Food and Drug Administration

The American Food and Drug Administration has approved several circumcision devices and products made from harvested infant foreskins.

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. Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications. The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction. In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries. Twenty-one of those reports were related to Mogen clamps, all but one of which involved injuries.

Products & Devices

Devices

• AccuCirc

Products

• Dermagraft-TC
• Apligraf
• AlloDerm
• TNS Recovery Complex

Lenient Regulatory Standards

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:

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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 University of California, 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.

Spying on dissenting scientists

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:

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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 ... The documents show that the operation identified 21 FDA employees, Congressional officials, journalists and outside medical researchers who were believed to be collaborating to release negative and "defamatory" information about the FDA. In defense of the surveillance operation, FDA officials said the computer monitoring targeted five agency scientists suspected of leaking confidential details about the design and safety of medical devices ... 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."

Investigations by the Department of Health and Human Services Office of Inspector General (OIG)

On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities. The report read in part:

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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. Finally, FDA failed to complete the required number of audits in one-third of the States with inspection contracts. FDA guidance requires that a minimum of 7 percent of a State's contract inspections be audited each year. However, FDA failed to complete the required number of audits in 14 of 41 States. Additionally, the audits in 10 States revealed systemic problems that needed to be corrected; however, FDA initiated corrective action in only 4 of these 10 States. 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.

On the 4 June 2012, the OIG published a report critical of the FDA's handling of scientific disagreements regarding medical device regulatory decisions. The report read in part:

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WHY WE DID THIS STUDY 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.

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HOW WE DID THIS STUDY 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.

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WHAT WE FOUND 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.

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WHAT WE RECOMMEND 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.