the drug obtained directly from the manufacturer. The research, published today in JAMA Ophthalmology, is likely to increase scrutiny of compounding pharmacies, which tailor-mix drugs for individual patients, and to question whether eye-care specialists should continue to prescribe the cancer drug Avastin for age-related macular degeneration (AMD).

IACP Launches Partnership for Personalized Prescriptions International Academy of Compounding Pharmacists

The International Academy of Compounding Pharmacists (IACP) announced today that it has enhanced its support of the compounding pharmacy profession with the establishment of the Partnership for Personalized Prescriptions.
The Partnership for Personalized Prescriptions or P3 is a new advocacy society that brings together over 150000 patients and practitioners who share a passion for compounding and are concerned about changes in prescription reimbursement programs that are increasingly threatening patient access to customized medicines.
P3 launched with a new website and social media channels on Facebook and Twitter which provide a forum for patients and practitioners to voice their support for compounding pharmacy or learn more about its important role in health care.
IACP is building on the association’s rich heritage of advocacy that began many years ago with the foundation of Patients and Professionals for Customized Care or P2C2.
“With the creation of the Partnership for Personalized Prescriptions we are expanding our original advocacy efforts and sharpening our tools to provide a strong platform to help raise compounding awareness as well as to restore the outstanding reputation of our profession” said Pat Stephens PharmD President of IACP and owner of Medi-Fare Drug an FDA-registered drug compounding outsourcing facility in Blacksburg S.C. “We encourage patients practitioners and pharmacists to join our effort to ensure continued access to personalized medicines.”


Knoxville pharmacists concerned as providers cut coverage of some compound medications

KNOXVILLE (WATE) - Some Knoxville area pharmacists are worried after a major prescription benefit provider is set to cut coverage for around a thousand drug ingredients commonly found in compound medications.
Some of those pharmacists are asking for patients to contact their employer's benefits office and urge them to keep their coverage for compound medicine.

Local pharmacists say Express Scripts has been cutting payments for some compound medications for the past several months. The cuts have been made in phases with the final phase occurring January 1.

Belew Drugs owner and pharmacist David Belew says his pharmacy has a lab dedicated to compounding medications. Each day, the pharmacy fills 300 prescriptions. About 10 of those will be compounded medications.

“We do a lot of compounding for children when commercially available products aren't made in the right dosage,” said Belew.

He's been paying close attention to policy changes related to compound medication coverage. He says several pharmacy benefits managers and insurance companies are cutting off payment for many compound medicines.

“The unwanted consequence of not covering these ingredients is that some patients who rely on compounded medications might not have access to those,” said Belew.

6 News contacted David Whitrap the Corporate Communications Director with Express Scripts and asked why the policy was changing.

He sent this statement reading in part "Some elements that are used to make compounded medications have been exorbitantly overpriced. If a patient truly needs a compounded medication covered by their plan, we will make sure they get it. But, by and large, compounded medications do not provide any additional clinical value over what is currently available. There are numerous FDA-approved or over-the-counter alternatives that patients can take."

Belew says there is waste in the health care industry, but blocking a thousand ingredients used to make compound medications isn't the best way to cut costs.

“There is going to be cost savings no question about that. Our real concern is that the cost savings comes at the risk of the patient's care,” said Belew.

Belew and other local pharmacists have been encouraging patients to contact their employer and opt out of the program cutting compound medications. Belew says if employers opt out though they may have to pay a higher premium since compound medications will continue to be covered.

The spokesperson for Express Scripts says 0.6 percent of their customers use compound medications.

He says the cost of the compound medication has been increasing exponentially with the average cost of compounded medication in 2012 being $90 to more than $1,000 now.

The price of pain: Indictments allege a massive compound cream scam

This is the third in a series on the compound cream industry. You can read Part One here andPart Two here.
Prosecutors in the Orange County District Attorney's office call it one of the largest cases they've taken on: 20,000 exhibits, 15 defendants and more than $100 million in alleged overbilling in an alleged workers' compensation fraud scheme centered around compound creams.
An Inland Empire businessman, Kareem Ahmed, is accused of masterminding the alleged scam. Prosecutors say he paid a dozen doctors, chiropractors and pharmacists a total of $25 million in kickbacks in exchange for writing, filling and billing for large numbers of compound cream prescriptions.
KPCC first reported on the indictments by the Orange County Grand Jury in June. The defendants are scheduled to be arraigned in Santa Ana on Friday.
What makes this case unusual was the volume of business, according to Assistant District Attorney Scott Zidbeck.
"We believe there were thousands of prescriptions being written and thousands being filled by multiple pharmacies in Orange County," and there were "huge markups billed to insurance companies," said Zidbeck. He said workers' compensation insurers would be billed in "the $1,500 to $3,000 range" for creams that had a wholesale cost of about $70.
Ahmed and three others formulated three creams based on the profitability of the ingredients, according to the indictments.
In California's workers' compensation system, a compound cream can be billed for every ingredient, which has been suggested as a reason why compound cream costs have skyrocketed.
Based on the high volume of prescriptions combined with the markups in price, prosecutors have calculated that participants in the case billed insurers for more than $100 million.
Compound creams are not approved by the Food and Drug Administration and are intended for limited use, typically for people who can't take oral medication. Prosecutors believe in this case compound creams were produced in bulk; federal law forbids their mass manufacture.
Zidbeck says the doctors involved in Ahmed's network were paid to participate. 
"They were given a financial incentive to write a prescription and refer that particular prescription to a certain pharmacy,"he said.

Top billers

Two of the doctors indicted for allegedly accepting kickbacks have been top compound cream billers, according to data from Los Angeles County.
In the three months spanning July-September 2012, Dr. Daniel Capen was number one in the county, the data show. Compound creams accounted for two-thirds of his prescriptions, and nearly 98 percent of the total amount of his billings.
Dr. Andrew Jarminski was the third top biller in the same time period, with creams accounting for 93 percent of his billings. 
Jarminski has declined comment. In an interview with KPCC, Capen said he thinks prosecutors went after him because of his volume of business.
"I don’t believe I committed any crime, nor did the other doctors," he said. "I think they targeted busier doctors."
Capen denied getting kickbacks in exchange for prescribing creams.
"It's not a kickback," he said. "I bought these creams, prescribe them to my patients and get remuneration, but doctors do that with injectables and other regular medicines."
Capen said he prefers compound creams because they are a less addictive option than FDA-approved narcotics.

Ahmed's attorney responds

In a written statement, Ahmed's attorney, Benjamin Gluck, said his client and the other defendants "never did anything wrong," and that he expects them to be "fully vindicated."
Gluck insisted that Ahmed's operation was completely legal. "Mr. Ahmed bought accounts receivable and billed those claims to insurance companies on letterhead showing his company’s name," wrote Gluck. "Each claim expressly set out the exact compound being used. Nothing was kept secret from anyone and every insurance company knew what it was paying for and why."
Internal emails from Ahmed's medical billing company, Landmark Medical Management, show some employees were concerned about the amounts of creams being produced.
In an email from May 2012 about another legal matter, a staff member wrote, "the problem will be that the compounds are not tailored [sic] made to every patient," and she added, "just look at our bills."
Gluck argued that there is nothing illegal about compounding drugs that are not tailor made for a patient. 
An illustration shows the alleged network of those indicted in June by the Orange County Grand Jury. (Photo courtesy of the Orange County D.A.)

FBI recordings

Among the 20,000 documents associated with the case are two FBI recordings that were made in 2010 as part of an insurance investigation involving businessman Cyrus Sorat, who eventually was convicted of mail fraud.
In October and December of 2010, Sorat wore a wire while eating lunch with Ahmed.
On the tapes, Ahmed can be heard boasting of his success: "I'm a behemoth, I make 8 to 10 million a month."
He also explained to Sorat how he marks up prices, while saying he does everything by the book. 
"It's the fee schedule man! You got to mark it up. It's like a 200 percent markup," Ahmed said. 
Ahmed also claims in the tapes that he had a hand in "shutting down" a bill in the state legislature that would have limited the reimbursements for compound creams.
"I shut it down for this year, the sleeping pile. AB 2779. Look it up, look what I did to it, what we did to it," Ahmed says.
Ahmed has donated well over $1 million to state and federal politicians and political action committees.
The recordings weren't part of the Orange County case and weren't presented to the jury that returned the indictments. Prosecutors say they’re holding on to the tapes, and will decide if they will be used as evidence at trial.
In response to the recordings, Gluck noted in his written statement that Ahmed "repeatedly told Mr. Sorat that he never pays doctors, he refused to enter a deal with a lab unless he knew it was legal."
Still, former FDA official Sarah Sellers is troubled by the nature of the conversations on the tapes.
"There is no evidence the practice of medicine is occurring," said Sellers. "There is no evidence that practice of pharmaceutical care is occurring. What is occurring is patients are being exploited as mere means for self-enrichment" said Sellers.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA keeps asking it to recall all of its sterile products, and NuVision Pharmacy keeps ignoring the request as it tests the limits of the FDA's authority over drug compounders. The FDA then warns healthcare providers they shouldn't use any drugs NuVision compounded, and NuVision tells customers that all is well.

The scenario is again playing out this week. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them. Included in the warning was a link to its letter to Dallas-based Downing Labs, which operates as NuVision, again asking the company to voluntarily recall its products and laying out a list of problems it said it discovered at the facility during an inspection that ran over 5 weeks in June and July.

The FDA said the inspection determined that 19 lots that were purportedly sterile drugs "tested positive for microbial contamination. In addition, three lots failed endotoxin testing." The FDA said that may be the result of poor aseptic filling processes and because APIs coming into the facility were contaminated with endotoxins.

But in a response on its website, NuVision said the 19 lots were never released. "We want to assure the public that the compounded lots with failed sterility and endotoxin test results were never released by our pharmacy. It is our policy to hold all compounded sterile products for a quarantine period of at least 14 days in order to wait for test results from a third party lab. Any products that fail sterility or endotoxin testing are investigated and destroyed by our pharmacy. These products are never dispensed to patients--we would be happy to provide all sterility results by our third party testing, as well as destruction logs of incineration, from our accredited third party for any lots in question."

The response goes on to outline a long list of changes it has made in response to FDA concerns. It has switched to an FDA-approved testing lab, changed gowning procedures and relocated and added HEPA filters in clean rooms. It said it is making changes that are outside the requirements of compounders to better serve its customers.

NuVision was among dozens of large-scale compounders caught up in a sweep by the FDA that began in 2012 after a fungal meningitis outbreak that killed 64 people was tracked back to a Massachusetts compounder. FDA Commissioner Margaret Hamburg was called on the carpet by Congress for not having a better fix on the situation. Because the compounding industry had fought federal oversight, the agency asked Congress for explicit authority to regulate the largest operators. Last year, Congress granted it some expanded powers: the authority to require certain standards and regularly inspect those companies which voluntarily sign up for oversight. Congress said then the market would punish bad players by giving business to those that are FDA approved.
So far, 56 sites out of more than 3,000 compounders have been registered. NuVision is not among them.

Federal jury indicts NECC pharmacist

A federal grand jury in Massachusetts on Tuesday indicted the pharmacist in charge of sterility at the New England Compounding Center.
The indictment follows last week’s arrest of Glenn A. Chin on a charge of one count of mail fraud. There were no additional charges in the indictment. Chin’s arraignment is set for 10 a.m. Thursday in U.S. District Court in Massachusetts.
The compounding pharmacy where Chin worked has been identified by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention as the source of tainted steroids that caused the 2012 outbreak of fungal meningitis.
The indictment accuses Chin of defrauding the customers of New England Compounding Center by failing to properly maintain cleanliness, instructing personnel to fraudulently complete cleaning logs, improperly sterilizing and testing preservative-free methylprednisolone acetate, and directing personnel to label vials of the medicine as “injectable.” The vials were then shipped by interstate carriers to customers of the compounding pharmacy.
Tennessee was one of the hardest-hit states in the 2012 outbreak that sickened 751 people nationwide with 64 deaths.

Compounding Pharmacy Recalls Potentially Contaminated Drug Products

A New Jersey-based compounding pharmacy has voluntarily recalled 4 prescription preparations distributed in 4 states due to potential contamination, according to the FDA.   Pharmacy Creations first announced the recall on September 6, 2014, following test results that indicated 4 of its drug product lots “may have the potential of not being sterile,” the company warned in a press release.   “Although we cannot be certain that the product subject to the recall is contaminated, to the extent it was, there are serious health implications for the use of contaminated product in all patients which could include development of a life-threatening infection,” the company stated. “We are voluntarily recalling the products as a precautionary measure, out of an abundance of caution and in order to ensure the public health and the safety of our patients.”   According to Pharmacy Creations, the recalled lots of ascorbic acid, glutathione, magnesium chloride, and tropi/cyclo/phenyl/tobra/flurb were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014, and June 18, 2014, via direct mail to patients and physicians. -

Baxter Initiates Voluntary Recall of Potassium Chloride Injection

Baxter International announced on Sept. 16, 2014 that it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826, lot P318220, NDC #0338-0709-48 distributed to the hospital/pharmacy/nurse level for the treatment of potassium deficiency. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, an antibacterial drug, 80 mg in 100 mL, product code 2B0862.
As both products are packaged in 100 mL containers, have similar code numbers, and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high-concentration potassium chloride.
The lot was distributed between May 26, 2014 and August 8, 2014. Any healthcare professionals with an existing lot are advised to carefully review the product label before administering.

Hospira Issues a Voluntary Nationwide Recall

Hospira initiated a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with an expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.
The drug being recalled is indicated as an anticoagulant to maintain catheter patency. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The root cause has not been determined and is under investigation.
The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies. Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle.

Sun Pharmaceutical's woes deepen as US arm Taro recalls Warfarin from markets

MUMBAI: Sun Pharma's recall worries continue with its American subsidiary Taro recalling its leading blood clot drug from the market after the USFDA found that the product did not meet its quality norms.
Taro has recalled Warfarin Sodium after the USFDA faulted its poor quality.
This is the third such recall for Sun which agreed to buy troubled fellow drug maker Ranbaxy in March this year to create the world's fifth largest generic drug maker. Sun shares slumped nearly 5 per cent early on Thursday after overnight reports of surprise inspection by the USFDA at its plant in Halol, Gujarat. It ended 4 per cent down at Rs 822.
The firm also announced plans to introduce an enabling resolution at its forthcoming shareholders meet to raiseRs 12,000 crore through a qualified institutional placement. Uday Baldota, the chief financial officer of Sun, said there are no plans to raise equity or debt and that this is just an enabling resolution as a similar permission from shareholders last year had lapsed. A QIP of the size mentioned in the resolution would be one of the largest in recent times, if it were to happen.
Baldota declined to comment on the drug recall. Warfarin is a significant drug for Taro which contributes onethird to Sun's revenue of Rs 3,927 crore and 4.5 per cent to Taro's sales of $130 million. 

Sun Pharma's recalls have increased ever since the drug maker received a warning letter from the USFDA in May this year for its Karkhadi plant in Gujarat. 
Among the many issues, the FDA found the company's staff to be hiding batch failures, conducting unofficial testing and deleting files.
In July this year, the firm had recalled 4 lakh bottles of its antidepressant drug Venlafaxine Hydrochloride for failing dissolution test. This was followed by the recall of four lakh units of its antibacterial drug Cephalexin for not following good manufacturing practices.
The recall took place under class II of the FDA recall guidelines which is defined as a situation in which the use of, or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The FDA in its letter in May wrote that there's a "general lack of reliability and accuracy of data generated by your firm's laboratory, which is a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm".
It had asked the company to address these issues and also expand its internal review to other facilities that might be involved in, or affected by, inaccurate data reporting.
The letter came one month after Sun announced the acquisition of Ranbaxy from Japanese drug makerDaiichi Sankyo for $3.2 billion. However, since the deal was announced, Sun has been battling controversies right from insider trading accusations from activist investors to answering the Competition Commission of India which has to clear the deal.
The US is the world's biggest pharma market at $24 billion and it contributes more than 50 per cent to the turnover of most Indian companies.
Indian drug makers have been battling drug recalls and quality issues for more than a year now forcing the USFDA to increase its presence and its inspections in India. This year Dr Reddy's had to recall thousands of bottles of its heartburn drug Metoprolol. Ranbaxy last year came out of a four year legal battle with the US Department of Justice which asked the company to pay $500 million fine for selling adulterated drugs in the US market.

Canadians kept in dark about defective drugs

North American patients have been put at risk by prescription drugs that Canadian pharmaceutical companies sold with knowledge that their products were defective, a Star investigation has found.
Using records obtained through U.S. freedom of information laws, the Star also found other Canadian companies have:
  • Hidden, altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe.
  • Not reported evidence of side-effects suffered by consumers taking their drugs.
  • Since 2008, more than 40 Canadian drug companies, including Toronto-based generic giant Apotex, have been cited for serious manufacturing violations.
    All of these violations are detailed in inspection reports provided to the Star not by Health Canada but the American Food and Drug Administration (FDA), which also inspects Canadian facilities.
    The Star investigation found that while the FDA strictly and transparently enforces drug manufacturing laws, Health Canada leaves Canadians in the dark by keeping secret details of problems its inspectors find.
    Meanwhile, drugs and drug ingredients banned from the U.S. market have been allowed by Health Canada into Canadian pharmacies.
    The inspection documents obtained by the Star reveal:
  • In June, at a facility in Bangalore, India, that makes drugs destined for North America, Apotex employees did not report undesirable test results and doctored bacterial growth test records.
  • Generic drug maker Taro Pharmaceuticals of Brampton kept drugs on the market despite company tests showing batches of the medications deteriorated before the expiry date listed on the label.
  • Cangene Corp., a Winnipeg drug manufacturer, failed to tell authorities of blood clots, fever and other side-effects associated with their products.
  • The U.S. FDA inspects facilities in Canada and around the world where drug and drug ingredients bound for the U.S. market are made. The regulator may ban drugs from the U.S. market or prevent a company from introducing new products until the manufacturing and safety problems are fixed.
    The FDA reports do not specify all the countries where drugs made by the inspected companies were shipped. The Star found many of these same drugs are also made for Canadian consumers, and the factories are subject to Health Canada inspections as well.
    There have been at least 19 Apotex inspections by the FDA since 2008, 16 of them resulting in findings termed “objectionable” or noted as “repeated deficiencies.” In one case, the FDA said the company failed to uphold “its legal obligation.”
    During an interview at one of Apotex’s Toronto factories, and in email correspondence, company president and CEO Dr. Jeremy Desai and another manager did not challenge the FDA’s findings and told the Star that the firm is fixing the problems and its products are safe.
    Desai told the Star “compliance is a journey” and his company has addressed what he calls the “procedural lapses” identified by the FDA and has invested in improved data collection and staff training programs.

    FDA Asks Recalcitrant Compounder to Recall Products, Again

    File this under ‘enough already.’
    FDA officials have asked a compounding pharmacy with which they have repeatedly sparred to recall all of its sterile products over concerns that medicines that are currently circulating may be contaminated and present a risk of illness or injury, according to a letter sent yesterday to Downing Labs, which operates NuVision Pharmacy in Dallas, Texas.
    The move comes after the FDA found a host of problems during an inspection earlier this summer and warned health care providers and consumers not to use the medicines made by the compounder. In fact, this was the third such warning in 15 months that the agency issued about NuVision and the safety of its compounded drugs.
    “Given the high rate of contamination, there is a high probability that contaminated units from other purportedly sterile drug product lots produced at the Downing Labs facility are currently in distribution,” the FDA wrote in what the agency calls a ‘formal request.’ “Based on the inspectional findings, FDA has serious concerns about the conditions and practices at the facility for the production of sterile drugs, which result in a lack of sterility assurance.”
    The letter goes on to cite various manufacturing problems, such as a lack of “sound scientific data” to support explanations for sterility failures and an inability to identify the cause of the sterility failures. The FDA also noted vials containing fibers and particles were culled from 184 lots of supposedly sterile drugs, but only visual exams took place and there was no investigation to determine the cause.
    We asked NuVision for comment and will update you accordingly.
    As we have written previously, the FDA issued alerts twice last year about sterility problems; NuVision recalled one product. And a year ago, the agency tried unsuccessfully to persuade the compounder to recall still more products and NuVision responded by posting a notice on its website saying it did not qualify as a drug manufacturer and so was not required to follow FDA standards for manufacturing.
    Some background from an earlier post: The defiant posture taken by NuVision was cited last year by the FDA as further need for Congress to pass legislation that would allow the agency to bolster its regulatory oversight and legal options when encountering recalcitrant compounders. At the time, the FDA was defending its actions in the wake of an outbreak of fungal meningitis in 2012 that was tied to a compounded and caused dozens of deaths.
    In response, the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. The law creates two classes of compounders. One group voluntarily registers with the FDA and must follow so-called good manufacturing standards. The agency hopes added requirements will give hospitals and physicians the confidence to purchase medicines from such compounders (here is the list).
    Such an imprimatur is designed to act as an incentive that could boost compounding orders at the expense of those that do not register and lack such a designation. Just the same, those compounders that do not register, such as NuVision, are still subject to warning letters, product seizures, injunctions and, possibly, criminal violations for distributing contaminated products, according to an FDA guidance.
    State boards of pharmacy are expected to provide added oversight of this group. We asked the Texas Board of Pharmacy if they took any recent action or planned any against NuVision and will provide you with any response.

    Alarm raised over drug and staff shortage in public hospitals

    NAIROBI, KENYA: A new survey of Level 3 hospitals in five counties across the country has revealed alarming shortage of drugs and critical staff in those facilities.
    According to the report by the National Taxpayers Association, the shortage of drugs is acute and patients are struggling to painfully bear additional costs of purchasing them in private facilities.
    “We note with a lot of concern the lack of medicines in our health facilities,” said the NTA Chairman Peter Kubebea in a speech read on his behalf by Laftif Shaban, a member of the NTA National Governing Council.
    “Patients have to fend for prescribed medicines from private units as public pharmacies do not stock enough drugs,” he said.
    Presenting findings of the report, NTA Project Officer-Health Irene Otieno said the shortage of drugs had significantly affected the cost of accessing health-care since most Kenyans cannot afford the additional costs.
    “This state of affairs raises the urgent need for counties to regularly review stock levels allocated to their health facilities,” Ms Otieno said.

    Drug shortage leaves Alzheimer's patients and caregivers scrambling

    By Greg Jaklewicz, Abilene Reporter-News, Texas
    McClatchy-Tribune Information Services
    Sept. 18--ABILENE, Texas -

    A new drug used by those with Alzheimer's disease, such as Libby Embry, is in short supply -- if available at all inAbilene.

    "I am very concerned," said Embry, who six years ago recognized the early signs of Alzheimer's -- her father had it -- and since has aggressively fought the onset of the disease.

    Namenda is the brand name for memantine HCl, a drug that treats the memory loss and mental changes from dementia, which signals Alzheimer's.

    Walk to End Alzheimer's

    The annual September Walk to End Alzheimer's begins at 8:30 a.m. Saturday with an opening ceremony at Rose Park Senior Center, with walking to begin at 9 a.m. Registration opens at 8 a.m. The event is free but it is a fundraiser; those raising $100 or more get a T-shirt. There will be refreshments and door prizes and entertainment. Call 325-672-2907 for information.

    Namenda (also known as Namenda IR) has been used in combination with the drug Aricept (donepezil HCl), aEisai/Pfizer product that treats mild, moderate and severe Alzheimer's disease. Patients took two 10 milligram Namenda tablets daily.

    The maker of Namenda, Forest Laboratories Inc., a subsidiary of Ireland's Activis, recently introduced to a new version of the drug -- Namenda XR -- to replace Namenda, which in 2015 will be available in generic form because its patent expires.

    The XR drug is a 28 milligram capsule that is taken once daily and can be broken apart to mix with food, for those unable to take the tablet. It is extended release, as opposed to immediate release of Namenda.

    Namenda XR treats moderate to severe Alzheimer's disease.

    Namenda phaseout

    Sales of the Alzheimer's drug Namenda are being discontinued as it goes generic and Forest Laboratories Inc.replaces it with Namenda XR. The change is not because of safety or product quality issues. If you have questions or for information, call 1-844-873-2823 or go to

    When she first tried Namenda XR earlier this year, 66-year-old Embry said, "I could tell a huge difference."

    Of the original Namenda, she said: "It wasn't working for me. I felt myself slipping."

    But patients cannot easily find the XR version. When refilling orders or placing new prescriptions, patients found pharmacies were not being resupplied with the drug. Production, it seems, has not met demand.

    "It's true," said James McCoy, the pharmacist who owns James McCoy's Drug Store in northeast Abilene. He has a waiting list and feels lucky when he checks his computer to see a two-bottle allocation. Bottles contain 30 capsules.

    "It happened this morning," he said Monday. "When I checked back later, there were none."

    On Wednesday, he could order two more bottles.

    Embry was down to six pills, she said, when she discovered that pharmacies in Abilene could not get Namenda XR.

    "We made calls -- my husband made the calls -- and I cried all day. I don't do that much," she said.


    According to the American Society of Health-System Pharmacists' website, "Forest states the reason for the shortage of Namenda XR capsules is manufacturing delay. Forest states the reason for discontinuing the Namenda immediate-release tablets is to focus on the Namenda XR extended-release capsules."

    Mindy Bannister, a caseworker at the local Alzheimer's Association office, said the demand for the Namenda XR was underestimated. She said she was told it will take Forest four to six months to catch up. Embry has heard it will be six months to a year.

    On Wednesday, David Belian, director of global media relations for Activis, emailed the Reporter-News: "We are aware that some pharmacies have experienced temporary supply issues with Namenda XR. Demand for Namenda XR has been steadily increasing over the past several months, exceeding expectations. We are currently releasing additional supply ... to meet this higher demand. We are in the process of resolving supply constraints and are working with wholesalers to deliver product as rapidly as possible."

    McCoy said he can fill Namenda orders, and some physicians have resubmitted prescriptions for the original drug while keeping a standing order for the newer version.

    "We get a lot of scripts every day and we put those in a queue that we fill as soon we can get (the drug)," he said. "Yes, some people are doing without it."

    Namenda XR in 7 mg doses is available.

    Theoretically, someone with Alzheimer's could take four of 7 mg capsules of Namenda to equal one 28 mg XR capsule. But price comes into play.

    A bottle of the 7 mg dosage costs the same as a bottle of the 28 mg dosage, meaning a month's supply of the lesser dosage would cost four times as much. Insurance companies, McCoy said, are not going to go for that.

    "Why would they?" he asked.

    Said Bannister, "We're recommending to everyone not to let the supply get low and call your pharmacy every day."

    That paid off for Embry. After calling local pharmacies and even some in Denver and Dallas with no luck, she called one in the Kansas City, Kansas, area. She is from that state and the

    pharmacist on the phone ironically recognized her name. His mother, he said, went to college with Embry.

    He found one bottle of Namenda XR and overnighted it to her. Embry has been able to build a three-month supply.

    The shortage baffles Bannister.

    "It's dicey right now," Bannister said. "I've been here six years and never once did it cross my mind there would be a shortage."


    On its website, Forest has alerted caregivers and health care providers of its plan to discontinue Namenda in 5 mg and 10 mg tablets in favor of Namenda XR. It advises caregivers to contact health care providers to avoid a disruption in treatment.

    However, there has been a disruption and it falls on the drugmaker.

    "You can blame the pharmaceutical company for not being prepared," McCoy said, not happy that he cannot promptly serve his customers.

    Embry agreed.

    "With the number of baby boomers now of this age, they should have been forewarned," she said. "Somehow money is involved."

    Bannister said a Forest institutional representative who now and then comes by the local office had this response when asked about the shortage: "We goofed."

    On Monday, the plot thickened.

    The New York attorney general filed an antitrust lawsuit against Activis, which acquired Forest Labs in February for $25 billion. The lawsuit claims the company is forcing patients to switch to its new version of the drug to negate the effects of generic Namenda, which could be cheaper.

    In a statement, AG Eric T. Schneiderman said: "A drug company manipulating vulnerable patients and forcing physicians to alter treatment plans unnecessarily, simply to protect corporate profits, is unethical and illegal."

    The patent for Namenda XR is through 2029.

    Bannister said the association was alerted three to four weeks ago there was a shortage of XR. Two weeks ago, she said, clients told her that their calls to pharmacies were turning up none of the drug in Abilene. This is not solely a local problem, she said. It's one that the national Alzheimer's organization has become aware. Those ordering Namenda XR by mail also cannot get the drug.

    Belian wrote the shortage is not widespread: "At this time, the majority of pharmacies and wholesalers in the United States have supply."

    That's not what local folks are finding.

    "I think we called every pharmacy in Abilene and some in the surrounding areas and were told they didn't have any," Bannister said.

    Embry compared the situation to that of a diabetic suddenly finding there is no supply on insulin.


    The Abilene office serves more than 7,000 clients in 14 counties of the 40-county North Central Texas Chapter of the Alzheimer's Association. That number, Bannister said, does not include those unaware they have Alzheimer's.

    Bannister said that stopping the drug or combinations of drugs would have a negative cognitive effect on the person with Alzheimer's. Should the patient restart using the drug, he or she could not make up the memory and mental capacities that were lost.

    "It doesn't take long," she said of stopping the medication.

    She said having a drug that at least helps with the effects is a positive for those with Alzheimer's and/or their caregivers -- they know they are doing what they can to slow the effects of the disease. The drug does not cure nor does it slow the onset of Alzheimer's but it helps with the progression of memory loss and other mental changes the disease brings.

    Embry wants to remain a voice for those with Alzheimer's as long as she.

    "I'm one of the lucky ones. I'm in the know," she said. "The little things I do are for the people who can't talk. I am going to fight this."

    NHRC Notice to Health Ministry Over HIV Drug Shortage

    NEW DELHI: The NHRC has issued a notice to the health ministry following a report that HIV patients were suffering due to shortage of medicines at government centres, a statement said Thursday.

    Taking suo motu cognizance of the report, the National Human Rights Commission (NHRC) sent a notice to the secretary of the health ministry, calling for a government response within two weeks.

    The commission has also asked the ministry secretary to submit a separate report on the measures proposed for preventing such shortages in the future.

    "As per media reports, treatment of HIV patients across India has taken a hit, especially in Delhi and Mumbai, due to severe stock-outs of life-saving medicines at government-owned centres. Delhi, Maharashtra, Gujarat, Karnataka and Manipur are the worst hit," the NHRC said in a statement.

    "The report raises a serious issue of violation of human rights of HIV patients," it added.

    According to the commission, treatment and control of HIV, including dispensing drugs and testing, is handled by the government-run public health programme through its centers.