PHARMACY

Leavitt seeks to avoid contempt charge in Congressional hearings

BY Drew Buono

WASHINGTON Health and Human Services Secretary Michael Leavitt is seeking to avoid a possible contempt of Congress charge from the House of Representatives.

The House is asking for compliance by the secretary in regards to a subpoena for documents that related to the Food and Drug Administration’s approval of the Sanofi-Aventis’ antibiotic Ketek. The drugmaker was banned from selling the drug for bronchitis and sinusitis last month after liver damage and death were shown to be linked with taking the medication.

Leavitt initially had refused to produce the documents in response to a subpoena the committee issued Feb. 1. The committee had requested a briefing book and related notes used to help FDA Commissioner Andrew von Eschenbach prepare for a March 22, 2007, hearing on the drug.

However, in a Feb. 29 letter responding to the contempt threat, the HHS secretary says the agency is “prepared to offer the committee access to the briefing book in a reading room setting within [HHS] facilities … and provide access to FDA staff for the purpose of engaging in further discussions about the contents of the book and how it was prepared.”

The House Energy and Commerce Committee wrote back to Leavitt, calling his response “a positive first step in resolving this impasse” but adding that the committee is “disappointed that it does not appear to adequately address certain outstanding areas of contention.”

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St. Charles Pharmaceuticals receives grant for research on new analgesic

BY Diana Alickaj

NEW ORLEANS St. Charles Pharmaceutical has announced that it has received funding for the first year of three for a research grant from the National Institute of Neurological Disorders and Stroke.

St. Charles Pharma is a Louisiana based company that will use the award, technically a Cooperative Small Business Phase II SBIR Grant for Translational Research, to fund the research of SCP-123, which the company is working hard to place into clinics. The award will also work in funding the preparation of the application to be submitted to the FDA.

SCP-123 is an analgesic that treats neuropathic pain, and according to published reports, offers greater pain reduction, reduced side effects and has the potential to also treat acute, migraine, post-operative and pediatric pain.

“We are excited. Dr. Narducy and his research team have now raised $6 million in NIH grant funding to support the Company’s drug development efforts,” John Koerner, St Charles’ chairman, stated. “If all goes well, SCP-123 could fill a large, unmet medical need and become a drug of first choice—a blockbuster—for the treatment of neuropathic pain. This grant award is a big plus toward mitigating development risk and making it all happen.”

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FDA issues warnings to makers of misbranded STD drugs

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Thursday issued six warning letters to five U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet indicated for the prevention and treatment of sexually transmitted diseases.

“The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective,” stated Janet Woodcock, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. “STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs.”

Some of these products, directed at U.S. consumers, falsely claim to have “FDA Approval” and some claim to be “more effective” than conventional medicine, the regulatory agency stated. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus.

Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.

The products claim to prevent or treat a variety of STDs, including herpes, chlamydia, human papilloma virus, cervical dysplasia and HIV/AIDS.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products, the agency stated. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

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