From Kaiser Daily Health Policy Report for 7.30.08--CAPITOL HILL WATCH--Grassley, Dingell Call for Overhaul of FDA, Say Agency Should Be Able To Levy Fines, Order Recalls, Limit Drug Industry Advertising

[Guest guest]

I thought this might be of interest to some or all in this group; particularly

those of you involved in and with the FTC Petition and other petition projects.

This is very important legislation. Let's give these individuals our support by

any and all means possible.~~Ruth/REU

=======================

CAPITOL HILL WATCH

1. Grassley, Dingell Call for Overhaul of FDA, Say Agency Should Be Able To

Levy Fines, Order Recalls, Limit Drug Industry Advertising

Sen. Chuck Grassley (R-Iowa) and Rep. Dingell (D-Mich.) have led an

effort to restructure FDA by " giving it broad powers to levy fines, order drug

recalls and restrict drug industry advertising, " and a " series of crises during

the past year ... have given ammunition to the lawmakers, both longtime critics "

of the agency, the Wall Street Journal reports. According to the Journal,

Congress likely will not " enact major changes to the agency this year because it

has only a brief fall session before the November elections, " but " 2009 may

bring the most significant overhaul at the FDA in a generation. "

Grassley and Dingell have said that FDA should have the authority to recall

medications and impose significant fines on pharmaceutical companies for safety

violations. In addition, they have said that FDA should inspect the

manufacturing facilities of generic pharmaceutical companies before they approve

their products. They also have said that the next president should appoint an

FDA commissioner who is independent of the industries regulated by the agency.

" To lay the groundwork for their FDA overhaul, " Grassley, Dingell and their

supporters have ordered about 20 investigations of medications and issues

related to the agency and have " directed their frustration " at FDA Commissioner

von Eschenbach, who has held the position since 2006, the Journal

reports.

Dingell said, " There's a total inability of the FDA to carry out its mission. "

According to Grassley, FDA officials " are too cozy with the companies they

regulate, " and new leadership must " fix the culture " at the agency.

Response

Von Eschenbach maintains that FDA officials are independent of the industries

regulated by the agency and have sought to improve agency response to possible

medication safety issues.

Meanwhile, the " pharmaceutical industry is digging in against changes it

believes would make it harder to bring innovative drugs to market, " such as

increased regulation of prescription drug advertising, but " drug companies can't

afford to appear too aggressive in protecting sales or deflecting stronger

safety standards because that might backfire and prompt embarrassing hearings in

Congress, " according to the Journal. Tauzin, president and CEO of the

Pharmaceutical Research and Manufacturers of America, said, " It's an

accumulation of things some companies did over the years. Now it's death by a

thousand cuts, " adding, " We gotta stop the bleeding " (Mundy, Wall Street

Journal, 7/30).

[Guest guest]

I thought this might be of interest to some or all in this group; particularly

those of you involved in and with the FTC Petition and other petition projects.

This is very important legislation. Let's give these individuals our support by

any and all means possible.~~Ruth/REU

=======================

CAPITOL HILL WATCH

1. Grassley, Dingell Call for Overhaul of FDA, Say Agency Should Be Able To

Levy Fines, Order Recalls, Limit Drug Industry Advertising

Sen. Chuck Grassley (R-Iowa) and Rep. Dingell (D-Mich.) have led an

effort to restructure FDA by " giving it broad powers to levy fines, order drug

recalls and restrict drug industry advertising, " and a " series of crises during

the past year ... have given ammunition to the lawmakers, both longtime critics "

of the agency, the Wall Street Journal reports. According to the Journal,

Congress likely will not " enact major changes to the agency this year because it

has only a brief fall session before the November elections, " but " 2009 may

bring the most significant overhaul at the FDA in a generation. "

Grassley and Dingell have said that FDA should have the authority to recall

medications and impose significant fines on pharmaceutical companies for safety

violations. In addition, they have said that FDA should inspect the

manufacturing facilities of generic pharmaceutical companies before they approve

their products. They also have said that the next president should appoint an

FDA commissioner who is independent of the industries regulated by the agency.

" To lay the groundwork for their FDA overhaul, " Grassley, Dingell and their

supporters have ordered about 20 investigations of medications and issues

related to the agency and have " directed their frustration " at FDA Commissioner

von Eschenbach, who has held the position since 2006, the Journal

reports.

Dingell said, " There's a total inability of the FDA to carry out its mission. "

According to Grassley, FDA officials " are too cozy with the companies they

regulate, " and new leadership must " fix the culture " at the agency.

Response

Von Eschenbach maintains that FDA officials are independent of the industries

regulated by the agency and have sought to improve agency response to possible

medication safety issues.

Meanwhile, the " pharmaceutical industry is digging in against changes it

believes would make it harder to bring innovative drugs to market, " such as

increased regulation of prescription drug advertising, but " drug companies can't

afford to appear too aggressive in protecting sales or deflecting stronger

safety standards because that might backfire and prompt embarrassing hearings in

Congress, " according to the Journal. Tauzin, president and CEO of the

Pharmaceutical Research and Manufacturers of America, said, " It's an

accumulation of things some companies did over the years. Now it's death by a

thousand cuts, " adding, " We gotta stop the bleeding " (Mundy, Wall Street

Journal, 7/30).

[Guest guest]

I thought this might be of interest to some or all in this group; particularly

those of you involved in and with the FTC Petition and other petition projects.

This is very important legislation. Let's give these individuals our support by

any and all means possible.~~Ruth/REU

=======================

CAPITOL HILL WATCH

1. Grassley, Dingell Call for Overhaul of FDA, Say Agency Should Be Able To

Levy Fines, Order Recalls, Limit Drug Industry Advertising

Sen. Chuck Grassley (R-Iowa) and Rep. Dingell (D-Mich.) have led an

effort to restructure FDA by " giving it broad powers to levy fines, order drug

recalls and restrict drug industry advertising, " and a " series of crises during

the past year ... have given ammunition to the lawmakers, both longtime critics "

of the agency, the Wall Street Journal reports. According to the Journal,

Congress likely will not " enact major changes to the agency this year because it

has only a brief fall session before the November elections, " but " 2009 may

bring the most significant overhaul at the FDA in a generation. "

Grassley and Dingell have said that FDA should have the authority to recall

medications and impose significant fines on pharmaceutical companies for safety

violations. In addition, they have said that FDA should inspect the

manufacturing facilities of generic pharmaceutical companies before they approve

their products. They also have said that the next president should appoint an

FDA commissioner who is independent of the industries regulated by the agency.

" To lay the groundwork for their FDA overhaul, " Grassley, Dingell and their

supporters have ordered about 20 investigations of medications and issues

related to the agency and have " directed their frustration " at FDA Commissioner

von Eschenbach, who has held the position since 2006, the Journal

reports.

Dingell said, " There's a total inability of the FDA to carry out its mission. "

According to Grassley, FDA officials " are too cozy with the companies they

regulate, " and new leadership must " fix the culture " at the agency.

Response

Von Eschenbach maintains that FDA officials are independent of the industries

regulated by the agency and have sought to improve agency response to possible

medication safety issues.

Meanwhile, the " pharmaceutical industry is digging in against changes it

believes would make it harder to bring innovative drugs to market, " such as

increased regulation of prescription drug advertising, but " drug companies can't

afford to appear too aggressive in protecting sales or deflecting stronger

safety standards because that might backfire and prompt embarrassing hearings in

Congress, " according to the Journal. Tauzin, president and CEO of the

Pharmaceutical Research and Manufacturers of America, said, " It's an

accumulation of things some companies did over the years. Now it's death by a

thousand cuts, " adding, " We gotta stop the bleeding " (Mundy, Wall Street

Journal, 7/30).

[Guest guest]

I thought this might be of interest to some or all in this group; particularly

those of you involved in and with the FTC Petition and other petition projects.

This is very important legislation. Let's give these individuals our support by

any and all means possible.~~Ruth/REU

=======================

CAPITOL HILL WATCH

1. Grassley, Dingell Call for Overhaul of FDA, Say Agency Should Be Able To

Levy Fines, Order Recalls, Limit Drug Industry Advertising

Sen. Chuck Grassley (R-Iowa) and Rep. Dingell (D-Mich.) have led an

effort to restructure FDA by " giving it broad powers to levy fines, order drug

recalls and restrict drug industry advertising, " and a " series of crises during

the past year ... have given ammunition to the lawmakers, both longtime critics "

of the agency, the Wall Street Journal reports. According to the Journal,

Congress likely will not " enact major changes to the agency this year because it

has only a brief fall session before the November elections, " but " 2009 may

bring the most significant overhaul at the FDA in a generation. "

Grassley and Dingell have said that FDA should have the authority to recall

medications and impose significant fines on pharmaceutical companies for safety

violations. In addition, they have said that FDA should inspect the

manufacturing facilities of generic pharmaceutical companies before they approve

their products. They also have said that the next president should appoint an

FDA commissioner who is independent of the industries regulated by the agency.

" To lay the groundwork for their FDA overhaul, " Grassley, Dingell and their

supporters have ordered about 20 investigations of medications and issues

related to the agency and have " directed their frustration " at FDA Commissioner

von Eschenbach, who has held the position since 2006, the Journal

reports.

Dingell said, " There's a total inability of the FDA to carry out its mission. "

According to Grassley, FDA officials " are too cozy with the companies they

regulate, " and new leadership must " fix the culture " at the agency.

Response

Von Eschenbach maintains that FDA officials are independent of the industries

regulated by the agency and have sought to improve agency response to possible

medication safety issues.

Meanwhile, the " pharmaceutical industry is digging in against changes it

believes would make it harder to bring innovative drugs to market, " such as

increased regulation of prescription drug advertising, but " drug companies can't

afford to appear too aggressive in protecting sales or deflecting stronger

safety standards because that might backfire and prompt embarrassing hearings in

Congress, " according to the Journal. Tauzin, president and CEO of the

Pharmaceutical Research and Manufacturers of America, said, " It's an

accumulation of things some companies did over the years. Now it's death by a

thousand cuts, " adding, " We gotta stop the bleeding " (Mundy, Wall Street

Journal, 7/30).