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.

By | October 1, 2012

image: Government Urges FDA to Speed Drug Approvals flickr, melloveschallah

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 patients facing severe illness, while protecting the general public from potential hazards," Ellen Sigal, chairwoman of the advocacy group Friends of Cancer Research, told The Wall Street Journal.

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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Avatar of: jhnycmltly


Posts: 65

October 2, 2012

One thing which strikes me as odd is when a simple treatment shows to be more effective than any other , it TOO would not be treated as one would a 'newly discovered drug with obvious efficacy'. In the case of a drug , it can be given accelerated approval DUE TO its' obvious efficacy , BUT , a medical treatment which costs very little , is NOT given the same 'orphan drug' privilege ?
Bloodletting , for everyone with metabolic syndrome , which means billions of people ?
"Effects of phlebotomy-induced reduction of body iron stores on metabolic syndrome"
"Phlebotomy with consecutive reduction of body iron stores lowered blood pressure and resulted in improvements of markers of cardiovascular risk and glycemic control."

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