Pharma Blog Watch

Ketek Loses Two Indications (Eye on FDA)
In his blog, Mark Senak discusses news that the FDA has changed the label for sanofi-aventis' Ketek, as well as adding a black box warning. The new label "strips away two indications for use of the drug — acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis — retaining the sole remaining indication, treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities)."

"The phrasing around removal of the two prior indications was that the FDA 'has determined that the balance of benefits and risks no longer support approval of the drug for these indications'," he writes. "It is unclear whether this move will address concerns of congressional critics. Also, the agency did not provide any insight in the press release on the topic as to how they came to that conclusion."

Investing in Drug Development (GoozNews)
"The United States is the world leader in investing in biomedical research and development," Merrill Goozner writes in this entry. "In the public sector, the National Institutes of Health spent $28.6 billion in 2005, largely for basic science research. The pharmaceutical industry spent an estimated $39 billion in 2004."

"Indeed, over the past quarter century, the private sector's investment in the search for new medicines has grown 8 percent per year on average, faster than the industry's growth in sales and profits."

"Despite this massive public and private effort, output, as measured by the number of new drugs, biologics, vaccines and devices approved for use by regulatory bodies like the U.S. Food and Drug Administration, has slowed in recent years. Last year, the FDA approved just 21 new drugs and biologics, the second lowest total since 1993. Moreover, about half of these new drugs were not given priority status by the FDA, which meant they were not considered a significant new advance in medicine."