|May 2013, Volume XXIII, No. 3|
Regulatory & Legislative Highlights
By Deepen Joshi
The FDA has approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix, manufactured for Ferring Pharmaceuticals of Parsippany, NJ by Rentschler Biotechnologie Gmbh of Laupheim, Germany, is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.
Other hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix does not exhibit this effect. (Source: FDA Web Site, 29 December, 2008)
The FDA has approved Gleevec (imatinib mesylate) for a new indication: keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST, a fairly rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which helps to control the movement of food and liquid through the stomach and intestines.
Gleevec is manufactured by Novartis AG of Basel, Switzerland and was first approved by the FDA in 2001. It is one of the first drugs in a class of agents that block cellular communications that result in tumor growth. (Source: FDA Web Site, 19 December, 2008)
The FDA has recommended that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.
The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo.
More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia. Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack.
The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control. (Source: FDA Web Site, 17 December, 2008)
The FDA and WebMD today announced a collaboration that expands consumers' access to the agency's health information. According to the FDA, this joint effort reflects the agency's emphasis on using innovative, technology-based strategies to carry out its foremost mission, which is to promote and to protect the public health. The partnership includes:
The FDA has approved a new drug, Banzel (rufinamide), manufactured by Eisai Medical Research Inc. of Woodcliff Lake, NJ, for use as an add-on treatment for seizures associated with Lennox-Gastaut syndrome. Banzel was granted orphan drug designation by the FDA.
Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances. (Source: FDA Web Site, 20 November, 2008).
FDA officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses. The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors - even when they involve uses that have not been federally approved.
For their part, companies like Pfizer and Eli Lilly said the guidelines merely reauthorize a longstanding policy that benefits doctors and patients. Companies are not allowed to advertise products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, FDA has allowed company salespeople to distribute articles about such uses if they are published in a peer-reviewed medical journal. The law permitting that practice expired in 2006, and drug makers have been lobbying the agency to renew it ever since.
The reliability of medical journal articles came into question last year when Merck was accused of ghostwriting articles about its painkiller Vioxx, which was withdrawn from the market in 2004 for safety reasons. The FDA said the new guidelines are designed to discourage ghostwriting and recommend companies disclose financial relationships with article authors. (Source: Associated Press, 13 January, 2009)
The US has opened a branch of the FDA in the Chinese capital, the first of several overseas offices that will seek to regulate the safety of food and medicine bound for American supermarkets and pharmacies. The opening follows a string of scandals involving contaminated Chinese-made products, including toys, toothpaste, pet food, cough syrup, and milk. Later this week, the agency will open inspection stations in Shanghai and Guangzhou; in the coming months, it plans to establish offices in India, Latin America, and Europe.
Secretary of Health and Human Services Michael Leavitt, who traveled to China to preside over the ribbon cuttings, said the overseas offices would ensure the safety and quality of goods that make up 15 percent of the food Americans consume. All three outlets will work with Chinese counterpart agencies to inspect products bound for the US. They will also certify third-party inspectors who can approve the quality of exports. (Source: The International Herald Tribune, 20 November 2008)
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