- Obama’s regulatory agenda will cost U.S. economy $143B next year: report
- Patriot Act author on James Clapper: Fire, prosecute him
- Russia P.M. Medvedev: No amnesty for political prisoners
- Michigan GOP Senate hopeful reminds government is the ‘servant’
- Christmas, by Congress: Members mull a 15-cent tax on trees
- U.S. unemployment falls to five-year low of 7 percent; 203K jobs added
- World mourns Nelson Mandela and celebrates his life; burial set for Dec. 15
- Bill O’Reilly reminds: Nelson Mandela ‘was a communist’
- John Boehner says GOP should support gay candidates: ‘I do’
- Grass-Whopper: Pan-fried cricket burgers go over big in New York City
Public lacks faith in FDA
The Food and Drug Administration gets a failing grade from the American public.
Half of respondents in a national survey rate the agency’s performance as poor, according to a report by the American University’s Center for Congressional and Presidential Studies.
“At a time when Congress is reviewing and debating legislation to strengthen the safety of prescription medicines and overhaul the FDA, this survey validates that drug safety is a real concern for the American public,” said James Thurber, the center’s director.
But Congress this week moved to beef up the FDA’s authority and ability to make our drugs safer. Almost three years ago to the day Vioxx was pulled off the market, House and Senate lawmakers agreed on a compromise drug safety bill that will increase the amount of money pharmaceutical companies pay the FDA to determine a drug’s safety and eventually give it the green light for consumer consumption.
Fees paid by drug manufactures to the FDA would increase to nearly $420 million for the next fiscal year, up from at least $305 million in the current year.
The House passed the bill on Wednesday, and the Senate passed it last night by voice vote.
Following the agency’s handling of Vioxx, the Merck & Co. painkiller withdrawn in 2004 after being linked to heart attacks and strokes, and Avandia, GlaxoSmithKline PLC’s diabetes pill linked in some studies to a risk of heart attacks, the legislation is a major step forward.
It has been said that the FDA focuses too heavily on data gathered during clinical trials, before the drug enters the market. The legislation addresses that concern by forcing the agency to more closely monitor side effects of drugs after they have been approved.
And, under current law, the agency can only request that drug makers conduct added studies after drugs are sold. The bill gives the FDA authority to require drug companies to rewrite drug labels warning doctors of new safety problems, to conduct new studies of drugs already on the market and limit distribution if needed.
“Congress is about to give the president legislation that should end the secrecy and foot-dragging when it comes to letting consumers know about unsafe medicines,” said Jim Guest, president of Consumers Union.
The legislation also requires the FDA to use databases to find side effects that occur after medications are on the market. In addition, results of clinical trials would have to be disclosed, which supporters of the legislation said would make it harder for drug makers to withhold results that show dangers.
“One of the biggest consumer victories in this legislation is that it will be harder for drug companies to fudge the results of their clinical trials,” said Bill Vaughn, a policy analyst with Consumers Union.
The powerful pharmaceutical lobby, known as the Pharmaceutical Research and Manufacturers Association, also praised the passage of the legislation.
“The legislation will enable FDA to hire additional employees to review broadcast advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated,” said PhRMA President Billy Tauzin.
c Health Care runs on Fridays. Contact Gregory Lopes at 202/636-4892 or email@example.com.
- Spike in battlefield deaths linked to restrictive rules of engagement
- Activists urge Obama to go rogue, sidestep Congress
- Bill OReilly reminds: Nelson Mandela was a communist
- PRUDEN: British press horrified as London's new mayor dares to proclaim the truth
- MILLER: Obamacare enrollees include 101 members of the House of Representatives
- Obama administration issues permits for wind farms to kill more eagles
- Inside China: Nuclear submarines capable of widespread attack on U.S.
- U.S. pilot scares off Iranians with 'Top Gun'-worthy stunt: 'You really ought to go home'
- Obama downplays IRS scandal, blames Obamacare rollout on 'outdated' agencies
- 'Hunger Games' delivers Obama's message on income inequality
Independent voices from the The Washington Times Communities
For moms, dads, kids, tech heads, travelers, kitchen mavens and everyone else on your holiday gift list
A politically conservative and morally liberal Hebrew alpha male hunts left-wing viper
This column will cover anything that has anything remotely to do with the game of baseball, from the game itself to mid-summer trades to offseason moves.
Entertainment News and Reviews from Washington, D.C. and beyond.
White House pets gone wild!