FDA Drug Security Program Targets Foreign Manufacturers

Drug recall lawyers at Pintas & Mullins Law Firm report that, in efforts to curtail contaminated or unapproved pharmaceuticals from being imported, the FDA recently implemented a new program to ensure the safety of drugs manufactured beyond U.S. borders.

The new Secure Supply Chain Pilot Program is a voluntary program through which qualified applicants can expedite their approval process, enabling the FDA to focus more scrutiny on suspect manufacturers. In order to qualify for the program, drug makers would have to either sponsor a New Drug Application or be a foreign drug maker that has already imported a completed drug product.

Once accepted, the manufacturer would be subject to random examinations of shipments, along with consistent review of records. Participants may be kicked out of the program if they do not adhere to its requirements, after which their drugs would go through the traditional, manual drug entry review process.

There has been much concern in recent years that foreign drug manufacturers go largely uninspected by their own governmental agencies, substantially increasing the likelihood that dangerous, ineffective, or unapproved drugs are imported into the U.S. About 40% of finished drugs in the U.S. are imported, along with a staggering 80% of active ingredients. Experts assert that the FDA should start working with Canada, Japan, and the European Union to inspect manufacturing facilities in the developing world.

In a particularly outlandish example, eleven people were recently charged in an alleged illegal pharmacological import and distribution scheme. According to the indictment, two principals of the Canadian Gallant Pharma International illegally imported prescription drugs into the U.S. from countries such as India, Switzerland, and Turkey. The drugs, many of which were chemotherapy agents, were not manufactured or packaged in accordance with FDA guidelines and many were not approved for sale in the U.S. at all.

Gallant shipped these drugs into the country with the assistance of co-conspirators in Canada and the U.K., who mislabeled the products and broke them into smaller packages to be shipped to a medical office in Virginia. Gallant, which is not licensed to distribute prescription drugs in the U.S., generated more than $8.6 million in revenue since 2009 from sales of its products in the country.

Even drugs made in the United States, however, are often contaminated with undeclared ingredients or harmful bacteria, causing national recalls and market withdrawals. Texas-based Herbal Giver Care recently issued a recall of all its Esbelder capsules due to concerns of undeclared Sibutramine and N-Desmethylsibutramine, among other ingredients. The presence of such undeclared ingredients renders Esbelder an unapproved drug.

Sibutramine can severely increase blood pressure and pulse rate in some patients, which can pose a life-threatening risk for those with a history of adverse cardiac events or conditions. The Esbelder products are packaged in white plastic bottles with screw caps and contain 30 capsules per bottle.

Similarly, Health and Beyond recently announced a recall of its Tranquility product due to unlisted pharmaceutical ingredients. The pills were found to have trace amounts of Doxepin and Chlorpormazine, which are drugs to treat sleep disorders and psychotic disorders, respectively. Patients taking Tranquility may experience sudden bouts of dizziness.

Hospira Inc., based in Illinois, also issued a recall of certain blood sets after reports of the outer wall of blood bags being punctured with the piercing pin during its insertion into the blood bag. This piercing may result in spillage of blood and any other products stored in the bag, leading to a delay or disruption of treatment. Any such delay could, and has, lead to significant injury or death. There has been one report of a patient death to therapy interruption due to this defect.

The affected products include Hospira’s Secondary Blood Set, Y-Type Blood Set, Plum Blood Set, and Plum Y-Type Blood Set, distributed between July 2011 and February 2013. The defect is now known to be caused by the design of the pin, which has a sharp point that can pierce the wall of the blood bags. Hospira recommends consumers use extreme caution when piercing the blood bags and make sure to follow all instructions for use to minimize the possibility of puncturing the outer wall.

Drug recall lawyers at Pintas & Mullins Law Firm will continue to report on any significant recalls, FDA initiatives, and investigations into dangerous drugs and manufacturers. If you or a loved one was seriously injured by a contaminated or recalled medication, you may be entitled to compensation for your medical bills and lost wages.