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FDA deal with drugmakers raises user fees 6 percent

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Drugmakers such as Pfizer Inc. and Eli Lilly an Co. have agreed with regulators on a 6-percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017.

The deal, disclosed in part Thursday, would renew for five years a federal law funding Food and Drug Administration evaluations of brand-name drugs. Congress must approve the accord before the law expires on Sept. 30, 2012.

The increase is expected to add $40.4 million to user-fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million, Karen Riley, a spokeswoman for the FDA, said in an e-mail. The agency in turn will have to meet with companies in the midst of reviews to raise concerns and ensure that evaluations are carried out in a timely way.

The agreement “should allow more timely access to safe and effective new medicines,” said David Wheadon, senior vice president for scientific and regulatory affairs at lobbying group the Pharmaceutical Research and Manufacturers of America, in a written statement.

Drugmakers fund about 60 percent of the cost of agency reviews, according to the FDA. The agreement includes additional review time for the agency to fit in extra meetings, extending the window for reviews after submitting applications to eight months from six months, and 10-month periods to 12 months.

The FDA and the industry also agreed to meet 12 days before the agency convenes advisory panels that evaluate drugmaker applications, giving companies time to gather needed data, according to the draft.

The agreement includes a third-party review of whether the FDA is meeting drug-review goals, according to the draft.

Drug safety also will be strengthened through standardization of the requirements for risk strategies the FDA mandates of some medicines and support for the use of an online drug safety tracking system to assess post-market risks, Wheadon said.

The last time user fees were reauthorized in 2007, Congress gave the FDA new responsibilities to promote drug safety including requiring risk strategies for some drugs, which caused the agency to slow its review process.

Jim Greenwood, president of the Biotechnology Industry Organization, a lobbying group in Washington for biologic drugmakers, said in a statement the agreement “would restore FDA’s review performance.”

Companies such as New York-based Pfizer and Eli Lilly of Indianapolis have been discussing with the FDA a user-fee renewal since July 2010. Medical-device companies such as New Brunswick, N.J.-based Johnson & Johnson are in separate talks on fees they pay the agency for product reviews.

The device industry rejected the agency’s proposal to more than double fees to $770 million across five years from $295 million, according to meeting minutes. Manufacturers are insisting on a safeguard against 11th-hour requests from regulators that the industry says delay approvals, according to Steve Ubl, president of the Advanced Medical Technology Association in Washington, D.C.



 

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  1. liek the rest of America

  2. These quaint,obsessed musings by the stalkers are certainly entertaining, but I'm trying to figure out what, if anything, all the yelping below has to do with Zak Brown.

  3. It's evident that Moffett was pushing the right buttons and corporate America is now trying to squash him. He just wanted to withdraw the free pilot services provided to the company by the pilots to try and put some pressure on a company that has not been interested in negotiating a contract in over 5 years. The company does not provide a contract because not having one has saved them a bundle of money. Shame on any Republic pilots not standing behind their union leader just because things are getting tough, can you not see such strategic moves by the company as putting the last union president in a corporate position and into THEIR pocket. Do you really believe the last union president is so appalled at the attempts by Moffett, do you not remember his oppositions to the company? We stood behind him. It has been proven over and over again for thousands of years without fail, a man cannot serve two masters. Anyone that believes people vote contrary to their paycheck and livelihood deserve to be taken advantage of, the recent statements by the former union president are laughable as he denounces the current union president from his new corporate position. Have you ever seen a drafted sports player score points for his previous team, it cannot be done, he is not on the pilots side anymore, he gets his money a different way now than you and I do, and he should not be allowed to remain on the seniority list. A drafted player brings strength, credibility, tactical knowledge, and a strategic advantage to his NEW team, he would not be drafted or paid were it otherwise. We are all forced to choose only one side to play for and support, not doing so has many references in life such as insider trading and shaving points, all illegal for good reason. This basic fact is why corporate moguls, scientist, and engineers all sign non-discloser agreements and non-compete clauses, as protection in case they are lured into switching sides as our former union president has done. No NFL coach ever drafted a player so that both teams could benefit and better understand each other, they are recruited to win the game against that former team, period. Likewise the company does not recruit the former union president by accident or mutual understanding, its strategy. Don't confuse playing the game with good sportsman-like conduct in support of common business and prosperity goals, with the requirement to only play for one side. Good men we all love and favor fall subject to this manipulation, often without their knowledge, and it is not a betrayal of their friendship to oppose them when they switch sides. If we did not love and trust them, they would not have been chosen and lured to the other side in the first place. The deception by the drafted player is not made at a conscious level, it's just human nature and it's all about money and power which corrupts our ability to be objective and loyal to two masters. This is why our court system created the defense attorney, and why our military created counter intelligence. Its strategy and its propaganda, and it works, and that's why the "powers to be" manipulate the chess pieces by sometimes changing their colors. Some players know they are being manipulated when their color is changed, but it brings them more money and power so they do not care. The rest have good intentions but do not even realize they are being manipulated. This tactic is also known by another name, Divide and Conquer. In battle sending an imperfect message with an imperfect team is obviously not ideal, but it's still being sent by YOUR team, your union leader, a leader that has common goals and common rewards with you, they are the best, because we have elected them to do a job for us. If you are not backing Moffett but believing the spin by those that have recently switched sides, you are taking food out of your own mouth. Showing unity and backing an imperfect situation still results in taking just as much ground, it's about unity and bargaining power. It's not necessary to wait around for that perfect attack because it will never come, the company will spin and attempt to destroy anyone that gets in their way. Ultimately it's not about any specific attack anyway, ASAP or whatever it makes no difference, it is and always has been only about power. If this company cared about safety it would not build pairings with 8 hour overnights, come on, are you that naive? Besides, do you really think Hoffa cares, no, he got a call from corporate America and was squeezed into denouncing Moffett. If he didn't they would spin the safety card against him and the Teamsters National with implication for truckers, future contracts, insurance rates etc...saying something like the Teamsters use safety as a bargaining chip, blah blah blah... Do you really think any pilot is going to do something unsafe for the contract, absolutely not, the only ones threatening safety here is the company with reduced rest, fatigue, and poverty. Do you not find it odd that Hoffa and the Teamsters are opposing a Teamster president publicly? Would the Teamsters National not normally support and work with one of their own? Why did they not sit down and help him strategize, correct any mistakes, and charge ahead? Would the Teamsters National not normally support and leverage a contract for all those pilots that have been paying Teamster dues, isn't that why we have all been paying Teamster dues in the first place? I sure haven't been paying dues so that the Teamsters National could come along and write this kind of an article undercutting our union leader and our unity. Whose side is the Teamsters National really on, it's obviously not the Republic pilots side.

  4. No matter what Moffatt does the company is going to spin it like he is the terrorist and brainwash people like you into believing it, wake up, back your players that are trying to change things for you and your livelihood. Where has Hoffa been for the last 6 years, except collecting our dues. Seriously, do you really think an FO going for upgrade, signed off by a checkairman ready for the upgrade, who then fails, is not even capable of returning as a First Officer.

  5. whoa!

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