FDA rejects sale of over the counter statins
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《英国医生杂志》
An expert advisory panel at the Food and Drug Administration last week rejected a proposal to permit over the counter sales of Merck抯 statin lovastatin (Mevacor), arguing that the risk of the drug could outweigh its benefits in many potential users.
If Merck抯 proposal had been accepted, lovastatin would have become the first long term preventive treatment to make the switch from prescription to over the counter status in the United States.
The decision is not binding, but the FDA hardly ever rejects the opinions of its own expert advisers. Although several leading cardiologists had publicly backed the proposal, the advisory panel voted against approval by a resounding margin of 20 to 3.
During the panel抯 public testimony session, several of the members who eventually voted against approval said they were theoretically in favour of over the counter statins but needed to see better data.
They were particularly concerned by a joint marketing study by Merck and Johnson & Johnson, in which the companies tried to gauge whether people who would benefit from the drug would buy it. To mimic the over the counter setting, they opened 14 mock pharmacies across the United States offering lovastatin without prescription. Of 3316 customers offered the drug, 1061 decided they would buy it. The companies?analysis suggested that 80% of these customers had risk factors that justified their decision.
But the FDA panel, after reviewing the data, concluded that only about 55% of the purchases would have been appropriate. It found that many of the buyers were too young, others did not know their lipid levels, and in some the drug was contraindicated because of their medical conditions.
Most worrying was the evidence that women of childbearing age would buy the drug. The panel heard expert testimony that statins could lead to birth defects in the central nervous system if taken by mothers during the first trimester of pregnancy.
Several panel members suggested a compromise "behind the counter" solution in which the drug would be sold without a prescription but only at a pharmacist抯 discretion. This approach was adopted last year in the United Kingdom for Merck抯 newer statin, simvastatin (Zocor), but Dr Charles Ganley, head of the FDA抯 division of over the counter products, said that such an arrangement might require the approval of Congress.
Permission to sell lovastatin over the counter could have opened the door to newer, more potent statins. Merck had said that if the proposal had been passed, it might have submitted a similar application for simvastatin, the world抯 second bestselling statin, which goes off patent next year. Bristol-Myers-Squibb抯 pravastatin (marketed as Lipostat in the United Kingdom and Pravachol in the United States), which holds third place in the statins market, also loses patent protection next year, and its manufacturer has announced plans to request an over the counter licence from the FDA.
Two weeks ago, Bristol-Myers Squibb抯 chief executive, Peter Dolan, told an industry conference that "in a theoretical perfect world, you want to have an prescription product that lives its full and maximum life with an prescription patent, then towards the end of it, it抯 switched to over the counter status."
Merck, which had already had one application for over the counter lovastatin rejected (in 2000), has not given up hope of eventually winning approval. "We continue to believe in the benefits of Mevacor as an over the counter medication to help lower cholesterol and contribute to improved overall health," said company spokesman Tony Plohoros. "We will continue to work with the FDA toward that end."
In August 2004 in the United Kingdom, simvastatin, one of the earliest and most used statins, was the first to be approved for over the counter sale in a low dose (10 mg) formulation under the brand name Zocor Heart-Pro, by Johnson & Johnson MSD (BMJ牋2004;329:310).<(London Owen Dyer)
If Merck抯 proposal had been accepted, lovastatin would have become the first long term preventive treatment to make the switch from prescription to over the counter status in the United States.
The decision is not binding, but the FDA hardly ever rejects the opinions of its own expert advisers. Although several leading cardiologists had publicly backed the proposal, the advisory panel voted against approval by a resounding margin of 20 to 3.
During the panel抯 public testimony session, several of the members who eventually voted against approval said they were theoretically in favour of over the counter statins but needed to see better data.
They were particularly concerned by a joint marketing study by Merck and Johnson & Johnson, in which the companies tried to gauge whether people who would benefit from the drug would buy it. To mimic the over the counter setting, they opened 14 mock pharmacies across the United States offering lovastatin without prescription. Of 3316 customers offered the drug, 1061 decided they would buy it. The companies?analysis suggested that 80% of these customers had risk factors that justified their decision.
But the FDA panel, after reviewing the data, concluded that only about 55% of the purchases would have been appropriate. It found that many of the buyers were too young, others did not know their lipid levels, and in some the drug was contraindicated because of their medical conditions.
Most worrying was the evidence that women of childbearing age would buy the drug. The panel heard expert testimony that statins could lead to birth defects in the central nervous system if taken by mothers during the first trimester of pregnancy.
Several panel members suggested a compromise "behind the counter" solution in which the drug would be sold without a prescription but only at a pharmacist抯 discretion. This approach was adopted last year in the United Kingdom for Merck抯 newer statin, simvastatin (Zocor), but Dr Charles Ganley, head of the FDA抯 division of over the counter products, said that such an arrangement might require the approval of Congress.
Permission to sell lovastatin over the counter could have opened the door to newer, more potent statins. Merck had said that if the proposal had been passed, it might have submitted a similar application for simvastatin, the world抯 second bestselling statin, which goes off patent next year. Bristol-Myers-Squibb抯 pravastatin (marketed as Lipostat in the United Kingdom and Pravachol in the United States), which holds third place in the statins market, also loses patent protection next year, and its manufacturer has announced plans to request an over the counter licence from the FDA.
Two weeks ago, Bristol-Myers Squibb抯 chief executive, Peter Dolan, told an industry conference that "in a theoretical perfect world, you want to have an prescription product that lives its full and maximum life with an prescription patent, then towards the end of it, it抯 switched to over the counter status."
Merck, which had already had one application for over the counter lovastatin rejected (in 2000), has not given up hope of eventually winning approval. "We continue to believe in the benefits of Mevacor as an over the counter medication to help lower cholesterol and contribute to improved overall health," said company spokesman Tony Plohoros. "We will continue to work with the FDA toward that end."
In August 2004 in the United Kingdom, simvastatin, one of the earliest and most used statins, was the first to be approved for over the counter sale in a low dose (10 mg) formulation under the brand name Zocor Heart-Pro, by Johnson & Johnson MSD (BMJ牋2004;329:310).<(London Owen Dyer)