FDA Comes Out With Draft Guidance for Drug Shortages
Source: Pharmalot
Last October, the FDA wrote drugmakers to remind them they are required to report any life-savings meds that are discontinued and encourage them to voluntarily report any supply disruptions that could lead to a shortage (read the letter). Now, the agency has issued a draft guidance that instructs drugmakers on the specific procedures for notifying the FDA and what will happen to that information.
At the same time, the agency disclosed plans to relieve shortages of two badly needed cancer meds – Doxil and methotrexate – both of which were made by a Boehringer Ingelheim subsidiary known as Ben Venue Laboratories that recently halted supplies and suspended operations after regulators found serious manufacturing violations (back story here, here and here).
To address the Doxil shortage, the FDA will allow temporary imports of a replacement drug called Lipodox that is made by Sun Pharma, a step the agency says should end the shortage “in the coming weeks.” For methotrexate, the agency approved an application by Hospira to maker of a preservative-free formulation that is expected “to further bolster supply and help avert a shortage.” The FDA says it expedited a review of an application for APP Pharmaceuticals.
The moves are an outgrowth of an executive order that was issued by the White House in response to the growing crisis over prescription drug shortages, and assigned the FDA to broaden reporting of potential shortages; speed reviews of applications to begin or alter production of these drugs; and provide more info to the US Department of Justice about possible collusion or price gouging (back story).
In fact, since the October letter was sent, the FDA maintains that a six-fold increase in voluntary notifications has been received from drugmakers concerning potential shortages. Put another way, since the executive order was issued, the FDA says 114 shortages have been prevented, out of a total of 195 shortages prevented overall last year, according to an agency statement.
Despite such statistics, the problem has grown more concerning. A recent survey of oncologists found that ongoing shortages – most of which are injectables used for treating cancer – are not only preventing patients from receiving timely or the most appropriate treatments, but patients are dying sooner than they would otherwise and tumors are recurring more often (see this).
Meanwhile, the FDA acknowledges that mandatory notification of permanent discontinuances is helpful in preventing or mitigating some drug shortages, but is a limited tactic. In 2010, for instance, only 8 percent of shortages were due to permanent discontinuation. Most shortages were due to problems at manufacturing facilities, delays in manufacturing or shipping, and shortages of active ingredients.
The guidance seeks to improve the odds by refining the definition of a sole manufacturer, which is required to report a discontinuation. The defintion is linked to specific strength, dosage form and route of administration, because “these characteristics may be critical for the targeted needs of particular patients. For example, a patient may be prescribed an injectable form of a particular drug product because the patient is not capable of swallowing an oral pill. If the injectable form is discontinued, the patient may be unable to continue life-saving treatment, even if the oral form is still available,” the FDA writes.
The guidance also specifies that the application holder is responsible for reporting a discontinuation, even if the actual production is contracted to a third party. This language was added, no doubt, in response to the troubles at Ben Venue, which was conducting extensive contract manufacturing work for other drugmakers – Doxil, for instance, was made for Johnson & Johnson.
What should be reported to the FDA, though? The agency lists the following: a business decision to permanently discontinue manufacture of a drug; a delay in acquiring API or inactive ingredients that leads to, or could lead to, a temporary interruption in manufacturing of a drug while alternative suppliers are located; equipment failure or contamination affecting the quality of a drug that necessitates an interruption in manufacturing while the equipment is repaired or a contamination issue is addressed, and manufacturing shut-downs for maintenance or other routine matters, if the shutdown extends for longer than anticipated or otherwise could disrupt supply of a drug.
What are the exceptions? These would include shutdowns for routine maintenance that would result in re-openings on a planned schedule and power outages in which a drugmaker expects to be able to resume production within a relatively short timeframe. Another example: regularly scheduled production stoppages of a particular drug in a plant used to make more than one med.
As to voluntary reporting, the agency encourages drugmakers to pick up the phone when they find: product quality problems, such as the presence of particulates or impurities, microbial contamination and stability concerns; interruptions or other adjustments in manufacturing that temporarily halt production and may adversely affect supply, such as renovations; delays in acquiring critical raw materials or components, or loss of raw material or components; transferring production to an alternate facility; import delays, and loss of a production line or production capacity, among other things.
Category : News
Patients Are Suing Feds Over Drug Shortages
More than two dozen people who suffered medication shortages have filed a lawsuit against the US Department of Health and Human Services, the FDA and the National Institutes of Health, arguing their rights were violated because the federal government failed to take adequate enforcement actions against such drugmakers and allow for alternative means to protect supplies.
In their lawsuit, which was filed this morning in federal court in Washington DC, the patients argue that FDA licenses to drugmakers that cause shortages should be invalidated and their patents declared unenforceable. And they want the federal government to escrow drugs and enter into contract manufacturing to maintain availability, much as the HHS already does for pandemic flu vaccines.
“Corporations that cause drug shortages through their own negligence and indifference to human life should be immediately excluded from interstate commerce for breaching the public trust,” says their attorney, Allen Black. “Corporations that cause drug shortages have demonstrated beyond a doubt that they cannot provide a reliable drug supply, so there is no rational to reward them with future profits from the remaining survivors of the shortage.”
The lawsuit was filed by patients who have encountered short supplies of two drugs. One is Fabrazyme, a medicine used to treat Fabry disease, a rare, but life-threatening genetic disease that is made by Genzyme (see a shortage report). The other is Aquasol A is an injectable drug made by Hospira used to treat vitamin A deficiency and often taken by Fabry patients. Both drugmakers have experienced numerous and sustained manufacturing problems (read here).
The lawsuit arrives as the US grapples with a worsening shortage of various prescription medications, from life-saving cancer drugs to pills that are taken by children who suffer from attention deficity hyperactivity disorder (read here and here). Shortages exist for hundreds of medicines (see the FDA list) and have spawned Congressional hearings and legislative efforts to bolster FDA authority.
The FDA is prevented from requiring drugmakers to provide info about shortages or take certain actions to prevent or alleviate them. As the US Government Accountability Office noted in a recent report, the only authority the FDA has pertains to reporting discontinued drugs that are life supporting, life sustaining or used to prevent a debilitating disease or condition – when such a drug is made by just one company (back story).
The FDA, meanwhile, has been caught in a conundrum. On one hand, the agency has attempted to get tougher on manufacturing violations in the wake of the Heparin safety scandal. But in doing so, some drugmakers complain that agency scrutiny has contributed to some shortages. Industry watchers, however, say shortages occur when some markets become less profitable or are exacerbated if other drugmakers have little incentive to try to compete.
The genesis of the lawsuit can be traced to the long-running manufacturing gaffes at Genzyme, which ultimately signed a consent decree with the FDA due to its string of problems (read here) and, meanwhile, rationed the amount of Fabrazyme to patients in the US. Some have previously filed a lawsuit against the drugmaker, which is now owned by Sanofi, as well as the NIH and Mt. Sinai, which had been awarded an NIH grant and invented Fabrazyme (back story and licensing agreement).
As part of their effort, the patients have also petitioned the NIH to override use patents held by Genzyme and have been seeking a so-called march-in petition. Their hope has been to secure rights that will attract a partner interested in producing a sufficient supply of the medication in light of ongoing shortages. Last month, both the FDA and the European Medicines Agency approved a new Genzyme plant to produce Fabrazyme, suggesting shortages would be alleviated in coming months (look here).
Nonetheless, the Fabry patients argue their situation was worsened because the federal government failed to take sufficient steps to ensure shortages could be alleviated. Black contends their civil rights were violated because the states require a drug to be available at “historically produced levels” that physicians and patients depend upon. “If there is no notice and a lack of planning then public health is compromised and individual patients cannot make treatment decisions for themselves. The violation is from the drug not being there when its needed and such a need is foreseeable,” he tells us.
The lawsuit argues that the the federal government “illegally interfered” with the treatment decisions that were made by state-licensed physicians, since the shortages precluded treatment, and also endangered patient health. Calling this an “intrusion against the practice of medicine,” they also argue that the federal agencies violated their Fifth and Tenth Amendment rights, as well as a right to privacy and control their own bodies.
“The FDA should not allow Americans to be held hostage by drug companies creating or threatening shortages,” he says. “Americans citizens, through the government, are the ones in control the drug market. The government can make all of the drug that is needed if corporations cannot. It is irrelevant whether a private corporation finds a drug profitable. If Americans need a drug to survive, they have a fundamental Constitutional right to access.”
Among the demand sought by the patients: prevent drugmakers from making allocation decisions based on private health information and require all drug shipments go to a court-appointed third party for allocation; prevent drugmakers from telling investors, doctors or patients about when shortages are expected to end until the FDA has been able to determine whether timelines are accurate; and prevent drugmakers from exporting drugs overseas outside of the jurisdiction of the courts and interstate commerce during a domestic shortage; and give the courts, Congress or the states authority for making rationing decisions.
Category : News
J&J Scandals Bring Down CEO
After more than two years of controversy over manufacturing gaffes and product recalls, Bill Weldon is retiring as Johnson & Johnson ceo in April, ending a 10-year reign at the top of one of the most venerable, but now tarnished names, in corporate America. The 63-year-old Weldon will be replaced by Alex Gorsky, 51, who currently oversees the medical device and diagnostics business, according to an SEC filing (see here).
The move comes after repeated calls for Weldon, who will remain for chairman for awhile, to step down following a consent decree; highly publicized congressional hearings; government investigations; hundreds of job losses; the closure of a key plant; a reorganization of its consumer health unit; eroded consumer confidence; numerous lawsuits, and hundreds of millions of dollars in lost sales.
In fact, the most recent corporate reputation poll from Harris Interactive was recently released and Johnson & Johnson ranked 7th on the closely watched list. This was the first time that the health care giant did not rank in first or second place; last year, J&J notched second on the list (read here).
alex-gorskyJ&J portrayed the change as the result of a carefully planned succession process and ignored mention of the ongoing turmoil. “This succession decision involved a rigorous, thorough and formal multi-year process, which included consideration of two superbly qualified internal candidates, as well as outside candidates,” Weldon says in a statement (read here).
In late 2010, the J&J board promoted Gorsky (pictured at right) and Sheri McCoy, the worldwide chair of the pharma group, to vice chairs of the executive committee. Gorsky, who will get a raise to $1.2 million, according to the SEC filing, has spent the last four years at J&J, having arrived from Novartis, where he was head of the US pharma biz. He had previously worked at J&J, though.
The lengthy and embarrasing list of problems at J&J largely began when the health care giant attempted a ‘phantom recall’ of various over-the-counter items, such as Tylenol and Motrin, in order to circumvent detection by the FDA and consumers. The episode triggered an ongoing series of product withdrawals due to bottles with musty smells and foreign particles.
Since then, a wide array of products have been recalled – contact lenses, hip replacements, syringes and prescription drugs – indicating system problems with quality control in manufacturing operations across the diversified company. There were also shortages of Tampons and certain shampoos, adding to the gaping holes on store shelves that have been filled by rivals.
To cope, Weldon attempted an old-fashioned media response by holding select interviews and touting a reorganization of the McNeil Consumer Healthcare unit, although the executive who oversaw its operations at the time, Peter Luther, was shifted to a new role as president of US Consumer Healthcare, suggesting Weldon was unwilling to clean house.
At the same time, hundreds of employees at the McNeil plant in Fort Washington, Pennsylvania – where McNeil maintained its primary offices and numerous production gaffes occurred – lost their jobs because the plant was closed for a massive retooling operation that is not expected to be completed until later this year or some time next year.
Meanwhile, J&J suffered other recent embarrassments. The health care giant is embroiled in litigation over the safety of hip replacements sold by its DePuy unit and recent reports indicated marketing continued in Europe and other countries even after the FDA rejected the product for the US market. J&J recently took a $3 billion charge for recalling the hip replacements.
And last month, the health care giant marched into a court in Austin, Texas, to defend a lawsuit brought by state officials, who charged J&J had orchestrated a controversial program that was designed to boost the use of the Risperdal antipsychotic in the public sector throughout the country. But J&J quickly settled for $158 million after just one week of scathing and unflattering testimony (see here and here).
Just the same, investors have taken the long view and decided that J&J remains greater than the sum of its parts, especially since the health care giant has benefited from acquisitions, such as HIV meds sold by the Tibotec unit. Over the past year, in fact, J&J stock has increased 18 percent, despite the recall debacle.
Analysts, meanwhile, do not expect Gorsky to conduct an overhaul. “Hello to the new boss, same as the old boss. The old Number One hangs around as chairman of the board and his Number Two becomes Number One. Don’t expect much to change,” Erik Gordon, a professor at the Ross School of Business at the University of Michigan, who last year urged Weldon to resign.
Category : News
Teva Doles Out $250 Mil to End Lawsuits on Propofol
Source: Pharmalot
Yet another drugmaker has agreed to settle a large backload of product liability lawsuits. In the latest instance, Teva Pharmaceutical will pay more than $250 million to settle more than 80 lawsuits alleging the drugmaker intentionally sold its Propofol anesthetic in vials that were large enough to be reused by doctors, but led some colonoscopy patients to develop hepatitis C, Bloomberg News reports.
The deal also resolves a May 2010 case that prompted a jury award of more than $500 million in punitive damages and $5 million in compensatory damages against the Israeli drugmaker, according to the news service, citing sources and a filing with the Nevada Supreme Court. A private school principal charged the sedative lacked appropriate warnings and large vials should not have provided to doctors (back story).
So far, Teva has settled about 120 Propofol lawsuits and reserved $270 million for the litigation, according to a filing with the US Securities and Exchange Commission (see page 39). A Teva spokeswoman confirmed the settlement to Bloomberg and noted that 15 lawsuits are still pending.
Teva, by the way, no longer makes Propofol, but agreed to indemnity Baxter Healthcare and McKesson for the Propofol cases in Nevada. Last fall, the companies lost a trial in which a jury determined they contributed to a 2008 hepatitis outbreak due to the way Propofol was marketed and three plaintiffs were awarded more than $162 million (back story).
And for those who were wondering, yes, Propofol is the same medication that was at the center of the controversy over the 2009 death of pop star Michael Jackson and his physician, Conrad Murray, who was convicted last fall of involuntary manslaughter and sentenced to four years in jail for injecting Jackson, who relied on the med as a sedative to help him sleep.
Category : News
Fake Avastin was shipped by accident, Danish distributor says
Danish drug distributor CareMed said it was an unwitting link in the journey of fake cancer medicine Avastin from Switzerland to Britain, in the latest twist in a saga that began when the counterfeit drugs surfaced in the United States last year.
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The fake version of the multi-billion dollar Roche drug had been traced back as far as Egypt before entering a complex supply chain that ended in California.
CareMed told Reuters on Friday it had sourced the drug from fully licensed Swiss distributor Hadicon, and the 167 vials of Avastin 400mg were sold from a transit warehouse in Switzerland directly to a transit warehouse in Britain.
Hadicon was also identified to Reuters as handler of the fake batch by Britain’s medicines regulator but the company is yet to confirm its role.
“We did not investigate the packages and the vials,” CareMed managing director Casper Tingkaer told Reuters in an emailed response to questions.
“In fact under our distribution license — for patient safety reasons — as a distributor, we are not even entitled to open the packages and check that, for example, batch numbers of the vials correspond to the batch numbers of the packages.”
The discovery of the fake medicine, which does not contain the active ingredient bevacizumab, highlights the growing problem of counterfeit drugs.
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“This is a global industry problem, in particular we have now seen that falsified products have found a way into the validated supply chain,” Tingkaer said.
CareMed sold the drugs to a “highly valued and experienced customer” in Britain, which informed it at the end of November that the batch numbers on the vials did not match the packages.
Tingkaer said the company immediately launched an investigation and told the Danish Medicines Agency, which contacted its counterpart in Britain.
The Danish Medicines Agency said that the Danish wholesale company had acted correctly.
Britain then informed Roche, which gets about $6 billion a year from Avastin sales globally, and the U.S. Food and Drug Administration.
Tingkaer said CareMed demanded documentation from Zug-based Hadicon but added the Swiss company did not supply the papers.
Hadicon said it was still not sure it was part of the supply chain that shipped the fake Avastin.
“We have no confirmation of evidence that the goods are definitely from us,” chief executive Klaus-Rainer Toedter said.
Regulator Swissmedic would not confirm Hadicon’s involvement, but said the fake drug was not sold in the country and it believed it was only stored in a Swiss warehouse.
A Swissmedic spokeswoman said it looked as if the distributor had no knowledge that the drugs were fake, a view echoed by Britain’s Medicines and Healthcare Products Regulatory Agency.
“There is no suggestion (CareMed and Hadicon) knew it was counterfeit,” a MHRA spokesman said.
Roche, which does not make Avastin in Egypt, said it was working with the FDA in the United States to stop the source of the counterfeit drugs.
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“Is anyone making the casing of Avastin here and exporting it illegally?” said Yousef Ehab, the head of the company’s operations in Egypt. “I do not know and would like to since this is something of great concern.”
Fake medicines are a particular problem in emerging markets, where up to 30 percent of drugs might be counterfeit, the European Parliament said last year.
MEP Marisa Matias said at the time that falsified medicines were “silent killers” and the absence of a legal framework encouraged counterfeiting, an organized crime.
Europe is introducing a series of measures to clamp down on fake medicines over the next three years, including authentication stamps on packaging.
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Category : News
Mylan Agrees to Settle Defamation Suit Against Paper
Nearly three years after The Pittsburgh Post-Gazette ran a controversial story that indicated Mylan Laboratories employees routinely violated quality-control procedures at a facility in Morgantown, West Virginia, the drugmaker and the newspaper have settled the litigation, according to a joint statement issued by Mylan and the newspaper.
“The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise,” according to the statement, which appears on the Mylan web site. The Post-Gazette article was prompted by an internal Mylan report on the handling of computer-generated warnings about potential manufacturing problems.
The drugmaker subsequently filed two lawsuits, charging the Post-Gazette omitted and distorted facts in the July 2009 article, which reported that Mylan employees regularly overrode computer-generated warnings about potential problems with production, according to the Associated Press. The other lawsuit alleged the paper misappropriated trade secrets, claiming the articles were based on improperly obtained and misconstrued confidential and proprietary documents.
In court documents, The Post-Gazette alleged that Mylan filed suit to obtain information on the confidential sources the paper used. Meanwhile, the FDA investigated Mylan plant shortly after the article appeared and but did not find any “objectionable” deficiencies or evidence that Mylan products had been compromised (back story). Post-Gazette executive editor David Shribman tells the AP that the paper “paid no money to Mylan in the course of this legal action” and “did not reveal any confidential sources.”
Category : News
Feds Bring Subpoena on Bristol Myers Regarding Marketing for Abilify
In September 2007, Bristol-Myers Squibb agreed to settle charges of giving kickbacks to docs and overcharging the government. Among the infractions alleged by the federal and state governments was off-label promotion of its Abilify antipsychotic, and the drugmaker subsequently paid $515 million and signed a five-year corporate integrity agreement.
Could there have been a violation? Clearly, the feds have renewed their attention. Last month, the US Attorney in New York issued a subpoena to the drugmaker “requesting information related to, among other things, the sales and marketing of Abilify,” according to a filing with the US Securities and Exchange Commission (see page 102). Bristol-Myers says the impact is not possible to determine.
At the time of the settlement, Bristol-Myers was charged with directed its sales force to call on child psychiatrists and other pediatric specialists, and reps then urged physicians and other health care providers to prescribe Abilify for children. The drugmaker also was charged with creating a specialized long=term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder (back story and the CIA).
This is not the first time that Bristol-Myers has generated scrutiny since signing the CIA. As the drugmaker also noted in its SEC filing, the Delaware Attorney General wrote a letter in March 2009 to say that a multi-state coalition was investigating whether certain Abilify marketing practices violated consumer protection statutes in various states.
Abilify, by the way, is the second-biggest selling drug in the Bristol-Myers portfolio. Last year, the antipsychotic generated nearly $2.8 billion in sales, or roughly 13 percent of net sales. The only medicine to generate more revenue for the drugmaker was the Plavix bloodthinner, which rang up nearly $7.1 billion in sales.
Category : News
Novartis Stops Parts of Production at Yet Another Manufacturing Plant
For the second time in less than three months, Novartis has been forced to halt production of medicines at one of its plants after recent FDA inspections found various manufacturing problems. This time, its Sandoz unit has suspended or discontinued production of some medicines at a facility in Boucherville, Quebec. In December, all production was suspended at a plant in Lincoln, Nebraska.
In letters written to customers late last week, Sandoz described the action as temporary, although it remains unclear when production will resume. Production of oral products, patches and the Omnitrope growth hormone will not be affected. Instead, production of ointments, ophthalmics, suppository dosage forms and injectables for illnesses that are not life-threatening ill be curtailed, according to Michel Robidoux, the president and general manager of Sandoz Canada (read the letter).
“Our objective is to restore normal levels of supply as soon as possible…,” according to a different letter from Gordon Meyer, vp of the Sandoz Canada hospital division, and Jacquelin Gagnon, vp of the Sandoz Canada retail division. “At present, we have focused all available capacity on the supply of life-saving and acute injectable care medicines to ensure that patients with critical medical conditions continue receiving adequate treatment.”
The drugmaker has been repeatedly scrutinized by the FDA over the past year as part of an agency effort to heighten its oversight of manufacturing facilities in the wake of the Heparin scandal. Since then, the FDA has attempted to get tougher with drugmakers and their ingredients suppliers, and Novartis has become a prime example. Following inspections at three Sandoz plants, the FDA last November issued warning letters to Novartis ceo Joe Jimenez (see this).
Meanwhile, the FDA found a boatload of embarassing problems at the Novartis plant in Nebraska, which makes over-the-counter items such as Excedrin, Theraflu, Triaminic, Maalox and Lamisil, as well as Animal Health meds and also does contract manufacturing work for other prescription drugmakers, such as Endo Pharmaceuticals.
One big problem: Novartis failed to investigate consumer complaints about mixed-up tablets in bottles, among other serious violations (read more here). There were also failures to to train employees in quality systems, extend investigations of known problems to all products affected; assure processes remain in a current validated state and have an adequate number of trained staff in the quality unit.
The FDA issued a pair of 483 inspection reports (which you can read here and here), and the drugmaker has recalled OTC and Animal Health meds and is estimated to lose hundreds of millions of dollars in sales (see here, here and here).
The agency has also visited a Novartis plant in Suffern, New York, according to sources who say the drugmaker recently retained the Quantic Group to assist with quality control upgrades. This is the same consulting firm that helped Genzyme, the Sanofi unit, after a consent decree was signed with the FDA. A Novartis spokesman described the assistance as “routine” and “not reflective of quality control issues nor should it be taken as an indication that a problem exists.”
Separately, the drugmaker experienced problems with the water system at this plant. A Novartis spokeswoman acknowledged that, last month, there was an “accidental discharge of propylene glycol into the facility’s domestic water system” and the material is “is considered non-toxic.” She added the system was flushed out to remove propylene glycol and will be tested and monitored. “There is no impact to any products produced at the Suffern facility and there is no risk to the surrounding community… Local government officials were notified.”
Category : News
Fake Avastin Causing Major Uproar in National Media
Source: Pharmalot
For the past couple of days, the controversy over counterfeit Avastin – the cancer med sold by Roche and its Genentech unit – has made national headlines and renewed fears about phony meds making their way through the supply chain. The timing could not be worse, coming just as the crisis over assorted prescription drugs reaches a fever pitch.
In discussing the Avastin episode, the FDA noted there are only four approved suppliers and the outfit that purportedly peddled counterfeit version was not on the list – Quality Specialty Products, which the agency described as a foreign supplier that may also be known as Montana Health Care Solutions. Meanwhile, Volunteer Distribution in Gainesboro, Tennessee, distributes QSP products (read here). Paul Bottomley, the business development director at Montana, did not answer a phone number listed on a Montana pricing sheet.
So far, the FDA has publicly identified 19 medical practices that potentially purchased the counterfeit med (here is the list). All but two are located in California. We have reached out and, so far, only two have responded. We received this statement from the office Mohamed Grhaowi of the South Texas Comprehensive Cancer Centers:
“We have been asked to assist the FDA in its investigation and we have conducted a preliminary investigation of our records concerning this matter. We are continuing our investigation into this situation and we are communicating with all of our pharmaceutical suppliers to insure and verify the integrity of their supply chains and of the medications that South Texas Comprehensive Cancer Centers and Dr. Ghraowi receive from those suppliers.”
And The Beverly Hills Cancer Center says the practice “is in the process of determining from its records whether it purchased any Avastin from Montana Healthcare Solutions that was part of the lot numbers recently identified by the FDA as possibly being counterfeit. The center also had no idea that MHS was a foreign supplier. In fact, the center believes that MHS is a licensed distributor of pharmaceuticals located in the State of Montana.
“At the time, the Center purchased drugs from MHS, we believed that the drugs were legal and approved and only recently learned from the FDA that some of the drugs may have been counterfeit or unapproved… To date, the center has identified no adverse effects for any of its patients who may have received drugs purchased from MHS.”
Meanwhile, the FDA has noted that phony Avastin could have been spotted. For instance, the counterfeit med says Roche on the packaging and writing on the box is in French, instead of English. And in the US, Genentech is the distributor, while Roche distributes Avastin outside the US, and the version approved in the US does not sport the Roche logo on the packaging or vials.
These may be more noticeable than other distinctions, such as differences in the coding for batch numbers and dates. And a source at one physician practice, who asked not to be named because an investigation is ongoing, insisted that none of the Avastin that was purchased in recent months sported French anywhere on the packaging.
avastin-pricing-montana-sheetNonetheless, this raises some questions about the purchasing process. Presumably, a lower cost may have prompted an office to buy the counterfeit version. A list of various meds sold by Montana Healthcare Solutions and priced a Avastin 400 mg vials for almost $2,000, compared with the nearly $2,400 that Genentech charges in the US, according to a pricing sheet (here it is).
It is not yet publicly known how much was paid for the phony Avastin, but a 17 percent discount is significant. Is it unreasonable to ask why those offices did not question the ability of a distributor to offer a much lower price? Or to wonder if there was something different about the supply that allowed for such a discount? Or was it a case of ‘buy now and ask questions later?’
Perhaps no one thought to ask. A good is a good deal. And hindsight, of course, is hindsight. And it may be easy now to say there were obvious distinctions in packaging, but one could also argue most differences between the kosher and the phony Avastin boxes and labeling were not that obvious, even to someone who checks a shipment, regularly places meds on a shelf or reaches for a vial.
Just the same, the chain of events is a cautionary tale that reminds us of an old adage – if something seems too good to be true, it must be. Unfortunately, at least some physician practices failed to keep this in mind and, presumably, felt they simply had gotten a good deal. Meanwhile, the FDA investigation is ongoing and some practices will likely wish they scrutinized purchases more closely.
Category : News
Trade Group CEO in Pakistan Resigns in Disgust
Source: Pharmalot
Over the past month, the Pakistani pharmaceutical industry has been roiled by a scandal in which at least 130 people died after taking a contaminated heart medication. Yesterday, however, the acting chair of the Pakistan Pharmaceutical Manufacturers Association added some drama to the episode by reading a statement at a press conference – and then suddenly crumpling it up and resigning.
“I was pressurised to read this statement, which does not include my input,” said Tariq Ikram, who also withdrew Opal Laboratories, which his family helped to start, from membership in the trade group. “I am done with PPMA. We have to answer to Allah.” Shortly after leaving the stunned room, he offered his real thoughts about what led to the recent disaster to The Express Tribune.
In a rare bit of candor for an industry under siege, Ikram was riled by what he called unchecked pharmaceutical expansion and insufficient government oversight, according to the newspaper. He maintained that up to 40 percent of drugs circulating in Pakistan are questionable and cited various dodgy conditions that, he wrote in a statement, made it possible for the tragedy to occur (back story).
For instance, Ikram noted that between 1947 and 1988, the health ministry issued three manufacturing licenses for drugmakers each year, or 126 in total, but between 1988 and 2011, 580 licenses were issued, at a rate of 26 per year. And the number of manufacturing units rose from 129 in 1988 to 709 in 2011 – an increase of 450 percent.
Meanwhile, the number of provincial drug inspectors across Pakistan was approximately 91 – one inspector per 1.4 factories. By 2011, there 263 inspectors, or one inspector for 2.6 factories. But Ikram also pointed out that the drug regulator is defunct, and inspectors cannot enter factories or inspect the quality of manufacturing there, the paper wrote.
In his statement to the paper, Ikram complained that the many pharma factories that opened over the years did so on the cheap – to save money, there was insufficient investment to build state-of-the-art plants that could meet quality standards. “How do regulators expect such companies to cope with the cost of manufacturing and sales in these inflationary years?” he wrote, according to the paper.
Ikram then complained that corruption allows substandard plants to remain in operation. He cited one example in which a delegation from drugmakers and pharmacists, along with an inspector, raided a pharmacy and caught a handful of allegedly spurious drugs. “No action could be taken against the manufacture due to political intervention,” he tells the paper, adding that the health could cause trouble by generating trumped-up cases.
He also pointed to what he wrote was inadequate training of inspectors, who are underpaid. For instance, he maintained that federal and provincial inspectors have so far not receiving training this year. And a provincial drug inspector in Sindh requires a monthly expense budget that far exceeds what is actually allotted.
At the same time, Ikram blamed the government for registering thousands of pharmacies, most of which he maintained do not comply with the Drug Act 1976. According to the paper, he wrote there were 20,000 registered pharmacies in 1988 and and more than 78,000 today, and only 6,142 pharmacists are registered with the Pharmacy Council of Pakistan.
Category : News
