- ‘Tis the Season: London florist creates $4.6 million Christmas wreath
- No tailgating allowed at Super Bowl XLVIII
- Pentagon to transport African troops to Central African Republic
- Chinese man fed up with his girlfriend’s shopping jumps to his death
- Ukraine leader to talk with protesters; Washington urges caution
- Pope Francis: A nun saved my life
- Israeli P.M. Netanyahu backs out of Mandela funeral
- Elian Gonzalez makes first trip outside Cuba since custody battle
- U.S., British intelligence agents enter online sci-fi world to spy on gamers
- Sarah Palin to host the outdoors show ‘Amazing America’
FDA admits mistake in approving implant
The Food and Drug Administration issued an unprecedented "mea culpa" Thursday, saying it made a mistake in approving a knee implant against the advice of its scientific reviewers.
The announcement comes a year after the agency first acknowledged that its decision to approve the Menaflex implant, made by ReGen Biologics, was influenced by outside pressure, including lobbying by four Democratic lawmakers from the company's home state of New Jersey.
The 2008 decision to approve the implant was made despite protests by FDA scientists that Menaflex - which reinforces damaged knee tissue - provides little, if any, benefit to patients.
FDA officials vowed last fall to revisit the decision made under President George W. Bush, after congressional investigators accused the agency of being too cozy with the companies it regulates. Since the device's approval, the top two device regulators who oversaw Menaflex's review have left the agency.
The four New Jersey Democratic lawmakers - Reps. Frank Pallone Jr. and Steven R. Rothman, and Sens. Robert Menendez and Frank R. Lautenberg - each had appealed to the FDA on ReGen's behalf, according to accounts last year from Mr. Rothman and spokesmen for the three others.
In a statement Thursday, the FDA said it is taking steps to revoke Menaflex's approval, although it also plans to meet with the company to discuss what data would be needed to prove the device is actually safe and effective.
ReGen, based in Hackensack, N.J., asked the FDA in 2005 to approve its device under the so-called "510k system," which allows speedy approval for devices that are similar to products already on the market.
ReGen argued that the Menaflex was comparable to shoulder joint implants sold by Johnson & Johnson, Stryker and other companies. FDA scientists repeatedly rejected that argument, saying the device should go through a more rigorous process that requires patient testing.
The head of FDA's device division overruled those scientists in late 2008. The agency said Thursday they were actually correct and that Menaflex is "technologically dissimilar from devices already on the market."
ReGen Chief Executive Gerald Bisbee said in a statement the company is "weighing its options" for Menaflex, adding that "there has never been a safety issue associated with the device."
By Tom Fitton
New photos confirm the attack's coordination and its cover-up
- Chinese man fed up with his girlfriend's shopping jumps to his death
- Israeli P.M. Benjamin Netanyahu backs out of Nelson Mandela funeral
- Obama lied about Syrian chemical attack, 'cherry-picked' intelligence: report
- CURL: Obama tells a whopper on IRS scandal
- Lawmakers see 'false narrative' of Obama as a terrorist fighter
- WOLF: The president's other Obamacare lies
- MSNBC host: Obamacare a 'wealthy white men' racist word
- Ted Cruz sees legal landmines ahead for Obamacare
- Bill OReilly reminds: Nelson Mandela was a communist
- Defense Secretary Chuck Hagel warns Pakistani leaders of U.S. aid losses over drone-strike protests
Independent voices from the The Washington Times Communities
The Constitution: Every issue, every time. No exceptions, no excuses. And how to get from here to there.
Crystal Wright is a black conservative woman living in Washington, D.C.
All of the world’s problems, solved on your back porch
Why can’t humans just be free to be humans?
White House pets gone wild!
Let it snow