Comments on: FDA Reviewers To Get Some Schooling http://www.pharmalot.com/2009/11/fda-reviewers-to-get-some-schooling/ News, Comment and Conversation Fri, 10 Feb 2012 20:05:19 +0000 http://wordpress.org/?v=2.6.2 By: Justice in MI http://www.pharmalot.com/2009/11/fda-reviewers-to-get-some-schooling/#comment-448059 Justice in MI Sun, 29 Nov 2009 22:25:31 +0000 http://www.pharmalot.com/?p=20109#comment-448059 There have been a few FDA regimes (Goddard, some of Kessler's time) with more of the skepticism needed. Even Frances Kelsey could not have done what she did if she didn't have the support of a couple of supervisory levels above her. BTW, I was surprised to learn recently that she was still at the agency in 2005! Steve Galson presented her with a drug safety award. Speaking of ironic........ There have been a few FDA regimes (Goddard, some of Kessler’s time) with more of the skepticism needed. Even Frances Kelsey could not have done what she did if she didn’t have the support of a couple of supervisory levels above her.

BTW, I was surprised to learn recently that she was still at the agency in 2005!

Steve Galson presented her with a drug safety award.

Speaking of ironic……..

]]> By: JaT http://www.pharmalot.com/2009/11/fda-reviewers-to-get-some-schooling/#comment-448056 JaT Sun, 29 Nov 2009 22:16:22 +0000 http://www.pharmalot.com/?p=20109#comment-448056 What came to me immediately was Quality by Design or like tools that result in a 'toss it in the hopper and if it shows some level of equivalence it passes' system. It doesn't look closely enough. But hey, as long as the numbers are there. Never mind that it completely misses clinical effectiveness testing. We are better off having an agency with the appropriate science background, willing to investigate, and tough enough to stand their ground. Regulators should be like detectives. If this investment aids in that then more power to them. If it is intended to make the job easier for the sake of being easier- it's bound to be a problem. What came to me immediately was Quality by Design or like tools that result in a ‘toss it in the hopper and if it shows some level of equivalence it passes’ system. It doesn’t look closely enough. But hey, as long as the numbers are there. Never mind that it completely misses clinical effectiveness testing.

We are better off having an agency with the appropriate science background, willing to investigate, and tough enough to stand their ground. Regulators should be like detectives. If this investment aids in that then more power to them. If it is intended to make the job easier for the sake of being easier- it’s bound to be a problem.

]]> By: Ex-FDAer http://www.pharmalot.com/2009/11/fda-reviewers-to-get-some-schooling/#comment-447357 Ex-FDAer Wed, 25 Nov 2009 18:07:39 +0000 http://www.pharmalot.com/?p=20109#comment-447357 I have my doubts on this program. FDA reviewers are told to simply accept whatever the companies feed them and to not question it. So long as a company makes some sort of claim it's to be accepted. This is the same thing that happened with Francis Kelsey and thalidomide. The company claimed they had done adequate studies and she kept saying where's the data, if you don't give me the data it's going to another review cycle until you give it to me. She had to put up with huge pressures and harassment but was fortunate in that it was only for a year until the information on the birth defects became public. Current FDA reviewers typically don't have those kinds of situations. Even when drugs are killing people via hepatotoxicity or CV events it's often too easy for it to be covered up and delayed. It's not so blatently obvious and alarming as with thalidomide. Most FDA basic science reviewers come to the FDA on H1-B visas and if they don't toe the line and cut and paste the sponsor's summaries they can find that the FDA has not submitted their visa renewals on time and they can be deported. Of course this is known within the agency and helps keeps reviewers from saying anything that might hold up approvals. Even after obtaining citizenship severe harassment can ensue until they build a case to fire you. Scientists who don't have professional backgrounds are then without a livelihood and are unlikely to ever find a position in the pharmaceutical industry. We know what to look for and fraud on the FDA occurs with almost every FDA I've seen but most reviewers simply don't say anything and simply look the other way. The FDA runs on harassment and fear and it's so blatent that many reviewers have documents to prove it. Until Congress, HHS-OIG, and the Justice Department actually do something with these documents and puts people in jail there will be no hope of ever preventing tragedies. I have my doubts on this program. FDA reviewers are told to simply accept whatever the companies feed them and to not question it. So long as a company makes some sort of claim it’s to be accepted.

This is the same thing that happened with Francis Kelsey and thalidomide. The company claimed they had done adequate studies and she kept saying where’s the data, if you don’t give me the data it’s going to another review cycle until you give it to me. She had to put up with huge pressures and harassment but was fortunate in that it was only for a year until the information on the birth defects became public.

Current FDA reviewers typically don’t have those kinds of situations. Even when drugs are killing people via hepatotoxicity or CV events it’s often too easy for it to be covered up and delayed. It’s not so blatently obvious and alarming as with thalidomide.

Most FDA basic science reviewers come to the FDA on H1-B visas and if they don’t toe the line and cut and paste the sponsor’s summaries they can find that the FDA has not submitted their visa renewals on time and they can be deported. Of course this is known within the agency and helps keeps reviewers from saying anything that might hold up approvals. Even after obtaining citizenship severe harassment can ensue until they build a case to fire you.

Scientists who don’t have professional backgrounds are then without a livelihood and are unlikely to ever find a position in the pharmaceutical industry. We know what to look for and fraud on the FDA occurs with almost every FDA I’ve seen but most reviewers simply don’t say anything and simply look the other way.

The FDA runs on harassment and fear and it’s so blatent that many reviewers have documents to prove it. Until Congress, HHS-OIG, and the Justice Department actually do something with these documents and puts people in jail there will be no hope of ever preventing tragedies.

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