From Deseret News archives:
Medicine monitoring gets boost in Senate
The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug not just the years before its approval as well as the experience of patients who later take it.
Under the bill, the government would establish a surveillance system to track the adverse effects of prescription drugs. Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.
In passing the measure by a 93-1 vote, the Senate sent a clear signal that it wanted stronger action by the agency to protect public health. Senators said the bill responded to a widespread loss of confidence in the ability of the agency to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004.
The bill, which would carry out many recommendations from the National Academy of Sciences, is likely to become law. It appears broadly acceptable to the House, which is working on its own version of the bill, and is unlikely to be vetoed by President Bush.
The bill is widely seen as "must-pass" legislation because it renews authority for the government to collect fees from drug companies to speed reviews of their products. Without action by Congress, the authority expires on Sept. 30.
Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, the main trade group for manufacturers of brand name drugs, applauded the passage, of the bill, saying it "will preserve and even strengthen the FDA's ability to do its job."
Drug companies would be required to do follow-up studies on certain medicines or risk fines. The FDA could require label changes for drugs.
An active surveillance program would replace the largely passive way the FDA now learns of potential problems with drugs on the market. It calls for the mining of federal and private databases that log side effects in tens of thousands of patients.
Comments
- Tiger opens with a 66 in Australia 1:18 a.m.
- Crash kills Utah County man 1:12 a.m.
- UCAT cheaper education option 1:12 a.m.
- Post office to be named for Rex Lee 1:11 a.m.
- Police probe synagogue vandalism 1:09 a.m.
- New charges added in fraud case 1:09 a.m.
- Mom takes plea deal in girl's beating 1:08 a.m.
- Drug trafficking operation busted 1:07 a.m.
- News yule writing contest starting up 12:59 a.m.
- Alpine District school honored 12:59 a.m.
- SLC council OKs gay rights policies
- 'Love story' of crash victim ends
- BYU football recruit turning heads
- Utah Jazz have a problem at point
- Alta's Ohai is Ms. Soccer 2009
- Prep football: Felt's Facts Week
- 12 Utes return to Texas
- Long days for BYU interns
- Cougars' defensive hoops clinic
- Civilians help S.L. officer make arrest
- House passes health care bill
287 - SLC council OKs gay rights policies
246 - TCU showdown has big implications
193 - Senators want food tax restored
157 - Cougars crush hapless Cowboys
155 - Utah Jazz fall apart against Kings
131 - TCU 4th in AP poll; U. 16th, Y. 22nd
119 - S.L. vote pending on gay protections
109 - Pratt pleads not guilty to sex charges
101 - Letters: Strange breed in Utah
92
Maybe someone out there can help me understand how raising the state...
Religious freedom is a "special protection" enshrined in the U.S....
But there's one major flaw in your thinking. Since ALL of Beck's,...
Why quote Boozer when he is a huge part of the problem. The problem will not...
What a great segment. I enjoy reading this very much. Thanks!!
Beck, Hannity, and Limbaugh get the audience they deserve and vice versa. ...
I find the rule,very discriminitory. I am not gay, I don't understand what...
I understand we were outmanned last night. However, this effort was awful....
My advice to Jonathan is shoot it when they pass it to you as soon as you...
Maybe they should try drafting a shooting guard who can shoot from outside ....
The sad thing about it is that there are actually people out there that are...


You can be the first to comment on this story.