Navigation Links
Tension Building Up in FDA Over Drug Approvals

The US Food and Drug Administration, caught on the wrong foot again in just two years over the safety of the drugs it approves, is facing congressional investigations.

First it was Vioxx, the painkiller, then some antidepressants and most recently Avandia, the diabetes pill.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations.

The hearing next week may highlight the growing internal dissension between officials who approve drugs and those who track the safety of drugs after they have been approval. Tension between the groups has long been common, but in recent months it has erupted into sniping.

It all came into the open at an advisory committee hearing last month on whether to approve a new arthritis drug.

On one side was Dr. David Graham, author of an internal report that found that Avandia substantially increased the risks of heart attack, findings similar to the medical journals report.

On the other, Dr. Robert J. Meyer, an office director in the drug review division, and his boss, Dr. John Jenkins, were in a group deciding against warning about the potential risks.

There was little chance that the advisory committee or the drug agency would approve the arthritis drug, Arcoxia, at the hearing.

Behind the scenes, agency officials were battling over Avandia. Dr. Graham told the committee that top agency officials had demanded an unreasonable level of certainty about a drugs risks before agreeing to warn the public.

They assume its safe, Dr. Graham said of the top officials analyses of safety data. Which is just looking at things all the way wrong.

Dr. Jenkins said Dr. Grahams characterization of how we look at safety data is simply false.

We make our best informed judgment about what the regulatory action should be, Dr. Jenkins added.

The fact remains tho ugh even during Avandias original trials, overseen by GlaxoSmithKline, the drugs maker, patients taking the drug had more than twice the rate of ischemic heart disease as recipients of placebos.

The medical reviewer for the F.D.A. expressed concerns, but in a further analysis decided that it was less of a problem.

Congressional investigators said the safety group recommended months ago that the drug agency put its severest warning on Avandia. The review group, which holds sway, has not done so.

Senator Charles E. Grassley, Republican of Iowa, and others on Capitol Hill, say the rift between the approval office and the safety office means that the two must separate and that the safety group must have more power. Mr. Grassley proposed such a split in an amendment this month; it failed by one vote.

Top House staff members said the Avandia case had breathed new life into Mr. Grassleys proposal, because the House will soon debate changing the drug agency.

When Dr. Andrew C. von Eschenbach took over the FDA in 2005, he promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety.

Now on the defensive, Dr. von Eschenbach said the agency had done its best in regard to Avandia. It intended to warn patients rapidly when it received information that a drug might be unsafe.

At the same time, he said, the agency had to find a way to ensure that patients did not overreact to uncertain safety problems.


'"/>




Related medicine news :

1. Acupuncture May Be An Effective Treatment Against Tension-Headaches
2. Children With Facial Anomalies Are Affected By Parental Tensions
3. Influence Of Heart Rate On Myocardial Oxygen Tension
4. Tension between MP And the Cancer Council Head Regarding Screening Test for Male Cancer
5. Milk Not So Good In Building Bones
6. Experts Building Bird Flu Warning System
7. Metamorphosis of U.S. Hospital Buildings
8. RMIT Business School Building Declared Safe
9. Researchers On The Path To Building Bone
10. Muscle-Building Exercise Improves Response to Flu Shot
11. Treat Childhood Trauma by Building on Parental Memories of Loving Care
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand ... project," said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s ... within Final Cut Pro X . Simply select a ProHand generator and drag ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... , ... National recruitment firm Slone Partners is pleased to announce ... experience, as Vice President of North American Capital Sales at HTG Molecular . ... sales team in the commercialization of the HTG EdgeSeq system and associated reagents in ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, Inc., ... development and manufacturing of collagen and mineral based ... today that Bill Messer has joined ... to further leverage the growing portfolio of oral ... Bill joins the Collagen Matrix executive ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
Breaking Medicine Technology: