Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, November 21, 2012

Where are consumer protections? Not FDA!

Wed, Nov 21 14:28 PM EST   FiDA highlight

By Tim McLaughlin
BOSTON (Reuters) - The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering infractions that could potentially harm patients at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents show.
The New England Compounding Center (NECC) chastised the FDA in a letter dated January 5, 2007, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released under an open records request.
"We believe that FDA's nearly two year delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products," NECC co-owner and chief pharmacist Barry Cadden said in the letter, released by the FDA under an open records request.
The FDA acknowledged in a letter to Cadden dated October 31, 2008, that there had been a "significant delay" in its response but insisted that the delay "in no way diminishes our serious concerns about your firm's operations."
On Wednesday, a spokeswoman for the FDA, Erica Jefferson, said the delay in issuing the warning letter was due to the agency's limited, unclear and contested authority.
"During the time between the inspection of NECC and the issuance of the warning letter, there was ongoing litigation pertaining to pharmacy compounding and significant internal discussion about how to regulate compounders, all of which delayed FDA," she said.
The FDA has asked lawmakers to clarify its authority to oversee large-scale drug compounders such as NECC. But several Republicans have argued that the agency already had the authority that could have prevented the outbreak.
And on November 19, a congressional panel investigating the outbreak told the FDA not to expect new authority until it releases documents about its role.
According to the Centers for Disease Control and Prevention, 34 people have died and 490 have been injured after Framingham, Massachusetts-based NECC shipped a tainted steroid, methylprednisolone acetate, to medical facilities throughout the United States. The steroid is typically used to ease back pain.
On Tuesday, defense lawyers for NECC's owners told a U.S. District Judge in Boston there was nothing to show they had a direct hand in the cause of the meningitis outbreak.
NECC has consistently pushed back against attempts by regulators to discipline it, despite a series of violations dating back to 1999.
And the pharmacy's principals have sometimes shown little respect for the FDA or its inspectors.
During a re-inspection of the pharmacy in 2004 following up on certain marketing and packaging violations, Cadden and his brother-in-law, Gregory Conigliaro, a co-owner of NECC, became indignant, according to a 2005 memorandum from the FDA inspector. Cadden declined to cooperate without speaking to a lawyer first and at one point instructed his brother-in-law not to answer any more questions.
Conigliaro said he had "a lot of things to finish and just did not have the time to sit with us to answer our questions," the inspector said in his memo.
The FDA's eventual warning letter to NECC in December 2006 was based on an inspection that began in September 2004 and ended on January 19, 2005, according to the documents.
(Reporting by Tim McLaughlin; Editing by Jeffrey Benkoe and Andre Grenon)

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