Life Science Items of Interest: counterfeit drugs

Showing posts with label counterfeit drugs. Show all posts

Thursday, February 14, 2013

IOM Report Calls For Tracking System To Fight Counterfeit Drug Trade.

The AP (2/14, Neergaard) reports that the Institute of Medicine on Wednesday released a report that concludes, tackling the "problem of fake drugs will require creating a national drug-tracking system." The IOM's report calling "for putting medications through a chain of custody like US courts require for evidence in a trial comes a week after the Food and Drug Administration warned doctors, for the third time in about a year, that it discovered a counterfeit batch of the cancer drug Avastin [bevacizumab] that lacked the real tumor-killing ingredient."

NPR (2/13, Knox) in its "Shots" blog reports that the "National Academies of Science, of which the IOM is part, was commissioned by the Food and Drug Administration to look at how to protect people against fake and substandard drugs." According to the report, the problem "extends to more than 120 countries...and has done incalculable damage to efforts to control tuberculosis, malaria, AIDS and other diseases."

The Wall Street Journal (2/14) "Corporate Intelligence" notes that the IOM report also emphasized that oversight of prescription drug wholesalers needs to be strengthened.

AFP (2/14, Santini) adds that FDA Commissioner Dr. Margaret Hamburg "commended the report" and the agency is already implementing many of its suggestions. "To meet the challenges of today's global marketplace, the FDA is transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," Dr. Hamburg said in a statement.

However, according to The Hill (2/14, Wilson) "Regwatch" blog, "Members of Congress want to create legislation to increase the crackdown and oversight effort." Rep. Henry Waxman (R-CA), the "ranking member of the House Energy and Commerce Committee" said "I hope we can pass a law at the federal level that provides the same level of protection as California's model legislation," which requires "individual units of drugs to be accounted for at each step along the supply chain."

Modern Healthcare (2/13, Zigmond, Subscription Publication), HealthDay (2/14, Gardner) and MedPage Today (2/14, Pittman) also cover the reports, which is titled, "Countering the Problem of Falsified and Substandard Drugs."

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Thursday, February 7, 2013

FDA issues warning on fraudulent drug product, purporting to be the injectable cancer treatment

The Wall Street Journal (2/6, Weaver, Subscription Publication) reports that the FDA on Tuesday, issued a warning to healthcare providers that a fraudulent drug product, purporting to be the injectable cancer treatment, Altuzan (bevacizumab), is being distributed in the US. The agency said the Great Neck, New York-based drug wholesaler, Pharmalogical, shipped two batches of Altuzan, the Turkish brand name for Roche Holding's Avastin, to providers in the US; and internal laboratory tests so far, have confirmed that there is no active ingredient in at least one of the batches. The FDA said that although it is not aware of any patients having received the fraudulent product, the agency is still working to identify physicians who may have purchased the product from Pharmalogical, which also does business under the names Medical Device King and Taranis Medical. Meanwhile, the Journal says an attorney representing Pharmalogical is claiming the FDA's warning is inaccurate.

from DIA Daily

Wednesday, December 19, 2012

Fake Drugs Spurring Increase In Drug-Resistant Malaria.

The NPR (12/19, Beaubien) "Shots" blog reports, "Counterfeit drugs are a growing scourge around the world. They're generating millions of dollars in revenue for organized crime and fueling the rise of drug-resistant parasites. Anti-malarials are among the most popular drugs to fake," and they are "particularly dangerous because malaria can kill a person in a matter of days." Although some of the "fake drugs are nothing more than repackaged sugar pills or chalk," sometimes they "contain small amounts of anti-malarial drugs." That can cause a drug resistance "to develop," which is what "appears to be happening now in Southeast Asia with one of the most powerful anti-malarials, artemisinin."

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Tuesday, October 16, 2012

Fake Internet-Sold Medicine Becoming Public Health Threat.

The Chicago Tribune (10/16) reports that the FDA in "recent years has confiscated millions of dollars worth of counterfeit and other illegal medicine" sold online. The agency, in "partnership with international regulatory, customs and law enforcement agencies from 100 countries, shut down thousands of Internet pharmacies selling illegal drugs and seized about $10.5 million worth of pharmaceuticals during a weeklong crackdown on counterfeit and unapproved medications that began in late September. But such enforcement action isn't nearly enough to stop the proliferation of phony medicine." The FDA's Center for Drug Evaluation and Research Office of Compliance Director Ilisa Bernstein said, "This is a drop in the bucket. ... We may have some impact on these 4,100 websites, but they can pop up days or weeks later using another URL and another way to deceive consumers."

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org. Click here to check your membership status.

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Friday, September 28, 2012

Counterfeit Prescription Drugs - Partnership for Safe Medicines -> live on c-span

http://www.c-spanvideo.org/program/308446-1

Public Affairs Event
September 28, 2012

MAIN SPEAKERS:
Dr. Margaret Hamburg, Commissioner, U.S. Food & Drug Administration
John Castellani, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
James Dinkins, Executive Associate Director, ICE s Homeland Security Investigations
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA
Linda Marks, Senior Litigation Counsel, Department of Justice
Damon McCoy, Assistant Professor, George Mason University
Ralph G. Neas, President and Chief Executive Officer, Generic Pharmaceutical Association (GPhA)
John Roth, Director of the U.S. Food and Drug Administration Office of Criminal Investigations

Tuesday, April 10, 2012

Improving the Integrity of the Drug Supply in a Global Marketplace

Last week FDA announced that a counterfeit version of a cancer drug had surfaced in the United States. It was labeled as Altuzan, a product approved in Turkey and not approved in the United States. The counterfeit did not contain the active ingredient of Altuzan. Unapproved foreign drugs, including the counterfeit, were purchased by medical practices in the U.S. from a foreign supplier.
This discovery comes only a few months after FDA informed 19 medical practices in three states that they had purchased unapproved foreign drugs, which may include the counterfeit version of Roche’s Avastin. Roche is the company that manufactures Avastin approved for marketing outside of the United States. This counterfeit also did not contain the active ingredient of Avastin. This counterfeit was also purchased from foreign suppliers and was also nothing but a sham.

For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). Genentech’s Avastin products are safe and effective for their intended uses, therefore cancer patients that have been receiving these products should not be concerned.
FDA does not know whether patients actually received counterfeit Altuzan or Avastin. Nevertheless, these cases illustrate that in today’s global economy much more needs to be done to ensure the integrity of the drug supply.

Margaret Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

for more... http://blogs.fda.gov/fdavoice/index.php/2012/04/improving-the-integrity-of-the-drug-supply-in-a-global-marketplace/

Life Science Items of Interest