.House: Obama's FDA causing drug shortages
President Obama's Food and Drug Administration has caused "a public health crisis" -- a prescription drug shortage over the past two years -- by increasing the number of threats issued to raid and close drug manufacturing plants, according to House investigators.
"This shortage appears to be a direct result of over-aggressive and excessive regulatory action," House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., said in a statement. "These drugs can save lives and keep people who need them living healthy lives. The FDA is failing to ensure the availability of quality products."
President Obama signed an executive order last year to help the FDA anticipate drug shortages while knocking Congress for failing to pass his preferred legislation on the issue. "Congress has been trying since February to do something about this," Obama said in November. "It has not yet been able to get it done . . . we can't wait."
The committee report concluded that a significant portion of the drug shortage is a problem of the Obama administration's making. "Among shuttered manufacturing lines that occurred over the previous two years, the committee’s review did not find any instances where the shutdown was associated with reports of drugs harming customers," the report says, noting a 30 percent drop in the manufacture of certain prescription drugs at the largest manufacturers in the country.
Instead, the drug shortage crisis began in 2010 after the FDA began sending letters to companies found to be in violation of a given rule, in which the company was warned that "failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction."
The FDA sent just 474 such letters in 2009, but that number spiked to 1720 in 2011. "A common sense approach to regulations must be restored at the FDA," the committee report advised, calling for more targeted measures to induce company compliance with regulations. "Agency protocols should be revised so that the agency is required to consider the implications of its actions on the nation’s supply of critical drugs."
Washington Examiner
"This shortage appears to be a direct result of over-aggressive and excessive regulatory action," House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., said in a statement. "These drugs can save lives and keep people who need them living healthy lives. The FDA is failing to ensure the availability of quality products."
President Obama signed an executive order last year to help the FDA anticipate drug shortages while knocking Congress for failing to pass his preferred legislation on the issue. "Congress has been trying since February to do something about this," Obama said in November. "It has not yet been able to get it done . . . we can't wait."
The committee report concluded that a significant portion of the drug shortage is a problem of the Obama administration's making. "Among shuttered manufacturing lines that occurred over the previous two years, the committee’s review did not find any instances where the shutdown was associated with reports of drugs harming customers," the report says, noting a 30 percent drop in the manufacture of certain prescription drugs at the largest manufacturers in the country.
Instead, the drug shortage crisis began in 2010 after the FDA began sending letters to companies found to be in violation of a given rule, in which the company was warned that "failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction."
The FDA sent just 474 such letters in 2009, but that number spiked to 1720 in 2011. "A common sense approach to regulations must be restored at the FDA," the committee report advised, calling for more targeted measures to induce company compliance with regulations. "Agency protocols should be revised so that the agency is required to consider the implications of its actions on the nation’s supply of critical drugs."
Washington Examiner
posted by madtom at 6:47 PM
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