Government Urges FDA to Speed Drug Approvals

The President’s Council of Advisors on Science and Technology is pressing the Food and Drug Administration to approve drugs for high-risk patients.

Edyta Zielinska
Oct 1, 2012

Patients who are morbidly obese or who have other high-risk diseases may get more attention from pharma companies in years to come if the US Food and Drug Administration takes the recommendation of The President’s science advisors, who unveiled a plan to double the number of prescription drug approvals for certain diseases on Tuesday (September 25).

The advisory panel proposed that the FDA approve certain drugs with side effects that may otherwise prevent approval, for use in patients who have no other options for treatment, but restrict those drugs from being used in the general population. For example, an individual with morbid obesity may be willing to take a drug with more severe side effects than a patient with moderate obesity if that drug is effective at reducing the obesity. However, those with milder obesity could not be prescribed the drug.

The move could "help deliver promising new medications to...

The panel, however, has not explained how such “exclusive medical use” will be enforced. Although pharma companies test and label drugs for particular indications, physicians are currently allowed to prescribe that drug off-label, or to patients with a different disease than that approved by the FDA.

The plan, if implemented by the FDA, could put patients at risk, Thomas Moore, director of the drug-safety publication QuarterWatch, told The Wall Street Journal. The report, he said, "recommends exposing more patients earlier to new drugs that have not yet undergone complete testing.”

 

 

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