OOS Representatives TO Meet With The Ohio Pharmacy Board To Discuss Enforcement Of Regulations Surrounding The Purchase Of Avastin From Compounding Pharmacies

11/28/2012

Last week the OOS made a formal meeting request to the Ohio State Board of Pharmacy to discuss the enforcement of current rules surrounding the purchase of Avastin from compounding pharmacies. We hope to hear back in the next several days regarding a proposed meeting date.

As you know, attention at the federal and state level regarding the regulation of drugs distributed from compounding pharmacies has increased dramatically since the deadly fungal meningitis outbreak linked to the New England Compounding Center. While Congress continues to investigate the current level of oversight and discusses developing legislation to create new regulations, state pharmacy boards are focused on enforcing current state level requirements.
The OOS has heard from several practices that have already been investigated or have questions about the current regulations. For a complete copy of the Ohio State Board of Pharmacy’s fact sheet Compounding in Ohio click here. The OOS has heard from several practices that are concerned that a number of the existing provisions make it extremely difficult for most practices to purchase and administer Avastin and potentially compromise what would be considered good patient care. The OOS is aware of these issues and will be articulating them to the Pharmacy Board.
We will update OOS members when we have a meeting date, and additional information to provide, from the Pharmacy Board. Should you have any questions now or in the future, please contact the OOS office directly at (614) 527-6799 or email us at tbaker@ohioeye.org.

How The Compounding Scandal Benefits One Drugmaker

Pharma & Healthcare

|11/19/2012 @ 4:07PM

One company’s pain is another company’s gain. For the past few years, a significant number of ophthalmologists have used the Avastin cancer medication to treat age-related macular generation, a common afflication among the elderly, even though the drug was never approved for this use. Avastin gained popularity because, until recently, the only alternative was another Roche drug called Lucentis, which is about 40 times more expensive for each injection.

Howeve, the off-label use of Avastin prompted concerns – particularly from Roche, which wanted the bigger sales associated with the higher-priced Lucentis - because rejiggering Avastin into vials was linked to reports of infections and blindness. At one point, the US Department of Veteran Affairs suspended Avastin usage for treating wet AMD (back story). But the landscape changed a year ago when the FDA approved yet another drug for wet AMD, Eylea, which is sold by Regeneron Pharmaceuticals.
In the recently ended third quarter, Eylea captured roughly one-third of the branded market share for wet AMD, according to Regeneron ceo Leonard Schleifer. Moreover, the branded market is growing, he believes, because there were additional indications for Lucentis for treating diabetic macular edema, the patient population expanded due to age and more patients switched from Avastin. “The market dynamics are not stagnant,” he said at the recent Credit Suisse Healthcare Conference (see this).
Yet another dynamic is shifting quickly. Thanks to medicines made by the New England Compounding Center, which led to an outbreak of fungal meningitis that has claimed 33 lives (look here), there is increased betting that Eylea will capture still more market share, since compounded Avastin is used by ophthalmologists to treat wet AMD. “I think there will be regulation,” Schleifer predicted. “And… anything that would make Avastin safer would be good for our patients and our doctors.”
Indeed, the NECC scandal has been cited as an example in which compounded Avastin may be worrisome. In 2006, the FDA sent a warning letter to the compounder that cited, among other things, concerns about marketing anesthetic creams and potential microbial contamination associated with splitting and repackaging Avastin. The agency also tagged NECC for sending promotional to ophthalmologists, when the drug was not approved for wet AMD (see here).

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David DiSalvo, Contributor

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FDA shoots warning across bow of CanadaDrugs.com Reports tie Internet drug company to FDA's probe of counterfeit Avastin Read more: FDA shoots warning across bow of CanadaDrugs.com - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-shoots-warning-across-bow-canadadrugscom/2012-10-02#ixzz28CzxTTp8 Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

October 2, 2012 | By Eric Palmer

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.

Read the remainder of the article here
The warning letter to CanadaDrugs.com
The letter to Arkadiy Kisin/White Forest Solutions

Maine wants the Canadian drugs FDA is trying to stop

September 12, 2012 | By Eric Palmer

Read more: Maine wants the Canadian drugs FDA is trying to stop - FiercePharma http://www.fiercepharma.com/story/maine-wants-canadian-drugs-fda-trying-stop/2012-09-12?utm_source=rss&utm_medium=rss#ixzz26MQL9EBK
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FDA finds 'filth' at compounder repackaging Avastin

September 6, 2012 | By Eric Palmer

The FDA has ordered a compounding pharmacy in Hollywood, FL, to stop repackaging Avastin after some of the syringes of the cancer drug were found to be contaminated with Streptococcus mitis/oralis and other microorganisms and tied to infections. The agency said that given the conditions of the facility and the practices of the employees, the drugs "may have been contaminated with filth."

In a hard-hitting letter hand-delivered during an outbreak investigation, the FDA said repackaging the Avastin, as well as human chorionic gonadotropin (HCG), was well beyond the purview of Infupharma. The FDA warning letter says investigators determined that Infupharma has a contract with another pharmacy to repack Avastin from sterile injectable single-use vials into sterile injectable 1 mL single-use syringes and to repack HCG multiuse vials into single-use syringes for further distribution. But the FDA said the repacking amounted to creating new drugs and that the company was not approved to do that.
Not only that, but the inspectors also found that the employees were untrained and inept and the conditions were unsanitary and that the company did not have separate work areas to "prevent contamination or mix-ups during the course of your aseptic processing."

Read rest of article at: FDA finds 'filth' at compounder repackaging Avastin - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-filth-compounder-repackaging-avastin/2012-09-06#ixzz25iFBBm4m 

Counterfeit Version of Avastin in U.S. Distribution

Statement Issued: Feb. 14, 2012

FDA sends letters to 19 medical practices about counterfeit product and other unapproved cancer medicines  

The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States.  Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. 

In a related action, FDA has issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin.  The counterfeit version is labeled as Avastin, manufactured by Roche. Roche is the company that  manufactures Avastin approved for marketing outside of the United States. 

Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.  Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017 

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials.  In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).  Genentech’s Avastin products are safe and effective for their intended uses.

The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions.  Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.  FDA has requested that the medical practices stop using any remaining products from these suppliers.  FDA cannot ensure the safety or efficacy of any of these unapproved products.

• Letters to Doctors About Purchasing Unapproved Injectable Cancer Medications  

Based on information to date, FDA has determined that none of the unapproved cancer medicines received by these medical practices from Volunteer Distribution are in shortage in the United States.  FDA-approved versions of these medicines are available in adequate supply to meet current demand. 

Medical practices that have obtained unapproved products from foreign sources, in particular from Volunteer Distribution and/or QSP, should stop using them and contact the FDA.  These products should be retained and securely stored.

To report suspect counterfeit products and other suspect unapproved products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions or other sources:

• Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or  
• Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
• Email - DrugSupplyChainIntegrity@fda.hhs.gov 

Health care professionals and consumers are asked to report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care profssionals and consumers can either:

• Complete and submit the report online: www.fda.gov/MedWatch/report.htm, or
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 

FDA continues to evaluate this counterfeit medicine situation and we will provide updates.

For information about this counterfeit medicine, see Roche’s statement: http://www.gene.com/gene/news/press-releases/press_statements/ps_021412.html

 

For more information about counterfeit medicine: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm. 

 

Pictures of the counterfeit version of Avastin are shown below: