The FDA has sent a warning letter to one of the most prolific Internet drug providers from Canada, which reports have tied to an investigation of counterfeits of the cancer drug Avastin that were sold to physician practices in the U.S. this year.The agency this week posted a warning letter sent to a lawyer in Manitoba claiming that hundreds of websites it identified, including CanadaDrugs.com, were offering for sale drugs made at unapproved facilities. It said the sites were even offering domperidone, which it said is no longer approved for sale in the U.S. because of dangers to breastfeeding women.
A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010.
An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.The FDA in February and April discovered the counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan, which is the brand name for Avastin in Turkey. Tests, however, determined that there was no active ingredient in the counterfeits. So far, there have been no reports of problems related to the drugs, according to the FDA and Genentech, the Roche ($RHHBY) unit that makes the cancer treatment.The letter came only days after the agency launched a new campaign it hopes will discourage the practice of buying drugs online, or at least, teach consumers how to determine what sites are potentially legit. The agency last week launched BeSafeRx, to warn against the dangers.- here's the warning letter to CanadaDrugs.com
- here's the letter to Arkadiy Kisin/White Forest SolutionsRelated Articles:
Fake of Roche's Avastin shipped from Canadian supplier
Phony Avastin vials contained chemicals, but no drugs
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FDA tries to teach consumers of Internet dangers read more..
Saturday, 4 January 2014
FDA shoots warning across bow of CanadaDrugs.com
Sunday, 8 July 2012
Corporate Integrity Agreement-Manufacturing Processes-Gsk
For the last two years leading up to last week's extensive settlement with U.S. authorities, GlaxoSmithKline ($GSK) already has been operating under an agreement that gives the Office of Inspector General in the Department of Health and Human Services broad authority over its manufacturing processes. The requirements are in addition to any company's usual obligations to the FDA and the agreement lays out a financial price tag if the U.K. company runs afoul of it.The provisions of the agreement are tied to deep problems at GSK's Cidra, Puerto Rico plant, which was closed in 2009. The problems, which included using tainted water in processes and mixing products in packaging, came to light in the whistleblower lawsuit brought by Cheryl Eckard, a former quality assurance manager with GSK. In October 2010, GSK agreed to pay the government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans. The details of the compliance program have now been made public and became Appendix D to the Corporate Integrity Agreement GSK signed as part of its $3 billion settlement announced last week."This is the first time that the government, as part of a Corporate Integrity Agreement, has required a pharma company to establish a formal program to provide ongoing oversight, including Board oversight, of product released to the market to ensure that it is not adulterated," Lesley Ann Skillen, a partner in the law firm of Getnick & Getnick, who settled a related whistleblower case against Glaxo in 2010, says in an email.The oversight program is run through the "Global Manufacturing and Supply business unit" (GMS) and essentially applies to all of its manufacturing operations and employees globally. It is centered at GSK's plant in Zebulon, NC, because employees there "are responsible for the release and post-release management of all Covered Products" manufactured by the company.The program establishes a code of conduct, which employees are schooled in and must sign. It is overseen by a "GMS compliance officer" that can't be the CFO or the General Counsel of the company or subordinate to them. The compliance officer and the president of the GMS unit are the co-chairs of a compliance committee that meets quarterly to make sure the company is meeting all of its obligations. They report at least quarterly to the GSK board of directors. Board members then must sign agreements that are sent to the inspector general that the company is complying with all cGMP requirements or explain why not. The agreement also permits the FDA to complain to the inspector general if the agency believes GSK is not adequately responding to its directives.The Cidra plant was closed in 2009, 7 years after Eckard first complained to her superiors about a host of problems. In an interview last year with CBS 60 Minutes, Eckard said, "All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career." She said tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles.In her email, Skillen points out, "When Cheryl Eckard reported her concerns about the Cidra plant to the compliance department in 2003, they covered it up. If GSK were to do that now, it could face exclusion from Medicare and Medicaid under this CIA. That should provide a powerful incentive for GSK to do heed warnings they receive from their own employees. That's why it's an important document for GSK and an object lesson for the industry: ignore whistleblowers at your peril."The GSK agreement may have served as a blueprint for the 5-year consent decree that Ranbaxy Laboratories announced earlier this year to settle manufacturing and data reporting problems found at three o read more..
Friday, 22 June 2012
Kv Pharmaceuticals-Compounders-Makena-FDA
The battle over KV Pharmaceuticals' ($KV.A) pricey preterm-labor drug, Makena, with pharmacy compounders who can make it for next to nothing has hit a new phase. The FDA this week announced it found no major safety problems with compounded versions of Makena. Then KV released a statement emphasizing another part of the FDA's announcement--that agency-approved drugs provide greater assurance of safety and efficacy. After getting approval for its drug, KV began charging $1,500 a dose, while previously women were able to buy it for about $20 a dose from compounders. In the outcry, KV lowered the price to $690 but the FDA allowed the compounded versions to remain on the market. Then KV asked the FDA to investigate whether they were safe and consistent. The FDA this week said it found that all of the APIs met standards for potency and total purity. When compared with Makena's NDA standards, a few of the samples fell short on some measures. And so the fight continues. Story | More read more..
Ranbaxy Laboratories-Consent Decree-Indian Plants-Regulators
Ranbaxy Laboratories, which is operating under an extensive consent decree with U.S. regulators, has now run afoul of authorities in India, which reportedly slapped it with a four-day suspension for "flouting" rules on product storage.The suspension, issued by the Maharashtra Food and Drug Administration, was prompted by a complaint by the Maharashtra Chemists & Distributors Federation (MCDF), reports Pharmabiz. Narendra Jain, general secretary of the MCDF, tells the publication he thinks Ranbaxy is getting off too easy for practices that expose products to potential contamination. A Ranbaxy spokesman told Pharmalot that the company was checking into the accuracy of the report.While this appears to be a local fight, even the hint of a suggestion of any manufacturing or handling shortcomings is sensitive for the drugmaker. It has only recently gotten FDA approval to ship products from three of its Indian plants and is under unprecedented scrutiny as part of a 5-year, 55-page consent decree announced earlier this year. In 2008, regulators uncovered a list of issues, including faked drug quality data, and banned 30 products from the U.S. Among other provisions, the decree requires the company to set up an independent oversight group that can take in complaints from employees and elsewhere. The auditors are to report all of their findings and recommendations to the FDA as well as the company. Ranbaxy has taken full advantage of its ability to ship products from its upgraded plants to the North American market. As a result of the FDA approval for Ranbaxy's generic of Pfizer's ($PFE) Lipitor, the company has seen its sales here surge. In its first full quarter selling copycat Lipitor, the Indian genericsmaker reported sales in North America doubled to $375 million.- check out the Pharmabiz story
- get more from PharmalotRelated Articles:
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Ranbaxy manufactures a colossal first quarter
Company whistleblower program part of Ranbaxy consent decree read more..
Thursday, 21 June 2012
Federal Authorities-Prescription Drugs-Internet Pharmacy-Canadian Internet-Counterfeit Drugs
The founder of a Canadian Internet pharmacy accused of selling counterfeit drugs will be arraigned this week in federal court, putting other operators around the world on notice that the U.S. is stepping up enforcement on that loose link in the supply chain in which thousands of Internet sites sell drugs of unknown origin to people without prescriptions.The 38-year-old Andrew Strempler, who was arrested last week, was a pioneer in this arena. In an indictment he and his former company RxNorth.com are accused of selling and shipping to U.S. consumers fake and misbranded drugs between early 2005 and the summer of 2006, The Wall Street Journal reports. Strempler sold his company to a competitor in 2006, and was believed to have hightailed it to the Caribbean after U.S. authorities accused him of selling counterfeit medications. Authorities globally have been trying to figure out how to attack the growing problem of counterfeit drugs making their way to consumers through this unregulated end-run around the legitimate supply chain.The arrest follows an FDA warning in May that fake versions of the ADHD drug Adderall, made by Teva Pharmaceutical Industries ($TEVA) and other generics companies, is showing up on Internet pharmacy sites. At least some of the counterfeit Avastin discovered in the U.S. in February squeezed its way in through a Canadian pharmacy company that delivers discounted prescription drugs from overseas to U.S. citizens.The owner of one Canadian Internet pharmacy acknowledged shipping at least some of the fake injectables of the Roche ($RHHBY) drug into the U.S. but said he notified authorities when he learned they were counterfeit.In a report in March 2011, the Counterfeit Pharmaceutical Inter-Agency Working Group, made up of a host of federal agencies and authorities, acknowledged the growing threat and said it was looking for ways to be proactive to a threat that is global in nature and difficult to monitor. In a recent interview, Connie Jung with the FDA explained that illegal Internet pharmacies presented a particular challenge to federal authorities because they may sell counterfeit or other unapproved drugs. Jung is the acting associate director for policy and communications within the Office of Drug Security, Integrity and Recalls. It was established last year to focus on such problems as drug counterfeiting in an industry that now relies on a global supply chain. Part of its work is to coordinate with other agencies like Customs and the FBI to find ways to be proactive in the face of a serious threat."Consumers and healthcare providers can be confident that consumers are receiving safe, effective, high quality drugs from their local pharmacies," Jung says. "It is when we have entities that choose to buy outside the legitimate drug supply chain that harmful products may be introduced." The U.S. is not alone in trying to figure out how to get on top of this new outlet for counterfeits. China Daily reports that after a 5-month investigation into counterfeiting there, the State Food and Drug Administration sent 670 cases to the police for investigation. "Many counterfeit drug cases featured online advertisements and sales, underground production workshops and transfers through postal express," Yin Li of the SFDA says.- read The Wall Street Journal story
- get the China Daily storyRelated Articles:
Fake of Roche's Avastin shipped from Canadian supplier
Adderall shortage spurs counterfeiters to step in, FDA says
FDA warns 56 more docs of fake Avastin supplies
FDA commish suggests putting more bite in laws for counterfeiting
Fake Adderall surfaces as Congress turns attention to track and trace read more..
Saturday, 9 June 2012
Price Controls-Drug Shortages-The Government-Formal Price
Shortages of some drugs in Pakistan are mounting as the government continues to dither over whether to keep price controls on a host of drugs.Both domestic and Western drug manufacturers have urged the government to act, saying shortages could become extensive and some foreign companies may just decide it is not worth doing business there, reports The Express Tribune. Citing sources, it says there has not been a formal price increase since 2001.There already have been shortages of some drugs, The Express Tribune reports, because margins got so thin that domestic drugmakers quit producing them. Last month, the American Business Council, which represents 65 American drug manufacturers in Pakistan, warned authorities that if matters are not sorted out soon, Pakistan could face shortages of more than 800 drugs. The ABC said its three largest clients--Pfizer Pakistan ($PFE), Johnson & Johnson ($JNJ) and Abbott Laboratories ($ABT)--are already being affected by the supply chain disruptions. The organization played the economic development trump card, saying Western companies might reconsider their commitment to Pakistan if problems persist.Meanwhile, analysts are warning the government that a price control policy will not be healthy for the industry in the long run, reports The Economic Times. Analysts say experience elsewhere shows price controls will not improve health access but will limit drug innovation in the country at a time when rising life expectancy calls for new varieties of pharmaceuticals.David Taylor, a professor at the University of London, points to his experience in India, which is currently debating the expansion of price controls on drugs. "Price caps have the opposite effect, though, by disincentivising the sale of innovative drugs or drug research in India. Patients with incurable endemic diseases will continue to suffer in silence since cures for such diseases may no longer be actively researched," he said.- read The Economic Times story
- more from The Express TribuneRelated Articles:
Pfizer, J&J, Abbott facing shortages of crucial ingredients in Pakistan
Even some domestic firms rail at India's price control plan read more..
Wednesday, 6 June 2012
Prescription Drug-Medical Providers-Alert Systems-Fda Drug
The FDA hasn't always been on top of notifications to medical providers about the most serious drug recalls, a study has found. Between 2004 and 2011, nearly 20% of the Class I drugs recalls were not included in either of the agency's two alert systems, reports Reuters. Class I drugs include those that can cause "serious adverse health consequences or death." Over the 8 years, Joshua Gagne of Brigham and Women's Hospital in Boston and other researchers counted more than 1,700 FDA drug recalls and found only 91 were serious Class I recalls. The agency sent out 2,900 announcements through the Recall Alert System but included alerts for just 55 of the 91 Class I recalls. Its MedWatch system picked up another 18 of the remaining recalls, but 18 more, or 20% of the Class I recalls, were not reported through either system, the study found. The researchers acknowledge they couldn't document any adverse effects related to the failure and also that FDA has made strides in the last year. They suggest, however, that the agency set up a system specific to Class I drugs. The problem of recalls is complex. A recent report found that last year there were 55 prescription drug recalls and 14 recalls related to OTC products, but the OTC recalls involved millions more products. Story | More read more..
Saturday, 12 May 2012
Consent Decrees-Fda Compliance
Abbot Laboratories ($ABT) has shed the smell of a consent decree more than a decade after its imposition and just before it splits itself up for the public markets.The FDA compliance order dates to 1999 and was issued after its diagnostics division for 6 years came up short on manufacturing practices, reports Pharmalot. The FDA relented after Abbott demonstrated its ability to practice current good manufacturing practices, the FDA tells the website."Many consent decrees that FDA enters with firms allow the firms, under defined circumstances, to seek court termination of the decrees following extended periods of compliance. That is the case with this one," an FDA spokeswoman explains.The company paid a $100 million fine at the time the decree was ordered, but of course there are all of the expenses of upgrading facilities and paying consultants to help get facilities up to snuff and back in the good graces of the agency.There also is the need to continually report in financial filings that the company is operating under a consent decree. Now that language can be erased from financial disclosures, and now is the time for that, as the company divides itself. One piece, to be called AbbVie, will focus on the portfolio of existing drugs and those in the pipeline. The other will be spun off to be a device- and diagnosticsmaker and will sell branded drugs outside the U.S.- read Pharmalot's storyRelated Articles:
Abbott split creates an $18B biopharma deal-maker with deep pockets
Abbott chief says biopharma ops not for sale (at bargain price) read more..
Sunday, 29 April 2012
Counterfeit Drugs-Fda Commissioner-Track And Trace-Cancer Drug
Drug manufacturers may have derailed the FDA's plan to force creation of a vial-specific tracking plan to combat counterfeit drugs.The plan is facing resistance from companies like Pfizer ($PFE) and Merck ($MRK), as well as from pharmacies and distributors. It is estimated it would cost pharmacies $6 billion to put their piece in place.The industry is backing a plan that tracks lots instead of individual containers. They say it could be refined later to track smaller quantities. The plan put up by an industry coalition would put unique serial numbers on individual drug packages, but require scanning drugs only in "lots" when they get to distributors."Often in crafting policy, there's the search for the perfect and we just walk by the good," Pfizer spokesman Peter O'Toole told Reuters. "We could be saying in 10 years, 'we have to work on something perfect.' And in the intervening years, we would have done nothing, and that would be a shame for patients."The discovery of fake versions of Roche's ($RHHBY) cancer drug Avastin throughout the U.S. in recent weeks has added to the urgency to create a program."To learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable," FDA Commissioner Margaret Hamburg recently wrote on the agency's blog. "We ... need authority to require a robust system to track and trace all drugs throughout the supply chain."The discussion of how to trace individual containers has been going on for a long time, but no one wants to foot the bills. The experience of California is an indication of how difficult it has been to get the industry's support. It passed a track and trace law in 2004, but opponents have repeatedly delayed implementation. It is now set to go online in 2015.The FDA and the industry are both seeking to have the outlines of a plan included in FDA user fee legislation now before Congress, but which plan, if any, makes it in is still up in the air.- here's the Reuters storyRelated Articles:
FDA warns 56 more docs of fake Avastin supplies
Fake Avastin case highlights need for supply-chain controls read more..
Saturday, 21 April 2012
The Government Accountability Office-Regulatory Compliance Services-Outdated Technology
The FDA will continue to rely on an outdated technology system for tracking foreign drugmakers while it continues to implement a new IT system it started on a decade ago. A report issued recently by the Government Accountability Office (GAO) says the agency has significant work left to do before it implements all of its Mission Accomplishments and Regulatory Compliance Services (MARCS) system. Until that is up and running--perhaps in 2014 if a lot gets done in the next two years--it will continue to use it OASIS system, which the GAO twice has criticized for not being able to provide accurate reporting of drug manufacturers outside of the U.S., inPharma Technologist reports. FierceGovernmentIT points out that part of the problem is that FDA has no unified, long-term IT strategy because it's had 5 chief information officers in the last four years. Story | More from FierceGovernmentIT read more..