Juvan's Health Law & Private Equity Report : Corporate & Health Care Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Private Equity, Corporate Governance

If you are interested in tracking incidents involving counterfeit drugs, SafeMedicines.org covers international counterfeit drug developments.  For example, the site provides links to a Washington Post article covering China's attempts to strengthen safety controls, along with discussion of China's recent discovery of 18,000 fake Viagra pills and Health Canada's new anti-counterfeiting strategy launched in response, at least in part, to the death of a woman who took counterfeit anxiety drugs purchased online and the deaths of four Ontario residents who took counterfeit heart drugs.

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Targeted Genetics Corporation ("Targeted Genetics") has alerted the Food and Drug Administration ("FDA") that a patient who received an investigational drug for the treatment of active inflammatory arthritis died shortly after injection.  The clinical trial is now on hold, meaning that enrollment is currently closed and the more than one hundred current participants will no longer receive doses of the drug. 

Describing the drug, the FDA states,

The product that was being studied uses a particle called a vector that is designed to deliver treatment genes to target cells. The vector used is a recombinant adeno-associated virus (AAV) derived vector and delivers the gene for Tumor-Necrosis Factor -Receptor, with the intent to inhibit a key mediator of inflammation. In the study, the gene therapy was administered into the joint affected by the disease to reduce inflammation and disease in patients with active inflammatory arthritis.

The FDA, with the assistance of the National Institutes of Health, is investigating whether the event was related to the treatment and stated that Targeted Genetics is cooperating with the investigation. 

 

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On July 12, Representative Peter DeFazio and other co-sponsors introduced H.R. 3023, also known as the "Drug and Medical Device Company Gift Disclosure Act," which proposes to mandate that drug and medical device companies disclose annually, and the Food and Drug Administration to publicize on its web site, the value, nature, and purpose of any marketing or promotional gift over $50 given to health professionals.  Supporting the legislation, Representative DeFazio's press release states, "There's a difference between educating doctors on the uses and effects of new drugs and enticing healthcare professionals with lavish gifts.  This bill will keep the pharmaceutical industry honest." 

The bill defines the term “gift” to mean “any gift, fee, payment, subsidy, amenity, object, service, or other economic benefit.”  Several items are exempted from the definition, however, including free drug samples and scholarships for medical students and residents. 

If passed in its current form, stiff penalties will apply for noncompliance, including civil monetary penalties of not more than $10,000 for each violation.

 

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On Monday, the Food and Drug Administration ("FDA") advised consumers to refrain from purchasing prescription drugs over the internet, citing multiple safety concerns, including risks associated with improper labeling and packaging.  The press release warned consumers that certain drugs available online have been withdrawn by the FDA in response to safety and efficacy concerns and suggested that generic drugs may actually be cheaper than the costs charged online by internet sellers, as many national pharmacy chains offer drugs for $4 per prescription.   

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"Oncologists do not usually need bodyguards when they present scientific data at a medical symposium," writes Rob Stein of the Washington Post, "[b]ut when Howard I Scher of Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at a recent meeting of the American Society of Clinical Oncology, they were in fear of their safety." 

According to Stein, the two physicians encouraged the Food and Drug Administration ("FDA") to delay approval of Provenge, a drug designed to treat advanced prostate cancer, causing some investors, patients and patient advocates to voice their dismay.  Some, he reports, have placed "vitriolic postings" on the internet, while, according to the two doctors, others have threatened them.  Of the threats, Hussain stated, "We have been harassed and trashed for giving our opinion in an area of our expertise. . . . It's been a nightmare, to say the least." 

Frank Burroughs, a spokesperson for Abigail Alliance, the group that sued the FDA in attempt to obtain increased access to experimental medications for the terminally ill, voiced support for allowing access to the drug for terminally ill patients.  He stated, "What we're saying is that when you have a drug like Provenge, you should let people have access to it who have run out of options."

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I have been on a short hiatus due to finishing major projects for clients and traveling to the east coast on business (special thanks to my friends at the New York City office of Crowell & Moring for their hospitality), but haven't stopped tracking developments on the drug counterfeiting front.  For my readers following these issues closely, if you haven't already done so, I would suggest that you review the posts listed below from two knowledgeable, savvy bloggers:

• Pfizer Questions RFID, published by Dr. Adam Fein, author of Drug Channels.  The post discusses an interview with John Theriault, Pfizer's vice president of global security, published by the Star Ledger.
• Counterfeit Drugs and the American Enterprise Institute, published by Eric Turkewitz of the Turkewitz law firm.  The post profiles an article entitled Bad Medicine in the Market written by Roger Bate and Kathryn Boateng. 

 

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