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The Food and Drug Administration is proposing to allow pharmaceutical companies to undermine official safety warnings in sales presentations to customers.
While an FDA warning about a drug’s dangers can scare off buyers, the new proposal would allow companies to provide doctors, hospitals and other customers with information that conflicts with official advice, which is typically developed after a rigorous scientific process.
The proposal is supported by pharmaceutical manufacturers, who argue that the policy would allow them to provide doctors and hospitals with the latest research.
The proposal “seriously undermines FDA authority,” Sidney M. Wolfe, founder of Public Citizen’s Health Research Group wrote Wednesday to the agency. “Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be.”
Exactly what drug-makers can tell customers about their products has been the subject of regulation and sometimes - such as when the side effect has led to heart attacks, cancer, or suicide - billion-dollar penalties. But the industry has pushed back in recent years, arguing that under First Amendment, the government cannot curtail their right to disseminate information.
A recent review of 27 testosterone safety trials showed that based on the 13 trials that were funded by the industry, testosterone drugs are relatively safe; over the 14 studies that were not paid for by pharmaceutical firms the risks of heart attacks and other troubles are doubled.
Full article can be found here. http://www.washingtonpost.com/blogs/wonkblog/wp/2015/03/11/how-the-first-amendment-is-undermining-the-fdas-power-to-regulate-drugs/?postshare=5721426119593875
While an FDA warning about a drug’s dangers can scare off buyers, the new proposal would allow companies to provide doctors, hospitals and other customers with information that conflicts with official advice, which is typically developed after a rigorous scientific process.
The proposal is supported by pharmaceutical manufacturers, who argue that the policy would allow them to provide doctors and hospitals with the latest research.
The proposal “seriously undermines FDA authority,” Sidney M. Wolfe, founder of Public Citizen’s Health Research Group wrote Wednesday to the agency. “Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be.”
Exactly what drug-makers can tell customers about their products has been the subject of regulation and sometimes - such as when the side effect has led to heart attacks, cancer, or suicide - billion-dollar penalties. But the industry has pushed back in recent years, arguing that under First Amendment, the government cannot curtail their right to disseminate information.
A recent review of 27 testosterone safety trials showed that based on the 13 trials that were funded by the industry, testosterone drugs are relatively safe; over the 14 studies that were not paid for by pharmaceutical firms the risks of heart attacks and other troubles are doubled.
Full article can be found here. http://www.washingtonpost.com/blogs/wonkblog/wp/2015/03/11/how-the-first-amendment-is-undermining-the-fdas-power-to-regulate-drugs/?postshare=5721426119593875
