WSJ Story Reveals Intense Debate At FDA Over Antibiotics
An interesting Wall Street Journal article published today reveals some interesting information about the ongoing debate at the FDA over the testing and use of new antibiotics. According to the Journal:
“An unusual clash among officials at the Food and Drug Administration is highlighting a dilemma: The FDA wants to make sure that drugs work before approving them, but it also faces pressure to be flexible and encourage the development of badly needed new antibiotics.
FDA officials battled earlier this year when deciding whether to approve the antibiotic Cubicin for heart-valve infections. Staff reviewers urged their boss to say no, citing ’serious misgivings’ about the drug’s effectiveness in the disease, according to documents reviewed by The Wall Street Journal. The head of the agency’s division for anti-infective drugs overruled the staffers, defending the drug and saying doctors need more weapons against dangerous bugs.
Behind the debate is growing concern among doctors about the rise of bacteria resistant to antibiotics. They want more investment by drug makers in the field, but many companies are hesitant. An antibiotic used for a day or two is far less lucrative than a pill that a patient might take daily for decades. What’s more, powerful antibiotics are sometimes kept in reserve for the most serious cases, which diminishes their commercial value.”
Look for this debate to intensify as the FDA stuggles to come up with new guidance on antibiotic clinical trials and encourage pharmaceutical companies to develop new drugs.
