BETHESDA, MD 16 September 2013—Purveyors of medications not approved by FDA have become so successful at selling their wares that the agency recently sought advice on how to better inform health care professionals about the risks posed by these products.
That’s despite having sent more than 500 letters in 2012 and January 2013 to clinics and medical practices that FDA had reason to believe had bought bevacizumab, onabotulinumtoxinA, denosumab, or zoledronic acid from foreign or unlicensed sources.
Some of the vials of bevacizumab from one source, FDA said, did not even contain the drug.
Money over safety? Physicians who bought the medication from that source might have been most interested in the potential to profit, FDA’s Office of Criminal Investigations learned from interviews. The source charged $1700 for a vial that, if produced for the U.S. market, would normally cost nearly $2300 and could be billed as an FDA-approved product to insurance programs.
As recently as May, FDA notified more than 750 clinics and medical or dental practices that they might have received medications from a distributor not licensed in any state. Again, some of the vials of bevacizumab did not contain the drug.
Part of the problem, said participants in the August 16 meeting of FDA’s Risk Communication Advisory Committee, may be that physicians and employees making the purchases do not know safe buying practices.
“They may not know [the product is not FDA approved],” Allergan Inc. attorney Bryan E. Smith said at the meeting. “They may just think they’re getting a good price. Or they may know and may incur that risk in order to save.”
The latter was apparently the case with William R. Kincaid, who previously practiced medicine at the McLeod Cancer and Blood Center in Johnson City, Tennessee. He now resides at the Federal Prison Camp in Montgomery, Alabama.
Safety checks in purchasing. McLeod Cancer and Blood Center closed without advance notice last November, according to local news reports.
A lot of the patients sought care nearby, at Mountain States Health Alliance’s regional cancer center on the grounds of Johnson City Medical Center, the health system said.
Neither the medical center nor the regional cancer center was a recipient of an FDA letter about the purchase of unapproved medications.
The medical center’s purchasing strategy, according to Marie Shinkle, pharmacy oncology specialist coordinator for the facility, is to use “every method in our armamentarium” to provide patients only FDA-approved medications.
She supplied the following details:
Although currently Tennessee does not mandate VAWD (Verified Accredited Wholesale Distributors) accreditation for wholesalers, we purchase only through VAWD-accredited distributors, or directly from manufacturers. . . . Additionally, for any wholesale distributor we utilize, we verify active licensure in our state and the state in which they are located. We verify their VAWD certification, and require in advance a drug pedigree with each shipment of drug, as well as an application through [the Mountain States Health Alliance].
Those steps take time and effort, Shinkle wrote, “but I feel strongly that our patients and providers deserve this level of scrutiny on our part.”
VAWD was established in 2004 by the National Association of Boards of Pharmacy.
The search feature for VAWD is at www.nabp.net/programs/accreditation/vawd/vawd-accredited-facilities.
Shinkle indicated that the pharmacy tells physicians and patients about its safety checks in purchasing medications. That openness has helped decrease physicians’ frustrations when asked to identify an alternative to a medication in shortage.
The pharmacy’s openness, she wrote, has also alleviated many of the drug-integrity concerns held by patients and physicians.
Signs of an effect. Allergan’s Smith, while at FDA’s meeting, said the agency’s letters are “having a significant impact.”
Physicians who previously did not purchase onabotulinumtoxinA, known commonly as Botox, from the company or its authorized distributors started doing so after receiving a letter from FDA, he said.
Also, physicians no longer ask Smith for proof that anyone faces legal consequences for buying a medication from a foreign source.
The prices for medications in countries with socialized medicine, he said in explaining the lure of foreign sources, may be “much cheaper.”
Allergan has acknowledged in financial reports that price controls in Canada and elsewhere keep the prices of prescription medications lower than in the United States.
Circuitous route. The purchasing behavior that led to closure of the McLeod Cancer and Blood Center and imprisonment of Kincaid apparently started with the attractive prices offered by a Canadian company, Quality Specialty Products.
According to documents filed with the U.S. District Court Eastern District of Tennessee, physicians at the oncology–hematology practice decided to follow through on the company’s faxed-in offer to sell certain medications at prices less than the U.S. normal.
But the nurses soon raised concerns about the products having labeling in a language other than English. The practice stopped buying from the Canadian company.
Then, during an offsite meeting with a company representative in August 2009, Kincaid decided the practice would resume the purchases. He had these purchases shipped to a storage facility in Johnson City and then brought to the practice’s building and mingled with FDA-approved medications from legitimate sources.
The court documents—plea agreements by Kincaid and the practice’s business manager—do not state that any of the products obtained from the company lacked the appropriate active ingredient.
Rather, the documents detail the journey of one product, rituximab, which started in Switzerland at the F. Hoffmann-La Roche Ltd. manufacturing facility and requires storage at 2–8 °C. From Switzerland, the product—legitimately labeled as MabThera and with some of the information in Hindi—went to a distributor in India, then to the United Kingdom, and then to the Canadian company’s reshipping service in Chicago and on to Johnson City. After administration of MabThera to patients, the oncology–hematology practice submitted claims to Medicare and Medicaid for Rituxan, the FDA-approved rituximab product.
As for the fake bevacizumab vials discovered in 2012, FDA traced them to Volunteer Distribution in Tennessee and Montana Health Care Solutions, which had become part of Canada Drugs Ltd., Quality Specialty Products’ parent company, in 2010. The Tennessee company had a contract to ship oncology drugs received from Quality Specialty Products to customers in response to a packing list, which bore the Montana-named company’s name and symbol.
Interviews by law enforcement personnel with some of the physicians and other purchasers revealed that they believed their oncology drugs came from Montana Health Care Solutions, FDA said.