Conflict-of-interest restrictions needed to ensure strong FDA review

Conflict-of-interest restrictions needed to ensure strong FDA review

The 2012 legislation removed measures put in place by an earlier law passed in 2007, according to the report by Susan F. Wood, PhD, an associate professor of health policy at SPHHS and Jillian K. Mador, a medical student at the GW School of Medicine & Health Sciences (SMHS). The 2007 FDA Amendments Act put caps on the number of experts with conflict of interest who could serve on FDA advisory panels in order to ensure an impartial review of new drugs, the authors said.

They say there is good reason to worry about the revisions in the law that now allow FDA panels to have more members who report a conflict -- such as consulting fees from drug companies. The removal of the requirement for "caps" on advisory committee members with financial conflicts was seen as a top priority of the pharmaceutical industry during the 2012 passage of the FDA Safety and Innovation Act.

"Panels top-heavy with experts who have financial ties to industry might be more likely to dismiss or ignore scientific evidence of risks or other problems," said Wood, who is a former FDA official and the lead author on the paper. "This analysis also suggests that loosening the restrictions could lead to an appearance of conflict -- and to potentially biased recommendations for approval or disapproval of a FDA regulated product."

The authors point to historical examples of cases in which loaded panels voted for drugs that were later found to have serious safety problems.

The 2012 law was passed after the drug industry complained that the conflict of interest restrictions slowed down the FDA approval process and made it hard to fill panel positions with qualified experts. But Wood and Mador looked at the evidence and concluded that there are plenty of scientists with expertise to fill these positions -- without the ties to the industry.

The analysis goes on to say that the restrictions did not affect FDA's productivity in the past and there is little reason to think that reinstituting the caps would slow down the process of bringing safe new drugs to market today. The analysis also demonstrates that the caps have never been reached, so FDA had apparently been successful in identifying experts without financial conflicts.

The analysis concludes that the evidence does not support the decision to remove the caps on conflict of interest and points out that Congress will soon begin discussing reauthorization of the 2012 law which is revised every five years. The authors urge the scientific and medical community to weigh in early on those discussions in order to point out concerns -- and to ensure that the FDA Advisory Committee and review process remains strong and effective.

Welcome to SUV System Ltd!

SUV System Ltd is ISO 90012008 Certified electronics distributor with 10 years of experiences.

We have built up long term business relationship with about many companies which are stockers and authorized agents. we have a steady and reliable supply to meet customer's demands to the greatest extent .Confidently, we are able to lower your cost and support your business with our years of professional service.

SUV System Ltd is Electronic Components Distributor Supplies,Find Quality Electronic Components Supplies Products IC(Integrated Circuits),Connectors,Capacitor,Resistors,Diodes,Transistors,LED at Suvsystem.com. Sourcing Other Energy, Environment, Excess Inventory Products from Manufacturers and Suppliers at Suvsystem.com

Electronic Components distributor:http://www.suvsystem.com

Connectors Distributor:http://www.suvsystem.com/l/Connectors-1.html

IC Distributor:http://www.suvsystem.com/l/IC(Integrated-Circuits)-1.html

LED Distributor:http://www.suvsystem.com/l/LED-1.html

Capacitor Distributor:http://www.suvsystem.com/l/Capacitor-1.html

Transistor Distributor:http://www.suvsystem.com/l/Transistors-1.html

Resistor Distributor:http://www.suvsystem.com/l/Resistors-1.html

Diode Distributor:http://www.suvsystem.com/l/Diodes-1.html

SUV System Ltd insists on the managing faith ofsincereness,speciality,foresight, win-win,so we build up stable-relationship customers located all over the world, including the States, Europe, Argentina, UAE, Malaysia, Australia,and India etc

we are focus on the following fields,and hope we can help you.

CPF1206B4R87E1 CPF1206B4R7E1 CPF1206B4R75E1 CPF1206B4K99E1 CPF1206B4K87E1 CPF1206B4K7E1 CPF1206B4K7E CPF1206B4K75E1 CPF1206B4K64E1 CPF1206B4K53E1 CPF1206B4K42E1 CPF1206B4K3E1 CPF1206B4K32E1 CPF1206B4K22E1 CPF1206B4K12E1 CPF1206B4K02E1 CPF1206B49R9E1 CPF1206B60R4E1 CPF1206B60K4E1 CPF1206B604RE1 CPF1206B604KE1 CPF1206B5R9E1 CPF1206B5R76E1 CPF1206B5R6E1 CPF1206B5R62E1 CPF1206B5R49E1 CPF1206B5R36E1 CPF1206B5R23E1 CPF1206B5R1E1 CPF1206B5R11E1 CPF1206B5K9E1 CPF1206B5K76E1 CPF1206B5K6E1 CPF1206B5K62E1 CPF1206B5K49E1 CPF1206B5K36E1 CPF1206B5K23E1 CPF1206B5K1E1 CPF1206B5K11E1 CPF1206B59RE1
http://www.suvsystem.com/a/2693.aspx