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The American Food and Drug Administration has approved several [[circumcision ]] devices and products made from harvested infant [[Foreskin| foreskins]].<ref name='fda-accucirc'>{{REFweb | last=Brogdon | first=Nancy C. | publisher=Food and Drug Administration: Department of Health & Human Services | work= | date=2007-09-07 | title=Dear Mr. Wallace | url=http://www.accucirc.com/documents/AccuCirc_510k.pdf | accessdate=2011-03-06
}}</ref><ref name='fda-dermagraft-tc'>{{REFweb
| quote=...fibroblast-derived temporary [[skin ]] substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA. | last= | first= | publisher=MediLexicon | work= | date= | title=Dermagraft-TC | url=http://www.medilexicon.com/drugs/dermagraft-tc.php#GeneralInformation | accessdate=
}}</ref><ref name='fda-apligraf'>{{REFweb
| quote=Apligraf® is the first bio-engineered cell based product to receive FDA approval (in 1998). | last= | first= | publisher=Organogenesis | work= | date= | title=Apligraf | url=http://www.organogenesis.com/products/bioactive_woundhealing/apligraf.html | accessdate=2011-03-06
}}</ref><ref name='fda-alloderm'>{{REFweb
| quote=...screened and tested according to FDA regulations... | last= | first= | publisher=LifeCell Corporation | work= | date= | title=AlloDerm®Tissue Matrix defined | url=http://www.lifecell.com/alloderm-regenerative-tissue-matrix/95/ | accessdate=2011-03-06
}}</ref><ref name='fda-tns'>{{REFjournal
| last= | first= | coauthors= | pubyeardate= | title=About SkinMedica | journal=SkinMedica Brochure | volume= | issue= | pages= | url=http://www.skinbrands.co.uk/SkinMedica_Brochure.pdf | quote=The cell banks used for NouriCel-MD™ (the key ingredient in SkinMedicaʼs TNS Cosmeceuti- cal product range) is already used in TransCyte™ and Cosmoderm Cosmoplast (Human Collagen) a dermal filler marketed by Allergan ‒ both FDA approved. | accessdate=2011-05-12
}}</ref>
== Circumcision Injury Reports ==
As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile [[amputation ]] and urethral damage.<ref>{{REFnews | last=Hennessy-Fiske | first=Molly | coauthors= | url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | title=Injuries linked to circumcision clamps | date=2011-09-26 | publisher=Los Angeles Times | quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice... | accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews | last=Hennessy-Fiske | first=Molly | coauthors= | url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | title=Injuries linked to circumcision clamps | date=2011-09-25 | publisher=Los Angeles Times | quote=Instead of recalling the devices, the FDA advised users to make sure... | accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews | last=Hennessy-Fiske | first=Molly | coauthors= | url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | title=Injuries linked to circumcision clamps | date=2011-09-25 | publisher=Los Angeles Times | quote=The agency also cautioned against using replacement parts on the Gomco clamp... | accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews | last=Hennessy-Fiske | first=Molly | coauthors= | url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | title=Injuries linked to circumcision clamps | date=2011-09-26 | publisher=Los Angeles Times | quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports... | accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews | last=Hennessy-Fiske | first=Molly | coauthors= | url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | title=Injuries linked to circumcision clamps | date=2011-09-26 | publisher=Los Angeles Times | quote=Twenty-one of those reports were related to Mogen clamps... | accessdate=2011-09-25}}</ref>
== Products & Devices ==
On the 28 March 2012, Consumer Reports magazine issued a report critical of lenient FDA standards for approval of new medical devices. As reported by HealthDay News:<ref>{{REFweb
| last= | first= | date=March 2012-03 | title=Report Slams Approval Process for Medical Devices | url=http://www.webcitation.org/66VuXY3Us | publisher=HealthDay News | accessdate=2012-12-12
}}</ref>
{{Citation
| Title= | Text=Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.
Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the {{UNI|University of California|UCSF}}, San Francisco. She said it's those lenient federal standards that are the problem.
"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."
In a report issued last year, the Institute for Medicine said the current approval process for medical devices is flawed and called on the FDA to develop new regulations to ensure patient safety.
| Author= | Source=
}}
As reported by HealthDay News, the FDA collected thousands of e-mails that agency scientists sent privately to members of Congress, journalists, labor officials, lawyers and even President Barack Obama:<ref> {{REFweb
| last= | first= | date=July 2012-07 | title=FDA Conducted Surveillance Operation Against Scientists | url=http://www.webcitation.org/69DN3PuxD | publisher=HealthDay News | accessdate=2012-07-16
}}</ref>
{{Citation
| Title= | Text=The scientists claimed that flawed review procedures at the FDA had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation
...
In May, the federal government's Office of Special Counsel concluded that the scientists' concerns were valid enough to warrant a full investigation into "a substantial and specific danger to public safety."
| Author= | Source=
}}
On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities.<ref>{{REFweb
| last= | first= | date=December 2011-12 | title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430) | url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf | publisher= | accessdate=2011-12-16
}}</ref> The report read in part:
{{Citation
| Title= | Text=Although FDA has increasingly relied on States to inspect food facilities, our report identified significant weaknesses in FDA's oversight of these inspections. Notably, in eight States, FDA failed to ensure that the required number of inspections was completed. Moreover, FDA paid for many inspections that were incomplete.
In addition, FDA did not ensure that all inspections were properly classified or that all inspection violations were remedied. Based on the violations found during an inspection, FDA assigns each inspection a classification; an official action indicated (OAI) classification is generally assigned when the most serious violations are identified. We found that FDA officials were often unclear about how to properly classify contract inspections. Specifically, officials responsible for 11 States reported that they would not assign OAI classifications to State inspections under any circumstances, contrary to FDA guidance. Additionally, FDA officials reported that when States are responsible for correcting violations, FDA was not always informed about actions taken by the States. As a result, FDA was unable to ensure that all inspection violations were remedied.
We recommend that FDA: (1) ensure that all contract inspections are completed, properly documented, and appropriately paid for; (2) ensure that contract inspections are properly classified in accordance with FDA guidance; (3) ensure that all inspection violations are remedied by routinely tracking all actions taken to correct violations; (4) ensure that the minimum audit rate is met in all States; and (5) address any systemic problems identified by audits. FDA concurred with four of our recommendations and agreed in part with the fifth.
| Author= | Source=
}}
On the 4 June 2012, the OIG published a report critical of the FDA's handling of scientific disagreements regarding medical device regulatory decisions.<ref>{{REFweb
| last= | first= | date=June 2012-06 | title=Scientific Disagreements Regarding Medical Device Regulatory Decisions (Report OEI-01-10-00470) | url=http://oig.hhs.gov/oei/reports/oei-01-10-00470.pdf | publisher= | accessdate=2012-06-05
}}</ref> The report read in part:
{{Citation
| Title=WHY WE DID THIS STUDY | Text=FDA plays a critical role in ensuring the safety and effectiveness of medical devices and other products. At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions. | Author= | Source=
}}
{{Citation
| Title=HOW WE DID THIS STUDY | Text=We surveyed CDRH managers and reviewers, requesting that they identify scientific disagreements that occurred during the fiscal year 2008-2010 period. We then reviewed the administrative files related to 36 reported scientific disagreements for the same period. We also surveyed respondents about their awareness of and training on CDRH's new policies and procedures for addressing scientific disagreements. | Author= | Source=
}}
{{Citation
| Title=WHAT WE FOUND | Text=Of the 36 reported scientific disagreements, 3 occurred after October 2009, and the new procedures were used to resolve them. The nature and resolutions of these 36 disagreements varied widely. Scientific disagreements often involved multiple issues, and most of their resolutions did not lead directly to the approval or clearance of devices. Most administrative files related to scientific disagreements contained required documentation, although accountability for file completeness is unclear. In addition, not all of CDRH's managers and reviewers have received training on the new procedures. CDRH also faces broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion. | Author= | Source=
}}
{{Citation
| Title=WHAT WE RECOMMEND | Text=We recommend that FDA: (1) define more clearly its requirements for documenting and resolving scientific disagreements, (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and (3) more clearly assign accountability for the contents of the administrative files of all submissions. FDA concurred with our three recommendations. | Author= | Source=
}}
{{REF}}
[[Category:Organizations]][[Category:CircLeaksOrganization]]
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